(175 days)
No
The summary describes a mechanical implant made of NiTi alloy and focuses on mechanical and biocompatibility testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated for fixation of bone fragments and joint arthrodesis, which are therapeutic interventions.
No
Explanation: The Superelastic Staple is described as an implant used for fixation and arthrodesis of bone fragments, indicating a therapeutic or prosthetic (repair/replacement) function rather than a diagnostic one. The mechanical and biocompatibility tests performed are for safety and efficacy as an implant, not for diagnosing a condition.
No
The device description clearly states it is a physical staple made of NiTi alloy, which is a hardware component. The performance studies also focus on mechanical and material properties, not software performance.
Based on the provided information, 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 a "Superelastic Staple" made of NiTi alloy, designed to be implanted in bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The device described is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Superelastic Staple are 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 Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.
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
Not Found
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)
The following mechanical tests were performed:
- о Static bending test according to ASTM F564 – Annex 4
- Dynamic bending test according to ASTM F564 Annex 1 O
- Axial pull-out strength according to ASTM F564 Annex 2 O
- Transition temperature according to ASTM F2004 O
- Corrosion susceptibility testing according to ASTM F2129 o
- Cytoxicity testing according to ISO 10993-5:2009 O
- Acute Systemic Toxicity testing according to ISO 10993-11:2006 O
- Chemical Characterization according to ISO 10993-18:2005 O
The results of these tests indicate that the Superelastic Staple are equivalent to predicate device.
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.
Biopro Memory Staples® (K061798) from Biopro
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.
Memometal Memory Staples (Memoclip – Easy Clip – For Fusion) (K070031) from Memometal, ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple (K142111) from Novastep
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
February 28, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neosteo % J.D Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S West Haven, Utah 84401
Re: K192447
Trade/Device Name: Superelastic Staple 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: January 28, 2020 Received: January 30, 2020
Dear J.D Webb:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Superelastic Staple:
Indications for Use (Describe)
The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Type of Use (Select one or both, as applicable)
ا Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left, resembling a stylized eye or gear. To the right of the spiral is the word "neosteo" in orange, with the words "EFFICIENT MOBILITY" in smaller, black font underneath. The logo appears to be for a company involved in efficient transportation solutions.
510(k) Summary
l. SUBMITTER'S INFORMATION
A. 510(k) Owner
NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34
B. Contact Person
JD Webb The Orthomedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 Tel: 512 590-5810 Email: jdwebb@orthomedix.net
C. Date of Preparation of the 510(k) Summary
August 30, 2019
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Image /page/4/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter font. The spiral design is made up of a series of lines radiating from a central orange circle.
510(k) Summary
II. DEVICE IDENTIFICATION
| Trade or proprietary name | Superelastic Staple |
|---|---|
| Common or usual name | Bone Staple |
| Classification regulation | 21 CFR 888.3030 |
| Proposed Regulatory Class | Class II |
| Panel | 87 "Orthopedic" |
| Product code | JDR |
| Primary Predicate Device | Biopro Memory Staples® (K061798) from Biopro |
| Reference Predicate Devices | Memometal Memory Staples (Memoclip – Easy Clip – For Fusion) (K070031) from |
| Memometal | |
| ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis Staple | |
| (K142111) from Novastep |
lll. DEVICE DESCRIPTION
The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.
A. Materials
Superelastic Staple: NiTi alloy per ASTM F2063
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Image /page/5/Picture/1 description: The image shows the logo for Neosteo Efficient Mobility. The logo consists of an orange spiral design on the left, resembling a stylized eye or gear. To the right of the spiral is the word "neosteo" in orange, with the words "EFFICIENT MOBILITY" in smaller letters underneath. The logo appears to be for a company involved in efficient transportation solutions.
510(k) Summary
IV. INTENDED USE
The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
V. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE
The Superelastic Staple is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
VI. NON-CLINICAL TEST SUMMARY
The following mechanical tests were performed:
- о Static bending test according to ASTM F564 – Annex 4
- Dynamic bending test according to ASTM F564 Annex 1 O
- Axial pull-out strength according to ASTM F564 Annex 2 O
- Transition temperature according to ASTM F2004 O
- Corrosion susceptibility testing according to ASTM F2129 o
- Cytoxicity testing according to ISO 10993-5:2009 O
- Acute Systemic Toxicity testing according to ISO 10993-11:2006 O
- Chemical Characterization according to ISO 10993-18:2005 O
The results of these tests indicate that the Superelastic Staple are equivalent to predicate device.
VII. CLINICAL TEST SUMMARY
No clinical studies were performed.
CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.
NEOSTEO considers the Superelastic Staple to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.