(105 days)
Not Found
No
The document describes a mechanical implant system and instruments for fracture treatment, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the treatment of stable and unstable fractures, as well as for stabilization of bones and correction of bone deformities, which are therapeutic interventions.
No
The document states the device "is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the Gamma4 System includes sterile implants (nails, lag screws, end caps) and non-sterile instruments (targeting devices, targeting sleeve), which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of bone fractures and deformities in the femur. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of implants (nails, screws, end caps) and instruments (targeting devices). These are physical devices used in surgery, not reagents, instruments, or software used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
The device is clearly a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers. The Gamma4 System was previously cleared in K222309, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur (intracapsular, trochanteric, subtrochanteric and shaft regions)
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)
Non-Clinical Testing:
- Targeting accuracy testing
- Bending Fatigue Strength per ASTM F1264
- Construct Fatigue Strength Testing
- Cut-out testing
- Torsional Stiffness per ASTM F1264
- MR evaluation
Testing demonstrated that the Gamma4 System is equivalent in mechanical performance to the Gamma3 System primary predicate device (K213328) and T2 Alpha Femur Antegrade GT/PF Nailing System (K203819) additional predicate device.
Clinical Testing: Not required for this submission.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2023
Stryker GmbH Cindy Leon Sr. Staff Specialist, Regulatory 325 Corporate Drive Mahwah, New Jersey 07430
Re: K230512
Trade/Device Name: Gamma4 System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 25, 2023 Received: May 25, 2023
Dear Cindy Leon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| Farzana | Digitally signed by |
| Farzana Sharmin -S | |
| Sharmin -S | Date: 2023.06.09 |
| 16:04:36 -04'00' |
Farzana Sharmin, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Gamma4 System
Indications for Use (Describe)
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). The RC Lag Screw is also indicated for rotationally unstable 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) |
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| Section 9: 510(k) Summary | |
|---|---|
| I. SUBMITTER | |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Cindy Leon |
| Sr. Staff Specialist, Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-5374 | |
| Fax: 201-831-6020 | |
| Date Prepared: | February 24, 2023 |
| II. DEVICE | |
| Name of Device: | Gamma4 System |
| Common Name: | Gamma4 System |
| Rod, fixation, intramedullary and accessories | |
| Regulation Number / Name: | Gamma4 System |
| 21CFR 888.3020 (Intramedullary fixation rod) | |
| Product Code: | Gamma4 System |
| HSB (Rod, fixation, intramedullary and accessories) | |
| Regulatory Class: | Class II |
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Traditional 510(k) Premarket Notification
III, PREDICATE DEVICE
Primary Predicate: Gamma3 System (K213328)
Additional Predicates:
T2 Alpha Femur Antegrade GT/PF Nailing System (K203819)
IV. DEVICE DESCRIPTION
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market new devices into the Gamma4 System, add new indications for use for the RC Lag Screws and update the current surgical technique to include an optional section to use bone void fillers.
The Gamma4 System was previously cleared in K222309, is a hip fracture nailing system and includes sterile implants (Trochanteric and Long Nails in various diameters and sizes, Lag Screws, and End Caps) as well as non-sterile instruments (targeting devices). The subject devices (Intermediate Nails and RC Lag Screw) are also sterile implants in various diameters and sizes as well as a non-sterile Intermediate Targeting Sleeve. All nails and screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136 and the targeting device is manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.
V. INTENDED USE
Gamma4 System
The introduction of the Intermediate Nails, RC Lag Screw and Intermediate Targeting Sleeve does not alter the intended use of the subject system previously cleared in K222309. The intended use is provided below:
The Gamma4 System is intended to achieve functionally stable osteosyntheses and stabilization of bones and bone fragments.
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VI. INDICATIONS FOR USE
Gamma4 System
The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).
The RC Lag Screw is also indicated for rotationally unstable fractures.
Summary of Technologies
A comparison of the systems demonstrated that the subject Gamma4 System is substantially equivalent to the following predicates in regards to intended use, material, design, and operational principles:
Non-Clinical Testing
The following performance assessment was made in support of substantial equivalence:
The following tests were performed:
- . Targeting accuracy testing
- Bending Fatigue Strength per ASTM F1264 .
The following performance assessment was conducted:
- Construct Fatigue Strength Testing ●
- . Cut-out testing
- . Torsional Stiffness per ASTM F1264
- MR evaluation ●
Testing demonstrated that the Gamma4 System is equivalent in mechanical performance to the Gamma3 System primary predicate device (K213328) and T2 Alpha Femur Antegrade GT/PF Nailing System (K203819) additional predicate device.
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CLINICAL TESTING
Clinical testing was not required for this submission.
CONCLUSION
The subject Gamma4 System is substantially equivalent to the previously cleared Gamma3 System (K213328) primary predicate.