(111 days)
The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
The Tenex Health TX System is an ultrasonic surgical aspirator that fragments, emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, inflation cuff and foot pedal. The console provides control over 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, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room.
The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for aspirating 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 and tubing are 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 an inflation cuff that is filled around the irrigating fluid bag, thus providing irrigation at a fixed pressure.
The foot pedal is used to control each of the functions (irrigation, aspiration, ultrasonic fragmentation/emulsification) of the system. It offers on/off functionality and is rated IPX8 (by the supplier) for protection against liquids.
The provided document is a 510(k) summary for the Tenex Health TX System, an ultrasonic surgical aspirator. It describes the device, its intended use, and compares it to a predicate device (TX1 Tissue Removal System) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets in the way one might expect for a diagnostic or AI-driven device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the studies for the Tenex Health TX System are focused on verifying performance characteristics and functionality against engineering specifications and comparison to the predicate device.
The reported performance revolves around demonstrating that the new TX System performs comparably to the predicate TX1 system and meets safety and functional requirements.
| Performance Characteristic Verified | Reported Device Performance |
|---|---|
| Non-clinical Performance Tests (Quantitative) | |
| Stroke length determination | Tested and passed. (Implicitly met design specifications, but specific values are not provided) |
| Ultrasonic frequency | Tested and passed. (Implicitly met design specifications, expected to be 26.5±1.5KHz as per MicroTip characteristics) |
| Aspiration vacuum | Tested and passed. (Implicitly met design specifications) |
| Irrigation flow (free flow) | Tested and passed. (Implicitly met design specifications) |
| Irrigation flow (aspiration volume) | Tested and passed. (Implicitly met design specifications) |
| Operating frequency | Tested and passed. (Implicitly met design specifications) |
| Device operating temperature | Tested and passed. (Implicitly met design specifications) |
| Functional Verification (Simulated Use) | |
| Automated priming | Tested and passed. (Functionally verified) |
| Durability verification | Tested and passed. (Functionally verified) |
| Pull strength of metal sheath | Tested and passed. (Functionally verified) |
| Effectiveness of TX2 MicroTip to fragment, | Demonstrated effectiveness in fragmentation, emulsification, and removal of soft tissue and found to be comparable to the TX1 MicroTip. (Qualitative comparison inferred) |
| emulsify and remove soft tissue | |
| Design Validation (Simulated Use) | |
| Functional validation | Tested and passed. (Implicitly confirmed overall functional performance) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for a software or AI device. The tests described are laboratory-based engineering and functional tests performed on devices. Therefore, information about sample size for a "test set" for data and data provenance (country of origin, retrospective/prospective) is not applicable here. These are physical device tests, likely using a sample of manufactured units or components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given this is a physical medical device (ultrasonic surgical aspirator) and not a diagnostic AI system, the concept of "ground truth" derived from expert consensus on a test set (e.g., image annotations) is not applicable. The "ground truth" for these types of tests would be established by engineering specifications, validated test methods, and performance against the predicate device.
4. Adjudication Method
As the "test set" and "ground truth" in the context of AI are not applicable here, an adjudication method is also not applicable. Device performance is assessed against predefined engineering and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device submission. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the function of the Tenex Health TX System. The document focuses on demonstrating substantial equivalence in physical and functional characteristics to a predicate device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm is not applicable because the Tenex Health TX System is a physical surgical device, not a software algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications: Defined parameters for stroke length, ultrasonic frequency, aspiration vacuum, irrigation flow, operating frequency, and operating temperature.
- Voluntary Standards Compliance: Adherence to standards like IEC 60601-1, IEC 60601-1-2, IEC 61847, ISO 10993-1, ISO 11137-1, ISO 11737-1, ISO 11737-2, ISO 11607-1, and ISO 11607-2.
- Performance Comparison to Predicate: Demonstrating that the device's effectiveness in fragmentation, emulsification, and soft tissue removal is comparable to the legally marketed predicate device (TX1 Tissue Removal System).
