BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Device Description

BioMend Extend™ Absorbable Collagen Membrane is a white, compressed, non-friable matrix fabricated from collagen derived from bovine deep flexor (Achilles) tendon. Bovine tendon is known to be one of the purest sources of Type I Collagen that can be readily obtained and processed in commercial amounts. BioMend Extend is completely absorbable, eliminating the need for the second surgical procedure often required to remove a non-resorbable membrane. The collagen is currently used for general and dental surgery as absorbable hemostatic agents and absorbable wound dressings.

Under scanning electron microscopy, BioMend Extend™ has a morphology of condensed laminated sheets in cross-section and a textured surface. BioMend Extend" appears paperwhite in the dry state and translucent and non-slippery when wet. BioMend Extend" can be cut to any size or shape in the wet or dry state, without tearing or fragmenting.

BioMend Extend™ has an effective pore size of 0.004 microns, which will effectively retard epithelial downgrowth during early phases of healing. Being semi-occlusive, it allows essential nutrients to pass through the membrane. BioMend Extend™ incorporates into the surrounding tissue and is completely absorbed within 18 weeks.

BioMend Extend™ is sterilized by ethylene oxide gas.

AI/ML Overview

The provided text describes a medical device, BioMend Extend™ Absorbable Collagen Membrane, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of a study demonstrating the device meets performance criteria. The document is a 510(k) submission for device clearance, focusing on safety and equivalence rather than a performance study with specific metrics.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states "BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device." Substantial equivalence is the primary acceptance criterion for a 510(k) submission, meaning the modified device is as safe and effective as a legally marketed predicate device. Specific performance metrics for a new study are not detailed as the claim is based on equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. No specific test set or clinical study data is described to assess performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to a predicate device and biocompatibility testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No experts were involved in establishing a ground truth for a test set for performance evaluation as no such study is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is mentioned as there is no test set or performance study described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This is not an AI device, and no MRMC study or comparative effectiveness study is described. The device is an absorbable collagen membrane for guided tissue regeneration.

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

Cannot be provided. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. No specific ground truth for performance evaluation is mentioned. The ground for the submission is the substantial equivalence to the predicate device, BioMend® Absorbable Collagen Membrane, which was previously cleared.

8. The sample size for the training set

Cannot be provided. No training set is applicable or mentioned for this device submission.

9. How the ground truth for the training set was established

Cannot be provided. No training set is applicable or mentioned.

Information that can be extracted relevant to acceptance criteria and safety:

The document focuses on demonstrating the BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the predicate device, BioMend® Absorbable Collagen Membrane (K924408).

The acceptance criteria for this 510(k) submission are implied by the demonstration of:

Identical Intended Use: "Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus."
Similar Technological Characteristics:
- Same basic design
- Same operating principle (Cell occlusive, implantable, resorbable, hemostatic, effective pore size 0.004 microns)
- Same materials (Type I Collagen from bovine deep flexor tendon)
- Same sterilization process (ETO)
- Biocompatible
- Non-pyrogenic
- Same shelf life (24 months)
- Same product sizes (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm)
Safety (Biocompatibility): The device must be non-cytotoxic, non-pyrogenic, non-irritating, and non-sensitizing.

Reported Device Performance / Evidence for Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which presents a comparison to a predicate device and biocompatibility testing. No clinical performance study with specific outcome measures, patient cohorts, or statistical analyses are presented in this document for the modified device.

The document indicates:

Comparison of technological characteristics in Table 1 shows direct correspondence for all listed features between BioMend Extend™ and BioMend® Absorbable Collagen Membrane.
Safety studies (biocompatibility) were conducted, demonstrating the new device is:
- Noncytotoxic
- Nonpyrogenic
- Nonirritating
- Nonsensitizing
- The manufacturing process complies with FDA and European Standards for animal tissue sourcing and viral inactivation.

