Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology. The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization. The plastic and metal materials used in the devices comply with biocompatibility requisites. The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds. The cautery has the weight, size and handle suitable to allow for easy use.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (F7255 Fiab Disposable Cautery battery powered). This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering performance study would.

Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics against those criteria, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not present in the provided text.

The document states: "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that the regulatory pathway for this device at the time did not require detailed performance studies against specific acceptance criteria to demonstrate efficacy beyond what was required for substantial equivalence.

Here's a breakdown of what information can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Not present. The document does not specify quantitative acceptance criteria for performance (e.g., specific temperatures, duration of heat, precision of cauterization, etc.) nor does it report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. No specific test set or data provenance for performance evaluation is mentioned. The submission relies on a comparison to a predicate device and adherence to general regulations.

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 applicable/Not present. No ground truth establishment for a test set is discussed in the context of device performance, as there's no performance study described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not present. No adjudication method is mentioned as there's no performance study with a test set.

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/Not present. This device is a simple battery-powered cautery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not present. As mentioned above, this is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not present. Given the nature of the device and the submission type, a "ground truth" for performance comparison as in diagnostic imaging or AI is not part of this document. The "ground truth" for regulatory approval here is substantial equivalence to a legally marketed predicate and compliance with general safety and effectiveness regulations.

8. The sample size for the training set

Not applicable/Not present. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable/Not present. No training set exists.

Summary of available information:

The provided document is a 510(k) summary for a "F7255 Fiab Disposable Cautery battery powered". The core of its regulatory submission is demonstrating substantial equivalence to an existing predicate device, the "AARON AA04 battery powered cautery".

Intended Use (from the document): "The device is intended for use in ophthalmology." and "Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology."
Comparison to Predicate: "The F7255 cautery has the same intended use as the predicate and do not imply new technological characteristics." This is the primary "proof" of meeting regulatory requirements for this type of submission.
General Compliance: The document states, "Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates general compliance with manufacturing and safety regulations, rather than specific performance metrics.
Risk Assessment: "According to the risk-benefit analysis, the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks."

In essence, the "acceptance criteria" here are met by demonstrating the device is substantially equivalent to a legally marketed predicate and adheres to general safety and effectiveness requirements, rather than through specific performance metrics outlined in a detailed study within this document.

Summary

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SEP - 1 2009

510(k) Summary	FIAB*	FIAB spa Vicchio, ITALY
Battery powered cautery	2009/08/03	510(k) notification - Section 05

Section 05 510(k) Summary

Submitter 1.

Fiab SpA Via Costoli, 4 50039 Vicchio Florence - Italy Tel : (39) 055 849 79 216 Fax: (39) 055 849 79 87 Contact: Silvia Calabrò, Official Correspondent Email: silvia@fiab.it

Device name and classification 2.

F7255 Fiab Disposable Cautery battery powered

Code regulation name:

886.4115 Thermal cautery unit.

3. Predicates

Lawfully marketed device to which is claimed equivalence:

AARON AA04 battery powered cautery

Device description 4.

Self-powered device for the cauterization of tissues and small vessels during surgery, without the use of a high frequency generator. The device is intended for use in ophthalmology.

The system is started by pressing the button on the body of the cautery. The resistance of the wire of the tip, when the current passes, causes its heating guaranteeing its capacity of cauterization.

The plastic and metal materials used in the devices comply with biocompatibility requisites.

The energy produced by the continuous current is distributed as heat through a tip at a high temperature; the distribution is at short intervals of few seconds.

The cautery has the weight, size and handle suitable to allow for easy use.

Šec.05 - 1/2

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K.08342s

510(k) Summary	FIAB+	FIAB spa Vicchio, ITALY
Battery powered cautery	2009/08/03	510(k) notification - Section 05

5. Intended use

The device is intended for use in ophtalmology.

Comparison to predicate 6.

The F7255 cautery has the same intended use as the predicate and do not imply new technological characteristics.

Although there are no performance standards as reported in Section 514, the cauteries are tested and produced according to all requisites laid down by the regulations in force so as to guarantee safety and effectiveness.

According to the risk-benefit analysis, the global residual risk has been deemed acceptable since it falls within the area between negligible risks and acceptable risks. See section 12 of the submission.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

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

Fiab SpA % Ms. Silva Calabrò Via Costoli, 4 50039 Vicchio Firenze - Italy

SEP. - 1 2009

Re: K083428

Trade/Device Name: F7255 battery-powered cauterv Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: Class II Product Code: HQP Dated: August 6, 2009 Received: August 26. 2009

Dear Ms. Calabrò:

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.

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Silva Calabrò

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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f.	Lol
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Indications for Use	Image: FIAB logo	FIAB spa Vicchio, ITALY
Battery powered cautery	2009/06/08	510(k) notification - Section 04

Section 04

Indications for Use

510(k) Number (if known): K083428

Device Name:

F7255 battery-powered cautery.

Indications For Use:

Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required. Specially suitable for ophthalmology.

AND/OR Over-The-Counter Use Prescription Use X

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS JINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surfative Devices

Concurrence of CDRH, Office of Device Evaluation (ODE)

No. of Acres of Children Companies ofSTATUTE LABOR COLUMN OF CHARACT LEAST OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLEASE OF CLAIM OF CLAIM OF CLAIM OF CLEASE OF CLAIM OF CLAIM OF CLAIM OF CLAIM OF CLAIM	And Analy Francisco and Children Article Art Property Comments of the Property of Children Comments of Children Comments of Children to Children the Children the Children the---------------------------------------------------------------------
Sec.04	1

Regulation Number and Section

§ 886.4115 Thermal cautery unit.

(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.