l ) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

Device Description

The Memograph® Staple system consists of two and four prong staples for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as in anterior crucate ligament reconstruction. The staple is fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the Warmsystem to the staple causes its prong to deflect inward. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site.

AI/ML Overview

This document K993714 details the 510(k) summary for the Memograph® Staple System. However, it does not contain the information required to populate the acceptance criteria and study details as requested. This document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results or effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The provided text focuses on the device description, intended use, and substantial equivalence to legally marketed predicate devices, which is typical for a 510(k) submission. It does not include information about specific performance studies with detailed acceptance criteria, test sets, or ground truth establishment.

Summary

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K993714

APPENDIX III 510(k) Summary

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Product:

Memograph® Staple System

BioMedical Enterprises, Inc. (BME) intends to introduce into commercial distribution the Memograph® Staple System consisting of shape memory Nitinol staples and accessories for setting and warming the staples to achieve compression.

Submittor Information તે.
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Contact: Dr. W. Casey Fox (President)

Date Prepared: January 25, 2000

Classification name: Staple, Fixation, Bone b. Common/Usual Name: Bone staple Proprietary Name: Memograph® Staple System

c. Intended Use:

The Memograph® Staple is intended for:

d. Device Description

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Substantial Equivalence: e.

The Memograph® Staple System is substantially equivalent to devices as described below. The FDA has classified these equivalent devices as Class II devices (e.g. 21 CFR 878.4400, 4750 and 886-4115). The Memograph® Staple System is a Class II medical device.

The Memograph® Staple is substantially equivalent to the Memory Staple™ (510(k) 964226). The Memory Staple™ and the Memograph® Staple use a shape memory material (Nitinol) to achieve compression when heat allows the material to return to its stable configuration. The Memograph® Staple is also substantially equivalent to the Zimmer Epiphyseal and Fracture staples and Smith & Nephew's Richard's Regular Fixation Staple. The Warmsystem heating unit is substantially equivalent to the Hemostatic Surgical System (K902307) by Hemostatic surgery Corporation and the Accu-Temp surgical cautery device (preamendment) by Concept, Inc. These predicate devices use the joule (heating) effect of electrical current in a conductor to increase the temperature of the conductor to cauterize or cut tissue. The Warmsystem uses the same effect to increase the temperature of the Nitinol staple (as the conductor) allowing it to return to its stable position thereby causing compression. Internal circuitry controls the heating effect and tissue damage by limiting current and time such that a limiting temperature of 55°C is achieved in a maximum of 5 seconds.

(Signature)

W. Casey Fox, Ph.D. P.E. President BioMedical Enterprises, Inc.

1/26/00
(Date)

29937/4

Ry. 242

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.

Public Health Service

FEB 2 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. W. Casey Fox, Ph.D., P.E. President Biomedical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K993714 Trade Name: Memograph® Staple System Regulatory Class: II Product Code: JDR Dated: December 14, 1999 Received: December 16, 1999

Dear Mr. Fox:

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 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.

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. A 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 regulation 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence 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.

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Page 2 - Mr. W. Casey Fox, Ph.D., P.E.

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) 594-4595. 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.

Russell Sage

Sor James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX II Indication For Use

Device Name: Memograph® Staple System

Indications for use: The Memograph® Staple is intended for:

hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Russell Sayer

(Division Sign-Off) Division of General Restorativ 510(k) Number

K993714

× Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _____________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.