The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse.

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

Device Description

The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).

AI/ML Overview

The provided document (K991669) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it is a 510(k) premarket notification for a traditional medical device (an electrosurgical handcontrol pencil).

The core of this submission is demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with specific performance metrics and acceptance criteria for a novel technology.

Therefore, many of the requested fields regarding AI/ML device evaluation are not applicable to this document. I will fill in the relevant available information and state "Not Applicable" where the information is not present or relevant to this type of device submission.

Here's a breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence rather than meeting specific quantifiable performance criteria compared to an absolute standard. The "performance" assessment is comparative to predicate devices.

Feature	Wallach Surgical PMS750 Fingerswitch (K991669)	Predicate Devices (Aaron, Medtrex, E&M, Conmed)	Acceptance Criteria (Implicit)
Materials	polypropylene	similar	Materials are similar to legally marketed predicate devices, implying comparable biocompatibility and durability.
Sterilization	autoclavable	equivalent	Device is autoclavable, demonstrating equivalent sterilization methods as predicate devices.
Design	Encapsulated circuit board	equivalent	Design features (e.g., encapsulated circuit board) are equivalent to predicate devices.
Intended Use	With an ESU for CUT & COAG	equivalent	Intended use for general electrosurgical applications (cutting and coagulating) is equivalent to predicate devices.
Where Used	By a Physician	equivalent	Usage by a physician is equivalent to predicate devices.
Hazard Analysis	No new hazards presented	N/A (compared to predicates)	Hazard analysis indicates no new hazards compared to predicate devices.
Limited Reuse	Intended for limited reuse (autoclavable for 100+ cycles)	N/A (implied by "reusable" predicates)	Durability for limited reuse (specifically 100+ cycles) is acceptable.

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

Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The document mentions "Testing that was performed on the PMS750 Fingerswitch," but no specific number of units tested is provided for performance validation.
Data Provenance: Not applicable. This is a conventional medical device, not an AI/ML system.

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

Not Applicable: This type of assessment (expert-established ground truth) is for AI/ML devices or diagnostic outputs. This submission for an electrosurgical pencil would typically involve engineering testing, material compatibility, and electrical safety assessments, not expert image review or diagnosis.

4. Adjudication Method for the Test Set

Not Applicable: There is no "test set" for expert adjudication in this type of submission. Performance is assessed through engineering testing and comparison to predicates.

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

Not Applicable: This is not an AI/ML device.

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

Not Applicable: This is not an AI/ML device.

7. The Type of Ground Truth Used

Not Applicable: For a device like an electrosurgical pencil, "ground truth" generally refers to established engineering standards, electrical safety standards (e.g., IEC standards), biocompatibility standards, and the functional performance of existing, legally marketed predicate devices. The "truth" is that the device performs its intended function safely and effectively, and is substantially equivalent to known safe and effective devices.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/ML device, so there is no training set.

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

Not Applicable: This is not an AI/ML device.

Summary

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AUG 12 1999

K991669

510(k) Safety and Effectiveness Summary

Applicant:	Wallach Surgical Devices, Inc.
	235 Edison Road
	Orange, CT 06477
Registration #:	1219739
Contact:	Michael Malis
Phone:	203-799-2000
Fax:	203-799-2002
Trade Name:	PMS750 Fingerswitch
Device Generic Name:	Fingerswitch or Handswitch Pencil.
Classification Name:	Device, Electrosurgical, Cutting & Coagulation & Accessories.

Predicate Devices to which we are claiming substantial equivalence:

1. Aaron Electrosurgical Handcontrol Pencil, Reusable, K983761, 12/30/98.
1. Medtrex's Encore™ Electrosurgical Pencil (35001-), Reusable, K970039, 02/26/97.
1. E & M Engineering's Reusable Hand Controlled ESP, Reusable, K936075, 06/06/94.
Conmed's Tech-Switch Electrosurgical Pencil, Reusable, K932518, 10/12/93. র্ব

Product Description:

Indications for Use:

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510(k) Premarket Notification Submittal Wallach Surgical Devices, Inc. PMS750 Fingerswitch SECTION 2 - Page 3 of 3 May 1999

Safety and Performance:

Substantial equivalence for this device is based on design, operation, intended use, materials, components and performance claims. Testing that was performed on the PMS750 Fingerswitch indicates that the devices are substantially equivalent in their performance and design of operation.

Hazard analysis evaluations performed on the PMS750 Fingerswitch indicated that there were no new hazards presented with the use of the PMS750 Fingerswitch as compared to the predicate devices.

	Wallach Surgical	Aaron	Medtrex	E & M Engineering	Conmed
	PMS750	Electrosurgical	Encore™	Reusable,	Tech-Switch
	Fingerswitch,	Handcontrol	Electrosurgical	Hand Controlled	Electrosurgical
	Reusable	Pencil,	Pencil (35001-),	ESP,	Pencil,
	K 991669	Reusable,	Reusable,	K936075,	Reusable,
	[this 510(k)]	K983761,	K970039,	06/06/94	K932518,
		12/30/98.	02/26/97.		10/12/93
Materials	polypropylene	similar	similar	similar	similar
Sterilization	autoclavable	equivalent	equivalent	equivalent	equivalent
Design	Encapsulatedcircuit board	equivalent	equivalent	equivalent	equivalent
Intended Use	With an ESU forCUT & COAG	equivalent	equivalent	equivalent	equivalent
Where Used	By a Physician	equivalent	equivalent	equivalent	equivalent

SUBSTANTIAL EQUIVALENCE CHART

Conclusion:

Based on the indications for use, technological characteristics and comparison to currently marketed devices, the PMS750 Fingerswitch has been shown to be safe and effective for its intended use.

Summaryfingerswitch.doc

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Image /page/2/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 enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Michael Malis General Manager Wallach Surgical Devices, Inc. 235 Edison Road Orange, Connecticut 06477

Re: K991669 Trade Name: PMS 750 Fingerswitch Regulatory Class: II Product Code: GEI Dated: May 11, 1999 Received: May 14, 1999

Dear Mr. Malis:

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.

い

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 - Mr. Michael Malis

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 vours.

Sincerely yours,

C. Seth Keller, Ph.D., M.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

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Wallach Surgical Devices, Inc. SECTION 7

Page_1__of_1_

510(k) Number (if known):_ K 991669

Device Name:__PMS750 Fingerswitch Pencil

Indications For Use:

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in The PMS 750 Keusable (Autoclavations for cutting and coagniating during electrosurgical
general electrosurgical applications for cutting and coagnerable for 100+ cvcl general electrosurgical applications for cuting and occagations and good
procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

(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	K991669
Prescription Use(Per 21 CFR 801.105)	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.