(274 days)
Not Found
No
The summary describes a collagen powder for wound management and does not mention any AI or ML components.
Yes
The product is intended for the management of various types of wounds, including diabetic and pressure ulcers, which are medical conditions that require therapeutic intervention.
No
The device is described as a "wound management device" and its intended use is for the "management of wounds," not for diagnosing them.
No
The device description explicitly states it is a "collagen matrix in powder form," indicating a physical substance, 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 wounds. This involves applying the product directly to the wound for therapeutic purposes (wound healing).
- Device Description: The device is described as a "collagen matrix in powder form intended for application as a wound management device." This further reinforces its role in wound treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are designed for diagnostic purposes, not therapeutic treatment.
- Performance Studies: The performance studies focus on biocompatibility, biochemical characterization of the collagen, viral inactivation, and particle size analysis. These are relevant to a wound care product, not an IVD.
In summary, the device is a wound care product intended for topical application to aid in wound healing, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
KGN
Device 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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
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 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
3
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
4
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
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