INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

K020334 · Jac-Cell Medic Corporation · GEI · Oct 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020334
• Device Name: INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC
• Applicant: Jac-Cell Medic Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The ATI-014 Insulation and Continuity Testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments.

Device Story

The ATI-014 Insulation and Continuity Testing System is a battery-operated, rechargeable voltage insulation tester. It is used in pre-operating room settings by nurses to verify the integrity of electrosurgical instrument insulation. The device functions as a non-destructive tester; it does not contact the patient. By applying a voltage to the instrument, the system checks for insulation defects or continuity issues. The output provides the operator with information regarding the insulation status of the instrument, allowing for the identification of damaged tools before they are used in surgery. This process helps ensure patient safety by preventing accidental burns or electrical hazards caused by compromised electrosurgical instrument insulation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Aluminum casing; battery-operated and rechargeable; voltage insulation testing principle; non-patient contacting; standalone device; no sterilization required.

Indications for Use

Indicated for pre-operation nurses in hospitals to perform non-destructive, non-patient contacting insulation and continuity testing of electrosurgical instruments.

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

• InsulScan Insulation Testing System

Submission Summary (Full Text)

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# OCT 0 3 2002

zos34

## Appendix A (Summary of Safety And Effectiveness)

#### Submitter:

John Gagliardi, President (contact person) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) [e-mail]

Trade Name: The ATI 014FC Insulation and Continuity Tester Common Name: Insulation Tester Classification Name: Insulation Tester (21 CFR, Part 884.4160, 85HFG)

#### Summary of Safety and Effectiveness:

The ATI 014FC Insulation and Continuity Tester and InsulScan Insulation Testing System have the same indications for use, basic design, both are battery operated battery operated and rechargeable.

| Device/Predicate | Jac-Cell Medic ATI-014 | InsulScan Insulation Testing System |
|---------------------|-----------------------------------|-------------------------------------|
| Indications for Use | Insulation / Continuity Testing | Insulation / Continuity Testing |
| Design | Tester and Accessories | Tester and Accessories |
| Materials | Aluminum Casing | Aluminum Casing |
| Performance | Voltage Insulation Tester | Voltage Insulation Tester |
| Sterility | N/A | N/A |
| Usage | Pre-operating Room | Pre-operating Room |
| Biocompatibility* | Not Required, Non-Patient Contact | Not Required, Non-Patient Contact |
| Target Population | Pre-operation nurses in Hospitals | Pre-operation nurses in Hospitals |
| Mechanical Safety | Accessory to a device | Accessory to a device |

Revised to read: Indications for Use: The ATI-014 Insulation and Continuity Testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments.

9/29/02

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jac-Cell Medic Corporation c/o Mr. John Gagliardi MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039

Re: K020334

Trade/Device Name: Insulation and Continuity Testing System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 12, 2002 Received: August 15, 2002

Dear Mr. Gagliardi:

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. Iisting 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 (PMA), 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 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); 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.

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Page 2 - Mr. John Gagliardi -

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours.

sincerely yours,

Stytl. Cliola

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(K) Number (if known): Yo 20334

Device Name: INSULATION & CONTINUITY TRITING SYSTEM

### Indications for USC:

The ATT-014 Insulation and Continuity Testing system is a non-destructive, non-patient The ATI-024 Insulation and Continuity Testing System is of 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)

Styfe Rucker

(Optional Format 3-10-98)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________