F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY

K083428 · Fiab Spa · HQP · Sep 1, 2009 · Ophthalmic

Device Facts

• Record ID: K083428
• Device Name: F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
• Applicant: Fiab Spa
• Product Code: HQP · Ophthalmic
• Decision Date: Sep 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4115
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use in ophtalmology.

Device Story

Self-powered, battery-operated cautery device for tissue and small vessel cauterization during surgery; eliminates need for high-frequency generator. User presses button on device body to activate; electrical current flows through wire tip, generating heat via resistance. Heat distributed at short intervals. Designed for ophthalmology; ergonomic weight and size for easy handling. Biocompatible plastic and metal construction. Provides localized thermal energy to achieve hemostasis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Battery-powered thermal cautery unit. Materials: Biocompatible plastic and metal. Energy source: Internal battery (continuous current). Form factor: Handheld device with wire tip. Operation: Resistance-based heating of tip. No high-frequency generator required.

Indications for Use

Indicated for cauterization of tissues and capillary vessels during surgical operations, specifically in ophthalmology. No high frequency generator required. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• AARON AA04 battery powered cautery

Submission Summary (Full Text)

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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 : [phone] Fax: [phone] Contact: Silvia Calabrò, Official Correspondent Email: [e-mail]

#### 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 [phone] or [phone] 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 |
|----|-----|
|----|-----|

| 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)

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