The Tenex Health TX System with the TXP MicroTip is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The Tenex Health TX System with the TXP MicroTip is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

Device Description

The Tenex Health TX System with the TXP MicroTip is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic ulcers. The Tenex Health TX System with the TXP MicroTip is intended for use in an office-based setting, clinical environment or hospital environment. The system consists of a console, ultrasonic MicroTip, inflation cuff, foot pedal and supply kit. The console provides power and control for the user functions including irrigation, aspiration, and ultrasonic fragmentation/emulsification. It has a large, color LCD and employs a touch-screen with a graphical user interface for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation valve, the irrigation pump and the aspiration pump. The Console is non-sterile when used and does not require processing.

The ultrasonic MicroTip connects to the console for electrical power, the transfer of irrigation fluid to the surgical site and the aspiration of emulsified tissue back to the collection bag. The MicroTip is single use, sterile packaged. A single use, disposable collection bag is integrated into the MicroTip tubing to collect the aspirated materials. The connections are made via an integrated wiring connector and tubing set. The handpiece is constructed from various biocompatible polymers and metals. The tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile, via electron beam irradiation. The handpiece and tubing are a single use disposable component of the system. Irrigation fluid is delivered from a user-provided surgical saline bag, under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes an inflation cuff that is fitted over the saline bag.

The foot pedal is used by the user to remotely control the function of the console. It connects to the back of the console via an electrical cable. It provides on/off functionality and is rated IPX8 for protection against liquids.

The System also includes accessories. A Travel Case is provided for shipping, handling and storage of the TX Console. A power cord is provided for connecting the Console to facility electrical power in order to operate the device. A replacement fuse set is also provided in case of the need for replacement of electrical fuses in the TX Console. The accessories are non-sterile when used and does not require processing.

The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. These include a syringe and needle, scalpel, an ultrasound probe cover, gauze, closure strips and dressing. The itemized contents of the kit with their manufacturer and regulatory information are provided in Table 4 below.

The Tenex Health TX System with the TXP MicroTip is an upgrade to the Tenex Health TX System (K153299), with the addition of the TXP MicroTip, an upgraded handpiece with indications for use for the treatment of hard tissue and the sharp debridement of wounds such as neuropathic ulcers.

AI/ML Overview

The provided text is a 510(k) Summary for the Tenex Health TX System with the TXP MicroTip. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML or human reader performance.

The "Performance Data" section details non-clinical performance tests which include:

Electro-mechanical bench testing (e.g., aspiration vacuum, irrigation flow, operating frequency, needle stroke length)
EMC and electrical safety testing
Biocompatibility evaluation
Sterilization validation
Packaging Validation
Simulated use testing in cadaver (evaluating design, usability, surgical technique, and effectiveness in sharp debridement of soft and hard tissue in wounds)
Simulated use testing in bovine tissue (validating durability, cutting, fragmentation, emulsification, aspiration, and quantifying tissue removal rates)

These tests are primarily focused on the physical and functional aspects of the surgical device, its safety, and its ability to perform its intended mechanical actions (fragmentation, emulsification, aspiration of tissue). There is no mention of an AI/ML component, diagnostic accuracy studies, or human reader performance studies (MRMC studies).

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance related to AI/ML or diagnostic accuracy.
Sample size for a test set in the context of AI/ML, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, or ground truth for such studies.
Training set details related to AI/ML.

