(90 days)
Not Found
Not Found
No
The summary describes a purely mechanical implant (intramedullary nail) and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is used to stabilize and fix fractures, which is a therapeutic function.
No
The device is described as an intramedullary nail, which is an implant for fracture fixation, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is an "anatomic implant" and "intramedullary nails," which are physical hardware components used for osteosynthesis. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "anatomic implant specially developed for osteosynthesis" to "stabilize and fix a fracture through intramedullary blocking." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description reinforces that it's an "anatomic implant."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
Therefore, the "Baumer Locking Nail" is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JDS, HSB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, Femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a row.
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.
1
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
2
| 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