(24 days)
The CrossFix® II Meniscal Repair Device is intended for approximation of soft tissue in meniscal repair procedures.
The CrossFix® II Meniscal Repair device is a sterile hand-held, manually operated, single procedure suture placement system for meniscus soft tissue approximation procedures.
The provided text describes the CrossFix® II Meniscal Repair Device, its intended use, and a summary of performance tests conducted. However, it does not contain a detailed study proving the device meets specific acceptance criteria with the level of detail requested in the prompt. The text references "predetermined acceptance criteria" for bench testing but does not list them or provide quantitative results in the form of a table.
Therefore, the following information is extracted from the document, and where specific details are not available, it is noted.
Acceptance Criteria and Device Performance Study for CrossFix® II Meniscal Repair Device
The CrossFix® II Meniscal Repair Device underwent performance tests in a simulated use environment and bench testing to demonstrate its functionality and strength.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in text) | Reported Device Performance |
|---|---|---|
| Simulated Use Environment | Device insertion, deployment, and removal functionality | Validated |
| Bench Testing | Suture knot pull out force (specific value not reported) | Meets predetermined criteria |
| Suture tensile strength (specific value not reported) | Meets predetermined criteria | |
| Suture diameter (specific value not reported) | Meets predetermined criteria | |
| Handle deployment force (specific value not reported) | Meets predetermined criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the simulated use environment testing or bench testing (e.g., number of devices, number of sutures tested). The data provenance is implied to be from in-vitro bench testing and simulated use, without information on country of origin or whether it's retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for the performance tests would be the established engineering and functional specifications for the device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The performance tests appear to be quantitative measurements against engineering specifications rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The document focuses on the device's functional performance and equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable to a mechanical medical device like the CrossFix® II Meniscal Repair Device, which is a suture placement system. There is no algorithm involved in its direct operation.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is based on engineering specifications and predetermined acceptance criteria for mechanical properties (suture knot pull out force, tensile strength, diameter, handle deployment force) and functional operation (insertion, deployment, removal).
8. Sample Size for the Training Set
This is not applicable, as there is no "training set" in the context of this mechanical device's performance validation. The device doesn't involve machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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510(k) Premarket Notification
CrossFix II Meniscal Repair Device
Revised 510(k) Summary
JUN - 4 2012
Cayenne Medical, Inc. Special 510(k): Device Modification
CrossFix® II Meniscal Repair Device
ADMINISTRATIVE INFORMATION
510(k) Number:
K121413
Manufacturer Name:
Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 502-3661 FAX (480) 502-3670
Official Contact:
Kereshmeh Shahriari 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 kshahriari@cayennemedical.com Telephone (480) 502-3661 FAX (480) 502-3670
DEVICE NAME
| Classification Names: | Suture, Nonabsorbable, Synthetic, Polyethylene |
|---|---|
| Trade/Proprietary Name: | CrossFix® II Meniscal Repair Device |
| Common Name: | Suture Punch, Endoscopic Accessories |
DEVICE CLASSIFICATION
FDA has classified sutures as Class II devices (21 CFR 878.5000). The product code for Suture, Nonabsorbable, Synthetic, Polyethylene is GAT. These devices are reviewed by the General and Plastic Surgery Branch.
INTENDED USE
The CrossFix® II Meniscal Repair Device is intended for approximation of soft tissue in meniscal repair procedures.
Revised Page 16 of 100
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DEVICE DESCRIPTION
The CrossFix® II Meniscal Repair device is a sterile hand-held, manually operated, single procedure suture placement system for meniscus soft tissue approximation procedures.
SUMMARY OF PERFORMANCE TESTS
Product performance test was conducted in a simulated use environment. Device insertion, deployment, and removal were validated.
Bench testing was conducted and showed that the implantable suture meets all predetermined acceptance criteria. These verification tests included suture knot pull out force, suture tensile strength, suture diameter, and handle deployment force.
EQUIVALENCE TO MARKETED PRODUCT
The CrossFix® II Meniscal Repair device has the following similarities to the unmodified predicate devices:
- · has the same intended use,
- uses the same operating principle, .
- incorporates the same basic design, .
- · incorporates the same polymer materials,
- · incorporates equivalent metallic materials, and
- · is packaged using the same materials and processes.
In summary, the CrossFix® II Meniscal Repair device described in this submission is, in our opinion, substantially equivalent to the predicate devices.
Revised Page 17 of 100
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 4 2012
Cayenne Medical, Inc. % Kereshmeh Shahriari Senior Director of Regulatory Affairs, Quality Assurance and Compliance 16597 North. 92nd Street, Suite 101 Scottsdale, Arizona 85260
Re: K121413
Trade/Device Name: CrossFix® II Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly (ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: May 08, 2012 Received: May 11, 2012
Dear Kereshmeh Shahriari:
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
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Page 2 - Kereshmeh Shahriari
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
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121413
CrossFix® II Meniscal Repair Device Device Name:
Indications For Use:
The CrossFix® II Meniscal Repair Device is intended for approximation of soft tissue in meniscal repair procedures.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K121413
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.