The device is a physical surgical instrument, not a diagnostic or AI-based software device. My capabilities are limited to extracting and rephrasing information explicitly present in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 28, 2018

Tenex Health, Inc. Mr. David Vancelette Vice President of QA/RA 26902 Vista Terrace Lake Forest, California 92630

Re: K181367

Trade/Device Name: Tenex Health TX System Regulatory Class: Unclassified Product Code: LFL Dated: May 22, 2018 Received: May 23, 2018

Dear Mr. Vancelette:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181367

Device Name

Tenex Health TX System with the TXP MicroTip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

A 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

Date:	August 25, 2018
Submitter:	Tenex Health, Inc.26902 Vista TerraceLake Forest, CA 92630Phone: 949-454-7500Fax: 949-580-1270
Official Correspondent:	David VanceletteVice President of Quality Assurance & Regulatory AffairsPhone: 949-238-8220Email: dvancelette@tenexhealth.com
Type of Submission:	Traditional 510(k). The Tenex Health TX System with the TXP MicroTipis a modification to the previously cleared Tenex Health TX System(K153299).
Trade Name:	Tenex Health TX System with the TXP MicroTip
Common Name:	Ultrasonic Surgical Instrument
Device Class:	Unclassified
Panel:	General & Plastic Surgery
Product Code:	LFL
Classification Name:	Instrument, Ultrasonic Surgical
Predicate Devices:	Ultrasonic Surgical Aspirator System Model FS 1000 RF (K062471)AUSS-6 Ultrasonic Surgical Aspirator System and Accessories (K050776)The Tenex Health TX System (K153299) is a reference device with regardto the device assembly process and technological characteristics.

Device Description:

{4}------------------------------------------------

selections. The console also houses the irrigation valve, the irrigation pump and the aspiration pump. The Console is non-sterile when used and does not require processing.

Indications for Use:

The Tenex Health TX System with the TXP MicroTip has the same Indications for Use as the reference device, existing Tenex Health TX System (K153299), for the fragmentation, emulsification, and aspiration of soft tissue in general surgery, orthopedic surgery, laparoscopic surgery and plastic and reconstructive surgeries.

{5}------------------------------------------------

The Tenex Health TX System with the TXP MicroTip has the same Indications for Use as the predicate Ultrasonic Surgical Aspirator System FS1000RF (K062471) for the fragmentation, emulsification, and aspiration of soft and hard (e.g.: bone) tissue in general surgery, orthopedic surgery, laparoscopic surgery and plastic and reconstructive surgeries.

The Tenex Health TX System with the TXP MicroTip has the same Indications for Use as the predicate AUSS-6 Ultrasonic Surgical Aspirator System and Accessories (K050776) for both the fragmentation. emulsification, and aspiration of soft and hard (e.g.: bone) tissue in general surgery, orthopedic surgery, laparoscopic surgery and plastic and reconstructive surgeries; and for the debridement of wounds, such as diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement. This Indication is a specific application of the same device performance to treat soft and hard tissue pathology. Simulated clinical use testing in this submission demonstrates the Tenex Health TX System with the TXP MicroTip to be safe and effective in this Indication.

Technical Characteristics (Compared to Predicate):

The subject and predicate devices are ultrasonic surgical instruments that use electrical energy in the ultrasonic frequency range to drive an applicator needle for the fragmentation and emulsification of diseased tissue. The systems use irrigation with the needle at the treatment site to emulsify the fragmented tissue. The systems also use aspiration to remove the fragmented and emulsified material from the treatment site.