The conclusion is that "BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device." This implies that the performance is expected to be equivalent to the predicate device.

Summary

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Integra LifeSciences Corporation Special 510(k): Device Modification BioMend Extend™ Absorbable Collagen Membrane

Kaqazale

BioMend Extend™ Absorbable Collagen Membrane SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's name and address:

Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, NJ 08536

Contact person and telephone number:

Judith E. O'Grady Senior Vice President, Regulatory Affairs, Quality Assurance and Clinical Research (609) 275-0500

Date Summary was prepared:

June 30, 1999

Name of the device:

Proprietary Name:	BioMend Extend™ Absorbable Collagen Membrane
Common Name:	Resorbable Periodontal Barrier
Classification Name:	Bone Filling Augmentation Material, Product Code LYC

Substantial Equivalence:

BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent in function and intended use to the product, BioMend™ Absorbable Collagen Membrane which has been cleared to market under Premarket Notification 510(k) K924408.

Device Description:

BioMend Extend™ is sterilized by ethylene oxide gas.

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Statement of the intended use:

Comparison of technological characteristics to predicate devices:

A table comparing characteristics of BioMend Extend™ Absorbable Collagen Membrane and the predicate device is provided in Table 1.

	BioMend Extend™ AbsorbableCollagen Membrane	BioMend® AbsorbableCollagen Membrane
Intended Use	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.
Incorporates Same BasicDesign	Yes	Yes
Utilizes the same operatingprinciple	Cell occlusive (effectivepore size 0.004 microns)ImplantableResorbableHemostatic	Cell occlusive (effectivepore size 0.004 microns)ImplantableResorbableHemostatic
Incorporates same materials?	Yes, Type I Collagen	Yes, Type I Collagen
Sterilization Process	ETO	ETO
Biocompatible	Yes	Yes
Non-pyrogenic	Yes	Yes
Shelf Life	24 months	24 months
Product Size	15 mm x 20 mm20 mm x 30 mm30 mm x 40 mm	15 mm x 20 mm20 mm x 30 mm30 mm x 40 mm

Table I: BioMend Extend™ Absorbable Collagen Membrane and Predicate, BioMend® Absorbable Collagen Membrane Comparison Chart

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Safety

Biocompatibility studies have demonstrated BioMend Extend™ Absorbable Collage Membrane to be: noncytotoxic, nonpyrogenic, nonirritating, and nonsensitizing. The following studies were conducted:

Cytotoxicity a)
b) Dermal Sensitization /Irritation
ISO Acute Intracutaneous Reactivity c)
d) Acute Systemic Toxicity
e) Genotoxicity
Implantation/ Absorption f)
Sub-Chronic Toxicity g)
h) Muscular Implantation
Hemolysis i)

The BioMend Extend™ Absorbable Collagen Membrane manufacturing process complies with the United States Food and Drug Administration and European Standards for animal tissue sourcing and viral inactivation.

Conclusion

BioMend Extend™ Absorbable Collagen Membrane is substantially equivalent to the unmodified device, BioMend® Absorbable Collagen Membrane. The modifications do not affect the intended use or fundamental scientific technology of the device.

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The logo is a stylized image of three human figures, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Judith E. O'Grady, RN, MSN Senior Vice President Requlatory Affairs, Quality Assurance and Clinical Research Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, New Jersey 08536

Re : K992216 BioMed® Extend™ Absorbable Collagen Trade Name: Membrane Unclassified Requlatory Class: Product Code: LYC Dated: June 30, 1999 Received: July 1, 1999

Dear Ms. O'Grady:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. O'Grady

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ens robet notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: BioMend Extend™ Absorbable Collagen Membrane

Indications for Use:

BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is Dioinend Exema - 110001 views - Somiga procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	Or	Over-the-Counter Use ______
(Per 21 CFR 801.109

Optional Format 1-2-96)

	Susan Runne (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices "(k) Number 1990216
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Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.