(49 days)
The Synthes (USA) Sterile Sternal Fixation System (SFS) is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes SFS is a system consisting of machined Titanium plates, a quick-release pin, and 3.0mm locking screws. The plates utilize screw fixation to create the construct.
I am unable to find the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies within the provided text. The document is a 510(k) summary for the Synthes Sterile Sternal Fixation System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results or acceptance criteria against specific performance metrics.
The document discusses:
- Sponsor and Device Information: Synthes (USA), Device Name, Classification, Predicate Devices, and Device Description.
- Intended Use: Primary or secondary closure/repair of the sternum following sternotomy or fracture.
- Substantial Equivalence: A statement that comparative information supports substantial equivalence.
- FDA Communication: An FDA letter confirming the 510(k) clearance based on substantial equivalence to predicate devices.
The FDA 510(k) clearance process primarily evaluates new medical devices against predicate devices for substantial equivalence regarding safety and effectiveness, rather than requiring extensive clinical trials with predefined acceptance criteria and performance metrics for the new device as would be seen in a PMA (Premarket Approval) application. Therefore, the detailed study information you're looking for is typically not present in a 510(k) summary.
{0}------------------------------------------------
K05 0041
FEB 25 2005
| 1*** | ST MITTER | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | PAGE A***A LINE LAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | 44. | |
|---|---|---|---|---|---|
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 | |
| Device Name: | Synthes Sterile Sternal Fixation System (Sterile) | |
| Classification: | 888.3010 - Cerclage, Fixation , Metallic (JDQ)888.3030 - Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)888.3040 - Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) | |
| Predicate Devices: | Synthes Sternal Fixation System | |
| Device Description: | The Synthes SFS is a system consisting of machined Titaniumplates, a quick-release pin, and 3.0mm locking screws. The platesutilize screw fixation to create the construct. | |
| Intended Use: | The Synthes (USA) Sternal Fixation System (SFS) is intended foruse in primary or secondary closure/ repair of the sternumfollowing sternotomy or fracture of the sternum to stabilize thesternum and promote fusion. | |
| SubstantialEquivalence: | Comparative information presented supports substantialequivalence. |
:
{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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Ms. Lisa M. Boyle Regulatory Specialist Synthes(USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K050041
Trade/Device Name: Synthes (USA) Sterile Sternal Fixation System Regulation Number: 21 CFR 888.3010, 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Bone Fixation cerclage;Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDQ, HBS, HWC Dated: January 4, 2005 Received: January 11, 2005
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Purist
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 Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A horizontal line is present below the logo.
Page 1 of l
Indications for Use
510(k) Number (if known):
Device Name:
2.0
Synthes (USA) Sterile Sternal Fixation System
Indications for Use:
The Synthes (USA) Sterile Sternal Fixation System (SFS) is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
(Division Sign-Off) Division of General, Kestorative, and Neurological Devices
510(k) Number K050041
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.