Collagen Dental Wound Dressings

K152600 · Collagen Matrix, Inc. · KGN · Jun 23, 2016 · SU

Device Facts

• Record ID: K152600
• Device Name: Collagen Dental Wound Dressings
• Applicant: Collagen Matrix, Inc.
• Product Code: KGN · SU
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including: Denture sores Oral ulcers (non-infected or viral) Periodontal surgical wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds

Device Story

Collagen Dental Wound Dressings are absorbent, porous matrices derived from purified bovine dermis collagen. Applied directly to oral wounds/sores, the device protects new tissue and manages local wound fluids. It can be removed, replaced, or left in situ, where it resorbs within 30 days. Available in tape, sponge, and plug forms, the device is intended for single use in clinical or dental settings. By providing a physical barrier and absorbing exudate, the dressing supports the healing environment for various oral lesions and surgical sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and animal studies. Bench tests included physical/chemical characterization (dimensions, density, weight, absorbency, pH, hydrothermal transition temperature). Biocompatibility testing (ISO 10993) included cytotoxicity, sensitization, and intracutaneous reactivity. Animal studies included a rat subcutaneous model for resorption and viral inactivation studies to ensure safety of bovine-derived tissue.

Technological Characteristics

Material: Purified bovine dermis collagen. Form: Porous matrix (tape, sponge, plug). Energy: None. Connectivity: None. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 22442-1/2/3 (animal tissue safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/reactivity).

Indications for Use

Indicated for management of oral wounds and sores in patients requiring wound care, including denture sores, non-infected/viral oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds.

Predicate Devices

• Collagen Dental Wound Dressing (K122115)
• Dental Collagen Wound Dressing (NovaTape and NovaPlug) (K142712)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2016

Collagen Matrix, Inc. Ms. Gloria Zuclich Senior Manager of Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436

Re: K152600

Trade/Device Name: Collagen Dental Wound Dressings Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: KGN Dated: May 24, 2016 Received: May 26, 2016

Dear Ms. Zuclich:

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. 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _ K152600

Device Name: Collagen Dental Wound Dressings

Indications for Use:

Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:

- Denture sores ●
- Oral ulcers (non-infected or viral) ●
- Periodontal surgical wounds ●
- Suture sites ●
- Burns ●
- Extraction sites
- Surgical wounds ●
- Traumatic wounds ●

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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)

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# 510(k) SUMMARY

#### 1. Applicant Information

| Applicant Name: | Collagen Matrix, Inc. |
|-----------------|---------------------------------------------------|
| Address: | 15 Thornton Road<br>Oakland, New Jersey 07436 USA |
| Telephone: | [phone] Ext. 317 |
| Fax: | [phone] |
| Contact Person: | Gloria Zuclich<br>Director of Regulatory Affairs |
| Date Prepared: | June 2. 2016 |

## 2. Name of the Device

| Device Trade Name: | Collagen Dental Wound Dressings |
|-----------------------------|---------------------------------------------------------------|
| Device Common Name: | Dental Wound Dressings |
| Device Classification Name: | Dressing, Wound, Collagen<br>Product Code KGN<br>Unclassified |

| 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed | | |
|-------------------------------------------------------------------------|--|-------------------------------------------------------------------|
| Primary Predicate: | | K122115 Collagen Dental Wound Dressing<br>Collagen Matrix, Inc. |
| Reference Predicate: | | K142712 Dental Collagen Wound Dressing<br>(NovaTape and NovaPlug) |

NovaBone Products, LLC

## 4. Description of the Device

Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.

#### 5. Intended Use

Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:

- Denture sores
- Oral ulcers (non-infected or viral) ●
- Periodontal surgical wounds ●
- Suture sites .

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- Burns ●
- Extraction sites .
- Surgical wounds ●
- Traumatic wounds

## 6. Summary/Comparison of Technical Characteristics

Collagen Dental Wound Dressings have been determined to be substantially equivalent to the predicate devices having similar technological characteristics as follows:

