(154 days)
The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs.
This document is a 510(k) premarket notification for a medical device called the "NeoSpan™ Compression Staple Implant w/instruments." It's a regulatory submission to the FDA, not a study report demonstrating the device meets clinical acceptance criteria.
Therefore, the information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria, such as specific performance metrics like sensitivity, specificity, or accuracy, is not present in this document.
This document focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating clinical efficacy or performance against specific acceptance criteria for an AI/device performance study.
Here's why the requested information cannot be extracted from the provided text:
- This is not an AI/Software as a Medical Device (SaMD) submission: The device is a physical implant (bone staple), not a software algorithm. Therefore, concepts like "ground truth," "expert consensus," "MRMC studies," "training set," or "test set" in the context of AI model performance are not applicable here.
- Performance Data Section VII: This section states, "Testing including pyrogenicity, corrosion, static bending, fatigue bending and pullout fixation was performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." These are engineering and biocompatibility tests for a physical implant, not clinical performance metrics or acceptance criteria for a diagnostic/AI device.
- Acceptance Criteria and Device Performance Table: Since this is a physical device establishing substantial equivalence, there are no "clinical acceptance criteria" in the sense of predictive performance (e.g., sensitivity, specificity) for an AI model. The criteria are related to mechanical properties and biocompatibility. The document only broadly states "results of the testing demonstrate that the device is substantially equivalent," without providing specific numerical performance data against pre-defined acceptance thresholds for these engineering tests.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These terms and concepts are relevant to the validation of AI/ML models or diagnostic devices. They are not applicable to the 510(k) submission for a physical bone staple, which relies on engineering testing and comparison to a predicate.
In summary, the provided document is a regulatory submission for a physical medical device (bone staple) seeking 510(k) clearance based on substantial equivalence. It does not contain the type of study data or acceptance criteria relevant to an AI/ML diagnostic or prognostic device as implied by your detailed questions.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a scarf.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
In2BonesUSA, LLC % Ms. Louise Focht President ENMED International, Inc. P.O. Box 249 Del Mar. California 92014
Re: K161426
Trade/Device Name: NeoSpan™ Compression Staple Implant w/instruments 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: September 15, 2016 Received: September 19, 2016
Dear Ms. Focht:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 | ||
|---|---|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K161426 |
|---|---|
| Device Name | NeoSpan TM Compression Staple Implant w/instruments |
Indications for Use (Describe)
The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
| 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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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary of Safety and Effectiveness K161426
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
- I. Submitter
| Date Prepared: | October 18, 2016 |
|---|---|
| Device Submitter: | In2Bones USA, LLC6060 Poplar Avenue, Suite 380Memphis, TN 38119 |
| Phone: | 901-260-7931 |
| Contact Person: | Louise Focht |
II. Device
| Proprietary Name: | NeoSpan™ Compression Staple Implant w/instruments |
|---|---|
| Regulation Name: | Single/Multiple Component Metallic Bone FixationAppliances and Accessories |
| Common Name: | Bone Staple |
| Classification Name: | Staple, Fixation, Bone |
| Regulatory Class: | 21 CFR 880.3030, Class II |
| Product Code: | 87 JDR |
III. Predicate Device
| Predicate Device: | Vilex eZ-Staple Superelastic Bone Fixation Staple K112837Stryker EasyClip K122113 |
|---|---|
| ------------------- | --------------------------------------------------------------------------------------- |
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IV. Device Description
The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression staple made of superelastic Nitinol. The devices are available in multiple sizes. The implant is designed to hold bones together until healing occurs. -
V. Intended Use and Indications for Use
The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
Comparison of technological characteristics with the predicate device VI.
The In2Bones USA NeoSpan™ Compression Staple Implant and the legally marketed predicate device have the same intended use and indications for use, same dimensions, geometry and
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materials. The In2Bones device and the predicate are both available in multiple sizes. The staples are fit into two holes drilled into various bones to provide fixation for bone fracture, osteotomy and fusion. The In2Bones USA NeoSpan™ Compression Staple Implant is made from superelastic nitinol.
VII. Performance Data
Testing including pyrogenicity, corrosion, static bending, fatigue bending and pullout fixation was performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified
VIII. Conclusions
The In2Bones USA NeoSpan™ Compression Staple Implant when compared to the predicate have the similar intended use and indications for use, technological characteristics, and principals of operation as the predicate device. Thus the In2Bones USA NeoSpan™ Compression Staple Implant design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.
§ 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.