(267 days)
No reference devices are stated in this traditional 510(k) Premarket Notification.
No
The summary describes a passive implant made of porcine pericardium with no mention of computational analysis, image processing, or any AI/ML related terms.
Yes
The device is intended for "implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes," which directly addresses the treatment of a medical condition.
No
Explanation: The device is an implant for reinforcing soft tissue and repairing damaged soft tissue membranes, which describes a therapeutic or reparative function, not a diagnostic one.
No
The device description clearly states it is a sterile implant consisting of porcine pericardium, which is a physical material, not software. The performance studies also focus on the physical and biological properties of the implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation to reinforce soft tissue and repair damaged or ruptured soft tissue membranes. This is a surgical implant used in vivo (within the body).
- Device Description: The device is a sterile implant made of porcine pericardium, intended for surgical use.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information clearly describes a surgical implant for direct use within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXK
Device Description
Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin and dry xenograft implant that provides the suitable strength, and biocompatibility for a soft tissue repair implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Non Clinical Tests Submitted: Colorado Therapeutics LLC followed the Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, issued March 2, 1999, which is attached as Appendix 1.
Biocompatibility covered testing for cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, hemolysis, subchronic toxicity, and chronic toxicity. Both predicates underwent the same testing.
Product characterization included data for glutaraldehyde residuals, heavy metals (final and unprocessed porcine pericardium), volatile organic compounds, collagen typing, collagenase degradation, pore structure, DNA concentration, mesh thickness, mesh weave characteristics, mesh density, tensile strength, device stiffness, suture pullout strength, and tear resistance.
The resorption profile of the XI material (glutaraldehyde crosslinked porcine pericardium) was characterized through exposure to physiological conditions in vivo using a small animal model: rabbits with inlay, bridged hernia repair. Histopathological matrix degeneration scores demonstrated equivalence to our predicate. K120605 Permacol. At 90 days, in the rabbit the Xenograft Implant and our predicate. K120605 Permacol, were both observed and had equivalent inflammatory response score of mild and moderate. In addition, the XI material was challenged with an in vitro accelerated degradation environment-collagenase solution. In the in vitro collagenase evaluation equivalent score of degradation for the XI material and K120605 Permacol device were observed. Thickness comparisons were made via measurements of the histological images. Mechanical strength was determined through uniaxial testing. Overall, both the animal and in vitro study findings are substantiated with predicate device or published literature.
Bench testing demonstrated the mechanical properties of the Xenograft Implant and the predicates are substantially equivalent.
Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k).
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.
No reference devices are stated in this traditional 510(k) Premarket Notification.
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is 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, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Colorado Therapeutics LLC Mr. William Jackson Vice President Regulatory, Clinical, And Compliance 2150 West 6th Avenue, Suite L Broomfield, Colorado 80020
Re: K160181
Trade/Device Name: Colorado Therapeutics Xenograft Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM, OXK Dated: September 19, 2016 Received: September 20, 2016
Dear Mr. Jackson:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160181
Device Name
Colorado Therapeutics Xenograft Implant
Indications for Use (Describe)
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5: 510(k) Summary
1. SUBMITTER
| Name and Address:
of Submitter | Colorado Therapeutics LLC
2150 West 6" Avenue Suite L
Broomfield, Colorado 80020
303.469.9459 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------|
| Contacts: | William (Bill) Jackson
Vice President Regulatory, Clinical, and Compliance |
| Prepared by and Date: | William (Bill) Jackson, October 18, 2016 |
2. DEVICE
| Name of Device: | Colorado Therapeutics Xenograft Implant |
|---|---|
| Common or Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh (21 C.F.R. §878.3300) |
| Device Class: | Class II |
| Product Code: | FTM and OXK |
3. PREDICATE DEVICES
| Predicate Device: | Permacol TM Surgical Implant, Covidien (K120605)
This product has not been subject to a design-related recall. |
|--------------------|----------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Surgisis® Biodesign® Hernia Graft, Cook Biotech (K980431)
This product has not been subject to a design-related recall. |
| Reference Devices: | No reference devices are stated in this traditional 510(k)
Premarket Notification. |
4. DEVICE DESCRIPTION
Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin and dry xenograft implant that provides the suitable strength, and biocompatibility for a soft tissue repair implant.
4
5. INDICATIONS FOR USE
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Colorado Therapeutics Xenograft Implant (XI) is an implantable, surgical implant that is derived from Porcine Pericardium. It is comprised primarily of Collagen Type II, Type III, and Type IV. It functions as a xenograft implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, as do the predicates.
Non Clinical Tests Submitted: Colorado Therapeutics LLC followed the Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, issued March 2, 1999, which is attached as Appendix 1.
Biocompatibility covered testing for cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, hemolysis, subchronic toxicity, and chronic toxicity. Both predicates underwent the same testing.
Product characterization included data for glutaraldehyde residuals, heavy metals (final and unprocessed porcine pericardium), volatile organic compounds, collagen typing, collagenase degradation, pore structure, DNA concentration, mesh thickness, mesh weave characteristics, mesh density, tensile strength, device stiffness, suture pullout strength, and tear resistance.
The resorption profile of the XI material (glutaraldehyde crosslinked porcine pericardium) was characterized through exposure to physiological conditions in vivo using a small animal model: rabbits with inlay, bridged hernia repair. Histopathological matrix degeneration scores demonstrated equivalence to our predicate. K120605 Permacol. At 90 days, in the rabbit the Xenograft Implant and our predicate. K120605 Permacol, were both observed and had equivalent inflammatory response score of mild and moderate. In addition, the XI material was challenged with an in vitro accelerated degradation environment-collagenase solution. In the in vitro collagenase evaluation equivalent score of degradation for the XI material and K120605 Permacol device were observed. Thickness comparisons were made via measurements of the histological images. Mechanical strength was determined through uniaxial testing. Overall, both the animal and in vitro study findings are substantiated with predicate device or published literature.
Bench testing demonstrated the mechanical properties of the Xenograft Implant and the predicates are substantially equivalent.
Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k).
Conclusion: The Colorado Therapeutics Xenograft Implant was found to be substantially equivalent to the predicate devices in technological characteristics, indications for use/intended use, biocompatibility, and product characterizations.