(238 days)
No
The 510(k) summary describes a mechanical device (memory metal staples) and focuses on material properties, engineering tests, and dimensional analysis. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is used for "osteotomy fixation and joint arthrodesis," which are therapeutic medical procedures.
No
The device, MEMORY METAL STAPLES, is indicated for osteotomy fixation and joint arthrodesis, which are treatment procedures, not diagnostic ones. Its description focuses on modifications to existing cleared devices for sale, and the performance studies mention physical strength and corrosion tests, not diagnostic accuracy.
No
The device description explicitly states it is a Traditional 510(k) for "Easy Clip," which are described as "MEMORY METAL STAPLES." The performance studies also detail physical testing (dimensional, strength, bending, corrosion), indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hand and foot bone fragments osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "MEMORY METAL STAPLES." These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes
87 JDR
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared Easy Clip' devices (K070031).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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: Dimensional (geometric cross section) and engineering strength analyses as well as static and dynamic bending tests were conducted and the results support the conclusion that there are no effects of the modifications subject to this premarket notification on the safety and effectiveness of the EasyClip staples. Corrosion Testing as per ASTM F2129 was also performed.
Clinical Testing: Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
| Proprietary Name: | Easy Clip | MAR 1 2 2013 |
|---|---|---|
| Common Name: | Staple, Fixation, Bone | |
| Classification Name and Reference: | Single/multiple component metallic bone fixation | |
| appliances and accessories 21 CFR §888.3030 | ||
| Regulatory Class: | Class II | |
| Product Codes: | 87 JDR- Single/multiple component metallic bone fixation | |
| appliances and accessories | ||
| For Information contact: | Estela Celi, Regulatory Affairs Specialist | |
| Stryker Trauma AG | ||
| Phone: (201) 831-6461 Fax:# (201) 831-3461 | ||
| Date Prepared: | July 16,2012 |
Description:
· This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market Easy Clip. Additional sizes to the existing range and modifications are being made existing cleared *Easy Clip' devices (K070031).
Intended Use:
The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Indications:
The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Summary of Technologies:
Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:
- . K070031 - Memometal Memory Staples
Non-Clinical Testing:
Dimensional (geometric cross section) and engineering strength analyses as well as static and dynamic bending tests were conducted and the results support the conclusion that there are no effects of the modifications subject to this premarket notification on the safety and effectiveness of the EasyClip staples. Corrosion Testing as per ASTM F2129 was also performed.
Clinical Testing: Clinical testing was not required for this submission.
Conclusion: The additional Easy Clip staples are substantially equivalent to the predicate devices identified in this premarket notification.
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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
Letter dated: March 12, 2013
Stryker. Corporation % Ms. Estela Celi Regulatory Affairs Specialist 132 Corporate Drive Mahwah. New Jersey 07430
Re: K122113
Trade/Device Name: Memory Metal Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: February 25, 2013
Received: February 26, 2013
Dear Ms. Celi:
i i
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Ms. Estela Celi
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark NEmelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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· Indications for Use
510(k) Number (if known): K122113
Device Name: Memory Metal Staples
Indications for Use:
The MEMORY METAL STAPLES (MEMOCLIP, EASYCLIP, and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices