(309 days)
No
The provided 510(k) summary describes a mechanical orthopedic screw device and its intended use, with no mention of AI, ML, image processing, or any related computational technologies.
Yes
The device is described as being used for "treatment" of Hallux Valgus and "compressive osteosynthesis of fractures," which aligns with the definition of a therapeutic device.
No
Explanation: The device, BePOD® Foot Screws, is described as being used for "treatment" and "compressive osteosynthesis" of conditions like Hallux Valgus and fractures, indicating a therapeutic or surgical purpose rather than diagnosis.
No
The device description explicitly states that the device includes "cannulated screws" and is "intended to be implanted using the dedicated instrumentation supplied by the manufacturer," indicating it is a physical implant and associated hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the BePOD® Foot Screws are implantable devices designed for surgical treatment of bone conditions (Hallux Valgus and fractures). They are used in the body, not to test samples from the body.
- Intended Use: The intended use is for compressive osteosynthesis, which is a surgical procedure to stabilize bones. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the BePOD® Foot Screws are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BePOD® 3A cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthsis of fractures of several bones in the forefoot.
BePOD® percutaneous cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthesis of fractures of several bones in the forefoot.
Product codes
HWC
Device Description
BePOD® Foot Screws includes the following elements: BePOD® 3A cannulated screws BePOD® percutaneous cannulated screws
The BePOD® Foot Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsal shaft (big toe), forefoot
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is 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 symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
Fournitures Hospitalieres Industrie Patricia Donnard Regulatory Affairs Manager Zi De Kernevez - 6 Rue Nobel 29000 Quimper France
Re: K163148 Trade/Device Name: BePOD® Foot Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 28, 2017 Received: August 18, 2017
Dear Patricia 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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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
2
Indications for Use
510(k) Number (if known) K163148
Device Name BePOD Foot Screws
| Indications for Use (Describe) | |
|---|---|
| --------------------------------------- | -- |
BePOD 3A cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthsis of fractures of several bones in the forefoot.
BePOD percutaneous cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthesis of fractures of several bones in the forefoot.
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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of 21 CFR 807.92.
Date prepared: September 12, 2017 The assigned 510(k) number is: K163148 Applicant FH industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13 Patricia DONNARD, Regulatory Affairs Manager Company Contact Tel: (+33) 2.98.55.68.95 Product BePOD® Foot Screws Trade name: Common name: Screw, Fixation, Bone Classification: Smooth or threaded metallic bone fixation fastener Panel: Orthopedic Product Code: HWC Regulation Number: 888.3040 Device Class: II
Information on predicate devices to which substantial equivalence is claimed:
| Manufacturer: | SBI (Acquired by Stryker in US) |
|---|---|
| Device Trade Name: | Auto® Fix Screws |
| 510 (k): | K052576 |
4
Reference devices
| Manufacturer: | FH Industrie |
|---|---|
| Device Trade Name: | BePOD® Cannulated Arthrodesis screws |
| 510 (k): | K170040 |
| Manufacturer: | FH Industrie |
| Device Trade Name: | CALCANAIL Fracture |
| 510 (k): | K150463 |
Device Description
BePOD® Foot Screws includes the following elements: BePOD® 3A cannulated screws BePOD® percutaneous cannulated screws
The BePOD® Foot Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
Indications for Use
BePOD® 3A cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthsis of fractures of several bones in the forefoot.
BePOD® percutaneous cannulated screws are designed for the following indications:
-
Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
-
Compressive osteosynthesis of fractures of several bones in the forefoot.
Comparison of Technological Characteristics
The BePOD® Foot 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. -
Performance
The BePOD® Foot Screws are identical in materials and size of the predicates selected.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
5
Substantial Equivalence
The substantial equivalence of our product, when compared to the selected predicate devices, 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® Foot Screws as being substantially equivalent to the already cleared predicate devices.
Conclusion
Following the examination of all the above mentioned information, we believe that the BePOD® Foot Screws is substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, and safety and effectiveness.