(27 days)
Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization.
The Biomet® Humeral Cable Plate System consists of two (2) 316LVM Stainless Steel (ASTM F138) Plates. The plates are straight and have a combination of cortical screw holes and integrated cable crimp sleeves. The first plate is 156mm in length and has six (6) cable crimps and five (5) alternating cortical screw holes. The second plate is 206mm in length with eight (8) cable crimps alternating with seven (7) cortical screw holes. Both plates will utilize 3.5mm Cortical Screws and standard 2.0mm Diameter 316LVM Stainless Steel BMPTM Cable Cerclage.
Here's an analysis of the provided text regarding the Biomet® Humeral Cable Plate, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification Summary for a medical device. For devices seeking 510(k) clearance, the primary method of "proving" a device meets acceptance criteria is demonstrating substantial equivalence to a previously legally marketed predicate device, rather than through extensive clinical trials or performance metrics against defined acceptance criteria for novel devices.
Therefore, the structure of the answer below reflects this context.
Acceptance Criteria and Study for the Biomet® Humeral Cable Plate
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for 510(k)) | Reported Device Performance (vs. Predicate) |
|---|---|
| Material Equivalence: Materials of construction are equivalent to predicate. | Met: The device is made of 316LVM Stainless Steel (ASTM F138). While not explicitly stated for the predicate in this document, the summary implies material similarity: "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices." |
| Design Equivalence: Device design (e.g., dimensions, features) is equivalent to predicate. | Met: Device consists of straight plates with cortical screw holes and integrated cable crimp sleeves (156mm/6 crimps/5 screw holes, 206mm/8 crimps/7 screw holes). "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices." |
| Sizing Equivalence: Size ranges are equivalent to predicate. | Met: Specific sizes (156mm, 206mm, 3.5mm cortical screws, 2.0mm cables) are provided. "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices." |
| Intended Use/Indications for Use Equivalence: Clinical use matches predicate. | Met: Fixation of humeral fractures near an intramedullary implant; fixation of fractures where screws and cerclage cables improve stabilization. These are listed under "Intended Use" and later confirmed as "Indications for Use" for the new device. |
| Technological Characteristics Equivalence: Fundamental technological methods are equivalent. | Met: "The Biomet® Humeral Cable Plate's material, design, sizing, and indications are similar or identical to the predicate devices." This implies that the fundamental way the device functions (plate and cable cerclage for fixation) is not novel compared to the predicate. |
| Safety and Effectiveness: Device presents no new questions of safety or effectiveness. | Met: "Finite Analysis and literature review determined that the Biomet® Humeral Cable Plate presented no new risks and were therefore, substantially equivalent to the predicate device." |
Note: For 510(k)s, "acceptance criteria" are often implicit in the demonstration of substantial equivalence. The "study" proving it meets these criteria is the comparison to the predicate device through non-clinical (and sometimes clinical) testing or analysis.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to a predicate device, not on a traditional "test set" of patient data for performance evaluation in the way a diagnostic AI device would.
- Data Provenance: Not applicable for a traditional test set. The data presented is primarily a comparison against a predicate device (Biomet's BMP™ Cable System - K982545). The "Finite Analysis and literature review" that supported the safety claim would be based on engineering principles and existing scientific/medical literature, not patient data from a specific "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth, in the context of diagnostic or prognostic devices, is not established for this type of 510(k) submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. The provided document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no comparative effectiveness study, including an MRMC study, was performed or submitted.
- Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study or AI component is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This device is a mechanical bone plate system, not an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the traditional sense of a diagnostic/prognostic device. For this submission, the "ground truth" is effectively:
- The established performance and safety profile of the predicate device (Biomet's BMP™ Cable System - K982545).
- Engineering principles and existing literature that support the safety and non-inferiority of the new device's design relative to the predicate (as determined by "Finite Analysis and literature review").
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
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 mechanical device.
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DEC 0 3 2001
Image /page/0/Picture/1 description: The image shows the Biomet corporate headquarters logo. The logo is a stylized version of the word "BIOMET" in bold, block letters. The words "CORPORATE HEADQUARTERS" are printed in a smaller font below the logo. The text "K01365 page 1 of" is handwritten in the upper right corner of the image.
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Inc.Airport Industrial ParkP.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Tracy J. Bickel(219) 267-6639 |
| Proprietary Name: | Biomet® Humeral Cable Plate |
| Common Name: | Bone Plate |
| Classification Name: | Bone, Fixation, Cerclage 888.3010Plate, Fixation, Bone 888.3030 |
| Substantially Equivalent Device: | Biomet's BMPTM Cable System- K982545 |
| Device Description: | The Biomet® Humeral Cable Plate System consists of two (2) 316LVM StainlessSteel (ASTM F138) Plates. The plates are straight and have a combination ofcortical screw holes and integrated cable crimp sleeves. The first plate is 156mmin length and has six (6) cable crimps and five (5) alternating cortical screw holes.The second plate is 206mm in length with eight (8) cable crimps alternating withseven (7) cortical screw holes. Both plates will utilize 3.5mm Cortical Screws andstandard 2.0mm Diameter 316LVM Stainless Steel BMPTM Cable Cerclage. |
| Intended Use: | Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization. |
| Summary of Technologies: | The Biomet® Humeral Cable Plate's material, design, sizing, andindications are similar or identical to the predicate devices. |
| Non-clinical Testing: | Finite Analysis and literature review determined that the Biomet®Humeral Cable Plate presented no new risks and were therefore,substantially equivalent to the predicate 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
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
.
0000039
OFFICE 219.267.6639
FAX =
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the circle. The eagle is depicted in black, and the text is also in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581
Re: K013657 Trade/Device Name: Biomet® Humeral Cable Plate Regulation Number: 888.3010, 888.3030 Regulation Name: Bone fixation cerclage Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDO, HRS Dated: November 5, 2001 Received: November 6, 2001
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.
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Page 2 - Ms. Tracy J. Bickel
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your e FDA finding of substantial equivalence of your device to a legally promated noticated 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 additionally 21 301) 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,
for Mark N. Millican
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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Page _ of _
510(k) Number (if known): K013457
Device Name: Biomet® Humeral Cable Plate
Indications for Use:
- Fixation of a humeral fracture near the site of an intramedullary implant. .
- Fixation of a numeral fracture near the eno eno eno enough the would improve . stabilization.
(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)
Division Sign-Off) Division of General, Restorative and Neurological Devices
K01365-7
(k) Number
000008
§ 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.