Not Found
No
The device description and intended use focus on a collagen matrix for wound management, with no mention of AI or ML capabilities. The predicate device is also a collagen sponge.
Yes
The "Intended Use / Indications for Use" section explicitly states that Procoll is "used for the management of full and partial thickness wounds," which implies a therapeutic purpose.
No
The provided text describes Procoll as a collagen matrix used for the management and treatment of various types of wounds. It does not mention any diagnostic capabilities, such as identifying diseases, assessing conditions, or providing information for diagnosis.
No
The device description explicitly states that Procoll is a "collagen matrix," which is a physical material, not software.
Based on the provided information, Procoll is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of Procoll is for the management of various types of wounds. This is a therapeutic application, directly treating a condition on the body.
- Device Description: Procoll is a collagen matrix applied to wounds. This is a physical device used externally.
- Lack of IVD Characteristics: There is no mention of Procoll being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. Procoll's function is to aid in wound healing, which is a direct treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
Procoll may be used for the management of full and partial thickness wounds including:
- Diabetic ulcers .
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Abrasions
- Traumatic wounds
- 1st and 2nd degree burns
- Dehisced surgical wounds
- Exuding wounds
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the biocompatibility of Procoll was completed in line with the requirements of ISO 10993 -1: 2009. There are no new biocompatibility issues arising with the use of Procoll; the materials of construction for Collagen Powder match Collagen Sponge (K092805).
Biochemical characterization of the collagen used to manufacture Collagen Powder was undertaken which characterized the collagen as being predominantly Type I collagen which is not denatured during the collagen rendering process.
Viral inactivation validation assessment was conducted on the collagen which demonstrates that the collagen material post processing can be assumed not to contain any pathogenic organisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K 120339 page 1/1
Page 10 of 224
JUN 2 1 2012
ﺔ
ترته
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
510(k) Summary
Date Prepared: Submitter:
24th January 2012 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath, Ireland.
Submission Correspondent:
Aaron Wyse Director of Requlatory Affairs Tel: +353 (0) 9066 90661 Fax: +353 (0) 9066 34895
Proprietary Name:
Procoll
Common Name:
Collagen matrix
Device Classification:
Product Code: Classification Name: Regulatory Class:
KGN Wound Dressing, Collagen Unclassified
Statement of Substantial Equivalence:
Procoll is substantially equivalent in materials of construction to Collagen Sponge (K092805). Procoll is produced using the same materials and processes as Collagen Sponge.
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K 120339 page 2/2
Page 11 of 224
Intended Use:
Procoll may be used for the management of full and partial thickness wounds including:
- Diabetic ulcers .
- . Venous ulcers
- Pressure ulcers .
- Ulcers caused by mixed vascular etiologies �
- Abrasions .
- . Traumatic wounds
- 1st and 2nd degree burns .
- Dehisced surgical wounds .
- Exuding wounds .
Description:
Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
Biocompatibility and testing:
Evaluation of the biocompatibility of Procoll was completed in line with the requirements of ISO 10993 -1: 2009. There are no new biocompatibility issues arising with the use of Procoll; the materials of construction for Collagen Powder match Collagen Sponge (K092805).
Biochemical characterization of the collagen used to manufacture Collagen Powder was undertaken which characterized the collagen as being predominantly Type I collagen which is not denatured during the collagen rendering process.
Viral inactivation validation assessment was conducted on the collagen which demonstrates that the collagen material post processing can be assumed not to contain any pathogenic organisms.
Conclusion:
Procoll 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
SUN. 2 1 2012
Innonoll Pharmaceuticals LTD. % Mr. Aaron Wyse Director of Regulatory Affairs Midlands Research and Innovation Centre, Dublin Road Athlone, Ireland EI
Re: K120339
Trade/Device Name: Procoll Regulatory Class: Unclassified Product Code: KGN Dated: June 12, 2012 Received: June 15, 2012
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
3
Page 2 - Mr. Aaron Wyse
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 yours,
FOR
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known): K120339
Device Name: Procoll
Indications For Use:
Procoll may be used for the management of full and partial thickness wounds including:
- Diabetic ulcers .
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Abrasions
- Traumatic wounds
- 1st 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 Kane ku MAXIM
(Division Sign-Off) Division of Surgical. Orthapedie, and Restorative Devices
510(k) Number K120339
Concurrence of CDRH, Office of Device Evaluation (ODE)
Procoll 510k Indications for Use
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