(29 days)
No reference devices are stated in this Special 510(k) Premarket Notification.
No
The document describes a xenograft implant made from porcine pericardium and mentions only changes in size. There is no mention of AI, ML, image processing, or any software-driven functionality.
Yes
The device is intended for reinforcing soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, which constitutes a therapeutic purpose.
No.
The device is described as an implant used to reinforce or repair soft tissue. Its function is to provide structural support, not to diagnose a condition.
No
The device is a physical implant made of porcine pericardium, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for implantation to reinforce and repair soft tissue. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a sterile implant made of porcine pericardium, used for surgical repair. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
Therefore, the Colorado Therapeutics Xenograft Implant is a surgical implant, not 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
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 rinsing or rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin, dry, and durable xenograft implant, which makes possible an advantageous xenograft product. The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181. This change represents a notification to the original device, K160181, and changes in dimensions are considered appropriate for review as a Special 510(k). Colorado Therapeutics followed their internal design control procedure/work instructions/forms. All phases/deliverable requirements with justification are summarized in the design control section (S-12) of this Special 510(k).
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
Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices are stated in this Special 510(k) Premarket Notification.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2017
Colorado Therapeutics LLC Mr. William Jackson Vice President Regulatory, Clinical and Compliance 2150 West 6th Avenue, Suite L Bloomfield, California 80020
Re: K172937
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 25, 2017 Received: September 26, 2017
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.
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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 (DICE) 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 (DICE) 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
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Indications for Use
510(k) Number (if known) K172937
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) |
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Section 5: Special 510(k) Summary
1. SUBMITTER
| Name and Address: | Colorado Therapeutics LLC |
|---|---|
| of Submitter | 2150 West 6th 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, September 25, 2017 |
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, OXK |
3. PREDICATE DEVICES
| Predicate Device: | Colorado Therapeutics Xenograft Implant (K160181)
This product has not been subject to a design-related recall. |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| Reference Devices: | No reference devices are stated in this Special 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 rinsing or rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin, dry, and durable xenograft implant, which makes possible an advantageous xenograft product.
The only change in this Special 510(k) Notification is the addition of two sizes: 02x03cm and 04x04cm. These sizes are both outside the 36cm² and 90cm² sizes in K160181. This change represents a notification to the original device, K160181, and changes in dimensions are considered appropriate for review as a Special 510(k).
Colorado Therapeutics followed their internal design control procedure/work instructions/forms. All phases/deliverable requirements with justification are summarized in the design control section (S-12) of this Special 510(k).
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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 DEVICE
The Colorado Therapeutics Xenograft Implant is an implantable, surgical implant that is derived from Porcine Pericardium. It is comprised primarily of Collagen Type I (35%), Type II (24%), Type III (26%), and Type IV (15%). 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 the predicate.
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 device in technological characteristics, indications for use/intended use, labels, labeling, instructions for use, packaging, storage, materials, sterilization, and cross-linking. The only difference is the two new sizes.