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.

Device 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.

AI/ML Overview

This document covers the 510(k) summary for the Tenex Health TX1 Tissue Removal System, an ultrasonic surgical aspirator. The submission focuses on demonstrating substantial equivalence to a predicate device (K101561 TX1 Tissue Removal System) rather than presenting a de novo study with specific acceptance criteria for performance as would be expected for a novel device or AI/ML product.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly concerning human readers, AI assistance, ground truth, and training data, is not directly applicable to this 510(k) submission. This submission primarily relies on comparing technological characteristics and non-clinical performance tests to a predicate device.

However, I can extract information related to the non-clinical performance and the basis for the FDA's clearance.

1. Table of "Acceptance Criteria" and Reported Device Performance (interpreted from non-clinical tests for equivalence):

Since this is a 510(k) submission for an ultrasonic surgical aspirator, the "acceptance criteria" are not reported as numerical thresholds like accuracy or precision for an AI/ML device. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and biocompatibility standards, demonstrating equivalence to the predicate device. The reported "performance" is whether these tests were passed.

Area of Assessment	Implicit Acceptance Criteria (for substantial equivalence)	Reported Device Performance
Functional Integrity	Maintain structural integrity under normal and stressed conditions	PASS
Integrity test – Case body/Case tail joint interface	(Specific criterion for joint integrity)	PASS
Functional verification – post sterilization	Function correctly after sterilization	PASS
Functional verification – accelerated aged conditioning	Function correctly after simulated aging	PASS
Functional verification – post transportation conditioning	Function correctly after simulated transportation stress	PASS
Cart strength verification	The cart (if applicable, implied for system stability) meets strength requirements	PASS
Electrical Safety & EMC	Comply with international electrical safety and electromagnetic compatibility standards (IEC 60601 series)	PASS
IEC 60601-1-2 (2004)	Meet EMC requirements	PASS
IEC 60601-1 (1999)	Meet general requirements for safety (including Amendments 1 & 2)	PASS
IEC 60601-2-2 (2006)	Meet particular requirements for safety of high-frequency surgical equipment	PASS
Biocompatibility	Be biologically safe when in contact with human tissue, as per ISO 10993 series	PASS
ISO 10993-1 (2009/Cor. 1:2010), -5 (2009), -10 (2010), -11 (2006)	Evaluation, in vitro cytotoxicity, irritation/sensitization, and systemic toxicity requirements	PASS

2. Sample size used for the test set and the data provenance:

This submission describes non-clinical performance tests for a physical medical device (ultrasonic surgical aspirator), not a software or AI/ML device relying on diagnostic images or patient data.
Therefore, there is no "test set" in the context of clinical data, images, or patient cohorts. The "test set" refers to the device units and components undergoing the specified engineering, electrical, and biocompatibility tests.
The document does not specify the number of units or components tested for each non-clinical test, nor does it specify data provenance (country of origin, retrospective/prospective) as these are not relevant for these types of engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. "Ground truth" in the context of expert review of data is irrelevant for the non-clinical performance tests of a physical surgical device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified standards (e.g., electrical resistance, mechanical strength, chemical reactivity).

4. Adjudication method for the test set:

This is not applicable. Test results for engineering and safety standards are typically determined by objective measurements against predefined criteria, not by expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an ultrasonic surgical aspirator, not an AI/ML diagnostic aid or image processing tool. No MRMC study was performed, nor is there any AI component to assess human reader improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. As noted, the device is a physical surgical tool, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the objective engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series). The device's performance against these standards determines if it "passes" or "fails."

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

This is not applicable.

Summary

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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: (949) 580.1266 Fax: (949) 580.1270

David Salzberg Tenex Health 26902 Vista Terrace Lake Forest, CA 92630 Phone: (949) 580.1266 Fax: (949) 580.1270 Email: Salzberg@tenexhealth.com

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

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MAR 2 0 2013

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1123640

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

Description

Intended Use

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

Indications for Use

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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 (800) 638-2041 or (240) 276-3150 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

!】
200300.100.100.1.1 = 1300369056
103.19 11:58:39 -04 00:

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Regulation Number and Section

N/A