(89 days)
No
The description focuses on the mechanical design and function of a surgical fixation device, with no mention of AI or ML.
No
The device is described as a fixation device for ligament and tendon grafts in cruciate ligament reconstruction surgeries, which supports the healing process rather than directly treating a disease or condition.
No
This device is for the fixation of ligament and tendon grafts in surgical procedures, not for diagnosis.
No
The device description clearly details physical components (central pin, outer sleeve, threads, ribs, suture) and mechanical testing, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries." This is a surgical procedure performed on a patient's body.
- Device Description: The device is a physical implant designed to be placed within bone to secure grafts.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction.
Product codes
MBI, HRX
Device Description
The Innovasive 10mm LinX HT utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm LinX HT will be offered in two sizes, 10mm outside diameter x 40mm length, and 10mm outside diameter x 55mm length.
The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.
The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Mechanical Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive 10mm LinX HT holding strength was found to be equivalent to the strength of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
1, 36 agus
APR 27 1998
510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: January 26, 1998
2. DEVICE:
Innovasive 10mm LinX HT Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices 10mm LinX HT Ligament Fastener
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the Innovasive Devices 10mm LinX HT Ligament Fastener was the 8mm LinX HT Ligament Fastener marketed by Innovasive Devices, Marlborough, MA.
4. DEVICE DESCRIPTION:
The Innovasive 10mm LinX HT utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone. The Innovasive Devices 10mm LinX HT will be offered in two sizes, 10mm outside diameter x 40mm length, and 10mm outside diameter x 55mm length.
The outer sleeve has threads on its exterior to hold to the bone and a central ID designed to accept the pin component.
The central pin has ribs along its length designed to expand the outer sleeve as it is placed down the sleeve inside diameter. The front of the pin has a through-hole to accept a piece of suture to guide the pin into the sleeve during the deployment of the device. The suture is then removed and discarded.
1
5. INTENDED USE:
The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction.
6. COMPARISON OF CHARACTERISTICS:
The Innovasive 10mm LinX HT utilizes the same basic design for fixation into bone as the currently marketed 8mm LinX HT (K970316). This design utilizes a central pin placed inside an outer sleeve resulting in the expansion of the outer sleeve and the ultimate fixation of the device into bone.
7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
-
- Mechanical Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive 10mm LinX HT holding strength was found to be equivalent to the strength of the predicate device.
. 30141
- Mechanical Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive 10mm LinX HT holding strength was found to be equivalent to the strength of the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 27 1998
Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
K980334 Re: Innovasive 10mm LinX HT Ligament Fastener Trade Name: Requlatory Class: MBI and HRX Product Code: II January 26, 1998 Dated: January 28, 1998 Received:
Dear Mr. Page:
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 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 (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. ਜੋ 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 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 regulations.
3
Page 2 - Mr. Stephen M. Page
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 one regaration Chercuses, "Milliams".
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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE 10mm LinX HT
The 10mm LinX HT is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
Prescription Use
X
(Per 21 CFR 801.109)
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Bcolley
rative D 1980335
30087