(245 days)
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.
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.
The provided text describes a 510(k) premarket notification for an Insulation and Continuity Testing System. However, it does not include acceptance criteria, specific study designs, performance data (beyond general statements about equivalence), or details about ground truth establishment, sample sizes for training/testing, expert involvement, or adjudication methods.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory equivalence to a predicate device rather than presenting detailed performance studies.
Here's how I would answer each point given the lack of information:
Acceptance Criteria and Device Performance Study Information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | The document states the device has "the same indications for use, basic design, both are battery operated and rechargeable" as the predicate device, implying equivalent performance, but no specific performance metrics or acceptance criteria are given. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified in the provided text. The submission relies on demonstrating equivalence to a predicate device rather than independent clinical or performance data with expert-adjudicated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or expert adjudication process is described.
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. The device is an Insulation and Continuity Tester, not an AI-assisted diagnostic tool that would involve human readers or AI improvement metrics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance comparison to a predicate device, but no specific study details are provided. This is a device for testing insulation, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not specified. The basis for equivalence seems to be "basic design" and "indications for use" being the same as the predicate, rather than comparison against an established ground truth for instrument insulation issues.
8. The sample size for the training set:
- Not applicable/Not specified. This is a hardware device submission, not an AI/ML algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. No training set is mentioned as this is not an AI/ML algorithm submission.
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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) 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
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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.
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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 (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
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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_________________________________________________________________________________________________________________________________________________________________
§ 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.