The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Description

The Geistlich Nexo-Gide™ device, manufactured by Geistlich Pharma AG, is a resorbable collagen membrane of porcine origin, consisting of a compact smooth structure and of a porous structure that serves as an interface between the tendon and the surrounding tissues. Nexo-Gide™ Bilayer Collagen Membrane will be used as a tendon protector sheet that provides a nonconstricting, protective encasement for injured tendon, in the same manner as other tendon cover products like the predicate device TenoGlide (K053655, Integra Life Science).

The Nexo-Gide membrane is made of collagen type I and III without further cross-linking or chemical additives and is sterilized by gamma irradiation. The available sizes are 20x30mm, 30x40mm and 40x50 mm.

AI/ML Overview

The provided text describes a medical device called Nexo-Gide™ Bilayer Collagen Membrane and its substantial equivalence determination to a predicate device, Tendon Wrap Tendon Protector (TenoGlide). However, the document does not describe a study involving an AI or algorithmic device that requires the detailed acceptance criteria and study information typically associated with such submissions (e.g., sample size, expert ground truth, MRMC study, training set details).

This document is a 510(k) summary for a physical medical device (a collagen membrane), not an AI/algorithm-based diagnostic or assistive device. Therefore, the questions related to AI/algorithm performance metrics, ground truth establishment by experts, MRMC studies, training set sizes, and data provenance in the context of an algorithm are not applicable to this submission.

The "Performance Data" section (Page 8-9) details bench testing and animal studies conducted to demonstrate that the Nexo-Gide membrane is substantially equivalent to its predicate.

Here's an attempt to extract relevant information from the provided text, while acknowledging that many of your questions are not applicable due to the nature of the device:

Device: Nexo-Gide™ Bilayer Collagen Membrane (a physical collagen membrane)

Purpose of Study/Submission: To demonstrate substantial equivalence to a predicate device (Tendon Wrap Tendon Protector) for the management and protection of tendon injuries.

Key Findings: The studies concluded that Nexo-Gide™ is substantially equivalent to the predicate device in terms of safety and effectiveness, despite differences in tissue source (porcine vs. bovine) and composition (Type I and III collagen vs. cross-linked Type I collagen and GAG).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes pre-determined acceptance criteria for various bench tests and animal study outcomes, indicating that the device "passed" or "met all acceptance criteria" and demonstrated "similar performance." Specific numeric acceptance criteria are provided for mechanical properties.

Characteristic	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Nexo-Gide™)
Physical Appearance	Beige collagen membrane	Almost white collagen membrane
Handling	Product is soft and conformable	Product is soft and conformable
Thickness	≥ 0.2 mm	≥ 0.2 mm
Porosity	Pores from 1 – 120 μm	Pores from 1 – 120 μm
Tensile Strength (maximal stress)	≥ 0.06 MPa	≥ 0.06 MPa
Stiffness (elasticity)	< 65 MPa	< 65 MPa
Suture Pull out forces	≥ 0.04 N, allows suturing	≥ 0.04 N, allows suturing
Integrity	Device has proven integrity under simulated physiological conditions	Device has proven integrity under simulated physiological conditions
Biocompatibility	Meets ISO 10993-1 requirements	Assessed according to ISO 10993-1 and confirmed biocompatible. Identical in raw material source, formulation, processing, sterilization, and geometry compared to legally marketed predicates (Bio-Gide K192042 and K050446).
Pyrogen Limits	Not explicitly stated for predicate in table, but implies standard limits	Must not exceed 20.0 USP EU per device (passed)
Chicken Tendon Flexor Model (Safety & Effectiveness)	Similar safety and effectiveness to TenoGlide (control), minimal/no reaction histologically, reduced WOF, non-inferior to predicate in WOF, similar tendon healing and adherence, no adverse events.	Met all acceptance criteria. Demonstrated similar safety and effectiveness, minimal/no reaction, reduced WOF, non-inferiority to predicate, similar tendon healing/adherence, no differentiating adverse events.
Rat Achilles Tendon Study (Degradation & Tissue Effects)	Similar tissue and inflammation responses with minimal or no reaction.	Demonstrated similar performance under conditions of the study, with similar tissue and inflammation responses and minimal/no reaction.

