(245 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on basic electrical testing functionality.
No.
The device is described as a "voltage insulation tester designed to test the insulation of electrosurgical instruments," making it a testing or maintenance device for medical equipment, not a therapeutic device that directly treats patients.
No
The device is described as an "Insulation and Continuity Testing system" designed to "test the insulation of electrosurgical instruments." It is not used to diagnose a patient's condition or disease.
No
The device description explicitly states it is a "system" and is "battery operated and rechargeable," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test the insulation of electrosurgical instruments. This is a quality control or maintenance function for medical devices, not a diagnostic test performed on biological samples from a patient.
- Non-patient contacting: The description explicitly states it is "non-patient contacting." IVDs are used to examine specimens derived from the human body.
- No mention of biological samples: There is no mention of the device interacting with blood, urine, tissue, or any other biological material.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pre-operation nurses in Hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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) JGAGL777@One.Net
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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
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.
2
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
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_________________________________________________________________________________________________________________________________________________________________