(241 days)
Not Found
No
The device description and other sections do not mention AI or ML, and the device appears to be a passive wound dressing.
Yes
The device is used for the management of wounds, including various types of ulcers and burns, which are conditions that require therapeutic intervention to heal or improve.
No
The device, Collexa, is a collagen matrix sponge intended for the management and topical use on wounds, not for diagnosis. Its description and intended use focus on treatment and wound care, not on identifying conditions or diseases.
No
The device description clearly states it is a "collagen matrix sponge with a polyurethane foam backing," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Collexa is for the "management of wounds" and lists various types of wounds it can be used on. This is a therapeutic or wound care application, not a diagnostic one.
- Device Description: The description details a "collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds." This describes a physical device applied to the body for healing, not a test performed on a sample outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. Collexa's function is to aid in wound healing, which is a treatment/management activity, not a diagnostic one.
N/A
Intended Use / Indications for Use
Collexa 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 .
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. 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)
Biocompatibility testing has confirmed that Collexa meets all the biocompatibility testing requirements in accordance with ISO 10993-1:2009. Biocompatibility data demonstrates that Collexa is safe for use as a wound management device.
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
K100574|S1 OCT 2 8 2010
Page 5 - 1
Page 5 - 1
Innocoll
Pharmaceuticals
.innocoll-pharma.com
FDA CDRH DMC
OCT 04 2010
Received K46
- Date Prepared:
510(k) Summary
September 9th , 2010
- Submitter
Innocoll 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
-
- Proprietary Name: Collexa
-
- Common Name: Topical Wound Dressing
-
- Device Classification: Product Code: KGN Classification Name: Dressing Wound Collagen Regulatory Class: Unclassified
6. Statement of Substantial Equivalence:
Collexa is substantially equivalent in materials of construction and intended use to Collatek Foam (K012997) and Collagen Sponge (K092805).
1
7. Intended Use
Collexa 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 .
8. Description
Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.
9. Biocompatibility
Biocompatibility testing has confirmed that Collexa meets all the biocompatibility testing requirements in accordance with ISO 10993-1:2009. Biocompatibility data demonstrates that Collexa is safe for use as a wound management device.
10. Conclusion
Collexa 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 depiction of an eagle or bird-like figure, with three overlapping lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innocoll Pharmaceuticals % Mr. Aaron Wyse Director of Regulatory Affairs Midlands Innovation and Research Centre Dublin Road, Athlone Co. Westmeath, Ireland
Re: K100574
OCT 2 8 2010
Trade/Device Name: Collexa Regulatory Class: Unclassified Product Code: KGN Dated: October 01, 2010 Received: October 04, 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
3
Page 2 - Mr. Aaron Wyse
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 (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 yours,
Mark N. Melkerson
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
OCT 2 8 2010
100574 510(k) Number (if known):
Device Name: Collexa
Indications For Use:
Indications:
Collexa may be used for the management of wounds including.
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Abrasions
- Traumatic wounds
- 154 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 Keane for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number K100574