(73 days)
The Osteo I-C Humeral Nail System is indicated for single-use in the humeral shaft to address the following indications: fractures of the humeral shaft, non-unions, malalignments, pathologic fractures, and impending pathologic fractures.
The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only.
Indications:
- Fractures of the humeral shaft
- Non-unions
- Malalignments
- Pathologic humeral fractures
- Impending pathologic humeral fractures
The Osteo I-C Humeral Nail System consist of the Osteo I-C Humeral Nail, a cylindrical tube which is intended to aid in the alignment and stabilization of humeral fractures and associated components include the Osteo I-C Humeral Nail Locking Screw, the Osteo I-C Humeral Nail Compression Screw and the Osteo I-C Nail Humerus Protection Screw which are intended to secure the Osteo I-C Humeral Nail in place.
The provided text is a summary of a 510(k) Premarket Notification for the Osteo I-C Humeral Nail System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving the device meets acceptance criteria.
The document explicitly states:
"The comparison of the Osteo I-C Humeral Nail System to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary."
This indicates that the device's approval was based on demonstrating substantial equivalence to already approved predicate devices, rather than conducting new performance studies against defined acceptance criteria. Therefore, I cannot extract the requested information from this document.
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JUN 22 1998
(
K98 1309
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteo I-C Humeral Nail System
Submission Information:
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Osteonics Corporation 59 Route 17 Allendale NJ 07401-1677
Marybeth Naughton Regulatory Affairs Team Member
Date of Summary Preparation:
April 6, 1998
Device Identification
| Proprietary Name: | Osteo I-C Humeral Nail SystemIncludes the following components:-Osteo I-C Humeral Nail-Osteo I-C Humeral Nail Locking Screw-Osteo I-C Humeral Nail Compression Screw-Osteo I-C Nail Humerus Protection Screw |
|---|---|
| Common Name: | Interlocking-Compression Humeral Nail System |
| Classification Name/Reference: | Intramedullary Fixation Rod21 CFR §888.3020 |
Predicate Device Identification:
The components of the Osteo I-C Humeral Nail System are substantially equivalent to those of the Biomet Uniflex™ Humeral Nail System and the Synthes Titanium Solid Nail System.
Description of Devices:
The Osteo I-C Humeral Nail System consist of the Osteo I-C Humeral Nail, a cylindrical tube which is intended to aid in the alignment and stabilization of humeral fractures and associated components include the Osteo I-C Humeral Nail Locking Screw, the Osteo I-C Humeral Nail Compression Screw and the Osteo I-C Nail Humerus Protection Screw which are intended to secure the Osteo I-C Humeral Nail in place.
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Intended Use:
The Osteo I-C Humeral Nail System is indicated for single-use in the humeral shaft to address the following indications: fractures of the humeral shaft, non-unions, malalignments, pathologic fractures, and impending pathologic fractures.
Statement of Technological Comparison:
The design, materials, and intended use of the Osteo I-C Humeral Nail System are substantially equivalent to those of predicate Biomet Uniflex™ Humeral Nail System and the Synthes Titanium Solid Humeral Nail.
Performance Data:
The comparison of the Osteo I-C Humeral Nail System to predicate systems which have been determined to be substantially equivalent through 510(k) premarket notifications demonstrates that no additional performance data are necessary.
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Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K981309 Osteo I-C Humeral Nail System Requlatory Class: II Product Code: HSB Dated: April 9, 1998 Received: April 10, 1998
Dear Ms. Staub:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Elizabeth A. Staub
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) 594-4659. 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,
Celia M. Witten. Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of 1
510(k) Number (if Known): K_98 130 9
Device Name: Osteo I-C Humeral Nail System
Indications For Use:
The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only.
Indications:
- Fractures of the humeral shaft ♪
- Non-unions ﺑ
- Malalignments •
- Pathologic humeral fractures
- Impending pathologic humeral fractures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH. Office of Device Evaluation (ODE)
tocoleto
(Division Sign-Off)
Division of General Restorative Devices K98/309
510(k) Number.
Prescription Use
(per 21 CFR 801.109
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.