(89 days)
Arthrodesis cannulated screws are designed for the following indication: Arthrodesis of the metatarsal-phalangeal joint of the big toe.
BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws. The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
This is a 510(k) premarket notification for a medical device, specifically the BePOD® Cannulated Arthrodesis Screws. Such notifications typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on a device's performance against specific acceptance criteria for AI algorithms.
Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document.
This document describes a traditional medical device (screws for bone fixation), not an AI/ML-driven device. The "Performance" section refers to material testing (LAL testing) and compliance with manufacturing regulations, not performance metrics based on data analysis or AI algorithms.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Fournitures Hospitalières Industrie Patricia Donnard Regulatory Affairs Manager Zi De Kernevez - 6 Rue Nobel Ouimper, 29000 FR
Re: K170040
Trade/Device Name: BePOD® Cannulated Arthrodesis Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 27, 2016 Received: January 5, 2017
Dear Ms. Donnard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K 170040
Device Name
BePOD Cannulated Arthrodesis Screws
Indications for Use (Describe)
Arthrodesis cannulated screws are designed for the following indication:
Arthrodesis of the metatarsal-phalangeal joint of the big toe.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.
Date: April 3, 2017 The assigned 510(k) number is: K170040
- Applicant Fournitures Hospitalières industrie 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel : (+33) 2.98.55.68.95 Fax : (+33) 2.98.53.42.13
Company Contact Patricia DONNARD, Regulatory Affairs Manager p.donnard@fh-industrie.com Tel: (+33) 2.98.55.68.95
Naoual RAHIMI, Experienced RA Officer - Overseas Export Specialist n.rahimi@fh-industrie.com Tel: (+33) 2.98.55.68.95
Product
| Trade name: | BePOD® Cannulated Arthrodesis Screws |
|---|---|
| Common name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | The BePOD® Cannulated Arthrodesis Screws components are includedin the following classifications: Screw, Fixation, Bone.Regulation Description: Smooth or threaded metallic bone fixationfastenerPanel: OrthopedicProduct Code: HWCRegulation Number : 888.3040Device Class : II |
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Predicate/ Legally Marketed Devices
Information on devices to which substantial equivalence is claimed:
| Manufacturer: | Fournitures Hospitalières Industrie |
|---|---|
| Device Trade Name: | Cannulated Screws |
| 510 (k): | K070617 |
| Reference Device | |
|---|---|
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | CoLS Fixation System |
| 510 (k): | K120740 |
The CoLS Fixation System is used to support the substantial equivalence
Device Description
BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws
The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
Indications for Use/ Intended Use
Be POD Arthrodesis cannulated screws are designed for the following indication: - Arthrodesis of the metatarsal-phalangeal joint of the big toe.
Comparison of Technological Characteristics
The BePOD® Cannulated Arthrodesis Screws and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:
- they are made out of the same materials,
- they are available in similar ranges of sizes,
- they bear design features similarities.
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Performance
The BePOD® Cannulated Arthrodesis Screws are identical in materials and size of the predicates selected.
The LAL testing meets the specified 20EU/device limit.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
Substantial Equivalence
The substantial equivalence of our product, when compared to the selected predicate devices and reference device, has been established following manufacturers' commercial documents, 510(k) submission's information available on FDA's website.
The analysis of these technical data allows us to submit the BePOD® Cannulated Arthrodesis Screws as being substantially equivalent to the already cleared predicate devices and reference device.
Conclusion
Following the examination of all the above mentioned information, we believe that the BePOD® Cannulated Arthrodesis Screw is substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, safety and effectiveness. The BePOD® Cannulated Arthrodesis Screw is also substantially equivalent to the reference device.
§ 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.