Characteristic	Subject DeviceTenex Health TXSystem with theTXP MicroTip	Predicate DeviceUltrasonic SurgicalAspirator SystemFS1000RF (K062471)	Predicate DeviceAUSS-6 UltrasonicSurgical AspiratorSystem (K050776)	Reference DeviceTenex Health TXSystem (K153299)
Energy source	100-240V 50/60Hz	Same	Same	Same
Fragmentation/emulsification	Ultrasonic energy	Same	Same	Same
Vibration system	Piezoelectric	Same	Same	Same
Aspiration	Vacuum	Same	Same	Same
Irrigation	Forced	Same	Same	Same
System Control	Foot pedal	Same	Same	Same
Character-istic	Subject DeviceTenex Health TXSystem with theTXP MicroTip	Predicate DeviceUltrasonic SurgicalAspirator SystemFS1000RF(K062471)	Predicate DeviceAUSS-6 UltrasonicSurgical AspiratorSystem (K050776)	Reference DeviceTenex Health TXSystem (K153299)	Comments
Powerdelivery	Constant (userselected duty cyclesof low, medium,and high)	Variable - usercontrolled	Variable - usercontrolled	Same as subjectdevice	Electronicconsole isidentical to thatof referencedevice K153299
Irrigationflow control	Forced, via airpressurization of aninflation cuff (forexternal saline bag)	Forced, viaperistaltic pump,flow rate controlknob	Forced, viaperistaltic pump,flow rate controlknob	Same as subjectdevice	Samefunctionality
Irrigationflow rates	Free-flow (in excessof 30 cc/min) with afull 1000cc salineirrigation bag.	Variable: 2-25cc/min	Variable: 0-300mL/min	Free-flow (inexcess of 30cc/min) with a full500cc salineirrigation bag.
Aspirationflow control	Vacuum pump,solenoid pinchvalves, 3 userselectable levels ona touchscreen GUI	Vacuum pump,valves, pressurelevel readout	Vacuum pump,valves, pressurelevel readout	Same as subjectdevice
Aspirationflow rates	Constant (userselectable levels of10cc/20cc/30cc/min)	Variable, limited byirrigation flow rateduring operation, 2-25 cc/min	Variable, limited byirrigation flow rateduring operation	Same as subjectdevice
Aspirationpotential(vacuumpressure)	Adjustable: 100mmHg, 300 mmHgor 500 mmHg	Adjustable: 75-585mmHg	Variable: 75-508mmHg	Same as subjectdevice
AspirationWasteContainer	1000cc sterilecollection bagintegrated into theMicroTip (affixedto cartridge)	2 liter sterile fluidcontainment bag	2 liter sterile fluidcontainment bag	500cc sterilecollection bagintegrated into theMicroTip (affixedto cartridge)
Frequency	26.5 ± 1.5kHZ	22.5kHz±500Hz	22.5kHz±500Hz	Same as subjectdevice
MicroTipCase Nose	Polycarbonate over-molded stainlesssteel sheath	Polycarbonate fronthousing component	Polycarbonate fronthousing component	Same as subjectdevice
Character-istic	Subject DeviceTenex Health TXSystem with theTXP MicroTip	Predicate DeviceUltrasonic SurgicalAspirator SystemFS1000RF(K062471)	Predicate DeviceAUSS-6 UltrasonicSurgical AspiratorSystem (K050776)	Reference DeviceTenex Health TXSystem (K153299)	Comments
MicroTipHorn/Needle	One-piece, stainlesssteel, 14 gageneedle, 1.6mm ID	Various sizes ofstainless steel ortitanium tips,including 1.1mmand 1.6mm IDneedle tips and a1.8mm ID boneshaving tip.Separate stainlesssteel horn internal tothe handpiece.	Various sizes ofstainless steel ortitanium tips.Separate stainlesssteel horn internal tothe handpiece.	Two stainless steelpieces brazedtogether, 18 gageneedle, 0.8mm ID	Various sizeneedle tips areappropriate forsoft and hardtissue. K062471includes 3comparably sizedtips. The singlehorn/needleassemblyprovides anequivalent finalconstruction.
Tip length	1.29"	Variable: 3" - 11.8"	Variable: 3" - 11.8"	1.74"	Longer tips arefor laparoscopicapplication, notapplicable tosubject device'sindications.
Distal Tipshape	Cylindrical	Cylindrical	Various, includingCylindrical	Same as subjectdevice
Tip sheath	Stainless steelsheath	Silicone rubbersheath	Various, dependingon probe tip	Same as subjectdevice	Both sheathsprovidecontainedchannel forirrigation.Subject devicehas a durablehard plasticsheath forpercutaneousapplication
ReusableSystemComponents	Console (generator),saline inflation cuff	Console,(generator),handpiece,handpiece fronthousing andwrenches	Console,(generator),handpiece,handpiece fronthousing andwrenches	Same as subjectdevice
Character-istic	Subject DeviceTenex Health TXSystem with theTXP MicroTip	Predicate DeviceUltrasonic SurgicalAspirator SystemFS1000RF(K062471)	Predicate DeviceAUSS-6 UltrasonicSurgical AspiratorSystem (K050776)	Reference DeviceTenex Health TXSystem (K153299)	Comments
Single-Use,SterileComponents	TX-Plus MicroTip(tip, integratedsheath, handpieceand tube set), fluidcontainment bagand Supply KitComponents	Probe tip, sheath,tube set and fluidcontainment bag	Probe tip, sheath,tube set and fluidcontainment bag	Same as subjectdevice
MicroTipSupply Kit	Commerciallyavailable medicalsuppliesmanufactured byother manufacturers	None provided	None provided	Same as subjectdevice	Supply Kit isidentical to thatof referencedevice K153299

