(48 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical components for fracture fixation and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as an "external fixator" intended for the "repair of Colles fractures," which directly addresses a medical condition (Colles fracture) to restore bone alignment and facilitate healing.
No
Explanation: The device is a Mini-Fixator for Colles Fractures, used for the repair and external fixation of fractures, not for diagnosing them.
No
The device description explicitly lists multiple hardware components, including a mini hammer, distractor bar, half pins, drill bit, and other instruments, which are surgically implanted or used externally.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair of Colles fractures" using an external fixator with surgically implanted pins. This is a surgical procedure performed on the human body.
- Device Description: The components listed are all instruments and parts used in a surgical procedure to stabilize a bone fracture.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside and on the body) for a surgical intervention.
N/A
Intended Use / Indications for Use
The Mini-Fixator for Colles Fractures are indicated for use with a Colles fractures requiring external fixator. The half pins are surgically implanted the remainder of the device is external.
Product codes
HRS
Device Description
There are several pieces that are included in this device package. This also includes the instrument required. The pieces are the mini hammer, the distractor bar, half pins, drill bit, drill guide, clamp assembly, 3/32 x 5 drill bit, tommy bar, alignment guide, 2.5 mm screwdriver and silicone pin caps. These are packaged in a single container for single use and are sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| OCT 13 1998 | SUMMARY OF SAFETY AND EFFECTIVINESS |
|---|---|
| SPONSOR: | Biomet, Inc. |
| P.O. Box 587 | |
| Airport Industrial Park | |
| Warsaw, Indiana 46581-0587 | |
| K982982 | |
| CONTACT PERSON: | Julie Ryan |
| PROPRIETARY NAME: | Mini-Fixator for Colles Fractures |
| Common or Usual Name: | External Bones Fixator |
| Device Code: | |
| Device Classification: | Class II |
| Device Name: | Mini-Fixator for Colles Fractures |
INTENDED USE: The Mini-Fixator for Colles Fractures are indicated for use with a Colles fractures requiring external fixator. The half pins are surgically implanted the remainder of the device is external.
DEVICE DESCRIPTION: There are several pieces that are included in this device package. This also includes the instrument required. The pieces are the mini hammer, the distractor bar, half pins, drill bit, drill guide, clamp assembly, 3/32 x 5 drill bit, tommy bar, alignment guide, 2.5 mm screwdriver and silicone pin caps. These are packaged in a single container for single use and are sterile.
POTENTIAL RISK: The potential risk is the same for any surgery, which include the following but are not limited to: Non-union or delayed union Bending or fracture of implant Metal sensitivity or allergic reaction to foreign body Bone resorption Decrease in bone density due to stress shielding Pain, discomfort or abnormal sensation due to the presence of the device Nerve damage due to surgical trauma Necrosis of the bone
SUBSTANTIAL EQUIVALENCE: There are several other devices similar to the sponsor already on the market. They are manufactured by ACE DePuy, Trend Medical, Zimmer, OrhtoFrame and SE.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bodies, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 13 1998
Ms. Julie K. Ryan Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K982982 Trade Name: Mini-Fixator for Colles Fractures Regulatory Class: II Product Code: HRS Dated: August 24, 1998
Received: August 26, 1998
Dear Ms. Ryan:
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 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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory 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 - Ms. Julie K. Ryan
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,
Ph.D., M.D. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| Page | ____________________ of ____________________ |
|---|---|
| ------ | ---------------------------------------------- |
K982982 510(K) NUMBER IF KNOWN:
DEVICE NAME: Mini-Fixator for Colles Fractures
INDICATIONS FOR USE:
The Mini-Fixator for Colles Fractures is intended for use in the repair of Colles fractures. The device is intended for single use only and is external with internal pins.
(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)
Acolle
(Division Sign-Off)
Division of General R 510(k) Number
000002