(238 days)
Memodyn Staple (K002695)
No
The description focuses on the material properties and mechanical testing of a nitinol staple for bone fixation, with no mention of AI or ML.
Yes
The device is used for bone fixation on osteotomies, arthrodesis, and fractures, which are therapeutic interventions.
No
The device is described as a nitinol alloy memory staple for bone fixation, indicating it is an implantable device used for treatment, not diagnosis. Its intended use is for actual physical repair (fixation), not for identifying or monitoring diseases.
No
The device description explicitly states it is a "nitinol alloy ASTM F2063-12 memory staple," which is a physical hardware component.
Based on the provided information, the Memodyn Staple is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for bone fixation during surgical procedures (osteotomies, arthrodesis, and fractures). This is a therapeutic and structural function within the body.
- Device Description: It's a nitinol alloy staple used for bone fixation. This is a physical implant.
- 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 outside the body to analyze samples and provide diagnostic information. The Memodyn Staple is an implantable device used within the body for structural support.
N/A
Intended Use / Indications for Use
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle and hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 verification and validation testing of the Memodyn Staple (Subject device) fixation implant included staple static four point bending, dynamic four point bending (fatique) and elastic compression distribution of the legs per ASTM F2063. through scientific rationale. Performance data demonstrates that the device performs as well as the 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.
Memodyn Staple (K002695)
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.
Vilex Staple (K112837)
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 & 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, stacked on top of each other, with flowing lines extending downward from the bottom profile.
February 1, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Austin & Associates, Inc./Telos Medical Equipment Al Austin Manager 212 Copperwood Court Millersville, MD 21108
Re: K161587
Trade/Device Name: Memodyn 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: December 30, 2016 Received: January 3, 2017
Dear Mr. Austin:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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)
Device Name Memodyn Staple
Indications for Use (Describe)
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [as required by 21 CFR 807.92(c)]
Memodyn Staple 510(k): K161587
| DATE PREPARED: | January 27, 2017 |
|---|---|
| APPLICANT | Austin and Associates, Inc./Telos Medical Equipment |
| 212 Copperwood Court | |
| Millersville, MD 21108 | |
| Phone: 410-903-9038 | |
| Fax: 410-544-3547 | |
| Email: telosusa@aol.com | |
| OFFICIAL | |
| CORRESPONDENT | Al Austin, Manager |
| 212 Copperwood Court | |
| Millersville, MD 21108 | |
| Phone: 410-903-9038 | |
| Fax: 410-544-3547 | |
| Email: telosusa@aol.com | |
| ADDITIONAL | |
| CORRESPONDENT | Cheryl Wagoner, Consultant |
| Wagoner Consulting LLC | |
| PO Box 15729 | |
| Wilmington, NC 28408 | |
| Phone: 910-386-9019 | |
| Email: cheryl@wagonerconsultingllc.com | |
| TRADE NAME: | Memodyn Staple |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §888.3030 |
| COMMON NAME: | Staple, Fixation, Bone |
| CLASSIFICATION | |
| NAME: | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| PRODUCT CODE | JDR |
| PREDICATE DEVICE: | Memodyn Staple (K002695) |
| REFERENCE DEVICE | Vilex Staple (K112837) |
Intended Use/Indications for Use
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
DESCRIPTION:
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
4
Comparison with predicate devices:
The Memodyn Staple is substantially equivalent in design, materials, intended use, indications for use, principles of operations and technological characteristics as the predicate Memodyn Staple (K002695).
The Memodyn Staple (Subject device) is a memory staple that is made of the same Nitinol alloy material as the predicate. The implant is single use which is the same as the predicate. The staple sizes are the same as the predicate but have barbs on the staple legs. There are differences in the packaging, provided non sterile. The accessory components are sterilized in the same manner as the predicate device. The risk analysis raises no new issues relative to safety or effectiveness.
| Name of Device | Memodyn Staple (Subject Device) | Memodyn Staple (Predicate) |
|---|---|---|
| 510(k) | Current Application | K002695 |
| Indications for Use | Memodyn Staple is intended | |
| for use in bone fixation on | ||
| osteotomies, arthrodesis and | ||
| fractures of the small bones | ||
| of the foot, ankle and hand. | Memodyn Staple is intended | |
| for use in bone fixation on | ||
| osteotomies, arthrodesis and | ||
| fractures of the small bones | ||
| of the foot, ankle and hand. | ||
| Sterilization | Non-Sterile to be steam | |
| sterilized by user facility | Gamma irradiation (ASTM | |
| 11137-1, 11137-2) | ||
| Shelf Life | N/A | 10 years |
| Overall Length | 8 – 20 mm | 8 – 20 mm |
| Staple Bridge/Top | ||
| Width | 8 – 20 mm | 8 – 20 mm |
| OD of staple | 1.7mm | 1.7mm |
The intended use/indications between the Subiect Device and its predicate are identical.
Non Clinical testing / Performance Data:
The verification and validation testing of the Memodyn Staple (Subject device) fixation implant included staple static four point bending, dynamic four point bending (fatique) and elastic compression distribution of the legs per ASTM F2063. through scientific rationale.
BIOCOMPATIBILITY:
The Subject device was compared to the predicate. All of materials used for Subject device are biocompatible and identical to the predicate and are manufactured in an identical manner. The change in sterilization method has no impact upon the biocompatibility of the material.
Conclusion:
The Subject device has same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device performs as well as the predicate device. Therefore, the Memodyn Staple is substantially equivalent to the predicate device.