(79 days)
The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
The Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 mm increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to a medical device's analytical or clinical performance (e.g. sensitivity, specificity, accuracy).
The document is a 510(k) premarket notification from the FDA for the Synthes Sacral Bar System, dated August 24, 2000. It primarily focuses on the substantial equivalence of the device to predicate devices for marketing purposes.
Here's what the document does include:
- Device Name: Synthes Sacral Bar System
- Intended Use: Fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
- Material: Implant quality stainless steel.
- Predicate Devices: Zimmer Threaded Sacral Rod, Synthes Threaded Bolt.
- Regulatory Class: II, Product Code: JDW.
However, the document does not include:
- A table of acceptance criteria (e.g., sensitivity, specificity, accuracy metrics).
- Reported device performance against such criteria.
- Details of any study (clinical or analytical) that would demonstrate performance such as sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets.
The FDA's 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing, biocompatibility, and sometimes limited clinical data, but not usually in the context of diagnostic performance metrics like those requested in your prompt. The standard approval for devices like bone fixation systems does not require performance metrics relating to AI.
Therefore, I cannot fulfill your request with the information provided.
{0}------------------------------------------------
< Φ Φ.1 7 2 Ø
AUG 2 4 2000
Summary of Safety and Effectiveness Information 3.0
SPONSOR:
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri
Synthes Sacral Bar System
DEVICE NAME:
CLASSIFICATION:
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener.
Zimmer Threaded Sacral Rod PREDICATE DEVICES: Synthes Threaded Bolt
DEVICE DESCRIPTION: The Synthes Sacral Bar System consists of a threaded bar, washers, and nuts. The bars are fully threaded. One end of the bar has a trocar point to guide the bar through pre-drilled holes. The bars are available in lengths ranging from 120 to 260 mm, in 10 mm increments. The washers that are used with this system are oval shaped and are designed to slide freely along the bars. Both rounded and straight nuts are provided with this system; the rounded nuts mate with the washers to create compression, while the straight nuts are then added to wedge against the rounded nuts to maintain compression.
INTENDED USE:
MATERIAL:
The Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
Implant quality stainless steel.
Synthes Sacra! Bar System 510(k) Synthes (USA)
CONFIDENTIAL
{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 image of three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2000
Ms. Angela Silvestri Manager, Regulatory Affairs Synthes U.S.A. 1690 Russell Road Paoli. Pennsylvania 19301
Re: K001720 Trade Name: Sacral Bar System Regulatory Class: II Product Code: JDW Dated: June 5, 2000 Received: June 6, 2000
Dear Ms. Silvestri:
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 (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 - Ms. Angela Silvestri
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,
Russell Page
Sw Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circled R symbol is located to the upper right of the word "SYNTHES".
Indications for Use Statement 2.0
Page _ 1 __ of _______________________________________________________________________________________________________________________________________________________________ 1
| 510(k) Number (if known): | K001720 |
|---|---|
| --------------------------- | --------- |
Synthes Sacral Bar System Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS/CONTRAINDICATIONS:
The Synthes Sacral Bar System is intended for fixation of fractures of the I ne Uyithes Dacrar Data of the posterior superior iliac spine and posterior posterior pervis, in areas and fractures and fracture-dislocations of the sacro-iliac joint.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Purnell Jury
(Division Sign-Off)
(Division Sign-On)
Division of General Restorative Devices
510(k) Number K001720
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Synthes Sacral Bar System 510(k) Synthes (USA)
CONFIDENTIAL
§ 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.