BAYLIS MEDICAL RF PERFORATION PROBE V2.0

K132374 · Baylis Medical Company, Inc. · GEI · Aug 30, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132374
• Device Name: BAYLIS MEDICAL RF PERFORATION PROBE V2.0
• Applicant: Baylis Medical Company, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coagulate soft tissue.

Device Story

Sterile, single-use RF perforation probe; delivers monopolar radiofrequency energy to distal electrode for soft tissue cutting/coagulation. Device comprises insulated nitinol wire core with rounded, uncoated active tip. Connects to separately cleared Baylis Medical Company Radiofrequency Puncture Generator via compatible connector cable. Used by clinicians in surgical/procedural settings. Energy delivery facilitates tissue perforation/coagulation; clinical utility relies on generator-controlled RF output. Benefits include precise tissue interaction during electrosurgical procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Verification testing included biocompatibility, mechanical, electrical, arc integrity, and general physical testing.

Technological Characteristics

Monopolar electrosurgical probe; nitinol wire core with insulated shaft and uncoated distal tip. Energy source: external RF generator. Single-use, sterile. Dimensions and materials similar to predicate.

Indications for Use

Indicated for cutting and/or coagulating soft tissue. No specific patient population, age, or gender restrictions provided.

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

• Baylis Medical RF Perforation Probe (K010265)

Submission Summary (Full Text)

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.. / . . . . .

# 7. 510(k) Summary

### Submitter Information

- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario Canada L4W 5S4
- C. Company Phone: [phone]
- D. Company Facsimile: [phone]
- E. Contact Person: Meqhal Khakhar
- F. Summary Prepared on: 26-July-2013

AUG 3 0 2013

# Device Identification

- A. Device Trade Name: Baylis Medical RF Perforation Probe V2.0
- B. Device Common Name: RF Perforation Probe
- C. Classification Name: 21 CFR 878.4400 Electrosurqical Cutting and Coagulation Device and Accessories
- D. Product Code: GEI
- E. Device Class: Class II

# Identification of Legally Marketed Predicate Device

| Device Name | Manufacturer | 510(k) |
|----------------------------------------|-----------------------------|---------|
| Baylis Medical RF<br>Perforation Probe | Baylis Medical Company Inc. | K010265 |

# Indications for Use

The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coaqulate soft tissue.

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#### Device Description

The Baylis Medical RF Perforation Probe V2.0 is a sterile, single-use device that delivers radiofrequency power in a monopolar mode to its distal electrode. The device consists of an insulated core nitinol wire with a rounded tip. The distal active tip is uncoated to deliver radiofrequency energy. The device connects to a separately cleared Baylis Medical Company Radiofrequency Puncture Generator at its proximal end through a compatible BMC Connector Cable.

### Comparison to Predicate Device

The Baylis Medical RF Perforation Probe V2.0 has the following similarities to the predicate device:

| Characteristic | Comment |
|-------------------------------------------------------|-----------|
| Intended Use | Identical |
| Indication for Use | Identical |
| Fundamental scientific technology | Identical |
| Operating Principle | Identical |
| Mechanism of action | Identical |
| Materials | Similar |
| Dimensions | Similar |
| Compatible devices and accessories | Identical |
| Packaging configuration | Identical |
| Sterility assurance level and Sterilization<br>method | Identical |

#### Performance Testing

To demonstrate substantial equivalence of the Baylis Medical RF Perforation Probe V2.0 to the cleared predicate device, the following verification tests were performed: biocompatibility, mechanical, electrical, arc integrity, and general physical.

# Conclusions

The Baylis Medical RF Perforation Probe V2.0 is determined to be substantially equivalent to the cleared predicate device with respect to intended use, principles of operation, and technological characteristics. The subject device met all requirements as specified by applicable standards and the test protocols. The differences between the subject and predicate devices do not raise any new concerns of safety or effectiveness.

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

Baylis Medical Company, Inc. Dr. Meghal Khakhar. MBBS. CerRAP, RAC Director, Regulatory and Scientific Affairs 2645 Matheson Boulevard, East Mississauga, Ontario Canada L4W 5S4

August 30, 2013

Re: K132374

Trade/Device Name: Baylis Medical RF Perforation Probe V2.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 26, 2013 Received: August 05, 2013

Dear Dr. 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

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### Page 2 - Dr. Meghal Khakhar, MBBS, CerRAP, RAC

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 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/ReportalProblem/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 yours,

# Mark N. Melkerson -S

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

Enclosure

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#### Indications for Use

K132374 510(k) Number (if known):

Device Name: Baylis Medical RF Perforation Probe V2.0

Indications For Use:

The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coagulate soft tissue.

Prescription Use × (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)

Joshua C. Nipper -S

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