The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.

Device Description

The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.

AI/ML Overview

The provided document describes a premarket notification for the "MicroGRASP Monopolar Coagulator," a device designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The document aims to demonstrate substantial equivalence to a predicate device, the "Microsurge Front-End Grasping Devices."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense with corresponding performance metrics for the new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be meeting applicable standards and not raising new safety/effectiveness issues compared to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with applicable standards (e.g., for electrical safety, performance)	"The MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993)."
No new issues of safety, effectiveness, or performance compared to predicate.	"The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product."
Similar intended use to predicate.	Intended Use for MicroGRASP is "For grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures," which is analogous to the predicate's "To remove tissue or control bleeding during general surgical endoscopic or laparoscopic procedures."
Similar operating principle to predicate (Monopolar Electrosurgical handpiece).	MicroGRASP: "Electrosurgical handpiece for coagulation." Predicate: "Electrosurgical handpiece for coagulation; electro-cautery." Both are Monopolar.
Similar materials and design to predicate.	"The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device." Specific material comparisons are provided in the table.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a "test set" in the context of clinical or performance data from a sample of cases or patients. The evaluation appears to be based on bench testing and comparison of technical characteristics. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as the submission relies on bench testing and comparison to standards, not human expert evaluation of a test set in the traditional medical device study sense.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a mon-AI surgical instrument (Monopolar Coagulator), not an AI diagnostic or assistance tool. Therefore, an MRMC study related to AI assistance for human readers was not performed or mentioned.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance appears to be:

Compliance with published standards: Specifically, ANSI/AAMI HF-18/1993 for electrosurgical devices.
Demonstration of substantial equivalence to a legally marketed predicate device (Microsurge Front-End Grasping Devices) in terms of intended use, operating principle, and technical characteristics.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical surgical instrument, and there is no mention of a "training set" in the context of machine learning or AI development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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August 10, 1999 Premarket Notification

OCT 5 1999

K992714

SECTION 15 SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter's name, address, telephone number, contact person, and date summary prepared;

a. Submitter:	HysteRx, Inc.
	32236-E Paseo Adelanto
	San Juan Capistrano, CA 92675 USA
	(949) 488-8701

b. Contact Person: Judy F. Gordon, D.V.M. Official Correspondent for HysteRx, Inc. (949) 854-6314
Date Summary Prepared: August 10, 1999 C.

Name of device, including trade name and classification name:

a. Trade/Proprietary Name: MicroGRASP Monopolar Coagulator
Electrosurgical cutting and coagulation device Classification Name: b.

3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

Company:	Microsurge, Inc.
Device:	Microsurge Front-End Grasping Devices
510(k) :	K922802
Date Cleared:	January 29, 1993

A description of the device that is the subject of the 510(k), including explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

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ട. Statement of intended use:

The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidanceassisted surgical procedures.

Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.

A comparison of the technological characteristics of the device and its predicate is shown in the following table:

CHARACTERISTICS	Microsurge Front-End GraspingDevices	MicroGRASP MonopolarCoagulator
Intended Use	To remove tissue or control bleedingduring general surgical endoscopic orlaparoscopic procedures	For grasping and coagulation of softtissue and blood vessels up to 3 mmduring open and guidance-assistedsurgical procedures
Operating Principle	Electrosurgical handpiece forcoagulation; electro-cautery	Electrosurgical handpiece forcoagulation
Bipolar/Monopolar	Monopolar	Monopolar
Bench Testing	ANSI/AAMI HF-18/1986	ANSI/AAMI HF-18/1993
Handpiece Configuration(s)	Scissor-type handpiece	Articulating jaws design, with 2 or 4jaw grasper, or blunt electrode
Materials:HandleInner shaftOuter shaftTipsConnector	Plastic, with stainless steel pin,washer, and springStainless steelTeflon sheath (implant grade)Stainless steel (implant grade)Nickel plated brass	Plastic, with stainless steel pins andgearsStainless steelNylon 11 sheath (implant grade - USPClass VI)Stainless steel (implant grade)Nickel plated brass
Disposable/Reusable	Single use, disposable	Single use, disposable

Comparative Technological Characteristics

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Brief summary of nonclinical tests and results: 7.

The MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993). The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, with three wavy lines representing hair or flowing fabric. The face is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT -5 1599

HysteRx, Inc. c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services 18732 Saginaw Irvine, California 92612

K992714 Re: Trade Name: MicroGRASP Monopolar Coagulator Regulatory Class: II Product Code: GEI Dated: August 10, 1999 Received: August 12, 1999

Dear Dr. Gordon:

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 (OS) 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.

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Page 2 - Judy F. Gordon, D.V.M.

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.

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,

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

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HysteRx, Inc. MicroGrasp Monopolar Coagulator

August 10, 1999 Premarket Notification

Page_____of___

510(k) Number (if known): K99 2714

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

: 上一

The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.

(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	K992714

Prescription Use (Per 21 CFR 801.109)	X
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.