(16 days)
Not Found
Not Found
No
The summary describes a mechanical system of cables, screws, and plates for sternal repair and reconstruction, with no mention of software, algorithms, or AI/ML terms.
No
The device is described as a system for sternal repair and reconstruction, which is a surgical intervention rather than a therapeutic treatment in the sense of addressing a disease or condition through non-surgical means. It is a mechanical support system.
No
Explanation: The device description states it is a cable-based system for sternal repair and reconstruction, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly states it is a "cable-based system comprised of stainless steel cable, cannulated screws and plates," indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in sternal repair and reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "cable-based system comprised of stainless steel cable, cannulated screws and plates." These are surgical implants and instruments used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose, monitor, or screen for diseases or conditions by testing samples taken from the body. This device is a surgical device used for structural repair.
N/A
Intended Use / Indications for Use
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
Product codes
JDQ, HRS, HWE
Device Description
The Synthes Sternal Reconstruction System is a cable-based system comprised of stainless steel cable, cannulated screws and plates. The system is designed to allow for multiple sternal repair and reconstruction options. It can be used as follows:
- Cable only
- Cable and cannulated screws
- Cable, cannulated screws, and plates
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternal
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)
Synthes Cerclage Wire (Pre-76)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 3 0 2003
KC3/508
page 1 of 1
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) Sternal Reconstruction System |
| CLASSIFICATION: | Class II § 21 CFR 888.3010: Cerclage, fixation
Class II § 21 CFR 888.3030: Plate, fixation, bone
Class II § 21 CFR 888.3040: Screws, fixation, bone |
| PREDICATE DEVICE: | Synthes Cerclage Wire (Pre-76) |
| DEVICE DESCRIPTION: | The Synthes Sternal Reconstruction System is a cable-based system
comprised of stainless steel cable, cannulated screws and plates. The
system is designed to allow for multiple sternal repair and reconstruction
options. It can be used as follows:
Cable onlyCable and cannulated screwsCable, cannulated screws, and plates |
| INTENDED USE: | Synthes (USA) Sternal Reconstruction System is intended for use in sternal
repair and reconstruction. |
| SUBSTANTIAL
EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping abstract shapes, possibly representing human figures or wings. The seal is black and white.
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Lisa Boyle Regulatory Associate Synthes USA 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K031508
Trade/Device Name: Syntehes (USA) Sternal Reconstruction System Regulation Number: 21 CFR 888.3010, 888.3030 and 888.3040 Regulation Name: Bone fixation cerclage, Single/multiple component metallic bone fixation appliances and accessories and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDQ, HRS, HWE Dated: May 12, 2003
Received: May 14, 2003
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 to 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. Iisting 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
2
Page 2 - Ms. Lisa Boyle
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours.
Mark A. Milleson
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
2.0 Indications for Use Statement
Page l of ﻠﺴﻴ
| 510(k) Number (if known): | K031508 |
|---|---|
| --------------------------- | --------- |
Synthes (USA) Sternal Reconstruction System Device Name:
Indications:
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
(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 CFR 801.109) OR
Over-The-Counter Use
Mark A. Millman
Divis noof General, Restorative and Neurological Devices
510(k) Number -
Confidential