INSULATION TESTER by SPECTRUM SURGICAL SUPPLY CORP.

Acceptance Criteria / Spectrum Specifications (Measured Values)	Spectrum Insulation Tester Reported Performance	Predicate Device (Jac-Cell Medic K020334) Performance	Comments
Normal (open) Batt. @ 9V - 32 - 40 mA	34.5mA	38.2mA	Spectrum lower = longer Batt. life.
Normal (open) Batt. @ 9V - 2200 - 2400 Volts	2.330 Volts	2.374 Volts	Slight voltage diff. performance is same
Normal (open) Batt. @ 7V - 32 - 40 mA	34.5mA	30.9mA	Not at 7V for long period of time. Low Battery.
Normal (open) Batt. @ 7v - 2200 - 2400 Volts	2.330 Volts	2.015 Volts	Spectrum voltage stable through 7V
Fault (short) Batt. @ 9V - 115 - 145mA	132mA	158mA	Spectrum lower longer Batt. life.
Fault (short) Batt. @ 7V - 115 - 145 mA	132mA	108mA	Not at 7V for long period of 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
Detection of insufficient insulation	100% success rate	Not explicitly stated, but implied as predicate standard	Achieved for both pinhole and abraded surface conditions. Not rejected known good insulated shafts.

2. Sample size used for the test set and the data provenance

Sample Size: A minimum of 30 tests were performed for each condition (pin hole, abraded surface) over 2 different time periods. In total, 180 tests were completed.
Data Provenance: The study simulated "real-world conditions" by modifying laparoscopic shafts. This suggests a laboratory-based, prospective testing scenario by the manufacturer, Spectrum Surgical Instruments. The country of origin of the data is not explicitly stated but can be inferred as the United States, given the company's address and submission to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not provided in the document. The device testing relies on the physical modification of laparoscopic shafts by introducing "a small pin hole" or "abrading the surface in an area" to simulate insufficient insulation. The success or failure of detection is based on the device's output (Red LED, Sound) rather than expert interpretation of the condition.

4. Adjudication method for the test set

Not applicable. The "ground truth" (presence or absence of insufficient insulation) was established by physically altering the laparoscopic shafts. The device's detection capabilities (activating LED and sound) were then directly observed.

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 done and not applicable. This document describes the performance of a standalone device (Insulation Tester), not an AI-assisted diagnostic tool or system involving human readers.

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

Yes, a standalone performance study was done. The entire performance testing section evaluates the "Insulation Tester's" ability to autonomously detect insufficient insulation without human interpretation or intervention beyond operating the device. The device had a "100% success rate in being able to detect insufficient insulation while not rejected known good insulated laparoscopic shafts."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth was simulated physical defects / known conditions. Laparoscopic shafts were intentionally modified to create "a small pin hole" or "abraded the surface in an area" to represent insufficient insulation. This provides a definitive, objective ground truth for the presence of a fault.

8. The sample size for the training set

Not applicable. This device is a physical instrument for detecting electrical faults, not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.

Summary

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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
EquivalencyInformation	Measured Values
	Conditions / SpectrumSpecifications	SpectrumInsulation Tester	Jac-Cell MedicK020334	Comments
	Normal (open) Batt. @ 9V- 32 - 40 mA	34.5mA	38.2mA	Spectrum lower = longerBatt. life.
	Normal (open) Batt. @ 9V2200 - 2400 Volts	2.330 Volts	2.374 Volts	Slight voltage diff.performance is same
	Normal (open) Batt. @ 7V -32 - 40 mA	34.5mA	30.9mA	Not at 7V for long period oftime. Low Battery.
	Normal (open) Batt. @ 7v -2200 - 2400 Volts	2.330 Volts	2.015 Volts	Spectrum voltage stablethrough 7V

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	Fault (short) Batt. @ 9V -115 - 145mV	132mA	158mA	Spectrum lower longer Batt.life.
	Fault (short) Batt. @ 7V -115 - 145 mA	132mA	108mA	Not at 7V for long period oftime. 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 andcontinuity tester with respect to insulation testing. Since the Spectrum tester doesnot 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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.