(243 days)
Not Found
No
The device description focuses on the biological composition and physical form of the wound care product, with no mention of computational analysis, algorithms, or learning processes.
Yes.
Excellagen is indicated for the management of various types of wounds, which is a therapeutic purpose.
No
The provided text explicitly states that Excellagen is "indicated for the management of wounds" and describes it as a "wound care device composed of formulated...collagen that is topically applied directly to the wound surface." This indicates a therapeutic or treatment function rather than a diagnostic one.
No
The device description clearly states that Excellagen is a wound care device composed of formulated fibrillar bovine dermal collagen, packaged in syringes with applicators. This is a physical substance and delivery system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Excellagen is for the "management of wounds." This involves topical application to the wound surface for healing purposes.
- Device Description: The description details a wound care device composed of collagen that is "topically applied directly to the wound surface."
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are used for diagnosis, monitoring, or screening.
Excellagen is a therapeutic device intended to aid in wound healing, not a diagnostic device.
N/A
Intended Use / Indications for Use
Excellagen is a wound care device intended for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for onetime use.
Excellagen is contraindicated for individuals with a known sensitivity to products of bovine origin.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (Type I) that is topically applied directly to the wound surface. Excellagen is packaged as single-use units to ensure safety and provide for easy topical application. The device is tested for sterility in accordance with USP. Excellagen is supplied in one of two kit configurations. One kit configuration consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% (26 mg/mL) formulated collagen, and four singleuse sterile flexible applicators. This kit can be used for smaller wounds. The second kit configuration consists of one single-use 10.0 cc syringe containing 4.0 cc of 2.6% (26 mg/mL) formulated collagen, and one single-use sterile flexible applicator. This kit can be used for larger or tunneling/undermined wounds. Excellagen is stored at standard refrigeration temperature (2-8°C).
During manufacture, the collagen component of Excellagen is purified using a specialized process that eliminates impurities (including endotoxins), and removes denatured molecules and collagen fragments. Excellagen consists almost exclusively of high molecular weight, intact, fibrillar collagen and is formulated at a concentration of 2.6% (26 mg/mL) in an isotonic buffer with protein stabilizing agents.
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)
The safety of Excellagen has been established based on standard non-clinical in vitro (cytotoxicity) and in vivo (sensitization and intracutaneous reactivity) biocompatibility testing in accordance with ISO 10993-1. Excellagen was found to be biocompatible in all tests.
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.
Integra Flowable Wound Matrix, K072113, Stimulen Collagen, K030774, Medifil gel, K910944, HyCure Hydrolyzed Collagen, K955506, Collatek Powder, K012990, HeliDerm Collagen Wound Dressing, K990086
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 110318
P 1/3
510(k) SUMMARY
OCT - 3 2011
Submitter's Information Name :
Address:
Tissue Repair Company 12255 El Camino Real, Suite 250 San Diego, CA 92130 858-793-6641 858-793-7243
Telephone: Fax:
Contact Person
Name: Telephone: Email:
Lois Chandler, Ph.D. 858-436-1012 Ichandler@cardiumthx.com
Date Summary was Prepared: October 4, 2011
Device Information
Proprietary Name: Common Name: Classification Name: Product Code:
Excellagen Collagen Wound Dressing Dressing, Wound, Collagen KGN
Predicate Devices
Integra Flowable Wound Matrix, K072113 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086
Device Description
Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (Type I) that is topically applied directly to the wound surface. Excellagen is packaged as single-use units to ensure safety and provide for easy topical application. The device is tested for sterility in accordance with USP. Excellagen is supplied in one of two kit configurations. One kit configuration consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% (26 mg/mL) formulated collagen, and four singleuse sterile flexible applicators. This kit can be used for smaller wounds. The
1
) to the following products which have been cleared to market under Section 510(k) premarket notifications: Integra Flowable Wound Matrix (K072113), Stimulen Collagen (K030774) Medifil gel (K910944), HyCure Hydrolyzed Collagen (K955506), Collatek Powder (K012990), HeliDerm Collagen Wound Dressing (K990086).
Conclusion
Excellagen is safe under the proposed conditions of use and substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text is small and difficult to read, but it appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a bird in flight or a stylized representation of water waves. The logo has a simple, clean design and is likely used to represent the organization or agency it belongs to.
Food and Drug Achumstration 10903 New Hamoshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Tissue Repair Company % Lois Chandler, Ph.D. 12255 El Camino Real. Suite 250 San Diego. California 92130
Re: K110318
Trade/Device Name: Excellagen Regulatory Class: Unclassified Product Code: KGN Dated: September 26. 2011 Received: September 27. 2011
OCT - 3 2011
Dear Dr. Chandler:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 - Lois Chandler, Ph.1).
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.
ff 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/CDRHQffices/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/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometries/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,
Sincerely yours,
for
Kim
Coalition
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KII 0318 510(k) Number (if known): __
Device Name: Excellagen
Indications for Use:
Excellagen is indicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 801 Subpart C) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |
| CONFIDENTIAL Number | 1k 110318 |