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

Test Set (Animal Study):
- Chicken Tendon Flexor Model: Not explicitly stated, but implies a "control article" (TenoGlide) for comparison. The study used a "chicken flexor tendon repair model."
- Rat Achilles Tendon Study: The study used a "rat achilles tendon study." No specific number of animals is provided.
Data Provenance: The animal studies were conducted to generate performance data for this submission. The origin of the animals (e.g., country) is not specified. They are inherently prospective studies as they were conducted to test the device.

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

Not Applicable: This is a physical device, not an AI/algorithm. Ground truth was established via direct measurement in bench tests and histological/functional assessments in animal models, not through expert human interpretation of images for an algorithm.

4. Adjudication Method for the Test Set

Not Applicable: As above, this is a physical device. Outcomes were assessed objectively through measurements (bench testing) and biological/histological evaluations in animal models. No multi-reader adjudication process is mentioned or relevant.

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

No: This is a physical device, not an AI-assisted diagnostic or workflow tool. Therefore, MRMC studies are not applicable.

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

Not Applicable: This is a physical device. There is no algorithm.

7. The Type of Ground Truth Used

Bench Testing: Quantitative measurements of physical properties (thickness, porosity, tensile strength, stiffness, suture pull-out forces), and qualitative assessment of appearance and integrity.
Animal Studies:
- Chicken Flexor Tendon Model: Histological evaluation of tissue reaction, functional assessment (WOF - presumably "Work Of Flexion" or similar mechanical outcome), assessment of tendon healing and adherence.
- Rat Achilles Tendon Study: Assessment of degradation profile and local tissue effects (inflammation response).

8. The Sample Size for the Training Set

Not Applicable: This is a physical device, not an AI/algorithm-based device that requires a training set.

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

Not Applicable: As above, there is no training set for a physical device.

Summary

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July 14, 2021

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Geistlich Pharma AG % Joshua Crist, MSE Senior Consultant Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria. Virginia 22314

Re: K203496

Trade/Device Name: Nexo-Gide™ Bilayer Collagen Membrane Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OWW Dated: June 14, 2021 Received: June 15, 2021

Dear Joshua Crist:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Laura C. Rose -S

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203496

Device Name Nexo-Gide™ Bilayer Collagen Membrane

Indications for Use (Describe)

The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	---------------------------------------	---------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

SUBMITTER 1.

Submitter:	Geistlich Pharma AGBahnhofstrasse 40CH-6110 WolhusenSwitzerlandPhone: +41 41 492 67 64Fax: +41 41 492 55 40
Contact Person:	Marco SteinerDirector Regulatory AffairsGeistlich Pharma AGPhone: +41 41 492 67 64Marco.Steiner@geistlich.ch
Submission Correspondent:	Joshua CristSenior ConsultantBiologics Consulting Group, Inc.1555 King Street, Suite 300Alexandria, VA 22314Phone: 216-387-0199jcrist@biologicsconsulting.com
Date Prepared:	October 15, 2020

2. DEVICE

Name of Device:	Nexo-Gide™ Bilayer Collagen Membrane
Common or Usual Name:	Surgical Mesh
Classification Name:	878.3300 - Surgical Mesh
Regulatory Class:	Class II
Product Code:	OWW, FTM

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PREDICATE DEVICE
Predicate Device Name:	Tendon Wrap Tendon Protector
Manufacturer:	Integra LifeSciences
510(k) Number:	K053655
Reference Devices:	K192042 Bio-Gide, Geistlich Pharma AG

PREDICATE DEVICE 3.

DEVICE DESCRIPTION 4.

INDICATION FOR USE ર.

The indications for use for the Nexo-Gide™ Bilayer Collagen Membrane are as follows:

The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

The indications for use are identical to the predicate device.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Discussion of Similarities

Both devices are collagen membranes used to protect and manage tendon injuries where is no substantial loss of tendon tissues. Both devices are used in the same manner. Both devices are of comparable thickness and pore size, and have similar mechanical properties such as suture pull-out force, stiffness, and tensile strength. Both devices are resorbable and biocompatible in accordance with ISO 10993-1 and FDA guidance. Both devices are sterile, single-use devices. The technological features and use of these products are overall very similar, with minor differences in the tissue sourcing and processing.

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Discussion of Differences

The proposed device differs from the predicate in its tissue source and composition. The predicate device is sourced from bovine tendon tissue and is composed of primarily cross-linked type I collagen. The proposed Geistlich Nexo-Gide device, however, is sourced from porcine tissue and is composed of primarily Type I and Type III collagen. The proposed device also has a bilayer structure intended to provide a tendon-facing and outward-facing surfaces suited for the intended use of protection and management of tendon injuries. These similarities and differences are summarized in the device comparison table below.

