Amnio‑Ring™ — Product Information 

Dehydrated Human Amniotic Membrane Ring Allograft
Regulated as a 361 HCT/P under 21 CFR 1271.10

1. Product Overview

Amnio‑Ring™ is a single‑use, devitalized, dehydrated human amniotic membrane allograft engineered in a ring‑shaped configuration to provide circumferential protection, structural support, and epithelial healing assistance for ocular surface procedures.

The controlled dehydration process preserves the native extracellular matrix (ECM)—including collagen, laminin, fibronectin, and proteoglycans—while eliminating cellular viability. This ensures room‑temperature stability, aseptic handling, and immediate clinical readiness.

Key attributes

• Ring‑shaped AM allograft for targeted ocular surface applications
• Devitalized, dehydrated, aseptically processed
• Terminal gamma sterilized to SAL 10⁻⁶
• Ambient storage (no cold chain)
• Fully compliant with 21 CFR 1271 and Section 361 of the PHS Act

2. Intended Use & Homologous Function

Intended Use

Amnio‑Ring™ is intended to serve as a temporary protective covering and structural scaffold for the ocular surface in clinical situations where circumferential epithelial support is required.
Typical applications include:

• Post‑surgical epithelial protection
• Limbal or peri‑limbal epithelial defects
• Conjunctival reconstruction
• Pterygium excision support
• Ocular surface stabilization during healing

Homologous Use Rationale

The amniotic membrane naturally functions as a protective, structural tissue layer that:

• Shields underlying tissues
• Maintains a moist microenvironment
• Supports epithelial repair

Amnio‑Ring™ performs the same basic protective and structural function at the ocular surface, satisfying the FDA’s homologous use requirement under 21 CFR 1271.3(c).

This homologous function is essential for qualification as a 361 HCT/P.

3. Product Description & Specifications

Composition

Amnio‑Ring™ is derived from full‑term, live‑birth placental tissue from consenting donors.
Processing preserves:

• Basement membrane
• Stromal ECM
• Structural proteins
• Native laminar architecture

The ring configuration allows precise placement around limbal or peri‑limbal zones without trimming.

Sterility

• Gamma irradiation to SAL 10⁻⁶
• Single‑use sterile packaging
• Aseptic processing throughout manufacturing

Storage

• Room‑temperature stable
• No refrigeration or freezing required
• Shelf‑stable in sealed sterile pouch

4. Minimal Manipulation — 21 CFR 1271.10(a)(1)

Amnio‑Ring™ meets the FDA definition of minimal manipulation for structural tissue because:

• Dehydration does not alter the original relevant characteristics of the amniotic membrane
• ECM architecture, mechanical properties, and biological matrix remain intact
• No chemical cross‑linking or exogenous additives are used
• No drugs, biologics, or device components are combined

The ring shape is achieved without altering the tissue’s structural utility, preserving its natural protective function.

5. Mechanism of Action

A. Physical Barrier

Provides a durable protective covering that shields compromised epithelium from mechanical irritation and environmental exposure.

B. Structural Scaffold

The preserved ECM supports:

• Epithelial migration
• Adhesion
• Proliferation

C. Moist Microenvironment

Maintains hydration essential for epithelial wound closure.

D. Circumferential Support

The ring geometry stabilizes the peri‑limbal region and supports uniform epithelial regeneration.

6. Donor Eligibility & Safety Standards

All tissue is recovered from healthy, consenting donors following full‑term live births.
Eligibility determination includes:

• Medical & behavioral risk assessment
• Physical examination
• Infectious disease testing per 21 CFR 1271 Subpart C
• Medical Director–supervised review
• Full donor‑to‑recipient traceability

Manufacturing complies with:

• CGTP (Current Good Tissue Practice)
• CGMP (Good Manufacturing Practice)

7. Clinical Handling & Application

Ready‑to‑Use Format

• No hydration required (optional brief hydration for pliability)
• Apply directly to ocular surface
• Conforms naturally to tissue contours

Placement

• Position the ring around the limbal or peri‑limbal zone
• Ensure full circumferential contact
• A bandage contact lens may be applied at surgeon discretion

Stability

• Maintains position during blinking and tear film movement
• Supports epithelial healing during the active recovery phase

8. Regulatory Classification — Section 361 HCT/P

Amnio‑Ring™ satisfies all criteria under 21 CFR 1271.10(a):

1. Minimally manipulated
2. Homologous use
3. Not combined with non‑permitted articles
4. No living cells
5. Local action only
6. Donor eligibility & CGTP compliance

Therefore, Amnio‑Ring™ is regulated solely under Section 361 of the PHS Act, with no requirement for FDA premarket approval or 510(k).

9. Procurement Summary

Operational Advantages

• Ambient storage
• Long shelf life
• No cold chain
• Single‑use sterile packaging
• Simplified regulatory documentation

Clinical Advantages

• Ring geometry for precise placement
• Supports uniform epithelial healing
• Compatible with standard ocular surface procedures

Institutional Benefits

• Predictable usage in cornea and ocular surface units
• Reduced storage cost
• Streamlined inventory management

10. Manufacturer

Akriti Ophthalmic Pvt. Ltd.
Medical Devices Park, Sultanpur Village
Patancheru Mandal, Hyderabad – 502319
Telangana, India
www.akritiophthalmic.com