(90 days)
Not Found
Not Found
No
The summary describes a mechanical device (skull pin) and its intended use in cervical traction. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended for use with cervical traction devices that facilitate healing and rehabilitation of cervical spinal cord injuries, indicating a therapeutic purpose.
No
The device description indicates it is a skull pin used for cervical immobilization in conjunction with traction devices, not for diagnosing a condition. Its purpose is mechanical support and stabilization.
No
The device description clearly states it is a physical skull pin made of titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cervical immobilization in conjunction with a halo system for healing and rehabilitation of cervical spinal cord injuries. This is a therapeutic and mechanical function, not a diagnostic one.
- Device Description: The device is a skull pin used for traction. This is a physical component of a medical device system, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical component used to apply traction to the skull for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
Product codes
JEC, HWC
Device Description
The Bremer Halo System Titanium Skull Pin described in this submission is a modification of the previously cleared Bremer Halo System Sterile Cervical Traction Skull Pin, The modified pin is longer than the previously cleared pin and the tip is a drill bit rather than a pointed tip. The Bremer Halo System Titanium Skull Pin is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spinal cord
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
Testing was presented to evaluate the performance characteristics of the Bremer Halo System Titanium Skull Pin.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
K99309
DEC I 5 1999
510(k) Summarv
SUBMITTER:
DePuv AcroMed 326 Paramount Drive Ravnham. MA 02767 Fax (508) 828-3797
Bremer Medical 4801 Dawin Road Jacksonville.FL 32207
- CONTACT PERSON: Frank Maas (508) 828-3390 Lisa Gilman (508) 880-8287
DATE PREPARED: 12-8-99
CLASSIFICATION NAME AND REFERENCE: Smooth or threaded metallic bone fastener, §888.3040 Skull tong for traction, §888.3070
COMMON NAME: Traction Skull Pin
Bremer Halo System Titanium Skull Pin PROPRIETARY NAME:
PURPOSE: Modification of an existing device.
DESCRIPTION:
The Bremer Halo System Titanium Skull Pin described in this submission is a modification of the previously cleared Bremer Halo System Sterile Cervical Traction Skull Pin, The modified pin is longer than the previously cleared pin and the tip is a drill bit rather than a pointed tip.
The Bremer Halo System Titanium Skull Pin is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.
Testing was presented to evaluate the performance characteristics of the Bremer Halo System Titanium Skull Pin.
The substantial equivalence of the Bremer Halo System Titanium Skull Pin is based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin.
The Bremer Halo System Titanium Skull Pin is intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories (Halo System), which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
1
Image /page/1/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 image of an eagle with three lines representing its body and wings. 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
DEC 1 5 1999
Mr. Frank Maas Manager, Regulatory Affairs DePuy AcroMed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K993099
Trade Name: Bremer Halo System Titanium Skull Pin Regulatory Class: II Product Code: JEC and HWC Dated: September 13, 1999 Received: September 16, 1999
Dear Mr. Maas:
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 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 (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 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 -- Mr. Frank Maas
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,
Neil A. P. Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K993099
Device Name:
Indications for Use:
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
Ro for
(Division Sign-Off)
Division of General Restorative Devices K993099
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (per 21 CRF 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)