FIAB SPA, MODELS F7244, F7233, F7234, F7277

K100333 · Fiab Spa · GEI · Jun 21, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100333
• Device Name: FIAB SPA, MODELS F7244, F7233, F7234, F7277
• Applicant: Fiab Spa
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator.

Device Story

Self-powered, battery-operated cautery device for tissue and capillary vessel cauterization during surgery. Operates without high-frequency generators. User presses button on device body to complete circuit; electrical current passes through wire tip, causing resistive heating to approximately 1200°C. Heat is distributed at short intervals. Used by clinicians in surgical settings. Provides localized thermal coagulation to achieve hemostasis. Benefits include portability, ease of use, and elimination of external power sources or high-frequency generators.

Clinical Evidence

Bench testing only. Testing verified incandescent filament reaches 1200°C using thermocouple and internal equipment. Battery performance verified to support at least 48 activations of predefined duration. Compliance with IEC 60601-1 and 60601-1-2 confirmed via test report TRP 015 04.

Technological Characteristics

Battery-powered electrosurgical cautery. Resistive heating principle using incandescent wire filament. Materials: plastic and metal (biocompatible). Dimensions/form factor: handheld, portable. Energy source: internal battery (continuous current). Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for cauterization of tissues and capillary vessels during surgical operations. No patient population age or gender restrictions specified. Contraindications not specified.

Regulatory Classification

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.

Predicate Devices

• AARON MEDICAL INDUSTRIES high-temperature fine tip cautery (K945492)
• AARON MEDICAL INDUSTRIES high-temperature loop tip cautery (K945759)

Submission Summary (Full Text)

{0}------------------------------------------------

3 2 IN 21 2010

| 510(k) Summary | FIAB+ | FIAB spa Vicchio, ITALY |
|---------------------------------------------|------------|----------------------------------|
| High temperature<br>battery powered cautery | 2010/17/06 | 510(k) notification – Section 05 |

## Section 05

# 510(k) Summary

#### 1. Submitter

Fiab SpA Via Costoli, 4 50039 Vicchio Florence - Italy Tel : [phone] Fax: [phone] Contact: Silvia Calabrò, Official Correspondent Email: [e-mail]

#### 2. Device name and classification

Fiab disposable High temperature battery powered cauteries:

F7244, F7233, F7234, F7277.

Code regulation name: .

878.4400 - Electrosurgical cutting and coagulation device and accessories.

#### Predicates 3.

Lawfully marketed device to which is claimed equivalence:

AARON MEDICAL INDUSTRIES high temperatures battery powered cautery, see model below.

| K number | Model | Description |
|----------|-------|----------------------------------------------------|
| 945492 | AA01 | High-temperature fine tip cautery. |
| 945759 | AA09 | High-temperature loop tip with esxtended 5" shaft. |

#### 4. Device description

Self-powered devices for the cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator.

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Free of the Research Party of Children Company of Children<br>18.11<br>הראשון החירות חייור וחורים חיצוניים ומחרירות מחורי המו | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |

{1}------------------------------------------------

| 510(k) Summary | FIAB | FIAB spa Vicchio, ITALY |
|---------------------------------------------|------------|-----------------------------------|
| High temperature<br>battery powered cautery | 2010/17/06 | 510(k) notification -- Section 05 |

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.

#### 5. Intended use

The device is intended for cauterization of tissues and capillary vessels during surgery, without the use of a high frequency generator.

#### 6. Compliance to standards and performance data

Following IEC standard related to electromedical devices were used to compile present submission:

- CEI EN 60601-1 "Electromedical devices part 1: General safety standard", ।
- CEI EN 60601-1-2 "Electromedical devices part 1: General safety standard. Collateral standard: Electromagnetic compatibility. - Requirements and tests".

Conformity to such above standards is certified by the test report TRP 015 04 (see section 17).

Since there are no specific guidelines regulating the performances of the devices in question (Performance Standards), we have deemed sufficient to carry out the following lab tests (all results related to performance tests are included in section 18):

- -Check the temperature reached by the incandescent filament is 12009 C. Temperature's measurement was made both internally (FIAB) and by a third party. Internal measurement was made with 2 methods: first using a simple encapsulated "S" thermocouple to get an indicative value of maximum temperature reached by tip and the second one using a Fiab self-built equipment to reduce inertia of temperature gauge, by this method it is possible a more accurate measurement of temperature. In order to get a confirmation of cautery ability to reach expected temperature a more accurate test was made by externally laboratory.
- -Check the length of operation of the battery: from theoretical calculations we get number of activations for a fixed duration of activation. A visual operation test was made in order to verify a sufficient heating of the tip for all expected number of activations with predefined duration, being such number at least equal to 48.

Results carried out from the test showed that FIAB cauteries met the design specifications.

#### 7. Comparison to predicate

The Fiab F72XX high temperature series cauteries have the same intended use as the predicate and do not imply new technological characteristics.

| Sec.05 - 2/3 |
|--------------|
|--------------|

{2}------------------------------------------------

| 510(k) Summary | Image: FIAB logo | FIAB spa Vicchio, ITALY |
|---------------------------------------------|------------------|----------------------------------|
| High temperature<br>battery powered cautery | 2010/17/06 | 510(k) notification - Section 05 |

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.

| A-4-4-4-4-4-4-4-4-4-4-80-8-4-4-4-4-4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>0. 06<br>WV-1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A ANNUAL LAND AND LEASE -- L -- L -- L -- |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A | 1<br>Carona Carona Carolina Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara C | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. The image is in black and white.

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

Fiab SpA % Mr. Francesco Batistini Via Costoli, 4 50039 Vicchio Florence - Italy

### JUN 2 1 2010

Re: K100333

Trade/Device Name: F7244, F7233, F7234, F7277 series of high temperature batterypowered cautery Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II · Product Code: GEI Dated: May 20, 2010 Received: May 24, 2010

Dear Mr. Batistini:

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. Ilsting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Mr. Francesco Batistini

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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barbara Buelow

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

| Indications for Use | FIAB | FIAB spa Vicchio, ITALY |
|---------------------------------------------|------------|----------------------------------|
| High temperature<br>battery powered cautery | 2010/05/28 | 510(k) notification - Section 04 |

Section 04

### Indications for Use

510(k) Number (if known): K100333

Device Name:

F7244, F7233, F7234, F7277 series of high temperature battery-powered cautery.

Indications For Use:

Cauterisation of tissues and capillary vessels during operations. No high frequency generator is required.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Digit

Division of Surgical, Orthopedic, and Restorative Devices

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number K100333

| Sec.04 - 1/1 |
|--------------|
|--------------|