The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

Device Description

The InsulScan™ system is comprised of a disposable hand-held instrument probe, a control unit, a cable adapter, and a ten-foot long connection cable. The InsulScan™ system is powered by a rechargeable battery housed in the control unit. A battery recharger unit and battery charger cable are provided for recharging. The InsulScan™ probe is provided sterile, single use and may not be resterilized.

AI/ML Overview

The provided document describes the InsulScan™ Insulation Testing System, which is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

The document does not include specific acceptance criteria or a detailed study proving the device meets those criteria. It focuses on the regulatory submission (510(k) summary) rather than performance validation. Therefore, the requested information cannot be fully provided from the given text.

However, based on the available information, here's what can be extracted and how the missing pieces would typically be presented:

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

The document provides "Device Specifications" which can be interpreted as design specifications or performance targets. However, it does not explicitly state acceptance criteria or show actual measured performance against those criteria.

Item	Acceptance Criteria (Inferred from Specifications)	Reported Device Performance (Not explicitly stated in document)
Output Voltage	6,500 Volts, DC ± 1,000 Volts, DC	Not reported
Operating Duration	Continuous: 30 minutes (automatic power off)	Not reported
Frequency	DC	Not reported
Intended Use	Non-destructive, non-patient contact, high voltage insulation tester for electrosurgical instruments	The 510(k) clearance implies the device meets its stated intended use.

2. Sample size used for the test set and the data provenance

The document does not provide details on a specific test set, its sample size, or data provenance. This type of information would typically be found in a detailed validation study report, which is not included here. This 510(k) summary refers to the device as being substantially equivalent to a predicate device (LIT Insulation Testing System K952889), which implies that the substantial equivalence was demonstrated through comparison to the predicate's established performance, but specific test data for the InsulScan™ is not presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a clinical study or a study involving expert assessment to establish ground truth for a test set. This device is an insulation tester, not a diagnostic or imaging device that would typically rely on expert ground truth.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set that would require an adjudication method.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware testing instrument, not an algorithm. Its performance is inherent in its design and function. The "standalone" performance would typically refer to its ability to accurately detect insulation breaches as designed, but specific testing details are not provided.

7. The type of ground truth used

For an insulation testing device, the "ground truth" would typically be established by:

Known defective insulation: Electrosurgical instruments with pre-engineered or confirmed insulation failures.
Known intact insulation: Electrosurgical instruments with confirmed, undamaged insulation.
Reference standard measurement: Using highly accurate and calibrated laboratory equipment to determine the actual insulation integrity (e.g., breakdown voltage, leakage current) against which the device's measurements are compared.

The document does not detail how the ground truth was established for any internal testing or validation studies.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.

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

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.

Summary

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JUL 22 1999

Summary of Safety and Effectiveness 11.0

Submitter Name and Address:	MediCor Corporation236-B EgidiWheeling, Illinois 60090
Contact Person:Telephone Number:	Scott B. Kerrigan847-465-1144
Date Summary Prepared:	April 21, 1999
Proprietary Name:	The InsulScanTM Insulation Testing System
Common Name:	Insulation Tester
Classification Name:	Gynecologic laparoscope and accessories21 CFR 884.1720
	Unipolar endoscopic coagulator-cutter andaccessories, 21 CFR 884.4160
Device Classification:	Class II per 21 CFR 884.1720 and 884.4160
Panel Code:	85
Procodes:	HET (884.1720) and HFG (884.4160)
Predicate Device Accessory:	LIT Insulation Testing System (K952889)

Product Design:

Intended Uses/Indications:

The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments

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Device Specifications:

ﻤﺴﺎﻣﻤ

Item	Specifications
Output Voltage	6,500 Volts, DC + 1,000 Volts, DC
Supply Voltage (Battery Charger)	100 - 240 Volts, AC, 50-60 HZ, 0.80 - 0.35 Amps
Frequency	DC
Operating Duration	Continuous: 30 minutes (automatic power off)
Input Voltage	14 Volts, DC
Fuse	Non-Replaceable in Charger
Dimensions	2.5" H x 8" W x 7" D
Shipping Weight	Control Unit, 2 pounds; Charger, 13 ounces

Biological Specifications:

Not required, non-patient contact.

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Image /page/2/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 an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2 1999

Mr. Scott B. Kerrigan Vice President. Corporate Development MediCor Corporation 150 Fairway Drive, Suite 164 Vernon Hills, IL 60061

Re: K991424 InsulScan™ Insulation Testing System Dated: April 21, 1999 Received: April 23, 1999 Requlatory Class: II 21 CFR §884.4160/Procode: 85 HFG

Dear Mr. Kerrigan:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 requirements, 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in viiro 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"(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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991424

InsulScan™ Insulation Testing System Device Name:

Indications For Use:

The InsulScan™ Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Per 21 CFR 801.109)

Over -The-Counter Use

(Optional Format 1-2-96)

Thoid A. Brymm

Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).