AMBIENT TURBOFLASH 90 IFS

K120791 · Arthocare Corporation · GEI · Dec 11, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120791
• Device Name: AMBIENT TURBOFLASH 90 IFS
• Applicant: Arthocare Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ambient TurboFlash 90 IFS is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including: [List of procedures for ankle, elbow, hip, knee, shoulder, and wrist joints].

Device Story

Bipolar, sterile, single-use, high-frequency electrosurgical wand; used in arthroscopic/orthopedic procedures. Input: electrical energy from Quantum 2 Controller. Operation: tungsten/titanium electrode tip performs soft tissue ablation, resection, and coagulation; integrated suction removes debris. Device features molded handle with finger switches; compatible only with Quantum 2 Controller (includes 'Use Limiting' feature to prevent reuse). Surgeon operates device in OR to treat joint tissues (e.g., cartilage, ligaments, tendons). Output: thermal energy for tissue modification; suction for fluid/debris removal. Benefits: smaller profile tip improves access to tight joint spaces; allows precise tissue management; aids in hemostasis.

Clinical Evidence

Bench testing only. Testing included ablation and coagulation performance, electrical safety (Hipot, continuity, IEC 60601-2-2:2009), tip strength, suction rate, ex vivo performance, and ambient temperature measurement.

Technological Characteristics

Bipolar electrosurgical wand. Materials: tungsten and titanium electrode tip, alumina ceramic spacer-cap, stainless steel shaft. Energy: high-frequency electrosurgical (powered by Quantum 2 Controller). Form factor: single-use, integrated suction, finger switches. Connectivity: proprietary connection to Quantum 2 Controller. Sterilization: sterile.

Indications for Use

Indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures (ankle, elbow, hip, knee, shoulder, wrist).

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

• Ambient Super TurboVac® 90 IFS Wand (K083306)

Submission Summary (Full Text)

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# K 120791

### DEC 1 1 2012

#### 510(k) Summary

ARTHROCARE® CORPORATION Ambient ® TurboFlash™ 90 IFS

#### · General Information

| Submitter Name: | ArthroCare Corporation |
|-----------------|--------------------------------|
| Address: | 7000 West William Cannon Drive |
| | Austin, TX 78735 |
| Contact Person: | Cheryl Frederick |
| | Director, Regulatory Affairs |
| Date Prepared: | October 8, 2012 |

#### Device Description

| Proprietary: | Ambient ® TurboFlash™ 90 IFS Wand |
|-----------------|---------------------------------------------------------|
| Common: | Electrosurgical Cutting and Coagulation and Accessories |
| Classification: | Class II |
| Product Code: | GEI |
| CFR Section: | 21 CFR 878.4400 |

#### Predicate Device

Ambient Super TurboVac® 90 IFS Wand included in:

ArthroCare ArthroWand Devices, K083306

#### Product Description

The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device..

#### Intended Uses/Indications for Use

The Ambient TurboFlash 90 IFS is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including:

| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints<br>(ankle, elbow, hip, knee,<br>shoulder, and wrist) |
|----------------------------------------|-----------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints<br>(ankle, elbow, hip, knee,<br>shoulder, and wrist) |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Fascia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoid Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |
| • Meniscectomy | Knee |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| Coagulation | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |

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#### Summary of Technological Characteristics

This Special 510(k) proposes modifications to the specifications for the Ambient Super TurboVac 90 IFS most recently cleared in K083306. The indications for use, fundamental scientific technology, principle of operation, and sterilization methodology remain the same as in previously cleared 510(k). The following table summarizes the technological differences between the subject device, the Ambient TurboFlash 90 IFS, and the predicate device, the Ambient Super TurboVac IFS 90).

| Ambient TurboFlash 90<br>IFS<br>(Subject Device) | Ambient Super TurboVac<br>IFS, K083306<br>(Predicate Device) | Rationale for Change |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| One-piece spacer-cap<br>design manufactured from<br>alumina. | Two-piece spacer-cap<br>manufactured from alumina<br>and stainless steel,<br>respectively. | Facilitates the<br>manufacturability of a<br>smaller profile tip which<br>provides the surgeon better<br>access to tight joint spaces |
| Screen is secured to the<br>spacer-cap with two<br>tungsten raised staples. The<br>screen and staples are<br>energized via a titanium<br>electrode leg which passes<br>through the spacer-cap via<br>an internal pathway and<br>conducts power from the<br>Quantum 2 Controller to<br>the screen. | Screen is energized and<br>secured to the spacer with<br>four tungsten ball wires<br>which pass through the<br>spacer and cap via an<br>internal pathway and<br>conduct power from the<br>Quantum 2 Controller to<br>the screen. | These design changes are<br>being proposed to provide:<br>• more efficient<br>manufacturability; and<br>• a smaller profile tip to<br>provide surgical access<br>to tight joint spaces. |
| Resistor in the connector of<br>the wand cable allows for a<br>maximum ablation set point<br>of 10. | Resistor in the connector of<br>the wand cable allows for a<br>maximum ablation set point<br>of 9. | Provides the surgeon more<br>flexibility in delivering<br>therapy. |

