INSULATION TESTER

K120416 · Spectrum Surgical Supply Corp. · GEI · Mar 27, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120416
• Device Name: INSULATION TESTER
• Applicant: Spectrum Surgical Supply Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

Verify insulation integrity on laparoscopic instruments

Device Story

Device is a handheld insulation tester used to verify integrity of laparoscopic instrument shafts. It generates an electrical current; detects current leakage when insulation is insufficient (e.g., pinholes, abrasions). Output is visual (red LED) and audible alarm upon fault detection. Used in clinical settings by healthcare staff to ensure instrument safety before use. Benefits patient by preventing unintended electrical burns during electrosurgical procedures.

Clinical Evidence

Bench testing only. 180 tests performed simulating real-world conditions (pinholes and abraded surfaces on laparoscopic shafts). The device demonstrated a 100% success rate in detecting insufficient insulation while correctly identifying intact insulation.

Technological Characteristics

Battery-powered (9V) electrical tester. Generates electrical current to detect insulation breaches. Features red LED and audible alarm for fault detection and low battery indication. Dimensions/materials not specified. No software or complex algorithms; operates via basic electrical circuit monitoring.

Indications for Use

Indicated for checking insulation integrity on laparoscopic instruments to detect defects.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Jac-Cell Medic (K020334)

Submission Summary (Full Text)

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## MAR 2 7 2012

Ki20416

## Section 5: 510k) Summary

The Summary of Safety and Effectiveness information on the Insulation Tester is heing submitted in accordance with the requirements of 21 C.F.R. 8807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or
recommendations set forth.

| Applicant | Spectrum Surgical Instruments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 4575 Hudson Drive |
| | Stow Ohio 44224 |
| Telephone | 330-686-4550 |
| Facsimile | 330-686-4555 |
| Date | December 9, 2011 |
| Name | Dennis A. Kovit Director of Operations |
| Classification | Electrosurgical, cutting and coagulation and accessories. |
| Predicate: | Jac-Cell Medic K020334 |
| Description: | Insulation Tester |
| Intended Use | Verify insulation integrity on laparoscopic instruments |
| Contraindication: | |
| Warning | Should not be used by or in the presence of someone with an electrical implanted device, such as a pace maker. |
| Technological Characteristics | This device generates an electrical current and detects the current when there is insufficient insulation covering a laparoscopic instrument. |
| Performance Testing | In actual test performance, real world conditions were simulated by modifying a laparoscopic shaft to include a small pin hole and also to abrade the surface in an area. These are the two scenarios that would typically be found, however any area not properly insulated would be detected by the insulation tester. A minimum of 30 tests in each condition over 2 different time periods were chosen to be performed in order to assure randomness. 180 tests were completed in all, which was well above the minimum number of verification testing requirements. The insulation tester had a 100% success rate in being able to detect insufficient insulation while not rejected known good insulated laparoscopic shafts. |

| Substantial | | | | |
|----------------------------|-------------------------------------------------|-------------------------------|---------------------------|----------------------------------------------------|
| Equivalency<br>Information | Measured Values | | | |
| | Conditions / Spectrum<br>Specifications | Spectrum<br>Insulation Tester | Jac-Cell Medic<br>K020334 | Comments |
| | Normal (open) Batt. @ 9V<br>- 32 - 40 mA | 34.5mA | 38.2mA | Spectrum lower = longer<br>Batt. life. |
| | Normal (open) Batt. @ 9V<br>2200 - 2400 Volts | 2.330 Volts | 2.374 Volts | Slight voltage diff.<br>performance is same |
| | Normal (open) Batt. @ 7V -<br>32 - 40 mA | 34.5mA | 30.9mA | Not at 7V for long period of<br>time. Low Battery. |
| | Normal (open) Batt. @ 7v -<br>2200 - 2400 Volts | 2.330 Volts | 2.015 Volts | Spectrum voltage stable<br>through 7V |

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| | Fault (short) Batt. @ 9V -<br>115 - 145mV | 132mA | 158mA | Spectrum lower longer Batt.<br>life. |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|----------------------------------------------------|
| | Fault (short) Batt. @ 7V -<br>115 - 145 mA | 132mA | 108mA | Not at 7V for long period of<br>time. Low Battery. |
| | Fault Detection | Red LED, Sound | Red LED, Sound | Spectrum & Jac-Cell Equal |
| | Low Battery Indicator | Red LED | Red LED | Spectrum and Jac-Cell Equal |
| Conclusion | The Spectrum insulation tester is equivalent to the Jac-Cell Medic insulation and<br>continuity tester with respect to insulation testing. Since the Spectrum tester does<br>not test for continuity, no statement can be made in this regard | | | |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spectrum Surgical Instruments, Corporation % Mr. Dennis A. Kovit Director of Repair Operations 4575 Hudson Drive Stow, Ohio 44224-1725

Re: K120416

Trade/Device Name: Insulation Tester Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 1, 2012 Received: March 6, 2012

Dear Mr. Kovit:

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

MAR 2 7 2012

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Page 2 - Mr. Dennis A. Kovit

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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/CDRH0ffices/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 vours.

For Peter De. Lid Dr.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K120416

Insulation Tester Device Name:

Indications For Use: The Spectrum Insulation Tester checks for insulation integrity on laparoscopic instruments

Prescription Use ×

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogden for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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. 510(k) Number K120416