(60 days)
These devices are to be implanted into the long bones for alignment, stabilization, and These devices are to be mapantrauma or disease, the fixation of long bones that have Itsation of nactor of thank by transmy for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur.
The G4 nail is an intramedullary rod used to stabilize fractures of the femur. It may be inserted in an antegrade or retrograde fashion.
The provided text describes a 510(k) Premarket Notification for the G4 Sleeved Nail, a femoral intramedullary rod. In this type of submission to the FDA, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive clinical trials as would be required for a novel device.
Therefore, the document explicitly states:
- Clinical Testing: None provided as a basis for substantial equivalence.
This means that while the device is intended for medical use, the application does not contain information about acceptance criteria or a study demonstrating that the device meets those criteria through clinical performance. Instead, substantial equivalence was established through a comparison to predicate devices, focusing on function, labeling, sizing, and non-clinical testing.
Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies, as these elements were not part of this specific 510(k) submission.
The document highlights:
- Non-Clinical Testing: "Testing determined that G4 Sleeved Nail presented no new risks and were; therefore, substantially equivalent to the predicate device. FEA was done in conformance to ASTM F-1264." This indicates physical and mechanical testing, likely to ensure structural integrity and biocompatibility, but not clinical performance.
To summarize, the request cannot be fully answered because the provided document is a 510(k) summary for a device demonstrating substantial equivalence based on engineering and comparison to existing devices, not a clinical study report with acceptance criteria and clinical performance data.
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MAY 24 2002
ARTERS CORPORATE
Summary of Safety and Effectiveness
Applicant/Sponsor:
Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Contact Person:
Tracy J. Bickel Telephone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name: G4 Sleeved Nail
Common Name: Femoral Nail
Classification Name: Intramedullary Rods (21 CFR 888.3020)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Intramedullary Nails- K982953; Küntscher Nails- Preamendment.
Device Description:
The G4 nail is an intramedullary rod used to stabilize fractures of the femur. It may be inserted in an antegrade or retrograde fashion.
Intended Use:
intention of to be implanted into the long bones for alignment, stabilization, and fixation of fractures are to to be implanted the the the fixation of long bones that have been surgically prepared fractions cataous of training of diobally, and for arthrodesis, Intramedullary rods are used in the femur.
Summary of Technologies: The G4 Sleeved Nail is similar to or Identical in terms of function, labeling, and sizing to the predicate device(s).
Non-Clinical Testing: Testing determined that G4 Sleeved Nail presented no new risks and were; therefore, substantially equivalent to the predicate device. FEA was done in conformance to ASTM F-1264.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
| MAILING ADDRESS | P.O. Box 587 |
|---|---|
| Warsaw, IN 46581-0587 |
| SHIPPING ADDRESS | 56 F. Bell Drive |
|---|---|
| Warsaw, IN 46582 |
| OFFICE |
|---|
| -------- |
| FAX |
|---|
| ----- |
219.267.6639
219.267.8137
E-MAIL biomet@hiomet.com
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2002
Ms. Tracy J. Bickel Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K020962
Trade/Device Name: G4 Sleeved Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 22, 2002 Received: March 25, 2002
Dear Ms. Bickel:
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.
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.
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Page 2 - Ms. Tracy Bickel
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) 594-4659. 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 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,
Muriàm C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) NUMBER (IF KNOWN): KO20962
DEVICE NAME: G4 Sleeved Nail
INDICATIONS FOR USE:
These devices are to be implanted into the long bones for alignment, stabilization, and These devices are to be mapantrauma or disease, the fixation of long bones that have Itsation of nactor of thank by transmy for correction of deformity, and for arthrodesis. Intramedullary rods are used in the femur.
(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 (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020962
§ 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.