(139 days)
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 .
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.
This document describes the 510(k) premarket notification for a device named "Procoll," a collagen matrix wound dressing. The submission asserts that Procoll is substantially equivalent to a predicate device, Collagen Sponge (K092805).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain any explicit acceptance criteria for device performance in terms of clinical outcomes or specific quantitative metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on material composition, manufacturing processes, and biocompatibility.
The "reported device performance" is essentially the evidence presented to support substantial equivalence:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | Procoll is produced using the same exact materials (purified type I collagen from bovine Achilles tendon) as Collagen Sponge (K092805). Biochemical characterization confirmed predominantly Type I collagen, not denatured during processing. |
| Manufacturing Process Equivalence | Procoll is produced using the same processes as Collagen Sponge. |
| Biocompatibility (per ISO 10993-1: 2009 requirements) | Evaluation completed in line with ISO 10993-1:2009. No new biocompatibility issues arising with the use of Procoll. |
| Sterility & Non-pyrogenicity | Procoll is supplied sterile and non-pyrogenic. |
| Viral Inactivation | Viral inactivation validation assessment on collagen demonstrates the material post-processing can be assumed not to contain any pathogenic organisms. |
| Intended Use Equivalence | Procoll's intended uses for full and partial thickness wounds (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) are implicitly considered equivalent to the predicate device, as this is a key component of substantial equivalence. |
| Mechanism of Action Equivalence (implied for collagen matrix) | Procoll is a collagen matrix, conformable and resorbable, consistent with the known mechanism of action for such wound dressings. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is a 510(k) for substantial equivalence, not a clinical trial report. Therefore, there is no "test set" in the sense of a patient cohort evaluated for clinical outcomes. The "testing" referred to is for material characterization, biocompatibility, and viral inactivation.
- Sample Size: Not applicable in the context of a clinical test set. Material samples were tested for composition and safety.
- Data Provenance: The biocompatibility testing and biochemical characterization were conducted internally or by contracted labs. The viral inactivation validation was also conducted. The country of origin of the data is not explicitly stated beyond the submitter's location in Ireland. This is retrospective in the sense that it's laboratory testing and characterization, not prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical "test set" or "ground truth" derived from expert consensus on clinical outcomes. The "ground truth" for the material properties and safety aspects would be established by standard analytical and biological testing methodologies and interpretations by qualified laboratory personnel and regulatory affairs experts. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical "test set" requiring adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here refers to the verifiable properties of the device and its safety characteristics, not clinical outcomes.
- Material Composition: Established through biochemical characterization (e.g., spectroscopy, chromatography) confirming Type I collagen and its non-denatured state.
- Biocompatibility: Established through in-vitro and in-vivo testing according to ISO 10993-1:2009 standards, interpreted by toxicologists and biocompatibility experts.
- Viral Inactivation: Established through validated viral inactivation studies demonstrating the reduction or elimination of pathogenic organisms.
- Sterility and Non-pyrogenicity: Established through standard microbiological and pyrogenicity testing methods.
Essentially, the ground truth is based on recognized scientific and regulatory testing standards for medical device materials and safety.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of machine learning or AI for this device. The development of Procoll involved material science, manufacturing process development, and safety testing, not statistical model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there was no training set.
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Page 10 of 224
JUN 2 1 2012
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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.
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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
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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
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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
4 - 1
N/A