(162 days)
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No
The provided text describes a system of physical implants and tools for surgical fixation, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device aids in fracture repair and reconstructive procedures by providing fixation and aiding in alignment and stabilization, but it does not directly treat a disease or condition for therapeutic purposes.
No
Explanation: The device is described as a fixation system used for fracture repair and reconstructive procedures. Its components (plates, meshes, sheets, screws, tacks) are used to provide fixation and aid in alignment and stabilization, which points to a therapeutic or supportive function rather than a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states that the system consists of physical components like Plates, Meshes, Sheets, Screws, and Tacks, which are hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Synthes Rapid Resorbable Fixation System is used for fracture repair and reconstructive procedures of the craniofacial skeleton. This involves implanting devices within the body to provide structural support and fixation.
The device is a surgical implant used for internal fixation, which is a completely different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes, Sheets, Screws and Tacks. The system is provided in a variety of shapes and sizes and, when used in conjunction with resorbable screws, the system provides fixation and aids in the alignment and stabilization of craniofacial bones. To facilitate shaping to the contours of the anatomy, the thermoplastic implants may be heated above the glass transition temperature of 55°C or they may be cut to the desired shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
craniofacial skeleton, craniofacial or mandibular areas
Indicated Patient Age Range
pediatric and adult populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A small "®" symbol is located to the upper right of the word "SYNTHES", indicating that it is a registered trademark.
: 上一篇:
Kob2789
| 3.0 | Summary of Safety and Effectiveness Information | Page 1 of 1 |
|---|---|---|
| ----- | ------------------------------------------------- | ------------- |
| SPONSOR: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19308
(610) 719-5000 | FEB 27 2007 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| DEVICE NAME: | Synthes (USA) Rapid Resorbable Fixation System | |
| CLASSIFICATION: | Class II, §872.4760 - Bone Plate
Class II, §888.3030 - Screw Fixation, Intraosseous
Class II, §882.5360 - Cranioplasty plate fastener | |
| PREDICATE DEVICE: | Synthes (USA) Rapid Resorbable Tack System
Synthes (USA) Poly (L-Lactide-co-Glycolide) Resorbable Fixation System
Synthes (USA) Rapid Resorbable Cranial Clamp
Biomet, Inc., Lactosorb Trauma Plating System | |
| DEVICE DESCRIPTION: | The Synthes Rapid Resorbable Fixation System consists of Plates, Meshes,
Sheets, Screws and Tacks. The system is provided in a variety of shapes
and sizes and, when used in conjunction with resorbable screws, the system
provides fixation and aids in the alignment and stabilization of craniofacial
bones. To facilitate shaping to the contours of the anatomy, the
thermoplastic implants may be heated above the glass transition
temperature of 55°C or they may be cut to the desired shape. | |
| INTENDED USE: | The Synthes (USA) Rapid Resorbable Fixation System is intended for use
in fracture repair and reconstructive procedures of the craniofacial skeleton
in pediatric and adult populations. In addition, resorbable meshes, sheets,
screws and tacks may be used in non-load bearing applications for
maintaining the relative position of, and /or containing, bony fragments,
bone grafts, (autograft or allograft), or bone graft substitutes in
reconstruction of the craniofacial or mandibular areas. | |
| CONTRAINDICATIONS: | These devices are not intended for use in load bearing applications, such as
the mandible, unless used in conjunction with traditional rigid fixation. The
Synthes Rapid Resorbable System is not intended for areas with active or
latent infection or for patient conditions including limited blood supply or
insufficient quantity or quality of bone. These devices are not intended for
use in the spine. | |
| SUBSTANTIAL
EQUIVALENCE | Comparative information presented supports substantial equivalence. | |
| MATERIAL: | Poly (L-lactide-co-glycolide) | |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey L. Dow Director, Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380
FEB 2 7 2007
Re: K062789
Trade/Device Name: Synthes (USA) Rapid Resorbable Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 2, 2007 Received: February 5, 2007
Dear Mr. Dow:
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, 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.
2
Page 2 - Mr. Dow
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.
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) 276-0115. 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,
Susan Rumer
~Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 a bold, sans-serif font. To the left of the word is a circular logo with a design inside. A registered trademark symbol is to the right of the word. The text and logo are black against a white background.
2.0 Indications for Use Statement
Page
| 1 | of | 1 |
|---|---|---|
| --- | ---- | --- |
Kob2789 510(k) Number (if known):
Device Name:
Indications:
The Synthes (USA) Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, sheets, screws and tacks may be used in non-load bearing applications for maintaining the relative position of, and /or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
Contraindications:
These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The Synthes Rapid Resorbable System is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
(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) | X | OR | Over-The-Counter Use __________ |
|---|---|---|---|
| ------------------------------------------ | ---------- | ---- | --------------------------------- |
Anesthesiology General Hospital
mi Control, Dansa, Devices
K060789
-5-