As a result of these modifications, the corresponding product labeling has also been updated.

#### Summary of Non-Clinical Performance Testing

In establishing substantial equivalence to the predicate device, ArthroCare compared the intended use, as well as features including materials, physical specifications, performance specifications and sterilization parameters. In addition, the Ambient TurboFlash 90 IFS was successfully evaluated using a variety of bench tests to simulate clinical use including:

- Ablation and coagulation testing; 트
- Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009; ■
- I Tip strength testing;
- 트 Suction rate testing;
- 트 Ex vivo performance testing; and
- l Ambient temperature measurement testing.

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This testing demonstrated that the proposed modifications for the Ambient TurboFlash 90 IFS are substantially equivalent and do not affect the safety or efficacy of the device.

#### Summary of Safety and Effectiveness

The Ambient TurboFlash 90 IFS is substantially equivalent to the Ambient Super TurboVac 90 IFS cleared via K083306. Both the subject and the predicate devices have the same indications for use and utilize the same fundamental scientific technology. The proposed modifications are not substantial and do not significantly affect the safety or efficacy of the device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved shapes that resemble a human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

December 11, 2012

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

Arthrocare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive, Building One Austin, Texas 78735

Re: K120791

Trade/Device Name: Ambient™ TurboFlash 90 IFS Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2012 Received: November 30, 2012

Dear Ms. Frederick:

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 10 merce 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

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#### Page 2 - Ms. Cheryl Frederick

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/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.

## Peter D. Rumm -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 Statement

510(k) Number: K120791

Device Name: Ambient® TurboFlash™ 90 IFS Wand

Indications for Use:

The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

| Arthroscopic and Orthopedic Procedures | Joint Specific or All<br>Joints (ankle, elbow,<br>hip, knee, shoulder, and<br>wrist) |
|----------------------------------------|--------------------------------------------------------------------------------------|
| Ablation and Debridement | |
| • ACL/PCL | Knee |
| • Acromioplasty | Shoulder |
| • Articular Cartilage | All Joints |
| • Bursectomy | All Joints |
| • Chondroplasty | All Joints |
| • Fascia | All Joints |
| • Ligament | All Joints |
| • Notchplasty | Knee |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Subacromial Decompression | Shoulder |
| • Synovectomy | All Joints |
| • Tendon | All Joints |
| Excision and Resection | |
| • Acetabular Labrum | Hip |
| • Articular Labrum | All Joints |
| • Capsule | All Joints |
| • Capsular Release | Knee |
| • Cartilage Flaps | Knee |
| • Cysts | All Joints |
| • Discoid Meniscus | Knee |
| • Frozen Shoulder Release | Shoulder |
| • Glenoid Labrum | Shoulder |
| • Lateral Release | Knee |
| • Ligament | All Joints |
| • Loose Bodies | All Joints |
| • Meniscal Cystectomy | Knee |

Page 1 of 2

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| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) |
|----------------------------------------|-----------------------------------------------------------------------------|
| • Menisectomy | Knee |
| • Plica Removal | All Joints |
| • Scar Tissue | All Joints |
| • Soft Tissue | All Joints |
| • Synovial Membrane | All Joints |
| • Tendon | All Joints |
| • Triangular Fibrocartilage (TFCC) | Wrist |
| • Villusectomy | Knee |
| <i>Coagulation</i> | |
| • ACL/PCL | Knee |
| • Articular Cartilage | All Joints |
| • Carpal Ligaments | Wrist |
| • Glenohumeral Capsule | Shoulder |
| • Ligament | All Joints |
| • Medial Retinaculum | Knee |
| • Rotator Cuff | Shoulder |
| • Tendon | All Joints |
| • Wrist Tendons | Wrist |

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

X

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)

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