(137 days)
Not Found
No
The summary describes a physical implant (staples) made of a specific alloy for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on biocompatibility and mechanical characteristics, not algorithmic performance.
Yes
The device is indicated for fixation of bone fragments and joint arthrodesis, which are therapeutic interventions.
No
Explanation: The device is a compressive osteosynthesis staple, which is an implant used for bone fixation and joint arthrodesis. It is not described as performing any diagnostic functions such as identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is a physical implantable device made of shape memory nickel titanium alloy, not software.
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 described as "single-use bone fixation appliances intended to be permanently implanted." This further confirms its use within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The compressive osteosynthesis staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes
JDR
Device Description
Compressive osteosynthesis staples are single-use bone fixation appliances intended to be permanently implanted. ARCAD osteosynthesis staples are bipodal compression staples made of shape memory nickel titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone fragments
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
The biocompatibility evaluation for new devices compressive osteosynthesis staples was conducted in accordance with Blue Book Memorandum #G95-1 (Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) and International Standard ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process) as recognized by FDA.
The new devices compressive osteosynthesis staples have similar technological characteristics in terms of design and mechanical characteristics (static bending, dynamic bending and pull-out resistance) and thus are believed to be substantially equivalent to the predicate STRYKER corp. memory metal staples, Easyclip (K122113).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.
December 19, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Novatsep % Mr. Gilles Audic QA/RA Director Espace Performance Alphasis-Batiment C1-C2 Saint Gregoire, 35769 France
Re: K142111 Trade/Device Name: ARCAD Compressive Osteosynthesis Staple, EXPRESS Compressive Osteosynthesis 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: November 17, 2014 Received: November 21, 2014
Dear Mr. Audic:
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 device
1
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 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" (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 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 yours,
Mark N. Melkerson -S
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
510(k) Number (if known) K142111
Device Name
ARCAD Compressive osteosynthesis staple EXPRESS Compressive osteosynthesis staple
Indications for Use (Describe)
The compressive osteosynthesis staples are 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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"510(k) Summary" as required by section 807.92(c)
| Submitter | NOVASTEP |
|---|---|
| Espace performance Alphasis | |
| Bâtiment C1-C2 | |
| 35769 SAINT GREGOIRE | |
| France | |
| Phone : + 33 (0)2 99 33 86 50 | |
| Fax :+ 33 (0)9 70 29 18 95 | |
| Contact person | Mister Gilles AUDIC |
| QA / RA Director | |
| Cell phone:+33 (0)6 30 93 96 08 | |
| e-mail: gilles.audic@novastep-ortho.com | |
| Preparation date | 17th November, 2014 |
| Trade name | ARCAD compressive osteosynthesis staple
EXPRESS compressive osteosynthesis staple |
|---------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name | Staple, Fixation, Bone |
| Classification Name | Single/multiple component metallic bone fixation appliances and
accessories (21CFR 888.3030, product code JDR) |
| Regulatory class | II |
| Legally marketed
predicate devices | 510(k) number: K122113
Device name: memory metal staples, Easyclip
Original applicant: STRYKER corp. |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Compressive osteosynthesis staples are single-use bone fixation
appliances intended to be permanently implanted. ARCAD osteosynthesis
staples are bipodal compression staples made of shape memory nickel
titanium alloy. |
| | |
| Intended use | The compressive osteosynthesis staples are intended for hand and foot
bone fragments osteotomy fixation and joint arthrodesis. |
| Comparison of the
technological
characteristics with the
predicate device | The new devices compressive osteosynthesis staples have similar
technological characteristics in terms of material (ASTM F2063-12
Standard Specification for Wrought Nickel-Titanium Shape Memory
Alloys for Medical Devices and Surgical Implants) and mechanical
characteristics (ASTM F564-10 Sections A1, A2 and A4 Standard
Specification and Test Methods for Metallic Bone Staples) and thus are
believed to be substantially equivalent to the predicate STRYKER corp.
|
| Performance data | The biocompatibility evaluation for new devices compressive
osteosynthesis staples was conducted in accordance with Blue Book
Memorandum #G95-1 (Use of International Standard ISO-10993,
Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)
and International Standard ISO 10993-1 (Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk Management
Process) as recognized by FDA.
The new devices compressive osteosynthesis staples have similar
technological characteristics in terms of design and mechanical
characteristics (static bending, dynamic bending and pull-out resistance)
and thus are believed to be substantially equivalent to the predicate
STRYKER corp. memory metal staples, Easyclip (K122113). |
| Indication for use | The compressive osteosynthesis staples are indicated for hand and foot
bone fragments osteotomy fixation and joint arthrodesis. |
| Clinical studies | Clinical studies were not required for this submission. |
| Animal studies | Animal studies were not required for this submission. |
| Conclusion | The compressive osteosynthesis staples are substantially equivalent to
their predicate devices STRYKER corp. memory metal staples, Easyclip
(K122113) in terms of intended use and indications for use, material,
design and function. Any minor differences between these two devices
do not raise new questions of safety and effectiveness. |
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