Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and The OSStaple™ is contraindicated for craniofacial patients with a skull cranioplasty. thickness less than the selected prong length.

Device Description

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm™ gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm" electrode and will cease if the button is released prior to the automatic cessation by the circuitry

AI/ML Overview

This document (K023488) focuses on the BioWarm™ Product, a device modification to an existing system, the Warmsystem, used to heat shape memory Nitinol staples (OSStaple™) for compression. The document primarily discusses the substantial equivalence of this modification to previously approved devices, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested elements for a performance study are not present in this submission.

Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission is a 510(k) summary for a device modification (BioWarm™), arguing for substantial equivalence rather than presenting an independent performance study with defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. As this is a 510(k) for a modification (BioWarm™) deemed substantially equivalent to a predicate, a new dedicated clinical performance study with a test set is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. This typically applies to studies evaluating diagnostic accuracy against an expert-established ground truth, which is not the nature of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was done. This document describes a medical device for heating staples, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a physical instrument (heater) and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not relevant in the context of this 510(k) submission for a device modification. The device heats staples; its "performance" would likely be around temperature control, heating time, and safety, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

This information is not provided. This is not a machine learning or AI device that would have a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this type of device.

Summary of what the document does provide regarding the BioWarm™ Product:

Intended Use: The BioWarm™ is a modification to the Warmsystem, which is used to heat shape memory Nitinol staples (OSStaple™) to achieve compression.
Indications for Use (for OSStaple™): Fixation of unloaded craniofacial bone fractures and cranioplasty.
Contraindications (for OSStaple™): Craniofacial patients with a skull thickness less than the selected prong length.
Device Description:
- Has an on/off switch.
- Two user-adjusted controls: current and time, set according to staple size/configuration.
- Provides visual and audible indications of current delivery.
- Audible signal upon automatic completion of current delivery.
- Electrode handle provides visual indication of positive contact and actual current flow.
- Current is activated by a button on the handle and stops if released or automatically.
Substantial Equivalence: The BioWarm™ is presented as a modification to the Warmsystem, previously approved via 510(k)s K993714, 001219, 001353, and 001354. No fundamental technology changes are claimed.

In essence, this 510(k) submission argues that the BioWarm™ modification does not introduce new questions of safety or effectiveness when compared to the original Warmsystem, thus negating the need for new, extensive performance studies with detailed acceptance criteria typically associated with novel devices. The "proof" is the demonstration of substantial equivalence to already approved predicate devices.

Summary

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Image /page/0/Picture/0 description: The image shows the text "APPENDIX IV (510(k) Summary)" along with a handwritten number above it. The number appears to be K023488. There is a line drawn underneath the number. The text is in a standard font and is left-aligned.

OCT 31 2002

BioWarm™ Product:

BioMedical Enterprises, Inc. (BME) intends to introduce a device modification to the original approved Warmsystem to heat shape memory Nitinol staples (the "OSStaple™") to achieve compression.

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

Date Prepared: September 25, 2002

Classification name: Staple, Fixation, Bone b. Common/Usual Name: Bone staple Proprietary Name: OSStaple™, BioWarm™
Intended Use: C.

Device Description d.
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm™ gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm" electrode and will cease if the button is released prior to the automatic cessation by the circuitry

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Substantial Equivalence: e.

The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are represented with the BioWarm" modification.

(Signature)

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

10/14/02
(Date)

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Image /page/2/Picture/0 description: The image shows a logo with a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, wave-like quality. The logo is surrounded by text that curves along the perimeter of a circle, with the words "PUBLIC HEALTH SERVICE" visible at the top and "DEPARTMENT OF HEALTH" at the bottom. The text is also in black, and the overall design has a formal and official appearance.

GEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2002

Dr. W. Casey Fox President BioMedical Enterprises, Incorporated 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K023488

Trade/Device Name: Memograph® Staple System (OSStaple™) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: 76 JEY and 87 HRS Dated: October 15, 2002 Received: October 17, 2002

Dear Dr. Fox:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.

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Page 2 - Dr. Fox

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); good manufacturing practice requirements as set forth in 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.

This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023488

APPENDIX III (Indication For Use)

Device Name: Memograph® Staple System (OSStaple

Indications for the OSStaple™ are fixation of unloaded craniofacial bone fractures and cranioplasty. The OSStaple™ is contraindicated for craniofacial patients with a skull thickness less than the selected prong length.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use レ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Curry

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K031188

Page 12 of 14

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.