(67 days)
The Synthes Translating Maxillary Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.
The Synthes (USA) Translating Maxillary Distractor is an intra-oral distraction device. It features a distractor body with two adjustable footplate components, each with contourable legs having screw holes that are fixed to the bone via 2.0 mm or 2.4 mm cortex screws.
This document is a 510(k) premarket notification for a medical device called the "Synthes (USA) Translating Maxillary Distractor." It is a regulatory submission to the FDA seeking clearance to market the device based on its substantial equivalence to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as it relates to AI/algorithm-driven device performance.
The 510(k) process for devices like the Translating Maxillary Distractor, particularly from 2002, primarily focuses on demonstrating substantial equivalence to existing devices through:
- Device description and intended use matching: Showing that the new device has similar design, materials, and purpose as a predicate.
- Material compatibility and mechanical testing: Ensuring the materials are safe and the device can withstand expected forces. This would typically involve engineering tests, not clinical performance metrics in the way AI models are evaluated.
Therefore, I cannot fulfill your request for the specified information because the provided text pertains to a traditional medical device submission (a mechanical surgical distractor) and not an AI/algorithm-driven diagnostic or treatment device.
If you have a document describing an AI-powered device, I would be happy to analyze it for the criteria you've outlined.
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020505
APR 2 3 2002
Summary of Safety and Effectiveness Information 3.0
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| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Contact: | Matthew M. Hull, RACPhone: (610) 647-9700 x7191 |
| Device Name: | Translating Maxillary Distractor |
| Classification: | Class II, 21 CFR 872.4760 (bone plate) and 872.4880 (intraosseousfixation screw or wire) |
| Substantial Equivalence: | Documentation was provided which demonstrated the SynthesTranslating Maxillary Distractor to be substantially equivalent to otherlegally marketed devices. |
| Device Description: | The Synthes (USA) Translating Maxillary Distractor is an intra-oraldistraction device. It features a distractor body with two adjustablefootplate components, each with contourable legs having screw holesthat are fixed to the bone via 2.0 mm or 2.4 mm cortex screws. |
| Intended Use: | The Synthes Translating Maxillary Distractor is intended for use incraniofacial surgery, reconstructive procedures, and selectiveorthognathic surgery of the maxilla. Specifically it is intended fordistraction of the maxilla utilizing a LeFort I osteotmy in adult andpediatric populations. |
| Material: | Stainless Steel |
Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 design featuring three curved lines that resemble a bird or a wave-like pattern.
Public Health Service
Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2002
Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K020505
Trade/Device Name: Synthes (USA) Translating Maxillary Distractor Regulation Number: 872.4760 and 872.4880 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 14, 2002 Received: February 15, 2002
Dear Mr. Hull:
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement 2.0
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510(k) Number (if known):
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Synthes (USA) Translating Maxillary Distractor Device Name:
Indications/Contraindications: The Synthes Translating Maxillary Distractor is intended for use in craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations.
(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_
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K020505
Confidential
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§ 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.