BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR

K122278 · Baylis Medical Company, Inc. · GEI · Nov 7, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K122278
• Device Name: BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
• Applicant: Baylis Medical Company, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BMC Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

Device Story

The Baylis Medical Company (BMC) Radiofrequency Perforation Generator (Model RFP-100A) is an electrosurgical unit used to cut and coagulate soft tissue. It operates by delivering monopolar radiofrequency (RF) power to a separately-cleared, compatible RF device connected via a BMC connector cable. The circuit is completed through a commercially available external dispersive electrode. An optional footswitch (Model RFA-FS) is available for operator control. The device is intended for use by clinicians in surgical settings. By delivering controlled RF energy, the generator enables precise tissue cutting and coagulation, facilitating surgical procedures.

Clinical Evidence

Bench testing only. The device conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 14971 standards.

Technological Characteristics

Electrosurgical generator; monopolar RF output; compatible with external dispersive electrodes; optional footswitch (RFA-FS). Conforms to IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (High Frequency Surgical Equipment), and ISO 14971 (Risk Management).

Indications for Use

Indicated for use in general surgical procedures to cut and coagulate soft tissue in patients requiring such surgical intervention.

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

• BMC Radio Frequency Perforation Generator, Model RFP-100 (K013904)

Submission Summary (Full Text)

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

K122278

BMC Radiofrequency Perforation Generator

Baylis Medical Company Inc

#### 6.0 510(k) Summary

V 7 ns

Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada

C. Company Phone: [phone]; ext 252

D. Company Facsimile: [phone]

E. Contoct Person: Meghal Khakhar

F. Summary Prepared on: October 09, 2012

#### Device Identification

A. Device Trade Name: Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RFA-FS)

B. Device Common Name: Electrosurgical Generator and optional footswitch

C. Classification Name: Electrosurgical Cutting and Coagulating Device 21 CFR 878.4400

D. Device Class: Class II

•

E. Device Code: GEI, General and Plastic Surgery

#### Identification of Predicate Device

- Device: BMC Radio Frequency Perforation Generator, Model RFP-100 510(k) Number: K013904 Manufacturer: Baylis Medical Company Inc.
#### Device Description

The Baylis Medical Company (BMC) Radiofrequency Perforation Generator is used with a compatible, separately-cleared radiofrequency (RF) device. The RF device is connected to the generator through the appropriate BMC Connector Cable, and delivers power in a monopolar

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

mode between its distal tip electrode and a commercially available external dispersive electrode. An optional footswitch (Model: RFA-FS) may be used with the generator.

#### Intended Use

ﺎﺭ

The BMC Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

### Substantial Equivalence

.

The indication for use and fundamental scientific technology of the current and predicate BMC Radiofrequency Perforation Generators is the same. The substantial equivalence of predicate · and current generators is supported by the device similarities and the results of verification and validation testing.

The BMC Radiofrequency Perforation Generator conforms to the following standards:

| Standard | Title |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical Electrical Equipment--Part 1: General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment--Part 1: General Requirements for Safety -<br>Section 2: Collateral Standard--Electromagnetic Compatibility -<br>Requirements and Tests |
| IEC 60601-2-2 | Medical Electrical Equipment--Part 2-2: Particular Requirements for the<br>Safety of High Frequency Surgical Equipment |
| ISO 14971 | Medical Devices – Application of Risk Management to Medical Devices |

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 7, 2012

Baylis Medical Company, Incorporated % Meghal Khakhar Director, Regulatory and Scientific Affairs 2645 Matheson Boulevard East Mississauga, Ontario L4W 5S4 Canada

Re: K122278

. •

Trade/Device Name: Baylis Medical Company Radiofrequency Perforation Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 09, 2012 Received: October 10, 2012

#### Dear Meghal Khakhar:

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. 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

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

Page 2 - Meghal Khakhar

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson

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

Enclosure

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

## Indications for Use

510(k) Number (if known):

Device Name: Baylis Medical Company Radiofrequency Perforation Generator

Indications for Use:

The Baylis Medical Company Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------|
| (Division Sign-Off) | |
| Division of Surgical, Orthop. and Restorative Devices | Page 1 of 1 |
| 510(k) Number | K122278 |

Vol 005-Page 2