(142 days)
No
The device description and summary do not mention any AI or ML components or functionalities. The device is a mechanical system for meniscal repair.
Yes
The device is described as an "OMNISPAN Meniscal Repair System" intended for "arthroscopic fixation of soft tissue procedures such as meniscal repair," which directly treats a medical condition (meniscal tears).
No
This device is described as a "Meniscal Repair System" intended for the "arthroscopic fixation of soft tissue procedures such as meniscal repair," and "provides compression across the tear in the meniscus." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists physical components like PEEK implants, suture, and a Deployment Gun, indicating it is a hardware-based medical device.
Based on the provided information, the OMNISPAN Meniscal Repair System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthroscopic fixation of soft tissue procedures such as meniscal repair." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implants, suture, and a deployment gun. These are all physical components used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The OMNISPAN system does not perform any such analysis of specimens.
Therefore, the OMNISPAN Meniscal Repair System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI, NEW, GAT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Meniscus
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)
Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.
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.
K071257, K080918, K072322, K073149
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
§ 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.
0
K092836 p. 10f 2
SECTION 2 – 510(%) SUMMARY
| | FEB - 4 2010
OMNISPAN Meniscal Repair System |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
| Contact Person | Ruth C. Forstadt, RAC
Manager, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-977-3988
Facsimile: 508-977-6955
e-mail: rforstad@its.jnj.com |
| Name of Medical Device | Classification Name: Smooth or threaded metallic bone fixation
fastener |
| | 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 is
classified as Smooth or threaded metallic bone fixation fastener under
21 CFR 888.3040. |
| Device Description | 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. |
| 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. |
Premarket Notification: Traditional
Omnispan Meniscal Repair System
1
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.
2
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
3
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
4
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