(49 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a cable sleeve, with no mention of AI or ML technologies.
No.
The device is described as a cable sleeve used for orthopedic repairs, such as fracture fixation and reattachment, serving a structural/mechanical purpose within the body rather than treating or preventing disease.
No
The device is described as an "Osteo-cable Sleeve" used for orthopedic repairs and fixation of fractures, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it is machined from 316 LVM stainless steel and is a physical component used in orthopedic repairs, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in surgical procedures for orthopedic repairs and fixation of fractures. This is a direct application within the body during surgery.
- Device Description: The device is a physical implant made of stainless steel, designed to be used with cables for bone fixation. This is a surgical implant, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Focus on Mechanical Function: The description and performance studies focus on the mechanical properties and performance of the device in a surgical context.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cable Sleeve is indicated for general orthopedic repairs, such as:
- Femur and Tibial Fractures
- Prophylactic banding .
- Trochanteric reattachment .
- Olecranon fractures .
- Patella fractures ●
- Ankle fractures .
- Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques .
- Sternum fixation after open heart surgery ●
- Stabilization of cortical onlay strut graft .
Product codes (comma separated list FDA assigned to the subject device)
87HWC, HXN, JDQ
Device Description
The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Tibial, Trochanter, Olecranon, Patella, Ankle, Sternum, Cortical
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)
Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
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.
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
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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K024022
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 3 2003
| Applicant or Sponsor: | Biomet Orthopedics, Inc
56 E. Bell Drive
P.O. Box 587
Warsaw, IN 46581-0587 |
|------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | Osteo-cable Sleeve |
| Common or Usual Name: | Bone Screw |
| Device Classification: | Screw, Fixation, Bone (888.3040) |
| Device Product Code: | 87HWC |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Biomet's BMP™ Cable System (K982545)
Indications for Use: The Cable Sleeve is indicated for general orthopedic repairs, such as:
- Femur and Tibial Fractures ●
- Prophylactic banding .
- Trochanteric reattachment .
- Olecranon fractures .
- Patella fractures ●
- Ankle fractures .
- Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques .
- Sternum fixation after open heart surgery ●
- Stabilization of cortical onlay strut graft .
Device Description: The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.
Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
| MAILING ADDRESS
P.O. Box 587
Warsaw, IN 46581-0587 | | SHIPPING ADDRESS
56 E. Bell Drive
Warsaw, IN 46582 | | | |
|----------------------------------------------------------|--|----------------------------------------------------------|--|--|------------------------------|
| OFFICE
574.267.6639 | | FAX
574.267.8137 | | | E-MAIL
biomets@biomet.com |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
JAN 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kacy Arnold, RN, MBA Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K024022
Trade Name: Osteo-Cable Sleeve Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: II Product Code: HXN and JDQ Dated: January 14, 2003 Received: January 15, 2003
Dear Ms. Arnold:
We have reviewed your Section 510(k) premarket 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) 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. Kacey Arnold. RN. MBA
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Mark N Millman
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
BIOMET
Page 1 of 1
510 (k) Number (if known): K024922
Device Name: Osteo-cable Sleeve
Indications for Use: The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as:
- Femur And Tibial Fractures .
- Prophylactic Banding .
- Trochanteric Reattachment .
- Olecranon Fractures ●
- Patella Fractures ●
- Ankle Fractures ●
- Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques .
- Sternum Fixation After Open Heart Surgery ●
- Stabilization Of Cortical Onlay Strut Graft .
to Mark N. Milkersen
Division Si ivision of General, Restorative and Neurological Devices
Number 1/23/03
(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) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
| MAILING ADDRESS | P.O. Box 587
Warsaw, IN 46581-0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive
Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
|---|---|
| FAX | 574.267.8137 |
| biomet@biomet.com |
8