(400 days)
Not Found
No
The summary describes a mechanical screw system and its intended use for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
The device is described as a system of screws used for fixation of bone and osteochondral fragments, which are mechanical interventions, not therapeutic in nature.
No
The device description indicates it is a collection of cannulated, headless screws, and the intended use specifies its purpose for fixation of bone fragments and fractures. It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "collection of cannulated, headless screws," which are physical hardware components. There is no mention of software as the primary or sole component of the device.
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 implant for fixing bone fragments. This is a therapeutic and structural function within the body.
- Device Description: The device is a collection of cannulated, headless screws, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The S4 Screw System™ is collection of cannulated, headless screws having fenestrations on the head and within the thread pitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments, apical fragments (patellar rim, navicular); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.
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)
Mechanical testing of the worst case S4 Screw System™ and a predicate component included torsion, insertion and pushout according to ASTM F543. The mechanical test results demonstrated that S4 Screw System™ performance is substantially equivalent to the predicate devices. In addition, bacterial endotoxin testing was performed and the implants were found to meet the specified pyrogenicity limit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 a human figure with three heads, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2017
Subchondral Solutions % Karen E. Warden, Ph.D. President Backroads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K162171
Trade/Device Name: S4 Screw System™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 7, 2017 Received: August 8, 2017
Dear Dr. Warden:
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
1
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,
Katherine D. Kavlock -S
for 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K162171
Device Name S4 Screw System™
Indications for Use (Describe)
The S4 Screw System™ is indicated for fixation of small bone fragments, osteochondral fragments and cancellous fragments, appropriate for the device which may include the following: simple metaphyseal fractures; condylar fractures; osteochondritis dissecans; areas where accurate screw placement is vital; apical fragments (patellar); cancellous fragments (talus); osteochondral fragments (talar vault, femoral condyle); intra-articular fractures and osteochondral fixation and fractures.
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)
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)
3
510(k) Summary
| Date: | 7 August 2017 |
|---|---|
| Sponsor: | Subchondral Solutions, Inc. |
| 147 Hillbrook Drive | |
| Los Gatos, CA 95032 | |
| Office: 408.891.9604 | |
| Contact Person: | Sheryl McCoy, Chief Financial Officer and VP of Administration |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | S4 Screw System™ |
| Common Name: | Bone screw |
| Device Classification: | Class II |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation: | 888.3040 |
| Device Product Codes: | HWC |
| Device Description: | The S4 Screw System™ is collection of cannulated, headless screws |
| having fenestrations on the head and within the thread pitch. | |
| Indications for Use: | The S4 Screw System™ is indicated for fixation of small bone fragments, |
| such as apical fragments, osteochondral fragments and cancellous | |
| fragments, appropriate for the size of the device which may include the | |
| following: simple metaphyseal fractures; condylar fractures; osteochondritis | |
| dissecans; areas where accurate screw placement is vital; apical fragments | |
| (patellar rim, navicular); cancellous fragments (talus); osteochondral | |
| fragments (talar vault, femoral condyle); intra-articular fractures and | |
| osteochondral fixation and fractures. | |
| Materials: | The S4 Screw System™ components are manufactured from titanium alloy |
| (Ti-6Al-4V per ASTM F136). | |
| Primary Predicate: | Acumed Cannulated Screw System (Acumed LLC. – K123890) |
| Additional Predicate: | Arthrex Compression FT Screws (Arthrex, Inc. - K132217) |
| Performance Data: | Mechanical testing of the worst case S4 Screw System™ and a predicate |
| component included torsion, insertion and pushout according to ASTM | |
| F543. The mechanical test results demonstrated that S4 Screw System™ | |
| performance is substantially equivalent to the predicate devices. | |
| In addition, bacterial endotoxin testing was performed and the implants | |
| were found to meet the specified pyrogenicity limit. | |
| Technological | |
| Characteristics: | The S4 Screw System™ possesses similar technological characteristics as |
| one or more of the predicate devices. These include: | |
| • performance (as described above), | |
| • basic design (cannulated, headless screws) and | |
| • implant materials (titanium alloy). | |
| Differences between the subject and predicate devices did not raise new | |
| questions of safety and effectiveness. Therefore the fundamental scientific | |
| technology of the S4 Screw System™ is similar to previously cleared | |
| devices. | |
| Conclusion: | The S4 Screw System™ possesses the same intended use and similar |
| technological characteristics as the predicate devices. Therefore the S4 | |
| Screw System™ is substantially equivalent for its intended use. |