(47 days)
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.
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.
The document provided is a 510(k) summary for the Jac-Cell Medic testers (models ATI-014A and ATI-021). It focuses on demonstrating substantial equivalence to a predicate device (ATI-014), rather than providing detailed acceptance criteria and a study report as typically seen for novel device performance claims.
Based on the information available, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with defined thresholds and confidence intervals. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical characteristics.
| Category/Parameter | Specific Element of Comparison | Predicate Device (ATI-014) | Subject Device (ATI-014A) | Subject Device (ATI-021) | "Acceptance Criteria" (Implicit) | Reported Device Performance (as stated) |
|---|---|---|---|---|---|---|
| Indications for Use | Identical | Insulation/Continuity Testing | Insulation/Continuity Testing | Insulation Testing | Identical or covered | ATI-014A: Identical. ATI-021: Covered. |
| Target Population | Identical | Pre-operation nurses in Hospitals | Pre-operation nurses in Hospitals | Pre-operation nurses in Hospitals | Identical | Identical |
| Material/Flammability Rating | Enclosure | ABS Plastic/UL94-HB | ABS Plastic/UL94-V0 (flame retardant) | ABS Plastic / UL94-HB | Equivalent or better | ATI-014A: Better (V0 vs HB). ATI-021: Equivalent. |
| Energy Used | Battery Powered | Yes | Yes | Yes | Yes | Yes |
| Level | 9V | 9V | 9V | 9V | 9V | |
| Average current consumption | 30mA | 20mA | 20mA | Equivalent or better | Better (lower current). | |
| Battery life (continuous test) | 30 hrs. | 41 hrs. | 41 hrs. | Equivalent or better | Better (longer life). | |
| Protection | Shortcircuit | Shortcircuit | Shortcircuit | Shortcircuit | Shortcircuit | |
| Battery level discharge warning | at 7V | at 7V | at 6.75V | Equivalent or early warning | ATI-014A: Equivalent. ATI-021: Earlier warning. | |
| Energy Delivered | 1.5nF Capacitor discharge | not available | 5.88 mJoules | 5.88 mJoules | New information | 5.88 mJoules |
| Performance | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation and Electrical Continuity Tester | Voltage Insulation Tester | Equivalent functionality | ATI-014A: Equivalent. ATI-021: Equivalent for insulation. |
| HV Output (High Level) | 2800 V | 2800 V | 2800 V | 2800 V | 2800 V | |
| Tolerance | +/-2.5% | +/-2.5% | +/-2.5% | +/-2.5% | +/-2.5% | |
| HV Output (Low Level) | 1500V | 1500V | not applicable | 1500V | ATI-014A: 1500V. ATI-021: Not applicable. | |
| Tolerance | +/-2.5% | +/-2.5% | not applicable | +/-2.5% | ATI-014A: +/-2.5%. ATI-021: Not applicable. | |
| Continuity testing level | 10 Ohms | 10 Ohms | not applicable | 10 Ohms | ATI-014A: 10 Ohms. ATI-021: Not applicable. | |
| Tolerance | +/-20% | +/-10% | not applicable | Equivalent or better | ATI-014A: Better (+/-10%). ATI-021: Not applicable. | |
| Shortcircuit testing level | 150 Kohms | 150 Kohms | not applicable | 150 Kohms | ATI-014A: 150 Kohms. ATI-021: Not applicable. | |
| Tolerance | +/-20% | +/-10% | not applicable | Equivalent or better | ATI-014A: Better (+/-10%). ATI-021: Not applicable. | |
| Compatibility | Non-RoHS | Non-RoHS | RoHS | RoHS | Equivalent or better | Better (RoHS compliant). |
| Standards Met | Basic safety and Essential performance | IEC60601-1:1988 | ES60601-1:2005/(R02012 and A1:2012) | ES60601-1:2005/(R02012 and A1:2012) | Updated medical device safety standards | Meets updated standards (better). |
| EMC/EMI Conformity | EN60601-1-2:2001 | IEC60601-1-2:2007 FCC Part 15-Subpart B ICES-003 | IEC60601-1-2:2007 FCC Part 15-Subpart B ICES-003 | Updated EMC/EMI standards | Meets updated standards (better). | |
| Risk Analysis | ISO 14971:2007 | ISO 14971:2007 | Performed | Performed (new for subject devices). | ||
| Visual Signals | "Pass" for insulation testing | Green Light/Led | Green Light/Led | Green Light/Led | Green Light/Led | Green Light/Led |
| "Fault" for insulation testing | Red Light/Led | Red Light/Led | Red Light/Led | Red Light/Led | Red Light/Led | |
| "Good" for electrical resistance testing | Green Light/Led | Green Light/Led | not applicable | Green Light/Led | ATI-014A: Green Light/Led. ATI-021: Not applicable. | |
| "Fault" for electrical resistance testing | Red Light/Led | Red Light/Led | not applicable | Red Light/Led | ATI-014A: Red Light/Led. ATI-021: Not applicable. | |
| "Battery Level" warning | Red Light/Led | Orange Light/Led | Orange Light/Led | Indicator present, perhaps different color | Orange Light/Led (different from predicate). | |
| Audible Signals | On "Fault" detection | Yes | Yes | Yes | Yes | Yes |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" for a performance study in the typical clinical or statistical sense. The assessment is based on bench testing of the subject devices (ATI-014A and ATI-021) against the characteristics of the predicate device (ATI-014). This implies testing of the manufactured device units themselves, not a dataset of patient cases.