	Proposed Device	Predicate Device1K053655	Bio-GideK192042 (MaterialReference Device)
510(k)Number	TBD	K053655	K192042
Applicant	Geistlich Pharma AG	Integra LifeSciences	Geistlich Pharma AG
Device Name	Nexo-Gide™ BilayerCollagen Membrane	Tendon Wrap TendonProtector (TenoGlide)	Bio-Gide
ClassificationRegulation	878.3300 - Surgical Mesh	878.3300 - Surgical Mesh	872.3930 - Bonegrafting material
Product Code	FTM – Surgical MeshOWW - Mesh, Surgical,Absorbable, Orthopedics,Reinforcement Of Tendon	FTM – Surgical Mesh	NPL - Bone graftingmaterial.
	Proposed Device	Predicate Device¹K053655	Bio-GideK192042 (MaterialReference Device)
Indicationsfor Use	The Nexo-Gide™ BilayerCollagen Membrane isindicated for themanagement andprotection of tendoninjuries in which there hasbeen no substantial loss oftendon tissue.	Tendon Wrap TendonProtector is indicated forthe management andprotection of tendoninjuries in which there hasbeen no substantial loss oftendon tissue.	Augmentation aroundimplants placed in immediateextraction sockets;augmentation aroundimplants placed in delayedextraction sockets;localized ridge augmentationfor later implantation;alveolar ridge reconstructionfor prosthetic treatment;filling of bone defects afterroot resection, cystectomy,removal of retained teeth;guided bone regeneration indehiscence defects; andguided tissue regenerationprocedures in periodontaldefects.
TargetPopulation	Patients with injuries totendons of the extremities	Patients with injuries totendons of the extremities	Bone grafting patients
PhysicalAppearance	Almost white collagenmembrane consisting of acollagen network ofmultiple layers	Beige collagen membraneconsisting of a collagennetwork of multiple layers	Almost white collagenmembrane consisting ofa collagen network ofmultiple layers
Handling	Product is soft andconformable	Product is soft andconformable	Product is soft andconformable
Thickness	≥ 0.2 mm	≥ 0.2 mm	≥ 0.2 mm
Porosity	Pores from 1 – 120 μm	Pores from 1 – 120 μm	Pores from 1 – 120 μm
TensileStrength(maximalstress)	≥0.06 MPa	≥0.06 MPa	≥0.06 MPa
Stiffness(elasticity)	<65 MPa	<65 MPa	<65 MPa
Suture Pull outforces	Suture pull out force: ≥0.04 N, allows suturing	Suture pull out force: ≥0.04 N, allows suturing	Suture pull out force: ≥0.04 N, allows suturing
Integrity	Device has provenintegrity under simulatedphysiological conditions	Device has proven integrityunder simulatedphysiological conditions	Device has provenintegrity undersimulated physiologicalconditions
	Proposed Device	Predicate Device1K053655	Bio-GideK192042 (MaterialReference Device)
Materials of Composition
Raw Material	porcine collagen	Type I Collagen frombovine flexor tendon	porcine collagen
MajorComponents	collagen type I and IIIwithout further cross-linking or chemicaladditives	Crosslinked type I collagenand glycosaminoglycan(GAG)	collagen type I and IIIwithout further cross-linking or chemicaladditives
Other Characteristics
Source of rawmaterial	sourced from pigs (Susscrofa domestica)	bovine	sourced from pigs (Susscrofa domestica)
Packaging	Sterile double blisterpackaging.Conforms to ISO 11607,Parts 1 and 2.	"double peel packages"	Sterile double blisterpackaging.Conforms to ISO 11607,Parts 1 and 2.
Manufacture /Packaginglocation	Geistlich Pharma AG,Wolhusen,SwitzerlandRegistration Number:9614442	Integra LifeSciences,Plainsboro, NJ08536 USAEstablishment RegistrationNumber 1121308	Geistlich Pharma AG,Wolhusen,SwitzerlandRegistration Number:9614442
Sterility	Gamma irradiationSAL 10-6;Sterile, for single use only	"sterile, single use"	Gamma irradiationSAL 10-6Sterile, for single useonly
Principles of Operation
Principles ofOperation	Single use, biocompatible,implantable and resorbablecollagen sheet whichserves as a protectiveencasement for injuredtendons	Single use, biocompatible,implantable and resorbablecollagen sheet whichserves as a protectiveencasement for injuredtendons	Single use,biocompatible,implantable andresorbable collagenmembrane which servesas a dental barriermembrane
Bicompatible	Biocompatibilityassessment conductedaccording to ISO 10993-1and confirmedbiocompatible	Biocompatibilityassessment conductedaccording to ISO 10993-1	Biocompatibilityassessment conductedaccording to ISO 10993-1 and confirmedbiocompatible