| Parameter | Collagen Dental Wound<br>Dressings (This<br>submission) | Collagen Dental Wound<br>Dressing (Predicate,<br>K122115) | Dental Collagen Wound<br>Dressings (Predicate,<br>K142712) | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) | Not assigned | K122115 | K142712 | |
| Indications for<br>Use | Intended for use in the<br>management of oral<br>wounds and sores,<br>including:<br>• Denture Sores<br>• Oral Ulcers (non-<br>infected or viral)<br>• Periodontal surgical<br>wounds<br>• Suture sites<br>• Burns<br>• Extraction sites<br>• Surgical Wounds<br>• Traumatic Wounds | Intended for use in the<br>management of oral<br>wounds and sores,<br>including:<br>• Denture Sores<br>• Oral Ulcers (non-<br>infected or viral)<br>• Periodontal surgical<br>wounds<br>• Suture sites<br>• Burns<br>• Extraction sites<br>• Surgical Wounds<br>• Traumatic Wounds | Intended for use in the<br>management of oral<br>wounds and sores,<br>including:<br>• Denture Sores<br>• Oral Ulcers (non-<br>infected or viral)<br>• Periodontal surgical<br>wounds<br>• Suture sites<br>• Burns<br>• Extraction sites<br>• Surgical Wounds<br>• Traumatic Wounds | |
| Material | Purified Collagen | Purified Collagen | Purified Collagen | |
| Collagen<br>Source | Bovine Dermis | Porcine Tendon | Bovine Dermis | |
| Form | Porous Collagen Matrix | Porous Collagen Matrix | Porous Collagen Matrix | |
| Color | White to off-white | White to off-white | White to off-white | |
| Shapes | Rectangular and<br>Cylindrical | Rectangular and<br>Cylindrical | Rectangular and<br>Cylindrical | |
| Sizes | 25mm x 75mm x 1mm<br>20mm x 40mm x 3mm<br>10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm<br>20mm x 40mm x 3mm<br>10mm (ID) x 20mm (L) | 25mm x 75mm x 1mm<br>20mm x 40mm x 3mm<br>10mm (ID) x 20mm (L) | |
| Absorbency | Absorbs local wound<br>fluids upon application | Absorbs local wound<br>fluids upon application | Absorbs local wound<br>fluids upon application | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Not Known | |
| Sterilization | Gamma Irradiation, SAL<br>10-6 | Gamma Irradiation, SAL<br>10-6 | E-beam irradiation, SAL<br>10-6 | |
| Single Use/<br>Reuse | Single use only | Single use only | Single use only | |
| Packaging | Single barrier (blister tray<br>or Tyvek pouch) | Single barrier (blister tray<br>or Tyvek pouch) | Single barrier (blister tray<br>or Tyvek pouch) | |

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# 7. Discussion of Non-clinical Testing

The substantial equivalence of Collagen Dental Wound Dressings and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies and an animal resorption study.

Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA guidelines as follows:

ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1 Analysis and Risk Management

ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2 Controls on Sourcing, Collection, and Handling

ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 3 Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents

ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro cvtotoxicity

ISO 10993-10:2009 Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization

## Non-clinical Testing Conducted

In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted which included an evaluation of physical, chemical, and biological properties as indicated.

| Test | Results |
|----------------------------------------|---------------------------------------------------------------------|
| Composition | Purified Collagen |
| Dimensions | Dimensions similar to predicate device |
| Thickness | Thickness similar to predicate device |
| Density | Density similar to predicate device |
| Weight | Weight similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Pyrogenicity | Non-Pyrogenic |
| Residues | Within acceptable limits |
| pH | pH similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Hydrothermal<br>transition temperature | Hydrothermal transition temperature similar to predicate<br>device. |

A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Collagen Dental Wound Dressings as a topical material. The biocompatibility testing performed is summarized in the table below.

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| Test | Test Method / Model | Results |
|------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Agarose Overlay, ISO 10993-5<br>ISO Elution Method, ISO 10993-5 | Non-cytotoxic |
| Sensitization | Guinea Pig Maximization,<br>ISO 10993-10 | No evidence of causing delayed<br>dermal contact sensitization in the<br>guinea pig. |
| Intracutaneous<br>Reactivity | Intracutaneous Study in Rabbits,<br>ISO 10993-10 | Under the conditions of the study,<br>there was no erythema or edema<br>from the extract injected<br>intracutaneously into rabbits. |
| Pyrogenicity | USP (151) Rabbit Pyrogen Study | The test article was judged as non-<br>pyrogenic. |

An in vivo resorption study utilizing a rat subcutaneous model was conducted to evaluate the device as compared to its predicate device with regards to device resorption.

A viral inactivation study was performed to ensure the viral safety of the product.

# 8. Conclusion of Non-clinical Studies

The predicate devices were cleared based on the results of non-clinical data. The results of the non-clinical tests conducted demonstrate that the device is substantially equivalent to the legally marketed predicate device.