(115 days)
Not Found
No
The description focuses on electrical testing and hardware components, with no mention of AI/ML terms or data processing that would suggest its use.
No.
The device is described as a high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments, not to provide therapy to a patient.
No
The device is an insulation tester for electrosurgical instruments, designed to test the integrity of insulation to ensure proper function and safety, not to diagnose a medical condition in a patient.
No
The device description explicitly lists multiple hardware components including a hand-held instrument probe, detector/control unit, wires, electrodes, battery, and charging adaptor.
Based on the provided information, the MicroMed PD-8K system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to test the insulation integrity of electrosurgical instruments. This is a quality control or maintenance function for medical devices, not a diagnostic test performed on biological samples from a patient.
- Device Description: The description details a system for electrical testing of instruments, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Intended User/Care Setting: The intended users are pre-operation nurses or central sterile personnel, and the setting is the pre-operating room or operating theater. This aligns with device maintenance and preparation, not patient diagnosis.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The MicroMed PD-8K system does not fit this definition.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HFG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pre-operation nurses or central sterile personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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K101606 page 1/4
Image /page/0/Picture/1 description: The image shows the logo for McGan Technology. The logo is black and white. The word "McGan" is on the top line, and the word "Technology" is on the bottom line. The font is sans-serif.
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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K101606 "Page 2/4
Image /page/1/Picture/1 description: The image shows the logo for McGan Technology. The logo consists of a large, bold letter "M" followed by the text "cGan" in a smaller, but still prominent, font. Below "cGan" is the word "Technology" in a smaller font size, completing the logo.
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: 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
6
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