Geistlich Wound Matrix PLUS

K213607 · Geistlich Pharma AG · KGN · Apr 28, 2022 · SU

Device Facts

• Record ID: K213607
• Device Name: Geistlich Wound Matrix PLUS
• Applicant: Geistlich Pharma AG
• Product Code: KGN · SU
• Decision Date: Apr 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Wound Matrix PLUS is intended for the management of wounds including: - Partial and full-thickness wounds - Pressure ulcers - Venous ulcers - Diabetic ulcers - Chronic vascular ulcers - Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) - Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - Draining wounds - Tunneled/undermined wounds The device is intended for one-time use.

Device Story

Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing derived from porcine tissue. It provides a moist environment conducive to wound healing. The device is supplied sterile in various sizes and a 6mm thickness; it can be shaped by clinicians using standard sterile instruments (scissors or scalpel). It is intended for single, one-time use by licensed healthcare practitioners. The device is terminally sterilized via gamma irradiation. It functions as a physical matrix for wound management, supporting the healing process in various chronic and acute wound types.

Clinical Evidence

Bench testing only. No clinical data. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, irritation, sensitization, acute/subchronic/chronic systemic toxicity, pyrogenicity, and genotoxicity. Chemical characterization performed per ISO 10993-18. Viral inactivation validated per ISO 22442-3 and ICH Q5A. Shelf life and packaging stability validated per ISO 11607.

Technological Characteristics

Porcine-derived acellular collagen matrix. Dimensions: 6mm thickness, various sizes (10x10mm to 25x25mm). Sterilization: Gamma irradiation (SAL 10^-6). Biocompatible, non-pyrogenic, non-mutagenic. Complies with ISO 10993 series for biological evaluation and ISO 22442-3 for viral safety.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, surgical wounds (donor sites, grafts, post-Mohs/laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, and tunneled/undermined wounds.

Predicate Devices

• ACell Inc.'s Cytal Wound Matrix (K152721)

Reference Devices

• Geistlich Fibro-Gide (K171050)

Submission Summary (Full Text)

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May 5, 2022

Geistlich Pharma AG % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Dr Chevy Chase, Maryland 20815

Re: K213607

Trade/Device Name: Geistlich Wound Matrix PLUS Regulatory Class: Unclassified Product Code: KGN

Dear Stephen Rhodes:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 28, 2022. Specifically, FDA is updating this SE Letter to correct the indications for use due to an administrative error.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, [e-mail].

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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April 28, 2022

Geistlich Pharma AG % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Dr Chevy Chase, Maryland 20815

Re: K213607

Trade/Device Name: Geistlich Wound Matrix PLUS Regulatory Class: Unclassified Product Code: KGN Dated: December 17, 2021 Received: December 20, 2021

Dear Stephen Rhodes:

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 mediation-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(@tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K213607

Device Name

Wound Matrix PLUS

Indications for Use (Describe)

Wound Matrix PLUS is intended for the management of wounds including:

- · Partial and full-thickness wounds
- · Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- Chronic vascular ulcers
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations,second-degree burns, and skin tears)
- · Draining wounds
- · Tunneled/undermined wounds

The device is intended for one-time use.

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

| <div> <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for Wound Matrix PLUS is provided below.

#### SUBMITTER 1.

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

Contact Person: Erik Wirth Phone: [phone] Email: [e-mail]

Prepared By: Stephen P. Rhodes, Streamline Regulatory [e-mail] Date Prepared: April 12, 2022

#### 2. DEVICE

Name of Device: Wound Matrix PLUS Common Name: Collagen Wound Dressing Classification Regulation: Unclassified Regulatory Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery

#### PREDICATE DEVICE 3.

Predicate Device: ACell Inc.'s Cytal Wound Matrix (K152721)

Reference Device: Geistlich Fibro-Gide (K171050)

#### 4. DEVICE DESCRIPTION

Geistlich Wound Matrix PLUS is an animal-sourced, acellular extracellular matrix (ECM) wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. Wound Matrix PLUS is terminally sterilized using gamma irradiation in its packaging.

The device is offered in various sizes and can be shaped to the required dimension using standard sterile instruments (scissors or scalpel).

The device is intended to be used by licensed healthcare practitioners and will be supplied sterile for single one-time use.

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#### ട്. INDICATIONS FOR USE

Wound Matrix PLUS is intended for the management of wounds including:

- Partial and full-thickness wounds 0
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers ●
- Chronic vascular ulcers ●
- Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, ● wound dehiscence)
- o Trauma wounds (abrasions, lacerations, superficial second-degree burns, and skin tears)
- Draining wounds ●
- o Tunneled/undermined wounds

The device is intended for one-time use.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The similarities and differences in technological characteristics between the subject device (Wound Matrix PLUS), predicate device (Cytal Wound Matrix - K152721), and the reference device (Geistlich Fibro-Gide - K171050) are summarized below.

Wound Matrix PLUS and Cytal Wound Matrix (K152721) are both porcine-derived matrices intended for wound management. The wound dressings provide a moist environment that is conducive to wound healing.