The following technological characteristics are identical for the subject, predicate and reference devices:

The following technological characteristics of the subject device and predicate were compared and found to have minor differences which do not affect the mode of operation:

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Performance Data:

The following non-clinical performance tests were conducted to evaluate the differences noted above and to demonstrate substantial equivalence to the predicate device:

1. Electro-mechanical bench testing verified that the system met requirements for:
- Aspiration vacuum ●
- Automated priming
- Irrigation flow
- Aspiration volume
- Operating frequency
- Operating temperatures ●
- Needle stroke length ●
- MicroTip pull strength
- Inflation cuff pressurization
- Collection bag performance
- Corrosion resistance ●
- Primary acoustic output area ●
- . Output acoustic power
1. EMC and electrical safety testing verified the system met the standards:
- IEC 60601-1:2005 + A1 2012. Medical electrical equipment = Part 1: General reguirements for ● basic safety and essential performance - Edition 3.1.

{9}------------------------------------------------

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests - Edition 4.0.
1. Biocompatibility evaluation verified the system met the standard: ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
1. Sterilization validation of the sterile packaged MicroTip showed the device met the standards:
- ANSI/AAMI/ISO TIR13004:2013, "Sterilization of health care products Radiation -● Substantiation of a selected sterilization dose: Method VDmax SD.
- ISO 11137-1:2013, Sterilization of health care products Radiation Part 1: Requirements for ● the development, validation and routine control of a sterilization process for medical devices
1. Packaging Validation of the sterile packaged MicroTip showed the device met the standards:
- . ISO 11607-1:2006. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2006. Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
1. Simulated use testing in cadaver validated the system's design, usability and surgical technique.

Simulated use testing involved use of the device in a simulated surgical setting with cadaveric evaluation by three surgeon advisors. Testing validated the instruction steps in the product labeling, usability (human factors) and the effectiveness of the system in sharp debridement of soft and hard tissue in wounds, such as diabetic foot ulcers.

1. Simulated use testing in bovine tissue validated the system's durability and ability to cut, fragment, emulsify and aspirate tissue as effectively as the predicate device. Testing also quantified the tissue removal rates in both soft and hard tissue.
  The testing involved multiple sample devices, both soft and hard bovine tissue media, actuation of all system functions (fragmentation/ emulsification, irrigation and aspiration), performance at each power setting (low, medium and high) and extended use of the device. Testing demonstrated the effectiveness of all system functions at all settings for performance in both soft and hard tissue, and provided quantitative data for tissue removal rates in soft and hard tissue.

Conclusions:

The Tenex Health TX System with the TXP MicroTip met all specified performance requirements. The non-clinical data, including the simulated use testing results, support the safety of the Tenex Health TX System with the TXP MicroTip, and demonstrate that it should perform as intended in the specified use conditions. Evaluation did not raise any new questions regarding safety and effectiveness. The Tenex Health TX System with the TXP MicroTip is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

N/A