(24 days)
The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
- Fractures management in the foot or hand -
- Fixation of bone fragments in long bones or small bones fractures -
- Arthrodesis in hand, foot or ankle surgery -
The size of the chosen screw should be adapted to the specific indication.
The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).
The provided text describes a 510(k) premarket notification for the QWIX® Positioning Screw. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than establishing new performance criteria through efficacy studies with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully provided from the given text.
Here's an analysis of what can be extracted:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion Reported Device Performance Mechanical Properties "Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)." Substantial Equivalence "The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346." Note: The document states "similar to properties" and "substantially equivalent" rather than specific quantitative acceptance criteria or numerical performance metrics. The 510(k) process is about demonstrating equivalence, not necessarily meeting a predefined performance target in the same way a de novo or PMA would require.
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Sample size used for the test set and the data provenance:
- No specific sample size for a "test set" (in the context of clinical or algorithmic performance evaluation) is mentioned.
- The study referenced is "Mechanical tests," which typically involves material and component testing, not human or patient data. Therefore, data provenance relevant to clinical outcomes is not applicable here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in a clinical or diagnostic sense is not established for this type of submission. The comparison is mechanical properties against existing devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" requiring expert adjudication in this context.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a bone fixation screw, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference for the mechanical tests would be the established mechanical properties of the predicate devices (Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)) and relevant material standards. This is not "expert consensus, pathology, or outcomes data" in a clinical sense.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable.
Summary of what the document does provide:
- Device: QWIX® Positioning Screw, a cannulated fully threaded screw for bone fixation.
- Indicated Use: Fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies, Hallux Valgus treatment, fracture management, fixation of bone fragments, and arthrodesis.
- Basis for Approval: Substantial equivalence to predicate device Stabilization Screw, K050346.
- Supporting Evidence for Equivalence: Mechanical tests showing "similar" mechanical properties to other predicate devices (Newdeal ICOS screws K011821 and Synthes 7.3 screw K962011). The submission also asserts same intended use, materials, basic design, instructions for use, and manufacturing process as previously cleared devices.
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Image /page/0/Picture/0 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with a circle of dots to the left of the word. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller font. The logo is simple and modern, and it effectively communicates the company's brand.
K071639 pg 1 + 2
510(k) SUMMARY
JUL - 9 2007
Submitter's Name and Address: A. Newdeal SAS 10. place d'Helvétie 69006 LYON FRANCE Tel.: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741
Contact Person: B.
Morgane GRENIER Director of Regulatory and Clinical Affairs Newdeal SAS 10. place d'Helvétie 69006 LYON FRANCE Tel: +33 4 37 47 51 51 Fax: + 33 4 37 47 51 52
- Date Summary Prepared: C. June 13, 2007
Name of Device: D.
Proprietary Name: QWIX® Positioning Screw
Common Name: Bone fixation screw
Classification Name and Reference: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Device Product Code: HWC
Proposed Regulatory Class: Class II
Panel: Orthopedic
Device Description E.
The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).
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K071639 pg 2 of 2
F. Indications for Use
The QWIX® Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand -
- ﺳ Hallux Valgus treatment
- Fractures management in the foot or hand -
- Fixation of bone fragments in long bones or small bones fractures -
- -Arthrodesis in hand, foot or ankle surgery
The size of the chosen screw should be adapted to the specific indication.
G. Substantial Equivalence
The QWIX® Positioning Screw is substantially equivalent to commercially marketed device, Stabilization Screw, K050346.
H. Comparison of Technological Characteristics
The modified device has the same fundamental scientific technology and intended uses as the predicate device.
The modified screw has the following similarities to those which previously received 510(k) concurrence:
- Same intended use -
- Same materials -
- Same basic design -
- Same Instructions for Use -
- -Same manufacturing process
I. Summarv of Studies
Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011).
J. Conclusion
The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346.
The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2007
Integra LifeSciences Corporation % Ms. Judith E. O'Grady Senior VP. Regulatory, Quality & Clinical Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K071639
Trade/Device Name: QWIX® Positioning Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 14, 2007 Received: June 15, 2007
Dear Ms. O'Grady:
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. Judith E. O'Grady
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 the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Barbara Bryant
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ¥071639
Device Name: QWIX Positioning Screw
Indications For Use:
The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
- Fractures management in the foot or hand -
- Fixation of bone fragments in long bones or small bones fractures -
- Arthrodesis in hand, foot or ankle surgery -
The size of the chosen screw should be adapted to the specific indication.
Prescription Use
(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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehm
(Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K071639
Page 1 of 1
§ 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.