AMNIOLENS by BIO-TISSUE, INC. | FDA 510(k) Summary

The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.

The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.

Device Description

The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure on adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.

AI/ML Overview

The provided text describes the ProKera™ device and its 510(k) submission, focusing on performance data related to its physical integrity and the amniotic membrane attachment, rather than clinical performance for diagnostic or treatment effectiveness. Therefore, many standard metrics for AI/ML performance (e.g., sensitivity, specificity, AUC) and associated study details (e.g., ground truth establishment, MRMC studies) are not applicable to this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section has been adapted as the 510(k) summary focuses on physical performance and integrity rather than diagnostic accuracy.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Integrity (Amniotic Membrane Attachment)
- Conformer holds amniotic membrane firmly.	- Tested by dropping stainless steel balls (12.138 g or 16.567 g) onto the attached membrane.
- Device does not pose a risk of coming loose.	- (Implicitly met by successful drop tests, though specific passing criteria are not detailed).
Cryopreservation Stability
- Cryopreservation does not negatively affect rings.	- Conformer ring placed in -80°C for up to three weeks.
- Cryopreservation does not negatively affect amniotic membrane.	- (Implicitly met through cryopreservation testing, though specific membrane integrity tests are not detailed beyond "no negative effects").
- No change in fastening strength after cryopreservation.	- Tested after -80°C storage for up to three weeks, showing "no change in the fastening strength."
- No change in integrity of skirt or inner ring after cryopreservation.	- Tested after -80°C storage for up to three weeks, showing "no change in... the integrity of the skirt or the inner ring."
- No cracks or chipping after cryopreservation.	- Microscopic evaluation revealed "no cracks or chipping" after -80°C storage for up to three weeks.
Regulatory Compliance (Implicit)
- Conforms to human tissue processing regulations.	- Conforms to 21 C.F.R. § 1270 and 1271 (human tissue processing).
- Conforms to AATB standards.	- Conforms to the standards of the American Association of Tissue Banks (AATB).
- Conforms to sterility and bioburden standards.	- Conforms to ISO 11737.1, EN 11743-3, USP XXV <1227> (Validation of Microbial Recovery), USP XXIV <61> (Microbial Limits), USP XXIV <71> (Sterility Tests), and PDA Technical Report No. 21 (Bioburden Recovery Validation).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the mechanical integrity and cryopreservation tests (e.g., how many devices were tested). The provenance of the data (country of origin, retrospective/prospective) is also not mentioned; however, the testing appears to be laboratory-based physical performance testing rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device submission. The "ground truth" here relates to the physical and material properties of the device (e.g., strength of attachment, integrity after freezing), which are determined by engineering and material science testing, not expert clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical interpretations of diagnostic images or data where human consensus is needed. For physical performance testing, the results are typically quantitative measurements or direct observations (e.g., visible cracks).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a physical medical device like the ProKera™ ophthalmic conformer.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims would be the objective results of the physical and material property tests. For example:

Mechanical Integrity: Measured force required to dislodge the membrane or the outcome of drop tests (e.g., membrane remained attached, no damage).
Cryopreservation Stability: Quantitative measurements of fastening strength before and after freezing, and qualitative/microscopic observations for cracks or chipping.
Sterility/Bioburden: Laboratory results from established microbiological testing protocols.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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510(k) SUMMARY ProKera™ Bio-Tissue, Inc.

This 510(k) summary of safety and effectiveness for the ProKera™ is submitted in accordance with the requirements of the SMDA and follows Office of Device In accordance with the requirement of a station and content of a 510(k) summary.

Applicant:	Bio-Tissue, Inc.
Address:	7000 SW 97 AvenueSuite 211Miami, FL 33173
Contact Person:	David J. BlochRegulatory Counsel
Telephone:	(202) 414-9209 (telephone)(202) 414-9209 (fax)
Preparation Date:	July 2, 2003
Device Trade Name:	ProKera™
Common Name:	Ophthalmic Conformer, with Amniotic Membrane
Classification Name:	Ophthalmic Conformer, 21 CFR §886.3130
Product Code:	NQB
Predicate Device:	Symblepharon Ring, 510(k) # K921221
Device Description:	The ProKera™ is a corneal-epithelial insert, consisting of anophthalmic conformer that incorporates amniotic membrane.The device is intended for use in eyes in which the ocularsurface cells have been damaged, or underlying stroma isinflamed and scarred.The device is inserted between the eyeball and the eyelid tomaintain space in the orbital cavity and to prevent closure onadhesions. Insertion of the conformer also enablesapplication of the amniotic membrane to the ocular surfacewithout the need for sutures.

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Performance Data:	Bio-Tissue has performed testing to confirm that theconformers hold the amniotic membrane in place firmly, andthat the device does not pose a risk of coming loose. Thestrength of the fastening of amniotic membrane by these tworings was tested by dropping stainless steel balls weighingeither 12.138 g or 16.567 g onto the attached membrane.
	In addition, because the amniotic membrane is preservedthrough cryopreservation prior to use, the ProKera™ wouldbe stored at freezing temperatures once the membrane is inplace. Bio-Tissue has performed testing to confirm thatcryopreservation does not negatively affect the rings or theamniotic membrane. The conformer ring was placed in the –80°C temperatures at which the membrane is stored for upto three weeks, and has shown no change in the fasteningstrength or in the integrity of the skirt or the inner ring.Microscopic evaluation has revealed no cracks or chipping.
Statement ofConformance:	Bio-Tissue conforms to the requirements of 21 C.F.R. §1270 and 1271 for establishments that process humantissue, as well as the standards of the American Associationof Tissue Banks (AATB), ISO 11737.1 and EN 11743-3, theUnited States Pharmacopeia standards USP XXV <1227>Validation of Microbial Recovery from PharmacopeialArticles, USP XXIV <61> Microbial Limits Tests, USP XXIV<71> Sterility Tests, and PDA Technical Report No. 21,Bioburden Recovery Validation.
CONCLUSIONS:	Based on the foregoing and other information in thisapplication, Bio-Tissue, Inc. believes that the ProKera™ issubstantially equivalent to its claimed predicates underconditions of intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Bio-Tissue Inc., c/o David J. Bloch 1301 K Street, N.W. Suite 1100 - East Tower Washington, D.C. 20005

Re: K032104

Trade/Device Name: ProKera™ Ophthalmic Conformer Regulation Number: 21 CFR 886.3130 Regulation Name: Ophthalmic Conformer Regulatory Class: Class II Product Code: NQB Dated: November 10, 2003 Received: November 15/2003

Dear Mr. Bloch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Alegi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K032104

Device Name: ProKera™

Indications For Use:

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K032104

Regulation Number and Section

§ 886.3130 Ophthalmic conformer.

(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.