(90 days)
Intramedullary nails are anatomic implants specially developed for osteosynthesis. Their objective is to stabilize and fix a fracture through intramedullary blocking. The "Baumer Locking Nail" is indicated to intramedullary fixation for fractures of the tibia (Tibial Locking Nail) and femur (Femoral Locking Nail). The device is for single use; it's should never be reused.
Intramedullary nails are anatomic implants specially developed for osteosynthesis.
I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria, study details, and performance of the Baumer Locking Nail.
The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the regulation numbers, product codes, and indications for use.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test or training sets.
- Information on data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
- Details of a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for the training set (if applicable) was established.
This type of information is typically found in the 510(k) submission itself, or in supporting documentation for clinical studies, which is not part of this FDA clearance letter.
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AUG 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Breno Correa Farago, Jr. Quality Coordinator Baumer, S.A. Av. Prefeito Antonio Tavares Leite, 181 13800-000 Mogi Mirim São Paulo
Re: K011504
Trade/Device Name: Baumer Locking Nail Regulation Number: 888.3030, 888.3020 Regulatory Class: II Product Code: JDS, HSB Dated: April 30, 2001 Received: May 16, 2001
Dear Mr. Farago:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Breno Correa Farago, Jr.
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" (21CFR 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 vours.
B Mitchell MD
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 KNOW) : | K011504 |
|---|---|
| DEVICE NAME : | BAUMER LOCKING NAIL |
INDICATIONS FOR USE :
Intramedullary nails are anatomic implants specially developed for osteosynthesis. Their:objective is to stabilize:and fix a fracture through_intramedullary blocking
The "Baumer Locking Nail" is indicated to intramedullary fixation for fractures :of the tibia (Tibial Locking Nail) and femur (Femoral Locking Nail).
The device is for single use; it's should never be reused.
(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)
Dsmtheleeeerw (on cm
(Division Sign-Of (Division Sigil-On)
Division of General, Restorative
Division of General, Devices Division of Courti
510(k) Number KO11504
N/A