(274 days)
Collagen Powder 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
Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
The provided text is a 510(k) summary for Collagen Powder. It asserts substantial equivalence to predicate devices based on materials, intended use, and biocompatibility. However, it does not include acceptance criteria or the details of a study proving the device meets specific performance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trial data, performance metrics).
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Reasoning: The document primarily focuses on demonstrating "substantial equivalence" based on materials, intended use, and biocompatibility testing against a predicate device. It does not define specific performance metrics (e.g., wound healing rates, infection reduction) for the Collagen Powder or report results against such criteria. The "testing" mentioned is for biocompatibility, viral inactivation, and particle size, which are typically safety and characterization tests rather than performance efficacy tests against clinical acceptance criteria.
Study Information
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Biocompatibility and Testing" and "Biochemical characterization," and "Viral inactivation validation assessment," and "Particle size analysis." These are laboratory tests, not clinical studies with human participants. No sample sizes or data provenance for a clinical test set are provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical test set with ground truth established by experts is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
-
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:
- No, not performed. This device is a topical wound dressing, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This is a physical wound dressing, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical performance. For the characterization tests (biocompatibility, viral inactivation, particle size), the "ground truth" would be established by validated laboratory assays and standards (e.g., ISO 10993).
-
The sample size for the training set:
- Not applicable. No training set for an algorithm is discussed.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is discussed.
Summary of Device Rationale from the Document:
The 510(k) submission for Collagen Powder relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Collagen Sponge K092805 and Collatek Powder K012990). This is achieved by:
- Stating that Collagen Powder has the same intended use (management of various types of wounds) as the predicates.
- Confirming that its materials of construction match Collagen Sponge (K092805).
- Providing biocompatibility evaluation (ISO 10993-1:2009) to show it meets requirements and introduces no new biocompatibility issues.
- Conducting biochemical characterization to confirm the collagen is predominantly Type I and not denatured.
- Performing viral inactivation validation to assure safety.
- Conducting particle size analysis for product characterization.
Crucially, this type of 510(k) submission for an Unclassified device like a topical wound dressing does not typically require extensive clinical efficacy studies with predefined "acceptance criteria" and "performance metrics" in the same way a novel diagnostic or therapeutic device might. Substantial equivalence is often established through comparison to predicates and demonstrating equivalent safety and performance characteristics via bench testing and material characterization, rather than comparative clinical outcomes data for specific performance metrics like wound healing rates.
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12
SEP 1 4 2011
Innocoll
Pharmaceuticals
Midlands Innovation and Research Centre Dublin Road, Athlone, Co. Westmeath, Ireland Tel: + 353 (0)90 6486834 Fax: + 353 (0)90 6486835 www.innoooll-pharma.com
510(k) Summary
Date Prepared: Submitter:
September 13" 2011 Innocoll Pharmaceuticals, Midland Innovation and Research Centre, Dublin Road, Athlone, Co. Westmeath Ireland.
| Submission Correspondent: | Aaron Wyse |
|---|---|
| Director of Regulatory Affairs | |
| Tel: +353 (0) 87 0520845 | |
| Fax: +353 (0) 9066 34895 |
Proprietary Name:
Collagen Powder
Common Name:
Topical Wound Dressing
Device Classification:
Product Code: Classification Name: Regulatory Class:
KGN Dressing Wound Collagen Unclassified
Statement of Substantial Equivalence:
Collagen Powder is substantially equivalent in materials of construction and intended use to Collagen Sponge (K092805) and Collatek Powder (K012990). Collagen Powder has been evaluated for its biocompatibility which meets requirements and is therefore substantially equivalent to the predicates delineated in this submission. Collagen Powder is manufactured from the same ingredients used for the manufacture of Collagen Sponge (K092805).
Collagen Powder 510k 510k Summary
5 - 1
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Intended Use:
Collagen Powder may be used for the management of wounds such as:
- Diabetic ulcers o
- o Venous ulcers
- Pressure ulcers o
- Ulcers caused by mixed vascular etiologies o
- Full-thickness & partial thickness wounds O
- Abrasions o
- Traumatic wounds o
- 1st and 2nd degree burns O
- o Dehisced surgical wounds
- o Exuding wounds
Description:
Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
Biocompatibility and Testing:
Evaluation of the biocompatibility of Collagen Powder was completed in line with the requirements of ISO 10993 -1: 2009. There are no new biocompatibility issues arising with the use of Collagen Powder; 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.
Particle size analysis was conducted on the finished product which verified a particle size range for Collagen Powder.
Conclusion:
Collagen Powder is substantially equivalent to the predicate devices delineated in this submission and meets the requirements for premarket notification as defined in CFR21, Part 807.
Collagen Powder 510k 510k Summary
5 - 2
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Innocoll Pharmaceuticals. Ltd. % Mr. Aaron Wyse Directory of Regulatory Affairs Midlands Innovation & Research Centre, Dublin Road Athione, Co. Westmeath Ireland
- Re: K103648
Trade/Device Name: Collagen Powder Regulatory Class: Unclassified Product Code: KGN Dated: September 1, 2011 Received: September 6, 2011
SEP 1 4 201
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
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Page 2 - Mr. Aaron Wyse
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.lda.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 io
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/det/ault.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/Industrv/default.htm.
DESIGN TOURNAMENT PARTICIPANTS
Sincerely yours,
Mark A. Milken
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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K103 648
Statement of Indications for Use
510(k) Number (if known):
Device Name:
Collagen Powder
Indications For Use:
Collagen Powder may be used for the management of wounds such as:
- Diabetic ulcers o
- 0 Venous ulcers
- Pressure ulcers 0
- Ulcers caused by mixed vascular etiologies 0
- Full- & partial thickness wounds 0
- Abrasions ಂ
- Traumatic wounds 0
- 1st and 2nd degree burns O
- Dehisced surgical wounds 0
- Exuding wounds O
Prescription Use X (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)
R
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Collagen Powder 510k Indications for Use
4 - 1
N/A