K Number
K092805
Device Name
COLLAGEN SPONGE
Date Cleared
2010-02-16

(158 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Sponge may be used for the management of wounds such as: - Pressure ulcers . - . Venous stasis ulcers - . Diabetic ulcers - First and second degree burns . - Partial and full thickness wounds . - Superficial injuries .
Device Description
Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.
More Information

Not Found

No
The summary describes a collagen matrix sponge for wound management and does not mention any AI or ML components.

Yes.
The device is indicated for the management of wounds such as ulcers and burns, which are conditions that require therapeutic intervention.

No
The device, "Collagen Sponge," is described as a "collagen matrix sponge intended for topical use" for the management of wounds. Its function is to treat wounds, not to identify or diagnose a condition.

No

The device description clearly states it is a "collagen matrix sponge," which is a physical, tangible product, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
  • Device Description: The device is described as a "collagen matrix sponge intended for topical use." This is a physical material applied to the body, not a reagent or instrument used to examine specimens from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.

IVDs are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This collagen sponge does not fit that description.

N/A

Intended Use / Indications for Use

Collagen sponge may be used for the management of wounds such as:

  • Pressure ulcers
  • Venous stasis ulcers
  • Diabetic ulcers
  • First and second degree burns
  • Partial and full thickness wounds
  • Superficial injuries

Product codes

KGN

Device Description

Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K061746, K081782

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

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Page 5 - 1

Pharmaceutic

Midlands Innovation and Research Centre Dublin Road, Athlone, Co. Westmeath, Ireland Tel: + 353 (0)90 6486834 Fax: + 353 (0)90 6486835 www.innocoll-pharma.com

FEB 1 6 2010

510(k) Summary

1. Date Prepared:September 1st, 2009
2. SubmitterInnocoll Pharmaceuticals
Midland Innovation and Research Centre
Athlone
Co. Westmeath
Ireland.
Tel: +353 (0) 9064 86834
Fax: +353 (0) 9064 86835
Submission
Correspondent:Aaron Wyse
Director of Regulatory Affairs
3. Proprietary Name:Collagen Sponge
4. Common Name:Topical Wound Dressing
5. Device Classification: Product Code: KGN

de: KGN Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified

6. Statement of Substantial Equivalence:

Collagen Sponge is substantially equivalent in materials of construction and intended use to CollaGUARD (K061746) and to Collieva (K081782) manufactured by Syntacoll GmbH.

1

K092805 2/2

Page 5 - 2

7. Intended Use

Collagen sponge may be used for the management of wounds such as:

  • · Pressure ulcers
  • · Venous stasis ulcers
  • · Diabetic ulcers
  • · First and second degree burns
  • · Partial and full thickness wounds
  • · Superficial injuries

8. Description

Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.

9. Biocompatibility

There are no new biocompatibility issues arising with the use of Collagen Sponge as the materials of construction and finished product material match that of CollaGUARD (K061746).

10. Conclusion

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

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

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

FEB 1 6 2010

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

Re: K092805

Trade/Device Name: Collagen Sponge Regulatory Class: Unclassified Product Code: KGN Dated: January 27, 2010 Received: February 2, 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 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

3

Page 2 - Mr. Aaron Wyse

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark A. Millmann

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

Enclosure

4

K092801

Statement of Indications for Use

510(k) Number (if known): _

Device Name: Collagen Sponge

Indications For Use:

Indications:

Collagen Sponge may be used for the management of wounds such as:

  • Pressure ulcers .
  • . Venous stasis ulcers
  • . Diabetic ulcers
  • First and second degree burns .
  • Partial and full thickness wounds .
  • Superficial injuries .

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

valuation (ODE)

Mark A. Millan

(Division Sign-(II) (Division Sign-() () Orthopedic, Orthopedic,
Division of Surgicul, Orthopedic, (Division of Surground
and Restorative Devices
and Restorative Devices 510(k) Number