(191 days)
K810193A
Not Found
No
The summary describes a mechanical device for cervical spine stabilization and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for stabilization of the cervical spine following injuries or surgery, which are therapeutic interventions.
No
The device is described as pins used for stabilization of the cervical spine in traction following injuries or surgery, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states that the skull pins are the only invasive component and are hardware (pins, ring, and tong). The summary does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided description clearly states that this device is used for stabilization of the cervical spine through physical means (pins, tongs, halo rings). It is an implantable or externally applied device that interacts directly with the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the intended use and device description, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
- Cervical fractures
- Ligamentous injury of the cervical spine
- Fusion or other surgery of the cervical spine
Product codes
87LXT
Device Description
The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DePuy ACE Standard Skull Pin, K810193A
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
MAY 2 9 1998
ﺳﺴﺴﺴ
مسيد،
NAME OF FIRM:
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE CODE:
510(k) CONTACT PERSON:
Image /page/0/Picture/2 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuy ACE" in a bold, sans-serif font. The letters are all capitalized, and the "TM" symbol is located in the bottom right corner of the "E" in "ACE". The logo is simple and modern, and the black color gives it a sense of authority.
510(k) SUMMARY
DePuv ACE Medical Company 2260 East El Segundo Boulevard El Segundo, CA 90245
Kathleen Dragovich Regulatory Affairs Specialist DePuy ACE Medical Company
DePuy ACE Ring Skull Pin - MRI DePuy ACE Spring Loaded Skull Pin - MRI DePuy ACE Fixed Tip Tong Pin - MRI
Pins
87LXT
.
888.3030 Single/Multiple Component Metallic Bone Fixation Appliances and Accessories
SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy ACE Standard Skull Pin DePuy ACE Spring Loaded (Trippi-Wells) Skull Pin DePuy ACE Fixed Tip Tong
INTENDED USE:
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
- 트 Cervical fractures
- Ligamentous injury of the cervical spine
- 이 Fusion or other surgery of the cervical spine
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.
The DePuy ACE Ring Skull Pin - MRJ is similar in design and indications for use to the DePuy ACE Standard Skull Pin, a preamendment device. The DePuy ACE Spring Loaded Tong Pin - MRI and the DePuy ACE Fixed Tip Tong Pin - MRI are similar in design and indications for use to the DePuy ACE Spring Loaded (Trippi-Wells) Skull Pin, which received approval under 510(k) K810193A.
Based on the above information, DePuy ACE Medical Company firmly believes that the new skull pins are substantially equivalent to the previously approved versions.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a symbol that appears to be three stylized human profiles facing to the right.
MAY 2 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Doner Director Regulatory and Clinical Affairs DePuy ACE Medical Company 2260 East El Segundo Boulevard El Segundo, California 90245
Re: K974245 DePuy ACE Ring Skull Pins, Loaded Tongs, and Fixed Tongs - MRI Compatible March 10, 1998 Dated: Received: March 11, 1998
Dear Mr. Doner:
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 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 requlations 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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.
2
Page 2 - Mr. Paul Doner
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 requlation (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,
C. Sabine M. Hillebrecht, Ph.D.
Witten, Ph.D., M.D. ia M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
DePuy ACE Ring Skull Pins - MRI Device Name: DePuy ACE Spring Loaded Tong Pin - MRI DePuy ACE Fixed Tip Tong Pin - MRI
Indication for User:
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
- Cervical fractures I
- Ligamentous injury of the cervical spine 피
- Fusion or other surgery of the cervical spine 트
Concurrence of CDRH, Office of Device Evaluation
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K974245 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter | |
|---|---|
| ------------------ | -- |