(286 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and mechanical strength of a shape memory alloy staple, with no mention of AI or ML.
Yes
The device is a bone fixation appliance intended to permanently implant, used for fixing osteotomies and arthrodesis of foot bones and joints. This direct intervention to treat a medical condition qualifies it as a therapeutic device.
No
Explanation: The device is described as a "bone fixation appliance" for "fixing osteotomies and arthrodesis." Its purpose is to physically stabilize bones, not to diagnose a condition or disease.
No
The device description clearly states it is a "single use bone fixation appliance intended to be permanently implanted" and is made of a "shape memory Nickel-Titanium alloy," indicating it is a physical hardware device, 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 "Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot." This describes a surgical procedure to fix bones, not a test performed on samples from the human body to provide diagnostic information.
- Device Description: The device is described as a "single use bone fixation appliance intended to be permanently implanted." This is a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant or bone fixation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Memory Staple is intended for bone fixations of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot.
For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.
Product codes (comma separated list FDA assigned to the subject device)
87JDR
Device Description
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot
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)
Prong separation tests were performed on the Memory Staple and the Landos Standard Staple. The results showed that the Memory Staple had more than twice the strength of the Landos Staple. Successful clinical use of the Memory Staple in 315 osteolomies of the great toc between 1991-1994 was reported by Barouk in 1994.
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.
The Landos Standard Staple, The Stryker Osteoclasp, The Mitek Anchor II™
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
Kaluzak
| SUMMARY OF SAFETY AND EFFECTIVENESS |
|---|
| ------------------------------------- |
AUG - 5 |997
| MANUFACTURER IDENTIFICATION: | Medinov-AMP
27 à 31 rue Lucien Langenieux
42335 Roanne FRANCE |
|------------------------------------------------------|---------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION
NUMBER (Manufacturer): | 9681744 |
| SPONSOR IDENTIFICATION: | Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46580 |
| ESTABLISHMENT REGISTRATION
NUMBER (Sponsor): | 1818910 |
| PROPRIETARY NAME: | Memory Staple™ |
| PRODUCT CLASSIFICATION CODE: | 87JDR |
| PROPOSED REGULATORY CLASS: | Class II |
DESCRIPTION:
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
INTENDED USE AND INDICATIONS:
The Memory Staple is intended for bone fixations of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot
PREDICATE DEVICES:
The Memory Staple is substantially equivalent to: 1) The Landos Standard Staple 2) The Stryker Osteoclasp 3) The Mitek Anchor II™
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Memory Staple, the Landos Standard Staple and the Stryker Osteoclasp are all intended for bone fixation. The Memory Staple and the Mitek Anchor II are both manufactured from Nickel-Titanium shape memory alloy.
SUMMARY OF STUDIES:
Prong separation tests were performed on the Memory Staple and the Landos Standard Staple. The results showed that the Memory Staple had more than twice the strength of the Landos Staple. Successful clinical use of the Memory Staple in 315 osteolomies of the great toc between 1991-1994 was reported by Barouk in 1994.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Manager Clinical Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K964226 Re : Trade Name: Memory Staple Requlatory Class: II Product Code: JDR Dated: May 30, 1997 Received: June 2, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
AUG - 5 1997
2
Page 2 - Ms. Cheryl Hastings
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrood in your sion, privalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
ONFIDENTIAL
Indications For Use:
For Fixing the osteotomies and arthrodesis
of the mid fout bones, the metatarsals, the
phalanges, and associated joints of the foot.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K964226
Prescription Use ✗
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)