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 Description

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/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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroMed PD-8K device:

Based on the provided 510(k) summary, the device is an insulation tester, and the documentation focuses on its substantial equivalence to predicate devices rather than reporting a detailed clinical study with specific acceptance criteria in the traditional sense of diagnostic or therapeutic devices.

The "acceptance criteria" here are met through demonstrating that the device has the same indications for use, similar design, and comparable performance to legally marketed predicate devices. The study proving this is primarily a comparison to predicate devices and an internal assessment of the device's technical specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Equivalence)	Reported Device Performance of MicroMed PD-8K
Indications for Use: Insulation / Continuity testing for electrosurgical instruments.	Indications for Use: Insulation / Continuity testing for electrosurgical instruments. Matches predicate devices.
Design: Tester and accessories, battery-operated, rechargeable.	Design: Tester and accessories (Detector, Battery, Probe handle, Wires, Electrodes, Carrying case), battery operated and rechargeable. Similar to predicate devices.
Materials: Housing materials acceptable for intended use.	Materials: Plastic housing (different from predicate's aluminum casing, but implicitly acceptable).
Performance (Voltage Insulation Tester): Capable of high voltage insulation testing comparable to predicate devices.	Performance (Voltage Insulation Tester): Voltage: 0 to 8kV adjustable; Current Output: < 0.1mA at probe; Resolution: 10V; Test current 0.1mA max. Comparable in function to predicate devices.
Usage: Pre-operating room use.	Usage: Pre-operating room. Matches predicate devices.
Biocompatibility: Not required (non-patient contact).	Biocompatibility: Not required - Non patient contact. Matches predicate devices.
Target Population: Pre-operation nurses or central sterile personnel.	Target Population: Pre-operation nurses or central sterile personnel. Matches predicate devices.
Mechanical Safety: Accessory to a device.	Mechanical Safety: Accessory to a device. Matches predicate devices.

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

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The document describes a comparison to predicate devices, not a test on a specific dataset of electrosurgical instruments for performance evaluation against a gold standard. The performance claims are based on engineering specifications and comparison to predicate devices.
Data Provenance: Not applicable in the context of this 510(k) submission. The submission relies on technical specifications and functional equivalence to predicate devices. No external data (e.g., from specific countries, retrospective/prospective) is cited for performance validation in the provided text.

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

Not applicable. There is no mention of human experts being used to establish a ground truth for a test set in the provided document. The device itself is an insulation tester, and its 'ground truth' would be determined by its ability to accurately detect insulation failures based on its technical specifications.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described because there wasn't a "test set" in the traditional sense involving interpretation or assessment that would require adjudication.

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 an insulation tester, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this device's function as described.

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

Yes, in a conceptual sense. The MicroMed PD-8K is a hardware device designed to perform insulation testing standalone. Its performance is based on its electronic and mechanical specifications (voltage output, current, resolution, alarm systems). There is no "algorithm" in the AI sense, but the device provides a direct measurement/assessment of insulation integrity without human interpretation being the primary determinant of the test result. The user operates the device, but the device itself identifies the insulation issue.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively engineering specifications and the physical principles of electrical insulation testing. The device is designed to measure electrical integrity against defined thresholds. While not explicitly stated as "ground truth," its performance is evaluated against its ability to meet these technical specifications and function equivalently to established insulation testers already on the market. There's no mention of pathology, expert consensus, or outcomes data as "ground truth" for this type of device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set. Its functionality is based on direct electrical measurement and comparison to established engineering principles.

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

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

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 /Continuitytesting	Insulation /Continuitytesting	Insulation /Continuitytesting
Design	Tester and accessories	Tester and accessories	Tester and accessories
Materials	Plastic housing	Aluminum Casing	Aluminum Casing
Performance	Voltage InsulationTester	Voltage InsulationTester	Voltage InsulationTester
Sterility	N/A	Probes and wires	N/A
Usage	Pre-operating room	Pre-operating room orin the operating theater	Pre-operating room
Biocompatibility	Not required- Non patientcontact.	Not required- Non patientcontact.	Not required- Non patientcontact.
Target population	Pre-operation nurses orcentral sterile personnel	Pre-operation nurses	Pre-operation nurses orcentral 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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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three curved lines representing the head, body, and legs. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo.

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 (800) 638-2041 or (301) 796-7100 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.

ion Sign oductive,

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Over-the-Counter Use

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).