(49 days)
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 .
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.
The provided document describes a medical device called the "Osteo-cable Sleeve" and its regulatory submission (K024022). It is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as an FDA approval (PMA) would require.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (implied): The device must perform comparably to or better than the predicate device in terms of mechanical properties relevant to its intended orthopedic fixation use. This is implied as a basis for establishing substantial equivalence for medical devices like bone screws. | "Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices." |
Note: The document doesn't explicitly state numerical acceptance criteria (e.g., minimum tensile strength, fatigue life). Instead, it states that the modified device met the performance of the predicate, which serves as the de facto acceptance criterion for a 510(k) notification.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The document states "Non-Clinical Testing: Mechanical testing..." but does not specify the number of devices tested or the sample size.
- Data Provenance: The document does not provide details on the provenance (e.g., country of origin, retrospective or prospective) of the data from the mechanical testing. These tests would typically be conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device's evaluation relied on mechanical testing, not a ground truth established by medical experts for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical testing does not involve adjudication by experts as clinical studies or imaging studies would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence." Therefore, no MRMC study with human readers was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (Osteo-cable Sleeve), not a software algorithm or AI-powered device. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the purpose of establishing substantial equivalence in this 510(k) submission, the "ground truth" was the mechanical performance of the legally marketed predicate device (Biomet's BMP™ Cable System, K982545). The performance of the modified device was compared against this established performance standard.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not a software algorithm or AI, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
Summary of the Study:
The document describes a non-clinical study involving mechanical testing. The purpose was to demonstrate that a modified medical device, the Osteo-cable Sleeve, performed "as well as or better than" a previously marketed, legally equivalent predicate device (Biomet's BMP™ Cable System). This type of testing is common for 510(k) submissions where the new device is substantially equivalent to an existing one and does not raise new questions of safety or effectiveness that would necessitate clinical trials. The specific methodology, sample sizes for mechanical tests, and detailed results are not provided in this summary. The FDA determined that, based on this non-clinical testing and comparison to the predicate, the device was substantially equivalent.
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K024022
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 3 2003
| Applicant or Sponsor: | Biomet Orthopedics, Inc56 E. Bell DriveP.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Kacy Arnold, RN, MBATelephone: (574) 372-1644Fax: (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 ADDRESSP.O. Box 587Warsaw, IN 46581-0587 | SHIPPING ADDRESS56 E. Bell DriveWarsaw, IN 46582 | ||||
|---|---|---|---|---|---|
| OFFICE574.267.6639 | FAX574.267.8137 | E-MAILbiomets@biomet.com |
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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.
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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
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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 587Warsaw, IN 46581-0587 |
|---|---|
| SHIPPING ADDRESS | 56 E. Bell DriveWarsaw, IN 46582 |
| OFFICE | 574.267.6639 |
|---|---|
| FAX | 574.267.8137 |
| biomet@biomet.com |
8
§ 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.