(83 days)
The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.
The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the STAPIX™ Superelastic Implant Bone Staples:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on comparison to predicate devices and performance testing to demonstrate substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bending Fatigue | Similar or equivalent to predicate devices | Performance testing consisted of bending fatigue. (Results not detailed, but concluded to be safe and effective as predicate) |
| Static Bending | Similar or equivalent to predicate devices | Performance testing consisted of static bending. (Results not detailed, but concluded to be safe and effective as predicate) |
| Corrosion | Similar or equivalent to predicate devices / Biocompatible | Performance testing consisted of corrosion. (Results not detailed, but concluded to be safe and effective as predicate) |
| Material Properties | Superelastic at room and body temperatures (A(f) temperature) | Finished A(f) temperature of 10°C +/-7° to ensure superelasticity at room and body temperatures. |
| Intended Use | Treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon; hand & foot surgery. | Indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet. (Consistent with stated intended use) |
| Technological Characteristics | Same as predicate devices | The proposed device has the same technological characteristics as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The summary only mentions "performance testing consisted of bending fatigue, static bending, and corrosion." This implies in vitro mechanical testing, not a clinical test set with human subjects.
- Data Provenance: Not applicable for in vitro mechanical testing. There is no mention of country of origin or whether the data is retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable as the provided documentation describes in vitro mechanical testing and a comparison to predicate devices for substantial equivalence, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
- This information is not applicable as the provided documentation describes in vitro mechanical testing, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technological characteristics and in vitro performance testing compared to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a bone staple. It is not an algorithmic or AI-based device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through physical and mechanical testing standards (for bending fatigue, static bending, and corrosion) and material science properties (like the A(f) temperature of Nitinol). The comparison point ("truth") for regulatory approval is the performance and characteristics of the legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware medical device (bone staple), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is a bone staple, there is no training set or associated ground truth establishment in the context of AI/ML.
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510(K) SUMMARY K133523
| Submission Correspondentand Owner: | Instratek, Inc.15200 Middlebrook Dr., Suite GHouston, TX 77058USA |
|---|---|
| Phone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyPresident | |
| Date summary prepared: | February 4, 2014 |
| Device trade name: | STAPIX™ Superelastic Implant Bone Staples |
| Device common name: | Bone Staple |
| Device classification name: | Staple, Fixation, BoneJDR at 21 CFR Part 880.3030 |
| Legally marketed device towhich the device issubstantially equivalent: | Memometal Easyclip Cleared March 19, 2007 under K070031Memory Metal Staples, Easyclip Cleared March 12, 2013 underK122113InteliFUSE, cleared June 29, 2005 under K051408 |
| Description of the device: | The Instratek STAPIX™ Superelastic Implant Bone Staples kits arecomprised of superelastic bone staples in 16 configurations. TheNitinol staples have a finished A(f) temperature of 10°C +/7° toensure that the material is superelastic at room and bodytemperatures. The Instratek STAPIX™ Superelastic Implant isindicated for use in the treatment of bone fractures, osteotomies,and arthrodesis for the reconstructive surgeon. The device isintended for hand and foot surgery. STAPIX™ bone staples aremade from superelastic nickel titanium that does not require coldstorage or heating. Implant sizes range from 9mm to 24mm. |
| Intended use of the device: | The Instratek STAPIX™ Superelastic Implant is indicated for use inosteotomy and arthrodesis of bones and joints of the hands and feet. |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate devices. |
| Testing: | Performance testing consisted of bending fatigue, static bending,and corrosion. |
| Conclusions: | The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices. |
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Image /page/1/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 symbol that resembles an eagle or a bird in flight, with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2014
Instratek, Incorporated Mr. Jeff Seavey President 15200 Middlebrook, Suite G Houston, Texas 77058
Re: K133523
Trade/Device Name: STAPIX™ Superelastic Implant Bone Staples 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: December 12, 2013 Received: December 13, 2013
Dear Mr. Seavey:
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
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Page 2 - Mr. Jeff Seavey
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.
Vincen制动Devlin -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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INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
STAPIX™ Superelastic Implant Bone Staples
Indications for Use:
The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet .
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Orthopedic Devices
§ 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.