(106 days)
No
The document describes a hip fracture nailing system and its accessories, focusing on mechanical components and targeting accuracy. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for the treatment of fractures and correction of bone deformities, which are therapeutic interventions.
No
The device is indicated for the treatment of stable and unstable fractures, stabilization of bones, and correction of bone deformities, which are therapeutic actions, not diagnostic. The "Targeting accuracy testing" mentioned in performance studies refers to the accuracy of the device in placement, not in diagnosing medical conditions.
No
The device description explicitly states that the submission is for two new accessory devices (Plus Targeting Arm and Plus Nail Holding Screw) which are described as physical instruments made of stainless steel, carbon fiber reinforced PEEK, and PEEK unreinforced. The Gamma4 System itself includes sterile implants and non-sterile instruments. 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 is for the treatment of bone fractures and deformities in the femur. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of implants (nails, screws, end caps) and instruments (targeting devices) used in surgery. These are physical devices used to stabilize and correct bone structures.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or conditions. This device is a surgical system used to treat a physical condition.
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).
Product codes
HSB
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw.
The Gamma4 System was previously cleared under K213328, 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 nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
The Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are 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
intracapsular, trochanteric, subtrochanteric and shaft regions of the femur
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
Non-Clinical Testing: Targeting accuracy testing
Key Metrics
Not Found
Predicate Device(s)
Gamma4 System (K213328), Gamma3 System (K213328)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 15, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker GMBH Cindy Leon Staff Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K222309
Trade/Device Name: Gamma4 System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 31, 2022 Received: October 31, 2022
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 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
1
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,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2022.11.15
14-05'00'
For Victoria Lilling, M.D. 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
2
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).
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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| 510(k) Summary | |
|---|---|
| I. SUBMITTER | |
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Cindy Leon |
| Staff Specialist, Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-5374 | |
| Fax: 201-831-6020 | |
| Date Prepared: | August 01, 2022 |
| 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 |
| Primary Predicate: | Gamma4 System (K213328) |
| Additional Predicates: | Gamma3 System (K213328) |
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Traditional 510(k) Premarket Notification
III. PREDICATE DEVICE
IV. DEVICE DESCRIPTION
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market two (2) new accessory devices into the Gamma4 System: Plus Targeting Arm and Plus Nail Holding Screw.
The Gamma4 System was previously cleared under K213328, 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 nails, lag screws and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
The Gamma4 System has two (2) types of targeting devices: (1) Proximal Targeting Arm (consisting of Targeting Sleeve and Nail Holding Screw) previously cleared in K213328 and (2) the subject devices, Plus Targeting Arm (consisting of the Plus Nail holding Screw and Targeting Sleeve, previously cleared in K213328). The previously cleared Proximal Targeting Arm has less of an extension out from the axis of the nail, whereas the subject device is more rounded and extends out further to ensure sufficient tissue clearance. Both targeting devices are manufactured from stainless steel per AISI 431, carbon fiber reinforced PEEK and PEEK unreinforced.
V. INTENDED USE
Gamma4 System
The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the intended use of the subject system previously cleared in K213328. The intended use is provided below:
5
The Gamma4 System is intended to achieve functionally stable osteosyntheses and stabilization of bones and bone fragments.
VI. INDICATION FOR USE
Gamma4 System
The introduction of the Plus Targeting Arm and Plus Nail Holding Screw does not alter the indication for use of the subject system previously cleared in K213328. The indication for use is provided below:
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).
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:
- . Targeting accuracy testing
CLINICAL TESTING
Clinical testing was not required for this submission.
6
CONCLUSION
The subject Gamma4 System is substantially equivalent to the previously cleared Gamma4 System (K213328) primary predicate and the Gamma3 System (K213328) additional predicate device.