(84 days)
Not Found
Not Found
No
The summary describes a mechanical system (cable and needle) for sternal repair and reconstruction and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended for sternal repair and reconstruction, which is a therapeutic purpose.
No
This device is described as a system for "sternal repair and reconstruction," indicating it is used for treatment or structural support, not for identifying a disease or condition.
No
The device description explicitly states it contains a stainless steel cable with a detachable needle, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "sternal repair and reconstruction." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "stainless steel cable with detachable needle." This is a surgical implant/instrument used during the procedure.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided description does not mention any such use or interaction with biological specimens.
Therefore, the Synthes Sternal Reconstruction System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
Product codes
JDQ
Device Description
The Synthes modified Sternal Reconstruction System contains a 1.0 mm stainless steel cable with detachable needle with ferrule The cable is 750 mm in length.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Sternal Reconstruction System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
mar - 2 2004
Ko 33816
page 1 of 1
Summary of Safety and Effectivencss 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) Modification to Sternal Reconstruction System |
| CLASSIFICATION: | Class II § 21 CFR 888.3010: Cerclage, fixation |
| PREDICATE DEVICE: | Synthes Sternal Reconstruction System |
| DEVICE DESCRIPTION: | The Synthes modified Sternal Reconstruction System contains a 1.0 mm
stainless steel cable with detachable needle with ferrule The cable is 750
mm in length. |
| 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 an eagle or bird-like figure, with three curved lines forming the body and wings.
Public Health Service
MAR - 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K033816
Trade/Device Name: Modification to Synthes (USA) Sternal Reconstruction System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: December 8, 2003 Reccived: December 9, 2003
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to conninered proc to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been rechasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, mererere, mains 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 If your device is olassinod (600 wor ols. Existing major regulations affecting your device can may be subject to back as a sateral 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 I lease of advised that 1 br over device complies with other requirements of the Act that I DT has made a acternmalations administered by other Federal agencies. You must or any I cacal 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 CITY art 6077, aboning (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic north in the quality byticles (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) I mis icity will anow you to ocgin mailing of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 If you desire specific acreoliation at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Wholfanting by reference to premessponsibilities under the Act from the Division of Small other general 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 yours,
Miriam C. Provost
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
Indications for Use Statement 2.0
Page __ 1 of
| 510(k) Number (if known): | K033816 |
|---|---|
| Device Name: | Modification to Synthes (USA) Sternal Reconstruction System |
| 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_
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K033816