(101 days)
Not Found
No
The summary describes standard bone screws and their mechanical testing, with no mention of AI or ML.
No.
The device, a bone screw, is used to fix bone fragments, which is a structural function rather than directly providing therapy to treat or heal a disease or condition.
No.
The device description indicates that the screws are used to fix bone fragments for osteosynthesis, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a range of screws made of titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a range of screws made of titanium alloy used to "fix bone fragments of the foot together for osteosynthesis." This is an implantable surgical device used directly on the body, not for testing specimens outside the body.
- Intended Use: The intended use is to "fix bone fragments of the foot together for osteosynthesis," which is a surgical procedure, not a diagnostic test.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The screws are used to fix bone fragments of the foot together for osteosynthesis.
Product codes
HWC
Device Description
This range of screws for foot includes several types of cannulated screws made of titanium alloy (according to ISO 5832/3 and ASTM F 136) with an hexagonal head.
-
The cannulated self-compression screw, and
-
The cannulated arthrodesis screw.
A specifical guide pin is used for implant placement. The following table shows our range of cannulated screws:
| Products | Lengths |
|---|---|
| Cannulated self-compression screw | 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34mm |
| Cannulated arthrodesis screw | 28, 30, 32, 34, 36, 38, 40mm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Rupture torque was performed on our cannulated screws and was compared with the requirements of the French Standard NF F 90-414 and found to have a resistance to torsion in compliance with the selected standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041456, K990622, K011262, K971070, K962236
Reference Device(s)
Not Found
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
CANNULATED SCREWS 510(k) Premarket Notification
510 (K) SUMMARY CANNULATED SCREWS
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92
SUBMITTER :
Fournitures Hospitalières 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
COMPANY CONTACT :
Franck HUNT General Manager Phone number : 33.2.98.55.68.95 Fax number : 33.2.98.53.42.13
Date prepared : January 31th 2007
DEVICE NAME :
Trade name : CANNULATED SCREWS Common name : Cannulated screw Classification name : Smooth or threaded metallic bone fixation fastener 21 CFR 888,3040
PREDICATE DEVICES :
Manufacturer : Fournitures Hospitalieres Industrie Device Trade Name : Snap-off screws 510 (K) : K041456 August 25" 2004 Date claered :
Manufacturer : NewDeal SA Device Trade Name : BOLD® screw 510 (K) : K990622 and K011262 June 1516 2001 and April 29th 1999 Date clacred :
Manufacturer : MEDINOV-AMP Device Trade Name : Scarf Thread-Head screw 510 (K) : K971070 and K962236 July 9th 1997 and September 20th 1996 Date claered :
1
DEVICE DESCRIPTION:
This range of screws for foot includes several types of cannulated screws made of titanium alloy (according to ISO 5832/3 and ASTM F 136) with an hexagonal head.
-
The cannulated self-compression screw, and
-
The cannulated arthrodesis screw.
A specifical guide pin is used for implant placement. The following table shows our range of cannulated screws:
| Products | Lengths |
|---|---|
| Cannulated self- | |
| compression screw | 10, 12, 14, 16, 18, 20, 22, 24, |
| 26, 28, 30, 32, 34mm | |
| Cannulated | |
| arthrodesis screw | 28, 30, 32, 34, 36, 38, 40mm |
INDICATIONS FOR USE:
The screws are used to fix bone fragments of the foot together for osteosynthesis.
PREDICATE DEVICES:
Numerous cannulated screws for foot have been cleared for commercial distribution by the Food and Drug Administration (FDA). We have selected two predicate devices based upon interded uses, material used in device manufacturing and design features.
These predicate devices are:
- Snap-off screws (K041456) manufctured by FH Industrie -
n BOLD Cannulated Compression screw (K990622 and K011262), manufactured by Newdeal.
Scarf Thread-Head screw (K971070 and K962236) manufactured by Medinov-AMP
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The cannulated screws have the same intended use and substantial similar indications for use as the predicate devices. They are all made of the same material (titanium alloy), are aveilable in similar diameters and lengths, with similar designs.
PERFORMANCES:
Rupture torque was performed on our cannulated screws and was compared with the requirements of the French Standard NF F 90-414 and found to have a resistance to torsion in compliance with the selected standard.
Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practises Regulations, questions, qu
CONCLUSION;
All these elements show the safety and effectiveness of our product. The cannulated screws are substantially equivalents to the selected predicate devices in terms of intended use, safety, and effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fournitures Hospitalieres Industrie c/o Ms. Patricia Donnard Regulatory Affairs Manager 6 Rue Nobel Z.I. de Kernevez 29000 Quimper, France
JUN 1 4 2007
Re: K070617
Trade/Device Name: Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 7, 2007 Received: May 16, 2007
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.
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.
3
Page 2 -- Ms. Patricia Donnard
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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Jubane breln
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CANNULATED SCREWS 510(k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name:
CANNULATED SCREWS The complete range of screws indicated for the foot includes the two following models :
the cannulated arthrodesis screw ; and រ
the cannulated self-compression screw. -
Indications for Use:
The screws are used to fix bone fragments of the foot together for osteosynthesis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over the counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ﮯ
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| and and the cases of the county of the county of | | | |
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative,
and Neurological Devices
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number K070617
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