TX1 TISSUE REMOVAL SYSTEM

K123640 · Tenex Health · LFL · Mar 20, 2013 · SU

Device Facts

• Record ID: K123640
• Device Name: TX1 TISSUE REMOVAL SYSTEM
• Applicant: Tenex Health
• Product Code: LFL · SU
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The TX1 Tissue Removal System is intended for use as an Ultrasonic Surgical Aspirator of soft tissue.

Device Story

TX1 Tissue Removal System is an ultrasonic surgical aspirator for soft tissue emulsification and removal. System comprises a console, ultrasonic handpiece, and foot pedal. Console manages irrigation, aspiration, cutting, and coagulation functions via touch-screen interface; includes integrated irrigation/aspiration pumps and connection for external cautery devices. Handpiece delivers ultrasonic energy and irrigation fluid to surgical site while aspirating emulsified tissue. Foot pedal provides on/off control for all four functions. Used in operating room by surgeons. Console provides audible confirmation of settings and visual feedback via LCD. System benefits patients by enabling precise soft tissue removal during various surgical procedures.

Clinical Evidence

Bench testing only. Performance testing included integrity testing of case interfaces, functional verification post-sterilization, accelerated aging, and transportation conditioning. Electrical safety and EMC testing performed per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Biocompatibility testing conducted per ISO 10993-1, -5, -10, and -11. All tests passed.

Technological Characteristics

Ultrasonic surgical aspirator; console-based control with touch-screen; single-use disposable ultrasonic handpiece (polymers/metals); biomedical grade PVC tubing. Irrigation via air-pump pressurized fluid bag. Connectivity: USB and Ethernet for software upgrades. Electrical safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. Sterilization: Handpiece provided sterile.

Indications for Use

Indicated for surgical procedures requiring fragmentation, emulsification, and aspiration of soft tissue in General, Orthopedic, Laparoscopic, and Plastic and Reconstructive Surgery.

Predicate Devices

• TX1 Tissue Removal System (K101561)

Submission Summary (Full Text)

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K123640

510(k) Traditional Submission Tenex Health TX1 Tissue Removal System

## 5. 510(k) Summary

## 510(k) SUMMARY

510(k) Owner

Contact person

Tenex Health 26902 Vista Terrace Lake Forest, CA 92630 Phone: [phone] Fax: [phone]

David Salzberg Tenex Health 26902 Vista Terrace Lake Forest, CA 92630 Phone: [phone] Fax: [phone] Email: [e-mail]

Date summarv was prepared

November 21, 2012

Primary Product Code: Common Name Trade Name Classification Name Regulation Class Panel Product Code

Secondary Product Code: Common Name Trade Name Classification Name

> Regulation Class Panel Product Code

Predicate

Ultrasonic Surgical Aspirator TX1 Tissue Removal System Instrument, Ultrasonic Surgical Unclassified Unclassified General & Plastic Surgery LFL

Ultrasonic Surgical Aspirator TX1 Tissue Removal System Electrosurgical, Cutting & Coagulation & Accessories 878.4400 2 General & Plastic Surgery GEI

ﻟﻢ ﺍﻟﺘﻲ

K101561 TX1 Tissue Removal System

15 of 82 | Regulatory Specialists, Inc.

MAR 2 0 2013

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1123640

510(k) Traditional Su Tenex Health TX1 Tissue Removal System

Description

The TX 1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, and foot pedal. The console provides control over the four user functions including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. The console provides a connection for a commercially available cautery pencil or forceps. Two USB ports and one Ethernet port are available for loading software upgrades.

The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for removing emulsified tissue by way of integrated tubing set. The handpiece is constructed from various polymers and metals, while the tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile. The handpiece is a single use disposable component of the system.

Irrigation fluid is delivered under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes a cuff that is fitted around the irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the height of the fluid bag.

The foot pedal is used to control each of the four functions (irrigation, aspiration, ultrasonic fragmentation/emulsification, coagulation) of the system. It offers on/off functionality and is rated IPX5 (by the supplier) for protection against liquids.

Intended Use

The TX1 Tissue Removal System is intended for use as an Ultrasonic Surgical Aspirator of soft tissue.

