(35 days)
Synthes Rapid Resorbable Tack System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Rapid Resorbable 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.
The Synthes Rapid Resorbable Tack System consists of resorbable tacks and accessory instruments, which are additional components of the Synthes Rapid Resorbable Fixation System. The Rapid Resorbable Tack System consists of 1.5 mm tacks and 1.7 mm emergency tacks and are available in lengths ranging from 4 - 6 mm.
This document is a 510(k) summary for the Synthes Rapid Resorbable Tack System, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study demonstrating performance against acceptance criteria for a new device.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria. The document is typical of a 510(k) submission, outlining device description, intended use, contraindications, and demonstrating equivalence to existing legally marketed devices, but it does not include detailed performance studies with acceptance criteria as one would expect for a novel device needing extensive validation.
Here's why the information you're looking for isn't present:
- 510(k) Substantial Equivalence: The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, materials, and intended use, and may include limited performance testing to show that the new device performs as safely and effectively as the predicate, but it's not usually a full-blown clinical trial against predefined acceptance criteria for a novel technology.
- No Acceptance Criteria or Performance Study Details: The document explicitly states, "Documentation is provided which demonstrates that Synthes Rapid Resorbable Tack System is substantially equivalent to other legally marketed Synthes devices." It does not provide a table of acceptance criteria or a description of a study conducted to prove the device meets specific performance targets (like sensitivity, specificity, accuracy, etc., which are common for diagnostic or AI devices).
- Focus on Mechanical Equivalence: For a resorbable tack system, the "performance" likely relates to mechanical properties, biocompatibility, and degradation profiles, which would be compared to the predicate device. These tests are usually conducted in a lab environment rather than clinical studies with human readers or ground truth established by experts.
In summary, the provided document does not allow for answering most of your questions as it pertains to a 510(k) submission focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is underneath the word. The logo and text are likely part of a company or brand identity.
Kosozoq
510(k) Summary 3.0
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Classification: | Class II, 21 CFR §882.5360Cranioplasty plate fastener |
| Predicate Device: | Synthes Resorbable Tack SystemSynthes Rapid Resorbable Fixation System (aka Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System |
| Device Description: | The Synthes Rapid Resorbable Tack System consists of resorbabletacks and accessory instruments, which are additional componentsof the Synthes Rapid Resorbable Fixation System. The RapidResorbable Tack System consists of 1.5 mm tacks and 1.7 mmemergency tacks and are available in lengths ranging from 4 - 6mm. |
| Intended Use: | Synthes Rapid Resorbable Tack System is intended for use infracture repair and reconstructive procedures of the craniofacialskeleton. In addition, Rapid Resorbable Tacks may be used in non-load bearing applications for maintaining the relative position ofand/or containing bony fragments, bone grafts (autograft or allograft)or bone graft substitutes in reconstruction of the craniofacial ormandibular areas. |
| Contraindications: | These devices are not intended for use in load bearing applications,such as the mandible, unless used in conjunction with traditionalrigid fixation. Synthes Rapid Resorbable Tacks are not intended forareas with active or latent infection or for patient conditionsincluding limited blood supply or insufficient quantity or quality ofbone. These devices are not intended for use in the spine. |
| SubstantialEquivalence: | Documentation is provided which demonstrates that Synthes RapidResorbable Tack System is substantially equivalent to other legallymarketed Synthes devices. |
Image /page/0/Picture/6 description: The image shows the number 000005 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K050204
Trade/Device Name: Synthes Rapid Resorbable Tack System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 2, 2005 Received: March 3, 2005
Dear Ms. Musgnung:
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 vour 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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Page 2 - Ms. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualice of a substant as with other requirements
mean that FDA has made a determination that your device cod by ather Foderal agencies mean that FDA nas made a decemmandin and your and your and limited to: posicties.
of the Act or any Federal statutes and regulations administered to: positively of the Act of of Federal statutes and regiraments, including, but not limited to: registration
You must comply with all the Act's requirements and manufacturing programs and You must comply with an the Act 3 requirements art 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Part 820); and 120); and if requirements as set form in the quality systems (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) I mis letter will anow you to begin mailering your substantial equivalence of your device to a premarket notification. The PDF Intellige or other of 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), II you desire specific advice for your de 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 may obtain other general meeting. International and Consumer Assistance at its toll-free Division of Director of Die (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smith Michael MD
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
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Indications for Use
| 510(k) Number (if known): | K050204 |
|---|---|
| Device Name: | Synthes Rapid Resorbable Tack System |
| Indications: | Synthes Rapid Resorbable Tack System is intended for use infracture repair and reconstructive procedures of the craniofacialskeleton. In addition, Rapid Resorbable Tacks may be used innon-load bearing applications for maintaining the relativeposition of and/or containing bony fragments, bone grafts(autograft or allograft) or bone graft substitutes in reconstruction ofof the craniofacial or mandibular areas. |
| Contraindications: | These devices are not intended for use in load bearingapplications, such as the mandible, unless used in conjunctionwith traditional rigid fixation. Synthes Rapid Resorbable Tacksare not intended for areas with active or latent infection or forpatient conditions including limited blood supply or insufficientquantity or quality of bone. These devices are not intended foruse in the spine. |
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
Station Sign-Off)
ision of Anesthesiology, General Hospital, Traction Control, Dental Devices
10(k) Number _________________________________________________________________________________________________________
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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.