ALPHA ORTHOPAEDICS AT2 SYSTEM

K120527 · Alpha Orthopaedics, Inc. · GEI · Jun 18, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120527
• Device Name: ALPHA ORTHOPAEDICS AT2 SYSTEM
• Applicant: Alpha Orthopaedics, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

Device Story

The AT2 System is an electrosurgical device using monopolar radiofrequency (RF) energy for coagulation and tissue modification. It comprises an RF generator, cooling module, handpiece, and sterile, single-patient-use treatment electrodes. The system delivers 6 MHz RF energy capacitively to tissue while simultaneously cooling the contact surface. Accessories include coupling fluid, return pads, coolant canisters, and skin marking paper. The device is used by clinicians in dermatologic and general surgical settings. The RF generator includes an automated, software-controlled tuning function to optimize energy delivery. By controlling the thermal effect on tissue through combined RF application and surface cooling, the device achieves hemostasis and electrocoagulation, providing a controlled surgical tool for tissue management.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility, EMC, and safety testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Monopolar/bipolar RF electrosurgical system; 6 MHz operating frequency; capacitive energy delivery; surface cooling mechanism; sterile, single-patient-use disposable electrodes (0.25cm² and 1.50cm² contact areas); software-controlled automated tuning function.

Indications for Use

Indicated for patients undergoing dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

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

• Thermage ThermaCool TC System (K031046)
• Alpha Orthopaedics AT2 System (K082956)

Submission Summary (Full Text)

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# alpha orthopaedics

JUN 1 8 2012

### 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

# 1. General Information

Date Summary Prepared: May 31, 2012

| Submitted by: | Alpha Orthopaedics, Inc.<br>7700 Edgewater Drive, Suite #405<br>Oakland, CA 94621<br>Phone: [phone]<br>Fax: [phone] |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact name: | Gina To<br>Vice President, Regulatory/Quality |

#### 2. Name of Device

| Trade Name: | Alpha Orthopaedics AT2 System |
|-----------------|----------------------------------------------------------------|
| Common Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Product code GEI, Class II, CFR §878.4400 |

#### 3. Legally Marketed Predicate Devices for Claimed Equivalence

- K031046 Thermage ThermaCool TC System: primary predicate device for . substantial equivalence claim
- K082956 Alpha Orthopaedics AT2 System: predicate device for substantial . equivalence claim

# 4. Device Description

The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².

# 5. Intended Use

The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

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### 6. Technological Characteristics

The technological characteristics of the AT2 System, including treatment electrodes, are identical to the Thermage ThermaCool TC System, as follows:

| Operational principle: | The system delivers RF energy while cooling the surface of the tissue in contact with the treatment electrode |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Modes: | Monopolar/Bipolar |
| Capacitive vs. Inductive: | Capacitive |
| Operating Frequency: | 6 MHz |
| Treatment Electrodes: | Sterile, disposable, single patient use |
| Tuning | Tuning function built into RF Generator and automated Process is software controlled. |

#### · 7. Substantial Equivalence

The AT2 System with the addition of 0.25cm² and 1.50cm² treatment electrodes has the same intended use and the same technological characteristics as the legally marketed predicate device cleared under K031046 and K082956.

#### 8. Summary of Performance Testing

Biocompatibility, EMC, safety, and bench tests have been completed. The technological characteristics demonstrate that the Alpha Orthopaedics AT2 System is as safe, as effective, and performs as well as the legally marketed predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Alpha Orthopaedics, Incorporated % Ms. Gina To 7700 Edgewater Drive Suite 405 Oakland, California 94621

Re: K120527

Trade/Device Name: Alpha Orthopaedics AT2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 31, 2012 Received: June 5, 2012

JUN 1 8 2012

Dear Ms. To:

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

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# Page 2 - Ms. Gina To

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 forth in the quality systems (OS) 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,

ely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): K120527

Device Name: Alpha Orthopaedics AT2 System

Indications for Use:

The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

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)

Signature of

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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K120527 510(k) Number .