Jac-Cell Medic testers

K170105 · Jac-Cell Medic · GEI · Feb 28, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170105
• Device Name: Jac-Cell Medic testers
• Applicant: Jac-Cell Medic
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.

Device Story

Handheld, battery-operated (9V) testers verify insulation integrity and electrical continuity of electrosurgical instruments. Used by nurses in pre-operating room settings. ATI-014A performs both insulation and continuity testing; ATI-021 performs insulation testing only. Operation involves applying high voltage (2800V for surface, 1500V for internal cable) to detect insulation breaks via electrical discharge; continuity testing measures electrical resistance (10 Ohms threshold). Microcontroller-based firmware processes inputs from user (via foot pedal/electrodes) and provides visual (LED) and audible output signals indicating 'Pass' or 'Fault'. Device helps ensure electrosurgical instrument safety by identifying insulation failures before clinical use, reducing risk of accidental patient burns.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Handheld, 9V battery-powered. Enclosure: ABS plastic (UL94-V0 or HB). Sensing: High voltage (2800V/1500V) discharge for insulation; resistance measurement for continuity. Connectivity: None. Sterilization: Not applicable (non-patient contacting). Software: Microcontroller-based firmware. Standards: ES60601-1:2005/(R02012 and A1:2012, IEC60601-1-2:2007, ISO 14971:2007.

Indications for Use

Indicated for pre-operation nurses in hospitals to perform non-destructive, non-patient contacting insulation testing (ATI-021 and ATI-014A) and electrical continuity testing (ATI-014A only) on 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

• Insulation and continuity tester (ATI-014) (K020334)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 28, 2017

JAC-CELL MEDIC % Mr. Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K170105

Trade/Device Name: Jac-Cell Medic testers Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 22, 2016 Received: January 12, 2017

Dear Mr. Mansour:

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170105

Device Name JAC-CELL MEDIC TESTERS

Indications for Use (Describe)

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

The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size: 1em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K170105

## 510k Summary

As required by 21 CFR 807.92 (c)

## 1- Date summary prepared: February 27, 2017

#### Owner/Submitter/Sponsor/Applicant information: 2-

JAC-CELL MEDIC 5764 Pare Street Tmr Mont - Royal Quebec, CANADA H4P 2M2

- 3- Device information:
Common/usual/classification name: Insulation tester & Insulation and continuity tester

### Device name: Jac-Cell Medic testers

| FDA 3 letter code | GEI |
|-------------------------------|---------------------------|
| FDA regulation number: 21 CFR | 878.4400 |
| Regulation medical specialty | General & Plastic Surgery |
| Review panel | General & Plastic Surgery |
| Class | 2 |

- 4- Substantial equivalency is claimed against the following predicate device(s):

| 510k number | Trade or Proprietary or Model Name | Manufacturer |
|-------------|--------------------------------------------|----------------|
| K020334 | Insulation and continuity tester (ATI-014) | Jac-Cell Medic |

### 5- Description of the device:

| | Device model name | | Model number |
|---|----------------------------------|---|--------------|
| 1 | Insulation tester | 1 | ATI-021 |
| 2 | Insulation and continuity tester | 2 | ATI-014A |

The tester is a non-sterile multiple use handheld device operated by 9V battery. An embedded software (firmware) is used to program a microcontroller hardware platform, that interface the user's actions with visual and audible output signals.

The tester is used pre-operating room by nurses in hospitals, for the purpose of verifying the insulation (for ATI-021 and ATI-014A) and continuity (for ATI-014A) of electrosurgical instruments.

The tester is tested for functionality prior to each use, and is made out of the following components:

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# K170105

| Component | ATI-021 | ATI-014A |
|-------------------------------|---------|----------|
| Foot pedal | yes | yes |
| End connector box | no | yes |
| Cable Male-Female (2) | yes | no |
| Adaptor Male-Male | no | yes |
| Adaptor Male- Alligator (1) | yes | no |
| Adaptor Male- Alligator (2) | no | yes |
| Test plate | yes | no |
| Brush test electrode | yes | yes |
| Hook test electrode | no | yes |
| Caring plastic case with foam | yes | yes |

#### 6-Intended use + indications for use

The ATI-014A insulation and continuity testing system is a non-destructive, non-patient contacting, voltage insulation tester designed to test the insulation of electrosurgical instruments. The ATI-021 has the same indications for use for insulation testing, but does not include continuity testing.