The subject device is offered in one thickness (6mm) and the following sizes: 10 x 10 mm, 10 x 20 mm, 10 x 40 mm, 10 x 80 mm, 15 x 20 mm, 20 x 20 mm, 20 x 40 mm, and 25 x 25 mm. The predicate's largest size is 100 x 150 mm and is provided in a range of thicknesses (one to eight layers) up to 3-4 mm. The difference in size and number of layers between Wound Matrix PLUS and Cytal Wound Matrix does not raise different questions of safety or effectiveness in the subject device. Both the subject and predicate device can be shaped to the desired dimensions or multiple devices can be used. Additionally, the predicate device is sterilized with electron beam irradiation and the subject device is gamma-sterilized. Both devices are provided sterile with an SAL of 10-6.

| | Wound Matrix PLUS<br>K213607 | Cytal Wound Matrix<br>K152721 |
|-----------------|------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Material Origin | Porcine derived collagen | Porcine derived collagen |
| Sizes/ Form | 10 x 10 mm, 10 x 20 mm, 10 x 40 mm,<br>10 x 80 mm, 15 x 15 mm, 15 x 20 mm,<br>20 x 20 mm, 25 x 25 mm, 20 x 40 mm | Up to 100 x 150 mm |
| Thickness | 6 mm | 3 – 4 mm |
| Sterilization | Irradiation (gamma) | Irradiation (electron beam) |
| Sterility Level | SAL of 10-6 | SAL of 10-6 |

# Technological Characteristics

Overall, the differences in technological characteristics of the subject and predicate devices do not raise any different questions of safety and effectiveness.

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Lastly, the subject Wound Matrix PLUS has the same technological characteristics as the cleared Geistlich Fibro-Gide reference device (K171050) although with different indications.

#### PERFORMANCE DATA 7.

For all performance testing, the testing was leveraged from the previously reviewed and cleared reference device (Geistlich Fibro-Gide (K171050) that is identical in composition and technology to the subject device. The substantial equivalence evaluation of Wound Matrix PLUS and Cytal Wound Matrix was supported by non-clinical performance including GLP biocompatibility testing, as per ISO 10993-1 and consistent with FDA Guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and laboratory testing.

Wound Matrix PLUS is classified as a permanent contact device. Biocompatibility information is summarized in the table below:

| Test (Standard) | Test method | Results |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity (ISO 10993-5) | In vitro mouse L929 fibroblast cell<br>culture assay | Non-cytotoxic |
| Irritation (ISO 10993-10) | Intracutaneous reactivity in the<br>rabbit | Not irritant |
| Sensitization (ISO 10993-10) | Guinea pig maximization test | Not sensitizing |
| Acute systemic toxicity<br>(ISO 10993-11) | Acute systemic toxicity test in the<br>mouse | No acute systemic toxicity |
| Pyrogenicity (USP <151>) | Rabbit pyrogen test | Non-pyrogenic |
| Genotoxicity (ISO 10993-3) | Bacterial reverse mutagenicity<br>assay in Salmonella typhimurium<br>and Escherichia coli (Ames test)<br>In vitro chromosomal aberration<br>study in human lymphocytes<br>Mouse peripheral blood<br>micronucleus study | Non-mutagenic<br>Not genotoxic<br>Not genotoxic |
| Local tissue response after<br>implantation (ISO 10993-6) | 4-week, 12-week and 26 week<br>subcutaneous implantation in rats | Local tissue effects: slight irritant.<br>Systemic toxicity: No evidence of<br>systemic toxicity |
| Subchronic systemic<br>toxicity (ISO 10993-11) | 4-week subcutaneous implantation<br>in rats, with systemic toxicity<br>endpoint | No subchronic toxicity |
| Chronic systemic toxicity<br>(ISO 10993-11) | 26-week subcutaneous<br>implantation in rats, with systemic<br>toxicity endpoint | No chronic toxicity |
| Chemical Characterization<br>Extractable Substances (ISO<br>10993-18) | GC/Headspace and ICP | No product-related semi-volatile<br>organic compounds were detected in<br>the GC/MS fingerprint<br>chromatograms of the test material |

Leachables and Biocompatibility Test Results

The results indicate that Wound Matrix PLUS is biocompatible.

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Per FDA guidance on shelf life, sterilization, and devices containing animal-derived material, the following laboratory studies were also conducted:

## Laboratory Testing

- Viral Inactivation: Viral validation studies per ISO 22442-3 Medical devices utilizing ● animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents and requirements of ICH Q5A Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
- Expiration Dating / Shelf Life for Three Year Shelf Life. Packaging stability was . confirmed by ISO 11607 Packaging for terminally sterilized medical devices, and realtime shelf life testing was conducted on device properties

The results support the viral safety of the device and the product shelf life of three years.

#### CONCLUSIONS 8.

The subject Wound Matrix PLUS has the same intended use and indications as the predicate Cytal Wound Matrix (K152721).

There are similar technological characteristics between the subject Wound Matrix PLUS and the predicate Cytal Wound Matrix. The differences in technological characteristics do not raise any different questions of safety or effectiveness.

Wound Matrix PLUS has the same design, material, manufacturing, packaging and sterilization to the reference device, Fibro-Gide (K171050).