Dental Collagen Wound Dressing (Nova Tape and NovaPlug)

K142712 · Novabone Products, LLC · KGN · Jan 8, 2015 · SU

Device Facts

• Record ID: K142712
• Device Name: Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
• Applicant: Novabone Products, LLC
• Product Code: KGN · SU
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dental Collagen Wound Dressings (NovaTape and NovaPlug) are intended 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

Dental Collagen Wound Dressings (NovaTape and NovaPlug) are resorbable, cross-linked bovine collagen dressings; supplied as sterile, single-use tapes or plugs. Used in dental offices, clinics, or hospitals by clinicians to manage oral wounds. Device applied directly to wound site; absorbs local fluids to maintain moist environment; aids healing. Resorbs within approximately 14 days. Provides protective barrier for various oral lesions/wounds. Benefits patient by maintaining moist wound environment and protecting site during healing process.

Clinical Evidence

Bench testing included SDS-PAGE, Circular Dichroism, DSC, collagenase digestion, absorption capacity, porosity, and cross-linking evaluation. Animal study (porcine oral model) compared NovaPlug to predicate; evaluated local reaction and material absorption. Results showed no statistically significant differences in histologic findings or implant site scores; both materials resorbed within 14 days. Biocompatibility testing (ISO 10993) confirmed safety.

Technological Characteristics

Resorbable, cross-linked bovine hide collagen. Supplied as sterile tapes or plugs. E-beam sterilized (SAL 10^-6). Flexible, compressible, non-load bearing. No electronic components or software.

Indications for Use

Indicated for individuals requiring acute or short-term dressings for protection of oral wounds, including denture sores, non-infected or viral oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds.

Predicate Devices

• Collagen Topical Wound Dressing - Oral (K040403)

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

January 8,2015

NovaBone Products, LLC Ms. Lisa Simpson Manager, Regulatory Affairs 13510 NW US Highway 441 Alachua, FL 32615

Re: K142712

> Trade/Device Name: Dental Collagen Wound Dressing (Nova Tape and NovaPlug) Regulatory Class: Unclassified Product Code: KGN Dated: December 11, 2014 Received: December 12, 2014

Dear Ms. Simpson,

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. 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Susan Runno DDS, MA

Erin Keith 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K142712

#### Device Name

Dental Collagen Wound Dressing (NovaTape and NovaPlug)

#### Indications for Use (Describe)

Dental Collagen Wound Dressings (NovaPlug) are intended 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

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services [phone]

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# 510(k) SUMMARY – NovaTape & NovaPlug

Image /page/3/Picture/1 description: The image is a logo for NovaBone. The logo is in teal and features the word "NOVABONE" in large, bold letters. Below the word "NOVABONE" is the tagline "DRIVING INNOVATION IN OSTEOBIOLOGICS" in smaller letters.

| Date Prepared: | January 5, 2015 |
|----------------------------|----------------------------------------------|
| 510(k) Holder / Submitter: | |
| Name: | NovaBone Products, LLC |
| Address: | 13510 NW US Highway 441<br>Alachua, FL 32615 |
| Telephone: | [phone], ext. 216 |
| Fax: | [phone] |
| Contact: | Lisa Simpson<br>Manager, Regulatory Affairs |
| Name of Device: | |
| Trade Names: | NovaTape (NT)<br>NovaPlug (NP) |
| Common Name: | Dental Collagen Wound Dressing |
| Regulation Number: | None |
| Regulation Name: | None |
| Regulatory Class: | Not Classified |
| Product Code: | KGN |

# Legally Marketed Predicate Devices:

| K040403 | Collagen Matrix |
|---------|----------------------------------------|
| | Collagen Topical Wound Dressing - Oral |

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Image /page/4/Picture/0 description: The image shows the title "510(k) SUMMARY - NovaTape & NovaPlug" in bold font. Below the title is the logo for "NOVABONE" in a stylized font. Underneath the logo is the text "DRIVING INNOVATION IN OSTEOBIOLOGICS".

#### Device Description:

Dental Collagen Wound Dressings are soft, white to off-white, resorbable collagen dressings produced from cross-linked, purified collagen derived from bovine hide. The thickness and pore structure of the device allow it to absorb fluids and blood at the defect site. Dental Collagen Wound Dressings are supplied sterile, non-pyrogenic, and are for single use only.

