MICROMED PD-8K INSULATION DEFECT DETECTOR

K101606 · Mcgan Technology, LLC · HFG · Oct 1, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K101606
• Device Name: MICROMED PD-8K INSULATION DEFECT DETECTOR
• Applicant: Mcgan Technology, LLC
• Product Code: HFG · Obstetrics/Gynecology
• Decision Date: Oct 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2

Intended Use

The MicroMed PD-8K kit or system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

Device Story

MicroMed PD-8K is a high-voltage, non-destructive, non-patient contact insulation tester for electrosurgical instruments. System comprises a base unit, rechargeable battery, probe handle with HV wire, ground wire with clamp, and brush/ring electrodes. Operated by pre-operation nurses or central sterile personnel in pre-operating room settings. Device applies adjustable high voltage (0-8kV DC) to detect insulation failures; audible and visual alarms indicate continuity/insulation status. Used post-cleaning but pre-sterilization to ensure instrument integrity and prevent patient injury from electrosurgical burns. Battery-powered design allows portability.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Plastic housing; high voltage DC source (0-8kV); LCD display; audible/visual alarm; battery-powered (3.5AH Lead Acid Gel Cell); includes brush and ring electrodes. Non-patient contact device.

Indications for Use

Indicated for pre-operation nurses or central sterile personnel to test insulation integrity of electrosurgical instruments prior to sterilization.

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)
• InsulScan™ Electrosurgical Instrument Insulation Testers (Mobile Instruments) (K991424)
• ATI-014 Insulation and Continuity Tester Jac-cell Medic Canada (K020334155)

Submission Summary (Full Text)

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### 510(k) Summary

Submitter Name Address:

Submitter Name Address:

Phone Number:

Fax Number:

Name of contact person:

Date Summary Prepared:

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Panel Code:

OCT] 2010

Jack Ganis

McGan Technology, LLC 410 Ridge Rd Middletown, CT 06457 USA

508-876-1070

508-883-3434

Jack Ganis

September 3, 2010

MicroMed PD-8K (MMPD-8K)

Insulation Tester

Gynecologic laparoscope and accessories 21 CFR 884.1720

Unipolar endoscopic coagulator-cutter and accessories 21 CFR 884.4160

Endoscope and accessories 21 CFR 876.1500

Class II per 21 CFR 884.1720 and 844.4160 and 876.1500

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510(k) Summary continued

Predicated Device accessory:

LIT Insulation Testing system (K952889)

InsulScan™ Electrosurgical Instrument Insulation Testers (Mobile Instruments) (K991424)

ATI-014 Insulation and Continuity Tester Jac-cell Medic Canada (K020334155)

#### Intended Uses/indications:

The MicroMed PD-8K system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

#### Device Specifications:

- · Weight: 2.2kg (4.85 lbs)
- Display: LCD
- Voltage: . 0 to 8kV adjustable
- · Current Output: < 0.1mA at probe
- Resolution: 10V • Short Circuit:

Test current 0.1mA max

- · Power Supply: 3.5AH Lead Acid Gel Cell
- · Dimensions: 260 x 160 x 70mm 10.25 x 6.3 x 2.75 inches
- . Alarm: Audible and Visual
- · Frequency DC
- Fuse Replaceable in control unit ●

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K101606

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Image /page/2/Picture/2 description: The image shows the logo for McGan Technology. The word "McGan" is written in a bold, sans-serif font, with the "M" being significantly larger than the rest of the letters. Below "McGan" is the word "Technology" in a smaller, sans-serif font. The logo is black and white.

### 510(k) Summary continued

## Product Components:

The MicroMed PD-8K system (MMPD-8K) is comprised of a reusable hand-held instrument probe, a detector or control/base unit, a ground wire and a high voltage wire in which the appropriate electrode (instrument probe) is control with and a fight vone in a mich in appropriate electrode
housed at the end of the detector (control/brea) write The Microly of rechargeable bat housed at the end of the detector (control/base) unit The battery adaptor (recharger) is provided with the system for recharging the battery. The MicroMed PD-8K electrodes are reusable.

## MicroMed PD-8K System includes:

- · Detector (base unit)
- · Battery with Charging adaptor
- · Probe handle with 2m (6ft) lead-Red HV Wire
- · 2m (6ft) lead ground wire with clamp-Green Wire
- · Brush electrode 8mm (0.31inch) wide brass wires
- Ring Electrode with brass wires
- · Carrying case
- · Standard Operating Instruction manuals. CD With additional information.

The MicroMed PD-8K system, the InsulScan™ Electrosurgical Instrument Insulation Testers (Mobile Instruments) and ATI-014 Insulation Continuity Tester by Jac-Cell have the same indications for use, similar designs, all are battery operated and rechargeable.

| Device/Predicated | MicroMed Pd-8K | Insulscan | Jac-Cell |
|---------------------|------------------------------------------------------|---------------------------------------------------|------------------------------------------------------|
| Indications for use | Insulation /Continuity<br>testing | Insulation /Continuity<br>testing | Insulation /Continuity<br>testing |
| Design | Tester and accessories | Tester and accessories | Tester and accessories |
| Materials | Plastic housing | Aluminum Casing | Aluminum Casing |
| Performance | Voltage Insulation<br>Tester | Voltage Insulation<br>Tester | Voltage Insulation<br>Tester |
| Sterility | N/A | Probes and wires | N/A |
| Usage | Pre-operating room | Pre-operating room or<br>in the operating theater | Pre-operating room |
| Biocompatibility | Not required- Non patient<br>contact. | Not required- Non patient<br>contact. | Not required- Non patient<br>contact. |
| Target population | Pre-operation nurses or<br>central sterile personnel | Pre-operation nurses | Pre-operation nurses or<br>central sterile personnel |
| Mechanical Safety | Accessory to a device | Accessory to a device | Accessory to a device |

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### 510(k) Summary continued

#### Testing of Electrosurgical instruments

McGan recommends the use of the MMPD-8K System after the electrosurgical instrument has been fully cleaned according to the instructions from the manufacturer of the electrosurgical instrument or the hospital's standard procedure BUT before sterilization of the instrument. This will eliminate any potential to cross-contaminate the surgical instrument.

#### Manuals

Please contact McGan Technology for copies of the user manuals for the MicroMed PD-8K System

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.

Mr. Jack Ganis Director/Owner McGan Technology, LLC 410 Ridge Road MIDDLETOWN CT 06457

## 2010

Re: K101606

> Trade Name: MicroMed PD-8K (aka MMPD-8K), MMUNI-0002 (base unit part number

Regulation Number: 21 CFR §884.4160

Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HFG

Dated: September 24, 2010

Received: September 27, 2010

Dear Mr. Ganis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert H. Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

### Enclosure

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## 510(k) Indications for Use

# 510(k) Number: K101606

Device Name: MicroMed PD-8K (aka MMPD-8K), MMUNI-0002 (base unit part number)

#### Indications for Use:

The MicroMed PD-8K kit or system is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments.

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Over-the-Counter Use