(90 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the hardware components and the function of insulation testing.
No.
The device is designed to test the insulation of electrosurgical instruments, not to diagnose, treat, or prevent disease in patients.
Yes
The device is designed to "test the insulation of electrosurgical instruments," which directly implies its use in diagnosing the integrity or functionality of these instruments. It performs a "non-destructive" evaluation, characteristic of diagnostic testing.
No
The device description explicitly lists multiple hardware components: a disposable hand-held instrument probe, a control unit, a cable adapter, a connection cable, a rechargeable battery, a battery recharger unit, and a battery charger cable.
Based on the provided information, the InsulScan™ Insulation Testing System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is designed to test the insulation of electrosurgical instruments. This is a test performed on a medical device, not on a biological sample from a patient.
- Non-patient contact: The description explicitly states it is a "non-patient contact" device. IVDs are used to test samples taken from a patient.
- Device Description: The components described (probe, control unit, cables) are consistent with a device used for testing equipment, not for analyzing biological samples.
IVDs are used to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The InsulScan™ system does not perform this function.
N/A
Intended Use / Indications for Use
The InsulScanTM Insulation Testing System is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation of electrosurgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
HET, HFG
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.
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
Not Found
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).
0
JUL 22 1999
Summary of Safety and Effectiveness 11.0
| Submitter Name and Address: | MediCor Corporation
236-B Egidi
Wheeling, Illinois 60090 |
|--------------------------------------|---------------------------------------------------------------------------|
| Contact Person:
Telephone Number: | Scott B. Kerrigan
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
21 CFR 884.1720 |
| | Unipolar endoscopic coagulator-cutter and
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
1
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.
2
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
3
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