(26 days)
Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
The device is the same as flexible pins and ender nails that have been used to fix fractures in long bones for years in an intramedullary fashion. When these types of nails are used they will be used opposingly in pairs. The nail will be bent to provide three-point fixation. The ideal fixation points will be at the insertion site, the fracture site, and some point beyond the fracture site.
The provided document is a 510(k) premarket notification for a medical device (2mm Flexible Pediatric Nail) and its clearance letter from the FDA. It does not describe acceptance criteria or a study that proves the device meets specific performance criteria through clinical testing, as would be expected for an AI/ML device or a device requiring new clinical data.
This device, an intramedullary rod, was determined to be "substantially equivalent" to a legally marketed predicate device (Pediatric Fixation Rods - K000764) based on "non-clinical testing" via an "engineering justification." This means no new clinical studies were required to demonstrate its safety and effectiveness for its intended use, as it was deemed to have similar technological characteristics (materials, design, sizing, and indications) to already cleared devices.
Therefore, many of the requested categories are not applicable to this specific submission.
Here's a breakdown based on the provided information, noting where information is not applicable:
Acceptance Criteria and Device Performance Study for the 2mm Flexible Pediatric Nail
Since this device received 510(k) clearance based on substantial equivalence to a predicate device via non-clinical engineering justification, there were no specific "acceptance criteria" for clinical performance metrics (like accuracy, sensitivity, specificity) and no clinical study conducted to directly prove the device met such criteria. The "acceptance criteria" in this context were primarily met by demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not applicable for clinical performance) | Reported Device Performance (Not applicable for clinical performance) |
|---|---|---|
| Clinical Performance | Not applicable as no new clinical performance criteria were established or evaluated in a de novo study. | No clinical performance metrics (e.g., accuracy, sensitivity, etc.) are reported. |
| Substantial Equivalence | Device is substantially equivalent to predicate device (K000764) in materials, design, sizing, and indications (Non-clinical justification only). | Device was determined to be substantially equivalent based on engineering justification. |
| Safety and Effectiveness | No new risks posed compared to predicate device. | An engineering justification concluded no new risks. |
2. Sample size used for the test set and the data provenance: Not applicable. No test set (clinical data set) was used for performance evaluation. The substantial equivalence was based on engineering justification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set was used requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device, and no standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for a performance study. The substantial equivalence was based on a comparison to an existing device and engineering principles.
8. The sample size for the training set: Not applicable. This is not an AI/ML device; therefore, no training set was used.
9. How the ground truth for the training set was established: Not applicable. No training set was used.
{0}------------------------------------------------
AUG 26 2002
022531
BOMET
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet, Inc.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Tracy J. Bickel(574) 267-6639 |
| Proprietary Name: | 2mm Flexible Pediatric Nail |
| Common Name: | Intramedullary Rod |
| Classification Name: | Smooth or threaded metallic bone fastener (21 CFR 888.3040) |
| Substantially Equivalent Devices: Pediatric Fixation Rods- K000764 | |
| Device Description: | The device is the same as flexible pins and ender nails that have been used to fixfractures in long bones for years in an intramedullary fashion. When these types ofnails are used they will be used opposingly in pairs. The nail will be bent to providethree-point fixation. The ideal fixation points will be at the insertion site, the fracturesite, and some point beyond the fracture site. |
| Indications for Use: | Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fracturesincluding non-comminuted and comminuted mid-shaft fractures, subtrochantericfractures, distal third fractures, combination fractures of the shaft and neck,intertrochanteric fractures, combination intertrochanteric and subtrochantericfractures. |
| Summary of Technologies: The device's technological characteristics (materials, design, sizing, andindications) are similar or identical to the predicate device. | |
| Non-Clinical Testing: | An engineering justification was used to determine that the 2mm flexible pediatricnail presented no new risks and were; therefore, substantially equivalent to thepredicate device. |
| 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
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
트
OFFICE 574.267.6639
FAX 574.267.8137
:
E-MAIL biomet@biomet.com
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 2002
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K022531
Trade/Device Name: 2mm Flexible Pediatric Nail Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: July 30, 2002 Received: July 31, 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.
{2}------------------------------------------------
Page 2 -- Ms. Tracy J. 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" (21CFR 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.
Sincerely yours,
Mark N. Millenson
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
{3}------------------------------------------------
Page
of
510(k) Number (if known): Device Name: 2mm Flexible Pediatric I Indications for Use:
Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures including r lextore roauted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third from conmination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
Mark N. Melleur
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number (02253)
(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)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.