(142 days)
The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.
The proposed OMNISPAN Meniscal Repair System consists of two sterile PEEK (polyetheretherketone) implants connected by a sliding loop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile, disposable Deployment Gun with malleable Graft Retractor. The implants together with the suture provide compression across the tear in the meniscus.
This submission describes the OMNISPAN Meniscal Repair System, a medical device for arthroscopic fixation of meniscal tears. The submission asserts substantial equivalence to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K092836) is a 510(k) summary for a medical device seeking substantial equivalence, rather than a clinical study reporting specific performance metrics against pre-defined acceptance criteria. Therefore, a direct table of acceptance criteria and reported device performance, as would be found in a clinical trial report, is not present in this document.
Instead, the document states: "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use." This general statement indicates that internal testing was conducted to support the device's suitability, but the specific acceptance criteria and detailed performance results are not disclosed in this summary. The FDA's decision to clear the device implies that the agency found these undisclosed tests satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical test set with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use, supported by internal performance and safety testing, the details of which are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set is described in detail, there is no information provided regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no clinical test set is described, there is no information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on substantial equivalence based on device characteristics and predicate devices, not on direct comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical medical implant (OMNISPAN Meniscal Repair System), not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not reported.
7. Type of Ground Truth Used
The document does not describe a specific "ground truth" as would be used in an AI or diagnostic device study. The "ground truth" here pertains to the device's functionality and safety, which would have been established through internal engineering tests, biocompatibility assessments, and mechanical testing, rather than expert consensus on diagnostic images or pathology.
8. Sample Size for the Training Set
This device is a physical medical system; it does not involve an AI algorithm with a training set. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this device does not involve an AI algorithm, the concept of a "training set" and its associated ground truth is not applicable.
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K092836 p. 10f 2
SECTION 2 – 510(%) SUMMARY
| FEB - 4 2010OMNISPAN Meniscal Repair System | |
|---|---|
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767 |
| Contact Person | Ruth C. Forstadt, RACManager, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-3988Facsimile: 508-977-6955e-mail: rforstad@its.jnj.com |
| Name of Medical Device | Classification Name: Smooth or threaded metallic bone fixationfastener |
| Common/Usual Name: Bone Fixation Fastener | |
| Proprietary Name: OMNISPAN Meniscal Repair System | |
| Device Classification | This device carries FDA product codes MBI, NEW and GAT, and isclassified as Smooth or threaded metallic bone fixation fastener under21 CFR 888.3040. |
| Device Description | The proposed OMNISPAN Meniscal Repair System consists of twosterile PEEK (polyetheretherketone) implants connected by a slidingloop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile,disposable Deployment Gun with malleable Graft Retractor. Theimplants together with the suture provide compression across the tear inthe meniscus. |
| Indications for Use | The proposed OMNISPAN Meniscal Repair System is intended foruse in the arthroscopic fixation of soft tissue procedures such asmeniscal repair. |
Premarket Notification: Traditional
Omnispan Meniscal Repair System
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Substantial Equivalence
The proposed OMNISPAN Meniscal Repair System is substantially equivalent to:
- K002406 Mitek Fapidloc Meniscal Repair Device 8 (February 15, 2001);
- K023388 Mitek PDS Rapidloc Meniscal Repair Device (December 27, 2002).
The size #2-0 Orthocord suture provided with the proposed OMNISPAN Meniscal Repair System is identical to the size #2-0 Orthocord in:
- K071257 Mini Quickanchor and Quickanchor Plus with Size #2-0 Orthocord (June 29, 2007);
- 트 K080918 Double Armed Meniscal Needles with Size #2-0 Orthocord (April 23, 2008).
The proposed OMNISPAN Meniscal Repair System is also similar to:
- 트 K072322 Smith &: Nephew Ultra Fast-Fix Device (September 18, 2007);
- K073149 Arthrex Meniscal Cinch (February 11, 2008).
Safety and Performance
Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed OMNISPAN Meniscal Repair System has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Depuy Mitek c/o Ms. Ruth Forstadt Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
FEB - 4 2010
Re: K092836
Trade/Device Name: OMNISPAN Meniscal Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastner Regulatory Class: Class II Product Code: MBI, NEW, GAT . Dated: January 29, 2010 Received: February 1, 2010
Dear Ms. Forstadt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Ruth Forstadt
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.fdg.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 vours.
Barbara Buell
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): K.092834
Device Name: OMNISPAN Meniscal Repair System
Indications for Use:
The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
Barbara Buell Dorman
Division Sign-O Division Sign-Only
Division of Surgical, Orthopedic, Division of Storative Devices
510(k) Number K092836
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.