INSULSCAN INSULATION TESTING SYSTEM

K991424 · Medicor Corp. · HFG · Jul 22, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991424
• Device Name: INSULSCAN INSULATION TESTING SYSTEM
• Applicant: Medicor Corp.
• Product Code: HFG · Obstetrics/Gynecology
• Decision Date: Jul 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2

Intended 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.

Device Story

InsulScan™ is a high-voltage insulation tester for electrosurgical instruments. System components include a disposable hand-held probe, control unit, cable adapter, and connection cable. Powered by a rechargeable battery. Device is non-patient contact; used to detect insulation defects on surgical instruments before use. Operation involves applying high voltage (6,500V DC) to the instrument to identify potential insulation failures. Benefits include preventing accidental patient burns by ensuring instrument integrity. Used in clinical settings by healthcare staff.

Clinical Evidence

No clinical data; bench testing only. Device is non-patient contact.

Technological Characteristics

High voltage insulation tester; output 6,500V DC (+/- 1,000V); battery-powered (rechargeable); dimensions 2.5" H x 8" W x 7" D; non-patient contact; disposable probe; control unit with automatic power-off after 30 minutes.

Indications for Use

Indicated for testing the insulation of electrosurgical instruments. Non-patient contact device.

Regulatory Classification

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.

Predicate Devices

• LIT Insulation Testing System (K952889)

Submission Summary (Full Text)

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JUL 22 1999

#### Summary of Safety and Effectiveness 11.0

| Submitter Name and Address: | MediCor Corporation<br>236-B Egidi<br>Wheeling, Illinois 60090 |
|--------------------------------------|---------------------------------------------------------------------------|
| Contact Person:<br>Telephone Number: | Scott B. Kerrigan<br>847-465-1144 |
| Date Summary Prepared: | April 21, 1999 |
| Proprietary Name: | The InsulScanTM Insulation Testing System |
| Common Name: | Insulation Tester |
| Classification Name: | Gynecologic laparoscope and accessories<br>21 CFR 884.1720 |
| | Unipolar endoscopic coagulator-cutter and<br>accessories, 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:

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.

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

OR

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