COLLEXA

K100574 · Innocoll Pharmaceuticals · KGN · Oct 28, 2010 · SU

Device Facts

• Record ID: K100574
• Device Name: COLLEXA
• Applicant: Innocoll Pharmaceuticals
• Product Code: KGN · SU
• Decision Date: Oct 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collexa may be used for the management of wounds such as: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies . Full-thickness & partial thickness wounds . Abrasions . Traumatic wounds . 1st and 2nd degree burns . Dehisced surgical wounds . Exuding wounds .

Device Story

Collexa is a topical wound dressing consisting of a collagen matrix sponge with an absorbent polyurethane foam backing. It is designed for single-use, sterile application to manage various wound types, including ulcers, burns, and surgical wounds. The polyurethane foam layer acts as a reservoir to absorb wound exudates. The device is applied topically by healthcare providers to the wound site to facilitate management. It provides a physical barrier and absorbent environment, aiding in wound healing and exudate control. No complex electronics, software, or automated processing are involved.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1:2009.

Technological Characteristics

Collagen matrix sponge with polyurethane foam backing. Sterile, single-use. Biocompatibility compliant with ISO 10993-1:2009.

Indications for Use

Indicated for management of diabetic, venous, pressure, and mixed vascular ulcers; full-thickness and partial-thickness wounds; abrasions; traumatic wounds; 1st and 2nd degree burns; dehisced surgical wounds; and exuding wounds.

Predicate Devices

• Collatek Foam (K012997)
• Collagen Sponge (K092805)

Submission Summary (Full Text)

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K100574|S1 OCT 2 8 2010

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**Innocoll**
Pharmaceuticals

.innocoll-pharma.com

FDA CDRH DMC

OCT 04 2010

Received K46

1. Date Prepared:

510(k) Summary

September 9th , 2010

2. Submitter

Innocoll Pharmaceuticals Midland Innovation and Research Centre Athlone Co. Westmeath Ireland. Tel: [phone] Fax: [phone]

Submission Correspondent:

Aaron Wyse Director of Regulatory Affairs

- 3. Proprietary Name: Collexa
- 4. Common Name: Topical Wound Dressing
- 5. Device Classification: Product Code: KGN Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified

#### 6. Statement of Substantial Equivalence:

Collexa is substantially equivalent in materials of construction and intended use to Collatek Foam (K012997) and Collagen Sponge (K092805).

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## 7. Intended Use

Collexa may be used for the management of wounds such as:

- Diabetic ulcers
- · Venous ulcers
- . Pressure ulcers
- Ulcers caused by mixed vascular etiologies .
- Full-thickness & partial thickness wounds .
- Abrasions .
- Traumatic wounds .
- 1st and 2nd degree burns .
- Dehisced surgical wounds .
- Exuding wounds .

# 8. Description

Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.

## 9. Biocompatibility

Biocompatibility testing has confirmed that Collexa meets all the biocompatibility testing requirements in accordance with ISO 10993-1:2009. Biocompatibility data demonstrates that Collexa is safe for use as a wound management device.

## 10. Conclusion

Collexa is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.

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

Innocoll Pharmaceuticals % Mr. Aaron Wyse Director of Regulatory Affairs Midlands Innovation and Research Centre Dublin Road, Athlone Co. Westmeath, Ireland

Re: K100574

OCT 2 8 2010

Trade/Device Name: Collexa Regulatory Class: Unclassified Product Code: KGN Dated: October 01, 2010 Received: October 04, 2010

Dear Mr. Wyse:

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

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Page 2 - Mr. Aaron Wyse

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Indications for Use

OCT 2 8 2010

100574 510(k) Number (if known):

Device Name: Collexa

Indications For Use:

#### Indications:

Collexa may be used for the management of wounds including.

- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Abrasions
- Traumatic wounds
- 154 and 2nd degree burns
- Dehisced surgical wounds
- Exuding wounds

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Daniel Keane for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K100574