(82 days)
Synthes Resorbable Fixation System is intended for fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoldal and infraorbilal areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. Do not use in the mandible.
Synthes Resorbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including: hinod supply limitations, insufficient quantity of quality of bone, or latent infections. This device is not designed for use in the mandible or for use in full load bearing procedures
Synthes (U.S.A.) Resorbable Fixation System contains various plates, and sercws which are made from a resorbable copolymer, 70:30 poly(L/DL-lactide). The product line consists of a small ayatem based upon 1.5 mm screws and a large system based on 2.0 mm screws.
The system is provided pre-sterilized by gamma radiation and is not intended to be resterilized by the user.
The provided document is a 510(k) summary and an FDA clearance letter for a medical device called the "Synthes (U.S.A.) Resorbable Fixation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the novel device itself.
Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, and multi-reader multi-case studies cannot be extracted directly from this document.
However, I can provide the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria or specific performance metrics for the Synthes Resorbable Fixation System. The clearance is based on substantial equivalence to existing metallic and resorbable fixation systems already on the market.
| Acceptance Criteria (Not explicitly stated for new device - implied by substantial equivalence) | Reported Device Performance (Not explicitly stated for new device - implied by substantial equivalence to predicates) |
|---|---|
| Biocompatibility | Material: 70:30 poly(L/DL-lactide) resorbable copolymer. |
| Mechanical integrity (strength, degradation profile suitable for intended use) | Designed for fractures of the craniofacial skeleton and reconstructive procedures of the midface/craniofacial skeleton. Not for full load-bearing or mandible. Implied to function similarly to predicate devices K912932, K953806, K955729, K960988. |
| Sterility | Provided pre-sterilized by gamma radiation. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI/algorithm performance. The clearance is based on a comparison to predicate devices, likely through material testing, mechanical testing, and potentially animal studies (though not detailed here) to demonstrate equivalence in performance characteristics and safety. No human clinical trial with a specific "test set" to prove device performance as an AI/algorithm is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm's output.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in this document. This is a clearance for a physical medical device (fixation system), not an AI diagnostic or interpretive tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" in the context of this 510(k) clearance is the established safety and effectiveness profile of the predicate devices. The new device is deemed substantially equivalent if it performs as safely and effectively as these already marketed devices. This would involve comparing material properties, mechanical properties, and intended use, often supported by bench testing and sometimes preclinical animal studies. There is no mention of pathology, outcomes data, or expert consensus in the typical sense of evaluating diagnostic accuracy for this type of device.
8. The Sample Size for the Training Set
No training set or training data is mentioned. This is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the numbers '9', '7', '4', '5', '5', and '4'. The characters are written in a cursive style, with some connections between the letters and numbers.
Summary of Safety and Effectivencss Information [510(k) Summary)
SPONSOR NAME AND ADDRESS l.
Synthes (U.S.A.) P.O. Box 1766 1690 Russell Road Paoli. PA 19301 (610) 647-9700 TEL:
Contact Person: Angela Silvestri, Regulatory Affairs Manager
న. DEVICE NAME
Common/Usual Namc: Cranioplasty plate and plate fastener Synthes (U.S.A.) Resorbable Fixation System Proprietary Name:
3 CLASSIFICATION
Craniuplasty plate and plate fastener have been classified as Class II devices, under 21 CFR 882.5320, 882.5330, and 882.5360.
INTENDED USE 4.
Synthes Resorbable Fixation System is intended for fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasocthmoidal areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. Do not use in the mandible.
Synthes Resorbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including; blood supply linitations, insufficient quantity of quality of bone, or latent infections. This device is not designed for use in the mandible or for use in full load bearing procedures.
DEVICE DESCRIPTION ર .
Synthes (U.S.A.) Resorbable Fixation System contains various plates, and sercws which are made from a resorbable copolymer, 70:30 poly(L/DL-lactide). The product line consists of a small ayatem based upon 1.5 mm screws and a large system based on 2.0 mm screws.
The system is provided pre-sterilized by gamma radiation and is not intended to be resterilized by the user.
SUBSTANTIAL EQUIVALENCE ર.
Synthes (U.S.A.) Resorbable Fixation System is substantially equivalent to Class II metallic mplants, such as Synthes Maxillofacial Titanium Micro Set (K912932), and Synthes Midfacial System (K953806). Synthes (U.S.A.) Resorbable Fixation System is also substantially equivalent to other absorbable platcs and screws, such as the Lorenz LactoSorb@ Traums Plating System (K955729, K960988), which is manufactured from 82:18 poly(L-lactide-co-glycolide)
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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Silvestri Manager, Regulatory Affairs Synthes® (USA) 1303 Goshen Parkway West Chester, Pennsylvania 19380
FEB 2 4 1998
Re : K974554 Synthes (U.S.A) Resorbable Fixation System Trade Name: Requlatory Class: II Product Code: JEY Dated: December 3, 1997 Received: December 4, 1997
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ತಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Ms. Silvestri
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.
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) 594-4692. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricio Cucurella Soler
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1 __ of __ l
K974534 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Synthes (USA) Resorbable Fixation System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
Synthes Resorbable Fixation System is intended for fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoldal and infraorbilal areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton. Do not use in the mandible.
Synthes Resorbable Fixation System is not intended for: 1) areas with active infection; 2) patient conditions including: hinod supply limitations, insufficient quantity of quality of bone, or latent infections. This device is not designed for use in the mandible or for use in full load bearing procedures
(PLEASE TIONOT WRITE BELOW THIS LINE - CONTINUE ON ANOTIIER PAGE IF NEFTIFIT)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Dental, Infection Control, |
| and General Hospital Devices |
510(k) Number KS7455 y
Prescription Use your (Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.