(34 days)
The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
The Large Screws range consists of screws and washers designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The implants of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial S) containing implants and/or instruments will be provided sterile by gamma sterilization. Additional sterile instruments will also be provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
The provided document is a 510(k) premarket notification letter and summary for the "Large Screws Range" by Newclip Technics. It details the device's substantial equivalence to predicate devices and provides information on non-clinical testing. However, it explicitly states that no clinical studies were performed.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as no such study is presented in this document.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided based on this document. The document does not define specific acceptance criteria for performance endpoints, nor does it report device performance from a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided based on this document. Since no clinical studies were performed, there is no test set, sample size, or data provenance to report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided based on this document. As no clinical studies were performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided based on this document. No clinical studies, no adjudication method.
5. 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:
- Cannot be provided based on this document. This device is a bone fixation screw, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided based on this document. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided based on this document. No clinical studies were conducted, so no ground truth for performance evaluation was established using these methods.
8. The sample size for the training set:
- Cannot be provided based on this document. No clinical studies were performed, and this is not an AI/algorithm-based device that would typically have a "training set" in that context.
9. How the ground truth for the training set was established:
- Cannot be provided based on this document. (See #8).
What was reported in terms of testing:
The document explicitly states:
- "No clinical studies were performed." (Page 5)
- "Engineering analyses have been conducted in comparison with Large Screws Range of Newclip Technics (K160617)." (Page 5) - This refers to non-clinical, mechanical testing to show equivalence to a predicate device. The specifics of these analyses (e.g., sample size for mechanical tests, specific criteria) are not detailed in this summary.
- "LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device." (Page 5) - This is a test for bacterial endotoxins and is a standard biological safety test.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2017
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K172596
Trade/Device Name: Large Screws Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 24, 2017 Received: September 5, 2017
Dear Mr. Webb:
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
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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.
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 (DICE) 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 (DICE) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172596
Device Name
Large Screws range
Indications for Use (Describe)
The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
| 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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Image /page/3/Picture/1 description: The image shows a logo for a company called NEWCLIP-TECHNICS. The logo features the letters 'nc' in a circle, with the 't' in 'nc' being stylized with an upward-pointing arrow. The company name is written in all caps below the circle.
510 (k) Summary for the LARGE SCREWS RANGE 4.
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Large Screws Range.
Summary preparation date: August , 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICSP.A. de la Lande Saint Martin45 rue des GarottièresF-44115 Haute-Goulaine - FranceTelephone: (33) 2 28 21 37 12 | J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199 |
| 2. Trade Name: | Large Screws Range |
| Common Name: | Large Screws |
| Product Code: | HWC |
Classification Name: Smooth or threaded metallic bone fixation fastener. (21 CFR part. 888.3040)
3. Primary predicate or legally marketed devices which are substantially equivalent:
- . Large Screws Range of Newclip Technics (K160617)
Secondary predicate or legally marketed devices which are substantially equivalent:
Reference device:
- Activ Ankle Locking Plating System of Newclip Technics (K143061) .
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Image /page/4/Picture/1 description: The image shows a logo for New Clip-Technics. The logo consists of a circle with the letters "nct" inside. The "t" is colored in pink. Below the circle, the words "NEW CLIP-TECHNICS" are written in a sans-serif font.
| 4. Description of the device: | The Large Screws range consists of screws and washers designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. |
|---|---|
| The implants of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. | |
| The instruments of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial S) containing implants and/or instruments will be provided sterile by gamma sterilization. Additional sterile instruments will also be provided sterile by gamma sterilization. | |
| Materials: | Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3). |
| Function: | The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia |
5. Substantial equivalence claimed to predicate devices:
in adults.
The Large Screws Range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances.
6. Indications for use:
The Large Screws range is indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.
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Image /page/5/Picture/1 description: The image shows a logo for Newclip-Technics. The logo consists of a circle with the letters 'nct' inside. The 't' has an upward-pointing arrow in red. Below the circle, the words 'NEWCLIP-TECHNICS' are written in a sans-serif font.
7. Non-clinical Test Summary:
Engineering analyses have been conducted in comparison with Large Screws Range of Newclip Technics (K160617).
LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of <20 EU/device.
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip Technics considers the Large Screws Range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.
§ 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.