(72 days)
Not Found
No
The device description focuses on mechanical fixation components and materials, with no mention of AI/ML terms or functionalities.
Yes.
The device functions to provide immediate stability and temporary fixation following fractures, which facilitates the natural healing process.
No
The device is a compression fixation system used in the treatment of fractures, not for diagnosing them.
No
The device description explicitly states it consists of physical components like plates and screws made of stainless steel, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The VHS™ Supracondylar Plate System is a surgical implant used to fix bone fractures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to treat supracondylar and distal femoral fractures, which is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the VHS™ Supracondylar Plate System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
Product codes
KTT, KTW
Device Description
The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femoral
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Compression Hip Screw Supracondylar Compression Tube & Plate System ( Zimmer ), AMBI Hip Screw System ( S &N Richards ), DHS / DCS Dynamic Hip and Condylar Screw System ( Synthes ), Versa-Fx Femoral Fixation System ( Zimmer ), Omega Plus Supracondylar Sideplates ( Howmedica ), Combination NoLok/ Keyed Compression Hip Screw System ( DePuy ), Medoff Supracondylar Plate System ( Wright Medical Technology ), BMP Supracondylar Cable Plate System ( Biomet )
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
991806
Summary of Safety and Effectiveness for VHS™ Supracondylar Plate System
This safety and effectiveness summary for the VHS™ Supracondylar Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter : | Contact Person : |
|---|---|
| Walter Abendschein, M.D. | Walter Abendschein, M.D. |
| 5530 Wisconsin Avenue, Suite 705 | 5530 Wisconsin Avenue, Suite 705 |
| Chevy Chase, Md. 20815 | Chevy Chase, Md. 20815 |
| Telephone: (301) 656 4317 |
Date Prepared: May 26,1999
Telephone: (301) 656-4317
| 2. Tradename: | VHS TM Supracondylar Plate System |
|---|---|
| Common Name: | Supracondylar Plate System |
| Classification Name: | Single/ multiple component metallic bone fixation appliances and accessories |
| (888.3030) |
3. Predicate or legally marketed devices which are substantially equivalent:
- Compression Hip Screw Supracondylar Compression Tube & Plate System ( Zimmer ) .
- . AMBI Hip Screw System ( S &N Richards )
- DHS / DCS Dynamic Hip and Condylar Screw System ( Synthes ) ●
- Versa-Fx Femoral Fixation System ( Zimmer )
- . Omega Plus Supracondylar Sideplates ( Howmedica )
- Combination NoLok/ Keyed Compression Hip Screw System ( DePuy ) .
- Medoff Supracondylar Plate System ( Wright Medical Technology ) ●
- BMP Supracondylar Cable Plate System ( Biomet ) .
4. Description of the device :
The VHS™ Supracondylar Plate System is a compression fixation system used for the treatment of distal femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.
Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the distal femur.
5. Intended Use:
The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the VHS™ Supracondylar Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 1999
Walter Abendschein, M.D. 5530 Wisconsin Avenue Suite 705 Chevy Chase, MD 20815
Re: K991806
Trade Name: VHS™ Supracondylar Plate System Regulatory Class: II Product Code: KTT/KTW Dated: May 26, 1999 Received: May 26, 1999
Dear Dr. Abendschein:
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 control provisions of the Act. The general control 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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.
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.
2
Page 2 - Dr. Walter Abendschein
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 at (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
3
Page__1__of_ 1__
510(k) Number (if known): K991806
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The VHS™ Supracondylar Plate System is indicated for use in the treatment of supracondylar fractures and distal femoral fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) /
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K991806
510(k) Number
| Prescription Use (Per 21 CFR 801.109) | Y |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | No |
|---|---|
| ----------------------------------------------- | ---- |