(229 days)
No
The summary describes a resorbable collagen membrane for tendon repair and protection. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML. The performance studies focus on biocompatibility, bench testing of physical properties, and animal studies comparing the device to a predicate.
Yes
The device is indicated for the management and protection of tendon injuries, which is a therapeutic purpose.
No
The device description indicates it is a resorbable collagen membrane used as a tendon protector sheet, and the intended use is for the "management and protection of tendon injuries," which are therapeutic applications, not diagnostic.
No
The device description clearly states it is a resorbable collagen membrane of porcine origin, which is a physical material, not software.
Based on the provided information, the Nexo-Gide™ Bilayer Collagen Membrane is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management and protection of tendon injuries." This is a therapeutic and protective function applied directly to the patient's body during surgery.
- Device Description: The device is a "resorbable collagen membrane" used as a "tendon protector sheet." This describes a physical barrier and support for tissue healing.
- Mechanism of Action: The description focuses on providing a "nonconstricting, protective encasement" and serving as an "interface between the tendon and the surrounding tissues." This is a mechanical and biological interaction within the body, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Nexo-Gide™ device is implanted directly into the body to aid in the healing process of a tendon injury.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OWW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendons of the extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
July 14, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" stacked on top of each other.
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
1
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
2
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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3
510(K) SUMMARY
SUBMITTER 1.
| Submitter: | Geistlich Pharma AG
Bahnhofstrasse 40
CH-6110 Wolhusen
Switzerland
Phone: +41 41 492 67 64
Fax: +41 41 492 55 40 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marco Steiner
Director Regulatory Affairs
Geistlich Pharma AG
Phone: +41 41 492 67 64
Marco.Steiner@geistlich.ch |
| Submission Correspondent: | Joshua Crist
Senior Consultant
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
Alexandria, VA 22314
Phone: 216-387-0199
jcrist@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.
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.
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.
5
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 Device1
K053655 | Bio-Gide
K192042 (Material
Reference Device) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | TBD | K053655 | K192042 |
| Applicant | Geistlich Pharma AG | Integra LifeSciences | Geistlich Pharma AG |
| Device Name | Nexo-Gide™ Bilayer
Collagen Membrane | Tendon Wrap Tendon
Protector (TenoGlide) | Bio-Gide |
| Classification
Regulation | 878.3300 - Surgical Mesh | 878.3300 - Surgical Mesh | 872.3930 - Bone
grafting material |
| Product Code | FTM – Surgical Mesh
OWW - Mesh, Surgical,
Absorbable, Orthopedics,
Reinforcement Of Tendon | FTM – Surgical Mesh | NPL - Bone grafting
material. |
| | Proposed Device | Predicate Device¹
K053655 | Bio-Gide
K192042 (Material
Reference Device) |
| Indications
for Use | 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. | Tendon Wrap Tendon
Protector is indicated for
the management and
protection of tendon
injuries in which there has
been no substantial loss of
tendon tissue. | Augmentation around
implants placed in immediate
extraction sockets;
augmentation around
implants placed in delayed
extraction sockets;
localized ridge augmentation
for later implantation;
alveolar ridge reconstruction
for prosthetic treatment;
filling of bone defects after
root resection, cystectomy,
removal of retained teeth;
guided bone regeneration in
dehiscence defects; and
guided tissue regeneration
procedures in periodontal
defects. |
| Target
Population | Patients with injuries to
tendons of the extremities | Patients with injuries to
tendons of the extremities | Bone grafting patients |
| Physical
Appearance | Almost white collagen
membrane consisting of a
collagen network of
multiple layers | Beige collagen membrane
consisting of a collagen
network of multiple layers | Almost white collagen
membrane consisting of
a collagen network of
multiple layers |
| Handling | Product is soft and
conformable | Product is soft and
conformable | Product is soft and
conformable |
| 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 |
| Tensile
Strength
(maximal
stress) | ≥0.06 MPa | ≥0.06 MPa | ≥0.06 MPa |
| Stiffness
(elasticity) | 1 Descriptive information on the predicate was obtained from the 510(k) summary and available FOI records of K053655
6
7
8
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 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.
9
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.