### Indications for Use

The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

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K123640

( ಷ

510(k) Traditional Submission Tenex Health TX1 Tissue Removal System

Technological Characteristics

The predicate and the TX1 Tissue Removal System were compared in the following areas and found to have similar technological characteristics and to be equivalent:

| Principle of Operation |
|----------------------------------|
| Method of tissue emulsification |
| Tip Amplitude |
| Method of aspiration (vacuum) |
| Vacuum level |
| Method of irrigation |
| Irrigation Flow |
| Electrical Safety standards met |
| Electrical |
| INPUT VOLTAGE |
| POWER CONSUMPTION |
| LINE FUSES |
| MAX. OUTPUT VOLTAGE (CUTTING) |
| MAX. OUTPUT VOLTAGE (FOOT PEDAL) |
| Irrigation |
| FLUID DELIVERY |
| VALVE TYPE |
| CONTROL |
| Cutting |
| HANDPIECE TYPE |
| CONTROL |
| SYSTEM PRIMING |
| Aspiration |
| ASPIRATION PUMP |
| AVAILABLE MAX. VACUUM LEVEL |
| AVAILABLE FLOW RATE |
| CONTROL |
| Coagulation |
| TYPE |
| OPERATING FREQUENCY |
| MAXIMUM POWER OUTPUT |
| HANDPIECE TYPE |
| CONTROL |
| Console Dimensions |
| HEIGHT |
| WIDTH |
| DEPTH |
| WEIGHT |

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Page 4 of 5

510(k) Traditional Submission Tenex Health TX1 Tissue Removal System

The predicate and the TX1 Tissue Removal System were compared in the following areas and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the TX1 Tissue Removal System:

| Material in contact with tissue |
|-----------------------------------|
| Pressure relief valve (console) |
| Sterilization, handpiece |
| Accessories |
| Electrical |
| MAX. OUTPUT VOLTAGE (COAGULATION) |
| Irrigation |
| OPERAT ING PRESSURE |
| Cutting |
| HANDPIECE TYPE |
| AVAILABLE POWER DELIVERY |
| OPERATING FREQUENCY |

The following non-clinical performance tests were conducted:

| Integrity test – Case body/Case tail joint interface | PASS |
|------------------------------------------------------------|------|
| Functional verification – post sterilization | PASS |
| Functional verification – accelerated aged conditioning | PASS |
| Functional verification – post transportation conditioning | PASS |
| Cart strength verification | PASS |
| EMC and General Electrical Safety | PASS |

- IEC 60601-1- 2 (2004): Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests PASS
- IEC 60601-1 (1999): Medical Electrical Equipment Part 1: . General Requirements for Safety, includes Amendment 1 (1991) and Amendment 2 (1995) PASS
- IEC 60601-2-2 (2006): Medical Electrical Equipment Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment.

Biocompatibility

PASS

- . ISO 10993-1:2009/Cor. 1:2010: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process PASS
- ISO 10993-5:2009: Biological evaluation of medical devices -- Part . 5: Tests for in vitro cytotoxicity PASS
- . ISO 10993-10:2010: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization PASS
- ISO 10993-11:2006: Biological evaluation of medical devices -- Part . 11: Tests for systemic toxicity PASS

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K123640

Page 5 of

510(k) Traditional Submission
Tenex Health
TX1 Tissue Removal System

## Conclusions from non-clinical performance data

After performing non-clinical performance studies, the data shows that the TX1 Tissue Removal System is substantially equivalent to the predicate as an Ultrasonic Surgical Aspirator.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 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 symbol resembling a bird or abstract human figure with three wing-like or arm-like extensions.

#### Public Health Service

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

Tenex Health % Mr. David Salzberg Director, Quality and Regulatory Affairs 26902 Vista Terrace Lake Forest, California 92630

March 20, 2013

Re: K123640 Trade/Device Name: TX; Tissue Removal System Regulatory Class: Unclassified Product Code: LFL Dated: February 19, 2013 Received: February 28, 2013

Dear Mr. Salzberg:

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.

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

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Page 2 – Mr. David Salzberg

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.fdagov/AboutFDA/CentersOffices/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours, For

# Peter DJRumm -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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510(k) Traditional Submission Tenex Health TX1 Tissue Removal System

## 1. Indications for Use Statement

510(k) Number (if known): ____K123640

Device Name:

Indications for Use:

The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

174211

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200300.100.100.1.1 = 1300369056
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