(154 days)
Not Found
No
The 510(k) summary describes a mechanical implant made of Nitinol and its associated instruments. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
Yes
The device is described as an implant designed to hold bones together for healing, indicating a therapeutic purpose for treating bone fragments, osteotomies, and joint arthrodesis.
No
Explanation: The device, a compression staple implant, is described as intended to "hold bones together until healing occurs" for "fixation and joint arthrodesis." This indicates a therapeutic or reconstructive purpose rather than a diagnostic one. There is no mention of it being used to identify or determine the nature of a condition.
No
The device description clearly states it is a "super elastic compression staple made of superelastic Nitinol" and includes "instruments," indicating it is a physical implant and associated hardware, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The In2Bones USA NeoSpan™ Compression Staple Implant is a physical implant designed to hold bones together within the body. It is a surgical device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use is for "hand and foot bone fragments, osteotomy fixation and joint arthrodesis," which are all surgical procedures involving the musculoskeletal system.
Therefore, based on the provided information, this device clearly falls under the category of a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JDR
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.
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 (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vilex eZ-Staple Superelastic Bone Fixation Staple K112837, Stryker EasyClip K122113
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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 SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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, LLC |
| 6060 Poplar Avenue, Suite 380 | |
| Memphis, 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 Fixation |
| Appliances 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 K112837
Stryker EasyClip K122113 |
| ------------------- | --------------------------------------------------------------------------------------- |
|---|
-
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.