(107 days)
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Not Found
No
The summary describes a mechanical fixation device and its instrumentation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance study is bench testing of mechanical strength.
Yes
The device is described as "for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee," indicating its use in a surgical procedure to repair or restore function, aligning with the definition of a therapeutic device.
No
The device is described as a fixation fastener for soft tissue grafts during ligament reconstruction, and its function involves physically securing a graft. It does not gather, analyze, or interpret data about a patient's health condition to inform diagnosis.
No
The device description clearly outlines physical components (Expansion Sheath, Expansion Screw, instrumentation) and a mechanical function (expanding the sheath to compress the graft), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a physical implant used to secure tissue within the knee. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or other laboratory components.
This device is clearly a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
Product codes
MBI
Device Description
The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Bench Testing: Comparison of the static holding strength of the Intratunnel Tibial Fixation Fastener compared to the predicate device in a porcine model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RCI Screw marketed by Smith & Nephen DonJoy, Carlsbad, CA
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
JAN 28 1999
K983560
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: October 8, 1998
2. DEVICE:
Innovasive Devices Intratunnel Tibial Fixation Fastener Classification Name: single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices Intratunnel Tibial Fixation Fastener
3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Innovasive Devices Intratunnel Tibial Fixation Fastener was the RCI Screw marketed by Smith & Nephen DonJoy, Carlsbad, CA
4. DEVICE DESCRIPTION:
The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.
5. INTENDED USE:
The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive Intratunnel Tibial Fixation Fastener consists of two components: the Expansion Sheath, fabricated from High Density Polyethylene, and the
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Expansion Screw, fabricated from either Acetal, or titanium. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.
The RCI Screw is fabricated from titanium and provides fixation through interface of the screw threads to the soft tissue graft.
The indications for use of the two devices are the same.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Bench Testing: Comparison of the static holding strength of the Intratunnel Tibial Fixation Fastener compared to the predicate device in a porcine model.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Mr. Eric Bannon Vice President of Requlatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
Re: K983560 Intratunnel Tibial Fixation Fastener Trade Name: Regulatory Class: II Product Code: MBI Dated: January 19, 1999 Received: January 20, 1999
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 regulations.
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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 diaqnostic 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,
cola
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 Intratunnel Tibial Fixation Fastener is for fixation of soft tissue I he intended use of the intraturiner reconstruction surgeries of the knee.
Prescription Use (Per 21 CFR 801.109)
Dcocey
(Division Sign-Off) Division of General Restors 510(k) Number