(77 days)
Synthes 1.3 mm Self-Drilling Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes 1.3 mm Self-Drilling Screws feature self-drilling self-tapping tips, stardrive recessed head, and are available in lengths ranging from 4 mm - 6 mm.
This document, a 510(k) summary, details the submission for the Synthes 1.3 mm Self-Drilling Screws. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The provided text describes a medical device (bone screws) and its regulatory approval process, which is very different from the evaluation of an AI-powered diagnostic or therapeutic device. Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document because it does not pertain to an AI/ML device.
To answer your request, I would need a document describing the evaluation of an AI/ML device, typically found in a clinical study report or a 510(k) submission for an AI-powered product.
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DEC 2 1 1998
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person inside of a circle. To the right of the word is a small circle with an R inside of it, indicating that the word is a registered trademark. The word is written in a sans-serif font.
Attachment VI:
SUBMITTER
Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Sheri L. Musgnung
COMMON OR USUAL NAME
Screw, Fixation Bone
DEVICE CLASSIFICATION: Class II, 21 CFR 888.3030
Synthes Midfacial System (K953806) PREDICATE DEVICE:
Synthes 1.3 mm Self-Drilling Screws feature self-drilling self-DESCRIPTION: tapping tips, stardrive recessed head, and are available in lengths ranging from 4 mm - 6 mm.
- Synthes 1.3 mm Self-Drilling Screws are intended for selective INTENDED USE: trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
MATERIAL:
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CONFIDENTIAL
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Image /page/1/Picture/2 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 representing the department's mission. 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
DEC 2 1 1998
Ms. Sheri L. Musgnung Requlatory Affairs Associate Synthes® (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301
K983485 Re : Synthes® 1.3 MM Self-Drilling Screw Trade Name: Requlatory Class: II Product Code: DZL October 2, 1998 Dated: Received: October 5, 1998
Dear Ms. Musgnung:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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. Musgnung
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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications for Use Statement 2.0
Page
510(k) Number (if known):
Synthes 1.3 mm Self-Drilling Screws Device Name:
Indications For Use:
Synthes 1.3 mm Self-Drilling Screws are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮧ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K983485 510(k) Number _
CONFIDENTIAL
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.