- 7-Basis for a determination of substantial equivalency:
- (a) Indications for use: The indication for use of ATI-014A and predicate ATI-014 are identical. The indication for use of ATI-021 is covered by indications for use of predicate device ATI-014.
- (b) Technological characteristics: The technological characteristics are the same as the predicate device(s), as tabulated below:

| Device | | Predicate Device | ATI-014A | ATI-021 |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------|
| Category/Parameter | Specific Element of comparison | ATI-014 | | |
| Indications for Use | Identical | Insulation/Continuity<br>Testing | Insulation/Continuity<br>Testing | Insulation Testing |
| Target population | Identical | Pre-operation nurses<br>in Hospitals | Pre-operation nurses<br>in Hospitals | Pre-operation nurses in<br>Hospitals |
| Designation | Identical | Tester and<br>Accessories | Tester and<br>Accessories | Tester and Accessories |
| Material/Flammability<br>rating | Enclosure | ABS Plastic/UL94-<br>HB | ABS Plastic/UL94-<br>V0 (flame retardant) | ABS Plastic / UL94-HB |
| Biocompatibility | | Not Required, Non-<br>Patient Contact | Not Required, Non-<br>Patient Contact | Not Required, Non-Patient<br>Contact |
| Energy Used | Battery Powered | Yes | Yes | Yes |
| | Rechargeable Battery | No | No | No |
| | Level | 9V | 9V | 9V |
| | Average current consumption | 30mA | 20mA | 20mA |
| | Battery life (continous test) | 30 hrs. | 41 hrs. | 41 hrs. |
| | Protection | Shortcircuit | Shortcircuit | Shortcircuit |
| | Battery level discharge warning | at 7V | at 7V | at 6.75V |
| Energy Delivered | 1.5nF Capacitor discharge | not available | 5.88 mJoules | 5.88 mJoules |
| Performance | | Voltage Insulation<br>and Electrical<br>Continuity Tester | Voltage Insulation<br>and Electrical<br>Continuity Tester | Voltage Insulation Tester |
| | Insulation testing section | | | K170105 |
| | Working principle: High Voltage (HV)<br>electrical discharge in area were insulation<br>is broken | Yes | Yes | Yes |
| | High Level (for surface insulation testing)<br>HV Output | 2800 V | 2800 V | 2800 V |
| | Tolerance | +/-2.5% | +/-2.5% | +/-2.5% |
| | Low Level (for inside cable insulation<br>testing) HV Output | 1500V | 1500V | not applicable |
| | Tolerance | +/-2.5% | +/-2.5% | not applicable |
| | Electrical continuity section | | | |
| | Working principle: Electrical resistance<br>measuring | Yes | Yes | not applicable |
| | Continuity testing level | 10 Ohms | 10 Ohms | not applicable |
| | Tolerance | +/-20% | +/-10% | not applicable |
| | Shortcircuit testing level | 150 Kohms | 150 Kohms | not applicable |
| | Tolerance | +/-20% | +/-10% | not applicable |
| Compatibility with<br>Environment and other<br>devices | | Non-RoHS | RoHS | RoHS |
| Usage | | Pre-operating Room | Pre-operating Room | Pre-operating Room |
| Standard met | Basic safety and<br>Essential performance | IEC60601-1:1988 | ES60601-<br>1:2005/(R02012 and<br>A1:2012 | ES60601-1:2005/(R02012<br>and A1:2012 |
| | EMC/EMI Conformity | EN60601-1-2:2001 | IEC60601-1-2:2007<br>FCC Part 15-<br>Subpart B | IEC60601-1-2:2007<br>FCC Part 15-Subpart B |
| | | | ICES-003 | ICES-003 |
| | Risk Analysis | | ISO 14971:2007 | ISO 14971:2007 |
| Sterility | | not applicable | not applicable | not applicable |
| Technical Information | Manufacturing Technology | Discrete<br>Components | Surface Mount | Surface Mount |
| | Microcontroller embeded system | n/a | Yes | Yes |
| | Hand Held device | Yes | Yes | Yes |
| | Enclosure Model | 1593-YGY | 1553TT Bat | 1553D Batt |
| | Dimensions | 5.5"x2.6"x1" | 6.5"x3.2"x1.4" | 6"x3.5"x1.2" |
| | Weight | 0.55 Lbs | 0.57 Lbs | 0.51 Lbs |
| | Tilt Stand | Yes | Yes | Yes |
| | Output Visual Signals | | | |
| | "Pass" for insulation testing | Green Light/Led | Green Light/Led | Green Light/Led |
| | "Fault" for insulation testing | Red Light/Led | Red Light/Led | Red Light/Led |
| | "Good" for electrical resistance testing | Green Light/Led | Green Light/Led | not applicable |
| | "Fault" for electrical resistance testing | Red Light/Led | Red Light/Led | not applicable |
| | "Battery Level" warning | Red Light/Led | Orange Light/Led | Orange Light/Led |
| | Output Audible Signals | | | |
| | On "Fault" detection | Yes | Yes | Yes |

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Tab 6 | Page 3 of 4

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# K170105

- (c) Non clinical tests- brief discussion:
Bench testing confirms same performance to predicate device(s).

The bench tests of subject tester (ATI-014A) confirm it is substantially equivalent with the predicate one (ATI-014), from the point of view of testing principles (using the high voltage), input commands, output voltage level used for test, output signals and electrical resistance measurement for cables (i.e., both functions of insulation and electrical continuity testing).

The bench tests of subject tester (ATI-021) confirm that he is substantially equivalent with the predicate one (ATI-014), from the point of view of testing principles (using the high voltage), input commands, output voltage level used for test and output signals for the function of insulation testing.

- (d) Clinical tests- brief discussion:
Not applicable.

- (e) Non clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as or better than the predicate device(s):
Jac-Cell Medic testers perform as designed, in accordance with requirements. It is as safe and effective as the predicate device(s).