(68 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a physical screw for meniscal repair, with no mention of AI or ML.
Yes
The device is described as "intended for meniscal repair" and its use in "arthroscopic fixation of longitudinal vertical meniscus lesions." These functions directly treat a medical condition (meniscal lesions) to improve patient health, classifying it as a therapeutic device.
No
The device is a Meniscal Screw intended for the surgical repair of meniscus lesions, not for diagnosing medical conditions.
No
The device description clearly states it is a physical screw fabricated from L-PLA and includes a stainless steel driver mechanism, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Meniscal Screw is a surgical implant used to physically repair a torn meniscus within the body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "arthroscopic fixation of longitudinal vertical meniscus lesions," which is a surgical procedure.
- Device Description: The description details a physical screw and driver for insertion into the meniscus.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, providing diagnostic information, or using any in vitro techniques.
Therefore, based on the provided information, the Meniscal Screw is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
Product codes
II
Device Description
The Meniscal Screw is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a cannulated, threaded member designed to be inserted into the meniscus across the tear. The device is screwed into location with the aid of a sterile, single use driver mechanism constructed of stainless steel. The driver is loaded with the Meniscal Screw and placed through a cannula to access the site requiring repair.
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
- Bench Testing: Comparison of the fatigue strength of the Meniscal Screw invitro compared to the predicate device. In addition the performance of the device was assessed under constant load as was the weight loss and intrinsic viscocity.
- Animal Testing: The testing demonstrated the efficacy of the Innovasive Meniscal Screw and confirmed that the device functions adequately to meet its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Eric Bannon, Vice President of Regulatory Affairs, Quality Assurance Date Prepared: February 10, 1998
2. DEVICE:
Innovasive Meniscal Screw Classification Name: Bioabsorbable Orthopedic Fixation Device Trade Name: Innovasive Devices Meniscal Screw
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Innovasive Devices Meniscal Screw was the Bionx Arrow marketed by Bioscience Ltd, Malvern, PA
4. DEVICE DESCRIPTION:
The Meniscal Screw is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a cannulated, threaded member designed to be inserted into the meniscus across the tear. The device is screwed into location with the aid of a sterile, single use driver mechanism constructed of stainless steel. The driver is loaded with the Meniscal Screw and placed through a cannula to access the site requiring repair.
5. INTENDED USE:
The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
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6. COMPARISON OF CHARACTERISTICS:
The Meniscal Screw is fabricated from L-PLA, the same material as the Bionx Arrow. The design differs in the use of an external screw thread designed to draw the edges of the tissue together as the device is placed into the meniscus.
The Bionx Arrow uses a different technique to approximate the tear. The Arrow is inserted over a wire using a cannula to establish the device location.
The indications for use of the two devices are identical.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Bench Testing: Comparison of the fatigue strength of the Meniscal Screw invitro compared to the predicate device. In addition the performance of the device was assessed under constant load as was the weight loss and intrinsic viscocity.
-
- Animal Testing: The testing demonstrated the efficacy of the Innovasive Meniscal Screw and confirmed that the device functions adequately to meet its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is composed of three curved lines that converge and then split into three wavy lines at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1998
Mr. Eric Bannon ·Vice President of Requlatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
K980681 Re: Trade Name: Meniscal Screw Regulatory Class: HWC and HRX Product Code: II Dated: February 18, 1998 February 20, 1998 Received:
Dear Mr. Bannon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. . A. ... .......... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Eric Bannon
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).
Prescription Use
(Per 21 CFR 801.109)
( ್ತಿ.
(Division Sign-Off)
(Division of General Restorative Devices K980681 510(k) Number ________________________________________________________________________________________________________________________________________________________________