(63 days)
The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The Super Staple™ is a two leg U-shaped staples fabricated from nitinol alloy with an S-shaped bridge design. These U-shaped compressive staples range in width from 9 to 30 millimeters. Staple prong length ranges from 7 to 30 mm and staples have prongs of equal and unequal length.
This is a summary of the performance data for the Super Staple™ Classic, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Corrosion Testing (ASTM F2129) | Acceptable corrosion behavior, substantially equivalent to predicate devices. | The corrosion behavior of the Super Staple™ was acceptable for all samples tested and substantially equivalent to the predicate devices. |
| Staple Compression | Substantially equivalent compression force compared to predicate staples. | Compression tests showed that the Super Staple™ has a substantially equivalent compression force when compared to the predicate staples tested. |
| Pull-out | Substantially equivalent pull-out force compared to predicate staples. | Pull-out tests showed that the Super Staple™ had a substantially equivalent pull-out force when compared to the predicate staples tested. In this test, the performance of the Super Staple™ meets the performance of the predicate devices. |
| Ultimate Strength (Failure Load, Stiffness, Deflection) | Substantially equivalent to the predicate device. | Strength of the Super Staple™ in failure load, stiffness, and deflection was measured and found substantially equivalent to the predicate device tested. |
| Fatigue Strength (S-N curves) | Substantially equivalent or better load at run-out compared to the predicate device. | Fatigue testing S-N curves and their characteristic equations showed that the Super Staple™ withstands substantially equivalent load at run-out when compared to the tested predicate device. Thus, the fatigue performance of the Super Staple™ is substantially equivalent or better than the predicate devices. |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes (number of staples) used for each individual test. It refers to "all samples tested" for corrosion and "predicate staples tested" for other mechanical tests. The data provenance is not explicitly mentioned (e.g., country of origin). Based on the nature of the tests (mechanical and corrosion), this would be laboratory-generated data, not human patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a mechanical implant, and its performance evaluation relies on objective physical and mechanical testing, not a ground truth established by human experts.
4. Adjudication Method for the Test Set
Not applicable. The performance evaluation is based on objective measurements from physical tests, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device (surgical staple) and not an AI/imaging diagnostic device. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting with AI is not relevant.
6. Standalone (Algorithm Only) Performance Study
No. This is a mechanical medical device, not an algorithm or software. Therefore, a standalone performance study in the context of AI algorithms is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical and mechanical measurements against defined engineering standards and comparison to legally marketed predicate devices. This includes:
- Corrosion resistance specified by ASTM F2129.
- Measured compression force.
- Measured pull-out force.
- Measured ultimate strength parameters (failure load, stiffness, deflection).
- Measured fatigue strength (S-N curves and load at run-out).
8. Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device.
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510(k) Summary of Safety and Effectiveness
JAN 0 3 2013
-82
KIZ3363 510(k) Summary As required by 21 CFR 807.92:
Name of Sponsor: Metric Medical Devices, Inc., 846 Silver Springs, Helotes, TX, 78023
Contact: W. Casey Fox, Ph.D., P.E., President
1/2/2013 Date Prepared:
Proprietary Name: The Super Staple™ Classic
Classification Name: Staple, Fixation, Bone
Device classification: Class II per 21 CFR 888.3030
Product Device Code: JDR
Substantial Equivalence: The Super Staple™ is substantially equivalent to the Memory™ Staple (Depuy), Memory Staple™ (BioPro, Inc.) EasyClip™ (Memometal Inc.), and OSStaple™ (BioMedical Enterprises, Inc.) in terms of intended use and indications for use, material, design and function. Any minor differences between these devices or their performance do not raise any questions of safety and effectiveness.
Intended Use: The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Performance Data: Corrosion testing per ASTM F2129 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices" was performed. The corrosion behavior of the Super Staple™ was acceptable for all samples tested and substantially equivalent to the predicate devices.
Staple Compression, pull-out, ultimate strength and fatigue strength were measured for the Super Staple™ and predicate devices. Compression tests showed that the Super Staple™ has a substantially equivalent compression force when compared to the predicate staples tested.
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Pull-out tests showed that the Super Staple™ had a substantially equivalent pull-out force when compared to the predicate staples tested. In this test the performance of the Super Staple™ meets the performance of the predicate devices.
Strength of the Super Staple™ in failure load, stiffness and deflection was measured and found substantially equivalent to the predicate device tested. Fatigue testing S-N curves and their characteristic equations showed that the Super Staple™ withstands substantially equivalent load at run-out when compared to the tested predicate device. Thus the fatigue performance of the Super Staple™ is substantially equivalent or better than the predicate devices.
Device Description: The Super Staple™ is a two leg U-shaped staples fabricated from nitinol alloy with an S-shaped bridge design. These U-shaped compressive staples range in width from 9 to 30 millimeters. Staple prong length ranges from 7 to 30 mm and staples have prongs of equal and unequal length.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2013
Metric Medical Devices, Incorporated % W. Casey Fox, Ph.D.,PE President 846 Silver Springs Helotes, Texas 78023
Re: K123363
Trade/Device Name: Super Staple™ Classic Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: October 30, 2012 Received: November 1, 2012
Dear Dr. Fox:
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
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Page 2 - W. Casey Fox, Ph.D.,PE
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,
Image /page/3/Picture/7 description: The image shows the name "Erin D. Keith" in a stylized font. The first name, "Erin," is written in a simple, bold font. The middle initial and last name, "D. Keith," are written in a more complex, geometric font, with the letters appearing to be constructed from multiple lines and shapes.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
Indications For Use
Page 1 of 1
510(k) Number (if Known):
Device Name: Super Staple™ Classic
Indications for use:
The Super™ Staple is intended for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD \2013.01.03 12:59:25 -05'00' Division of Orthopedic Devices
Page 7 of 64
§ 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.