## Intended Use / Indications for Use

Dental Collagen Wound Dressings (NovaTape and NovaPlug) are intended 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

## Technological Characteristics and Substantial Equivalence:

The proposed NovaTape / NovaPlug (NT/NP) Dental Collagen Dressings are substantially equivalent to the predicate Collagen Topical Wound Dressings – Oral (K040403). The predicate devices are marketed as under the name "ACE Resorbable Collagen Tape (RCT) & ACE Resorbable Collagen Plug (RCP)". The predicate and proposed devices have the same clinical indications for use.

#### Design / Mode of Action

The predicates (K040403) and proposed NT/NP dental collagen wound dressings are composed solely of collagen and both are provided in tape and plug formats. The dressings act to absorb moisture from the oral wound site, thereby maintaining a moist environment. The dressings resorb within approximately 14 days of implantation. Because the basic design technology and mode of action are similar between the proposed device, no new issues of safety or effectiveness are presented.

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# 510(k) SUMMARY – NovaTape & NovaPlug

Image /page/5/Picture/1 description: The image is a logo for NovaBone. The logo is in blue and teal, with the word "NovaBone" in large, bold letters. Below the name is the text "DRIVING INNOVATION IN OSTEOBIOLOGICS". The "O" in bone has a starburst in the middle.

| Substantial Equivalence (SE) | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison Table | | |
| | NovaBone Products, LLC<br>NovaTape / NovaPlug | ACE RCT / RCP<br>Collagen Topical Wound Dressing-Oral |
| 510(k) # | K142712 | K040403 |
| Intended Use | Temporary topical wound dressing for oral wounds and sores. | Temporary topical wound dressing for oral wounds and sores. |
| Target Population | Individuals requiring acute or short-term dressings for protection of oral wounds | Individuals requiring acute or short-term dressings for protection of oral wounds |
| Where Used | Intended for hospital, clinic, or dental office use | Intended for hospital, clinic, or dental office use |
| Indicated Sites | Denture sores Oral Ulcers (non-infected or viral) Periodontal surgical wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds | Denture sores Oral Ulcers (non-infected or viral) Periodontal surgical wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds |
| Preparation | No preparation required. | No preparation required. |
| Application | Can be applied directly to the site. | Can be applied directly to the site. |
| Material | Crosslinked collagen from - Bovine Hide | Crosslinked collagen from - Bovine Tendon |
| Device Action | On application, the dressing absorbs local wound fluids to maintain a moist wound environment to aid wound healing. | On application, the dressing absorbs local wound fluids to maintain a moist wound environment to aid wound healing. |
| Performance1 | Resorbs within approximately 14 days. | Resorbs within approximately 14 days. |
| Biocompatible | Biocompatible* | Biocompatible |
| Mechanical | Wound covering only; no mechanical performance characteristics. | Wound covering only; no mechanical performance characteristics. |
| Package Format | Provided Sterile<br>Single Barrier Format | Provided Sterile<br>Single Barrier Format |
| Device Forms | Tape & Plug | Tape & Plug |
| Sterilization | E-beam irradiation / SAL 10-6 | Gamma irradiation / SAL 10-6 |
| Voluntary Standards met | No applicable standards | No applicable standards |
| *The following statement is provided in the Package Insert (Warnings): | | |
| "Denatured collagen in the wound dressing has the potential to illicit an immune response." | | |

¹ Report SVT14-03 on file at NovaBone Products, LLC.

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Image /page/6/Picture/0 description: The image shows the text "510(k) SUMMARY - NovaTape & NovaPlug" at the top. Below this text is the logo for "NOVABONE" in a stylized font. The logo is in blue and teal colors. The text "DRIVING INNOVATION IN OSTEOBIOLOGICS" is written below the logo.

## Collagen Material Safety

The proposed NT/NP and predicate devices are comprised of collagen derived from animal sources. All collagen used for the production of NT/NP devices is obtained from a single source, from a geographical BSE Risk I, or GBR I country. The GBR I designation is the lowest risk rating, indicating the potential for one or more animals to infected with BSE agents as "Highly Unlikely". Whereas NT/NP and the predicate are both sourced from Geographical BSE Risk I collagen, no new issues of safety are presented by the type of bovine material utilized. It has been established that the manufacturing processes used for NT/NP have sufficient viral inactivation capacity.

Because of the safeguards established to mitigate BSE risk in the bovine herds and the viral inactivation capacity of the manufacturing steps, no new issues of safety are presented for the collagen used to manufacture NT/NP devices as compared to that of the predicate.

#### Biocompatibility

Like the predicate devices (K040403), the proposed NT/NP devices are intended to be permanent implants that resorb over time. Biocompatibility tests in accordance with ISO 10993 (cytotoxicity, genotoxicity, irritation, systemic toxicity (4-week), system toxicity (13week), endotoxin, and exotoxin) were conducted on the proposed NT/NP devices and the results did not raise any issues of biological safety for the device material.

#### Performance - Bench Testing

The following tests were conducted to evaluate the properties of the NT/NP device components: sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), Circular Dichroism (CD), Differential Scanning Calorimetry (DSC), Collagenase Digestion, Absorption Capacity, Percent Porosity, EDC (and NHS Residuals, Extent of Cross-linking, and Sulfide Evaluation.

#### Performance - Animal Testing

The NovaPlug device was evaluated in a porcine (minipig) model to evaluate the local reaction and material absorption as compared to the predicate device (K040403). The study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). The NovaPlug results are considered representative of NovaTape since the collagen, crosslinking and manufacturing processes are equivalent and differ only in final casting, cutting and pressing.

Based on the similarity and frequency of the histologic findings, the mean group implant site scores, and the absence of statistically significant differences between treatments there was no difference in responses to the NovaPlug 510(k) subject device and the predicate (K040403) device. The resorption and reaction of the NovaPlug and predicate device materials were substantially equivalent and the 510(k) subject device material completely resorbed within approximately fourteen (14) days of implantation.

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Image /page/7/Picture/0 description: The image contains the text "510(k) SUMMARY - NovaTape & NovaPlug" at the top. Below this text is the logo for "NOVABONE" in a stylized font. Underneath the logo is the text "DRIVING INNOVATION IN OSTEOBIOLOGICS".

Based on the results of the oral minipig implantation study, the NovaTape/NovaPlug 510(k) subject device is substantially equivalent to the predicate (K040403) when used as an oral wound dressing.

## Mechanical

NT/NP devices are not intended to be load bearing. Mechanical testing comparisons are therefore not relevant to a substantial equivalence determination.

#### How Supplied

The proposed NovaTape/NovaPlug (NT/NP) devices are supplied sterile, in a single-barrier packaging configuration similar to the predicate device (K040403).

The device is provided in two forms, thin rectangular sheets of two sizes, (25mm x 75mm x 1mm and 20mm x 40mm x 3mm) and small cylindrical plugs (10mm diameter x 20mm length). The materials and processing methods are similar between the two device forms, varying only in the compression and cutting process used to fabricate the tape forms.

The different device shapes are solely to aid in device placement as wound dressings. The devices are both flexible and compressible and may be cut or trimmed to meet the user's needs.

All the devices are terminally sterilized to a sterility assurance level (SAL) of 10°. NT/NP devices are sterilized via e-beam radiation whereas the predicate is sterilized by gamma irradiation. E-beam radiation is used for the NT/NP devices to preserve handling properties that may be modified by other forms of sterilization. Because the device packaging and sterility assurance level are equivalent, no new issues of safety of effectiveness are presented by the packaging and sterilization methods used for the proposed NT/NP devices. An initial shelf life of twelve (12) months is supported by real-time stability studies.

## Conclusion:

NovaTape and NovaPlug Dental Collagen Wound Dressings are similar to the predicate device (K040403), Collagen Topical Wound Dressing - Oral that was cleared for marketing by FDA on May 10, 2004 and marketed under as ACE Resorbable Collagen Tape (RCT) and Plug (RCP).

In vivo performance testing (porcine oral model) and biocompatibility testing were conducted on the 510(k) subject device. In the porcine oral model, the proposed device performed in an equivalent manner to the K040403 ACE predicate.

Therefore, the NovaPluq / NovaTape devices are substantially equivalent to the K040403, Collagen Topical Wound Dressing - Oral when used for the specified indications for use.