Device Comparison Table:

1 Descriptive information on the predicate was obtained from the 510(k) summary and available FOI records of K053655

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7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

According to the requirements of FDA's guidance on the Use of International Standard ISO 10993, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, Geistlich Nexo-Gide is categorized as an implant in contact with tissue and bone for a permanent duration (> 30 days). Geistlich Nexo-Gide is identical in raw material source, formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents), when compared to legally marketed predicates with the biocompatibility contact/duration (Geistlich Bio-Gide K192042 and K050446).

Additionally, however, a Chicken Tendon Flexor study was conducted which provided safety and effectiveness information. including biocompatibility insights for the intended anatomical use location, that also support biocompatibility and substantial equivalence to the predicate.

Geistlich Nexo-Gide meets the pyrogen limits specification. Bacterial endotoxins are determined by the Limulus Amoebocyte Lysate (LAL) test according to USP <85> Bacterial Endotoxins, gel-clot technique and must not exceed 20.0 USP EU per device.

Electrical Safety and electromagnetic compatibility (EMC)

Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

Software Verification and Validation Testing

Not Applicable. The subject device contains no software.

Bench Testing

Bench testing was conducted versus the predicate to support substantial equivalence, including the following tests:

Physical Appearance ●
Thickness
Porosity ●
Tensile Strength and Stiffness ●
Suture Pull out forces
Integrity

All tests passed the predetermined acceptance criteria, demonstrating substantial equivalence to the predicate.

Animal Study

The Geistlich Nexo-Gide® device has been studied in various different animal models involving tendon and other relevant anatomical locations.

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Nexo-Gide, demonstrated similar safety and effectiveness when compared to the control article, TenoGlide, in a chicken flexor tendon repair model. Histologically, Nexo-Gide was considered to have minimal or no reaction compared to the TenoGlide predicate device. The application of Nexo-Gide reduced WOF when compared to the surgical control and, statistically, was noninferior compared to the predicate device. Tendon healing and adherence formation was similar between Nexo-Gide and the predicate TenoGlide, and there were no adverse events differentiating the two groups. The study therefore met all acceptance criteria and

Additionally, Nexo-Gide was compared to the predicate device in a rat achilles tendon study to assess the degradation profile and to evaluate local tissue effects. Nexo-Gide had similar tissue and inflammation responses compared to the control article with minimal or no reaction. Nexo-Gide demonstrated similar performance under the conditions of the study.

Further, previously conducted animal studies had been leveraged to demonstrate product safety and performance. Local tissue reactions, product degradation and systemic toxicity with the implant was assessed in these studies.

Any differences in technology for the Geistlich Nexo-Gide do not negatively impact safety and effectiveness of the device. This testing therefore demonstrates that Geistlich Nexo-Gide is substantially equivalent to the predicate in its ability to protect and manage tendon injuries in which there has been no substantial loss of tendon tissue.

Clinical Study

Not applicable - clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSIONS 8.

The Geistlich Nexo-Gide device has the same intended use and few technological differences when compared to the predicate TenoGlide. The primary difference is Geistlich Nexo-Gide uses a different tissue source which may impact biocompatibility and mechanical properties. The biocompatibility of the device is supported by identical composition to previously marketed devices, and bench testing demonstrates any differences in material composition do not impact safety and effectiveness of mechanical properties. Finally, a chicken tendon flexor model demonstrates that Geistlich Nexo-Gide is substantially equivalent to the predicate in its ability to protect and manage tendon injuries in which there has been no substantial loss of tendon tissue. Taken together, Geistlich Nexo-Gide has the same intended use as the predicate and all concerns regarding differences in technology have been addressed through bench and animal testing, and therefore Geistlich Nexo-Gide can be considered substantially equivalent to the predicate.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.