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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Colorado Therapeutics Xenograft Implant." It details the device's characteristics, intended use, and comparison to predicate devices, focusing on non-clinical testing to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes compliance with guidance and equivalence to predicate devices for various tests. Therefore, the table below will summarize the tested parameters and the finding of equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Non-Clinical Tests:	Equivalence to Predicate Devices (Permacol™ Surgical Implant, K120605, and Surgisis® Biodesign® Hernia Graft, K980431) or compliance with published guidance.
Biocompatibility (cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, hemolysis, subchronic toxicity, chronic toxicity)	Both the Xenograft Implant and predicate devices underwent the same testing, suggesting comparable biocompatibility.
Product Characterization:
- Glutaraldehyde residuals	Data reported.
- Heavy metals (final and unprocessed porcine pericardium)	Data reported.
- Volatile organic compounds	Data reported.
- Collagen typing	Device is comprised primarily of Collagen Type II, Type III, and Type IV.
- Collagenase degradation	In vitro collagenase evaluation showed equivalent degradation scores for the XI material and K120605 Permacol device.
- Pore structure	Data reported.
- DNA concentration	Data reported.
- Mesh thickness	Comparisons made via measurements of histological images, suggesting comparable thickness.
- Mesh weave characteristics	Data reported.
- Mesh density	Data reported.
- Tensile strength	Bench testing demonstrated mechanical properties (including tensile strength) of the Xenograft Implant and predicates are substantially equivalent through uniaxial testing.
- Device stiffness	Bench testing demonstrated mechanical properties (including device stiffness) of the Xenograft Implant and predicates are substantially equivalent through uniaxial testing.
- Suture pullout strength	Bench testing demonstrated mechanical properties (including suture pullout strength) of the Xenograft Implant and predicates are substantially equivalent.
- Tear resistance	Bench testing demonstrated mechanical properties (including tear resistance) of the Xenograft Implant and predicates are substantially equivalent.
In Vivo Resorption Profile and Inflammatory Response	Animal model (rabbits with inlay, bridged hernia repair) showed histopathological matrix degeneration scores equivalent to predicate K120605 Permacol. At 90 days, both had equivalent mild to moderate inflammatory response scores.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Biocompatibility: Not specified. The text indicates "Both predicates underwent the same testing," implying the Xenograft Implant also underwent this testing, but the number of samples or subjects is not provided.
- Product Characterization: Not specified for each individual test.
- In Vivo Resorption Profile and Inflammatory Response: Rabbits were used in an animal model, but the specific number of rabbits is not disclosed.
- Bench Testing (Mechanical Properties): Not specified.
Data Provenance: The studies were non-clinical (bench testing and animal studies). The document does not specify the country of origin for these studies, but the submitting company is based in the USA (Colorado). The studies are inherently "prospective" in the sense that they were conducted for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the studies are non-clinical (bench testing and animal studies) and do not involve human expert interpretation of data in the way a clinical study or AI algorithm validation would. The "ground truth" here is derived from objective measurements and histological assessments by trained personnel in laboratory settings.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. There is no mention of adjudication by human experts for the non-clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k)." The entire submission focuses on non-clinical data and substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a "Xenograft Implant" (surgical mesh), not an AI algorithm or software device. Therefore, the concept of standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Objective Measurements: For product characterization (e.g., glutaraldehyde residuals, heavy metals, collagen concentration, pore structure, thickness, mechanical properties like tensile strength, stiffness, suture pullout, tear resistance).
Histopathological Assessments: For in vivo studies on resorption profile and inflammatory response in animal models.
Established Test Methods: Compliance with standard biocompatibility testing protocols.
Comparison to Predicate Devices: The primary method of establishing "ground truth" for substantial equivalence is demonstrating that the new device performs equivalently to previously cleared predicate devices for the same tests.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical implant, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no training set for a physical implant device.

Summary

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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.

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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 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

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Indications for Use

510(k) Number (if known) K160181

Device Name

Colorado Therapeutics Xenograft Implant

Indications for Use (Describe)

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: 510(k) Summary

1. SUBMITTER

Name and Address:of Submitter	Colorado Therapeutics LLC2150 West 6" Avenue Suite LBroomfield, Colorado 80020303.469.9459
Contacts:	William (Bill) JacksonVice 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

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5. INDICATIONS FOR USE

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.

Regulation Number and Section

§ 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.