(92 days)
The Large Screws range is intended 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 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 Large Screws range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V ELI (conform to ASTM F 136-12a and/or 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 text describes a medical device (Large Screws range) and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study, nor does it present the results of a study designed to meet specific acceptance criteria.
The document is a 510(k) summary, which is a premarket notification to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison of technological characteristics, materials, and non-clinical testing, rather than a study against specific performance acceptance criteria as one might see for a novel AI/software medical device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document lists "Non-clinical Test Summary" items (Comparative torsional tests, Comparative pullout engineering analysis, Driving torque tests) but does not provide specific acceptance criteria or performance data for these tests. It also explicitly states "No clinical studies were performed."
- Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" described. The non-clinical tests would have involved samples of the screws, but details on sample size, other than implied through "comparative", are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here as no clinical studies were performed.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical bone fixation fastener, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, not on a study with specific acceptance criteria as would be typical for an AI/software medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Newclip Technics % J.D. Webb Official Correspondent The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K160617
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: April 1, 2016 Received: April 4, 2016
Dear J.D. 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 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
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Page 2 - J.D. Webb
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 yours,
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) K160617
Device Name
LARGE SCREWS range
Indications for Use (Describe)
The Large Screws range is intended 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)
X | 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: April 13, 2015
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICS | J.D. Webb |
| P.A. de la Lande Saint Martin | The OrthoMedix Group, Inc. |
| 45 rue des Garottières | 1001 Oakwood Blvd |
| F-44115 Haute-Goulaine - France | Round Rock, TX 78681 |
| Telephone: (33) 2 28 21 37 12 | Telephone: 512-388-0199 |
| 2. Trade name: | Large Screws range |
| Common Name: | Large Screws |
| Product code: | HWC |
| Classification Name: | Screw, Fixation, Bone(21 CFR part. 888.3040) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
Secondary predicate or legally marketed devices which are substantially equivalent:
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| 4. Description of the device: | The Large Screws range consists ofscrews designed for the fixation of bonefractures, pseudarthroses, fusions andosteotomies of foot and ankle as well asmedium and large bone fragmentsincluding radius, humerus, femur, tibia inadults. |
|---|---|
| The Large Screws range will be providednon sterile for sterilization by health careprofessionals prior to use or providedsterile by gamma sterilization. | |
| Materials: | Titanium alloy Ti-6Al-4V ELI (conformto ASTM F 136-12a and/or ISO 5832-3). |
| Function: | The implants of the Large Screws rangeare indicated for the fixation of bonefractures, pseudarthroses, fusions andosteotomies of foot and ankle as well asmedium and large bone fragmentsincluding radius, humerus, femur, tibia inadults. |
5. Substantial equivalence claimed to predicate devices:
The Large Screws range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
The technological characteristics of the Large Screws are the same as the characteristics of predicate devices in terms of intended use and design. All of these screws have the following characteristics:
- Self-tapping -
- Cannulated -
- Available in titanium alloy -
- Partially or totally threaded -
- Available sterile or non-sterile -
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- Equivalent size ranges -
- Equivalent diameters ranges -
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.
7. Non-clinical Test Summary:
The following tests were conducted:
- Comparative torsional tests. .
- Comparative pullout engineering analysis. .
- Driving torque tests. .
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.