(252 days)
No
The device description and intended use are purely mechanical, describing a physical screw and its surgical application. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as being used for the "Treatment of metatarsalgia" and its function is to provide fixation after osteotomies, which are surgical procedures performed to correct deformities or treat conditions. This direct involvement in the treatment of a medical condition qualifies it as a therapeutic device.
No
Explanation: The device is described as a threaded titanium screw used for the treatment of metatarsalgia, specifically for Weil osteosynthesis. This is a therapeutic and implantable device, not one that performs diagnostic functions or provides information about a patient's medical condition.
No
The device description clearly states it is a threaded titanium screw, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure for treating metatarsalgia by fixing bone osteotomies in the foot. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device is a threaded titanium screw designed for implantation in the foot. This is a surgical implant, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, the BePOD® EZ Weil screws are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BePOD® EZ Weil screws are designed for the following indication:
-Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out:
- by the opened surgery (standard Weil) technique,
- by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).
Product codes
HWC
Device Description
The BePOD® EZ Weil Screws are threaded titanium screws which are self-drilling and selftapping designed for use in the foot. Once completely implanted, the screw is designed so the surgeon can snap off the introducer at the snap off axis.
The BePOD® EZ Weil 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
lateral metatarsal shafts (side toes)
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
Engineering Analysis was performed to compare the subject and predicate screws. Bacterial endotoxin levels were evaluated using LAL pyrogen testing.
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 is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol is black, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2017
Fournitures Hospitalières Industrie Patricia Donnard Regulatory Affairs Manager 6 Rue Nobel, Z.I. de Kernévez 29000 Quimper, France
Re: K163710
Trade/Device Name: BePOD® EZ Weil 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 11, 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 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.
1
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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K163710 Device Name
BePOD® EZ Weil Screws
Indications for Use (Describe)
BePOD® EZ Weil screws are designed for the following indication:
-Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out:
-
by the opened surgery (standard Weil) technique,
-
by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
3
K163710 Page 1/3
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: September 06, 2017
The assigned 510(k) number is: K163710
| 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
Tel: (+33) 2.98.55.68.95 |
| Product | |
| Trade name: | BePOD® EZ Weil Screws |
| 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: | FHI |
|---|---|
| Device Trade Name: | Snap Off Screws |
| 510 (k): | K041456 |
| Manufacturer: | Newdeal (Now Integra) |
| Device Trade Name: | SPIN Snap off Screws |
| 510 (k): | K011946 |
4
Reference devices
| Manufacturer: | FHI |
|---|---|
| Device Trade Name: | ARROW Reverse Shoulder System |
| 510 (k): | K112193 |
| Manufacturer: | FHI |
| Device Trade Name: | CoLS Fixation System |
| 510 (k): | K120740 |
Device Description
The BePOD® EZ Weil Screws are threaded titanium screws which are self-drilling and selftapping designed for use in the foot. Once completely implanted, the screw is designed so the surgeon can snap off the introducer at the snap off axis.
The BePOD® EZ Weil Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
Indications for Use
BePOD® EZ Weil screws are designed for the following indication:
- -Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out:
- by the opened surgery (standard Weil) technique,
- by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).
Comparison of Technological Characteristics
The BePOD® EZ Weil Screws and the above selected predicate devices have the same intended use and 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.
Non-Clinical testing
Engineering Analysis was performed to compare the subject and predicate screws. Bacterial endotoxin levels were evaluated using LAL pyrogen testing.
5
Substantial Equivalence
The substantial equivalence of our product, when compared to the selected predicate devices, has been established through the companion of indications for use, material, range of size, and design features.
Conclusion
Following the examination of all the above mentioned information, we believe that the BePOD® EZ Weil Screws are substantially equivalent to the selected predicate devices.