- Data Provenance: The document only states "Bench testing confirms same performance to predicate device(s)." This indicates the testing was conducted internally by the manufacturer or a contracted lab. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are not relevant for bench testing of device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench test comparing device specifications and performance characteristics, not a diagnostic or AI-assisted interpretation of medical images/data requiring expert ground truth establishment. The "ground truth" here would be the known, objective specifications and performance of the predicate device and the measurement results from the subject devices.
4. Adjudication method for the test set
Not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons of technical specifications and performance during bench testing, not subjective interpretations.
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 applicable. This device is an electrosurgical instrument tester, not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an instrument tester with embedded firmware, not an AI algorithm. Its performance is inherent to its design and functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence claim is:
- Predicate Device Specifications: The known, documented technical characteristics and performance of the legally marketed predicate device (ATI-014).
- Engineering Measurements and Standards: The measurements obtained during bench testing of the subject devices (ATI-014A, ATI-021) compared against the predicate's performance and relevant industry standards (e.g., IEC, FCC).
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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/ContinuityTesting | Insulation/ContinuityTesting | Insulation Testing |
| Target population | Identical | Pre-operation nursesin Hospitals | Pre-operation nursesin Hospitals | Pre-operation nurses inHospitals |
| Designation | Identical | Tester andAccessories | Tester andAccessories | Tester and Accessories |
| Material/Flammabilityrating | Enclosure | ABS Plastic/UL94-HB | ABS Plastic/UL94-V0 (flame retardant) | ABS Plastic / UL94-HB |
| Biocompatibility | Not Required, Non-Patient Contact | Not Required, Non-Patient Contact | Not Required, Non-PatientContact | |
| 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 Insulationand ElectricalContinuity Tester | Voltage Insulationand ElectricalContinuity Tester | Voltage Insulation Tester | |
| Insulation testing section | K170105 | |||
| Working principle: High Voltage (HV)electrical discharge in area were insulationis broken | Yes | Yes | Yes | |
| High Level (for surface insulation testing)HV Output | 2800 V | 2800 V | 2800 V | |
| Tolerance | +/-2.5% | +/-2.5% | +/-2.5% | |
| Low Level (for inside cable insulationtesting) HV Output | 1500V | 1500V | not applicable | |
| Tolerance | +/-2.5% | +/-2.5% | not applicable | |
| Electrical continuity section | ||||
| Working principle: Electrical resistancemeasuring | 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 withEnvironment and otherdevices | Non-RoHS | RoHS | RoHS | |
| Usage | Pre-operating Room | Pre-operating Room | Pre-operating Room | |
| Standard met | Basic safety andEssential performance | IEC60601-1:1988 | ES60601-1:2005/(R02012 andA1:2012 | ES60601-1:2005/(R02012and A1:2012 |
| EMC/EMI Conformity | EN60601-1-2:2001 | IEC60601-1-2:2007FCC Part 15-Subpart B | IEC60601-1-2:2007FCC 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 | DiscreteComponents | 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).
§ 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.