8. Sample Size for the Training Set
The concept of a "training set" is not applicable for this physical medical device. This is not an AI or machine learning product.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of AI, this question is not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Tenex Health, Inc. Ms. Gloria Pendergrass Regulatory Affairs 26902 Vista Terrace Lake Forest, CA 92630
Re: K153299
Trade/Device Name: Tenex Health TX System Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Unclassified Product Code: LFL Dated: February 5, 2016 Received: February 8, 2016
Dear Ms. Pendergrass:
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 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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
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
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Indications for Use
510(k) Number (if known) K153299
Device Name Tenex Health TX System
Indications for Use (Describe)
The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) – Submitter information | |
|---|---|
| Name | Tenex Health, Inc. |
| Address | 26902 Vista Terrace, Lake Forest, CA 92630 USA |
| Phone Number | 949-454-7500 |
| Fax Number | 949-580-1270 |
| Establishment Registration Number | 3009750704 |
| Name of Contact Person | Gloria Pendergrass |
| Date Prepared | February 29, 2016 |
| 807.92(a)(2) – Name of Device | |
| Trade or Propriety Name | Tenex Health TX System |
| Common or Usual Name | Ultrasonic Surgical Aspirator |
| Classification Name | Instrument, Ultrasonic Surgical |
| Classification Panel | General and Plastic Surgery |
| Regulation | Unclassified |
| Product Code(s) | LFL |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed |
TX1 Tissue Removal System K123640
807.92(a)(4) - Device description
The Tenex Health TX System is an ultrasonic surgical aspirator that fragments, emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, inflation cuff and foot pedal. The console provides control over 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, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room.
The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for aspirating 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 and tubing are 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 an inflation cuff that is filled around the irrigating fluid bag, thus providing irrigation at a fixed pressure.
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| The foot pedal is used to control each of the functions (irrigation, aspiration, ultrasonicfragmentation/emulsification) of the system. It offers on/off functionality and is rated IPX8(by the supplier) for protection against liquids. | ||
|---|---|---|
| 807.92(a)(5) – Intended use of the device | ||
| Indications for Use | The Tenex Health TX System is indicated for use in surgicalprocedures where fragmentation, emulsification and aspiration ofsoft tissue are desirable, including General Surgery, OrthopedicSurgery, Laparoscopic Surgery and Plastic and ReconstructiveSurgery. | |
| 807.92(a)(6) Summary of the technological characteristics of the device compared to thepredicate | ||
| The Tenex Health TX System is identical to the predicate TX1 Tissue Removal System in itsmode of operation and Indications for Use. Specifically, the following areas were comparedand found to have similar technological characteristics and to be equivalent: | ||
| Device Characteristics | Similarities between Tenex Health TX System and TX1 TissueRemoval System | |
| Mode of Operation | • Method of tissue emulsification (ultrasonic energy)• Method of aspiration (vacuum)• Aspiration flow (10cc/20cc/30cc per minute)• Method of irrigation (forced)• Control (foot pedal) | |
| MicroTip | • Material in contact with tissue (304 SS, polycarbonate)• Frequency (26.5±1.5KHz)• Vibration system (piezo)• Power source (100-240V, 50/60Hz)• Shelf-life (12 months)• Sterility (E-beam radiation)• Single use, disposable | |
| Console | The same console may be used with the predicate device TX1MicroTip or the modified TX2 MicroTip | |
| Convenience Kit | Supply kit containing commercially available devices designed/manufactured by other manufacturers | |
| The Tenex Health TX System and the predicate TX1 Tissue Removal System were compared inthe following areas and found to have minor different technological characteristics: | ||
| Device Characteristics | Subject Device:Tenex Health TX System | DifferencesPredicate Device:TX1 Tissue Removal System |
| Technology/TX SystemFunctions | Technology is based on ultrasonicsurgical aspiration, which mayperform the following functions:Irrigation, aspiration, ultrasonic | Technology is based on ultrasonicsurgical aspiration, which mayperform the following functions:Irrigation, aspiration, ultrasonic |
| fragmentation/emulsification, coagulation | ||
| MicroTip Needle | Brazed; 18 gage; 2.3" overall needle length and extend 1.7" from the ultrasonic horn | Brazed; 19 gage; 1.3" overall needle length and extend 1" from the ultrasonic horn |
| MicroTip Case Nose | TX2 is comprised of a molded polycarbonate case nose and a 304 SS sheath | TX1 is comprised entirely of a molded polycarbonate sheath |
| 807.92(b)(1-2) – Nonclinical and clinical tests submitted | ||
| The Tenex Health TX System has been designed and tested to pass the following non-clinical performance tests: | ||
| Performance Characteristic Verification | stroke length determination ultrasonic frequency aspiration vacuum irrigation flow (free flow) irrigation flow (aspiration volume) operating frequency device operating temperature | |
| Functional Verification (under simulated use) | automated priming, durability verification pull strength of metal sheath effectiveness of TX2 MicroTip to fragment, emulsify and remove soft tissue in comparison to the TX1 MicroTip | |
| Design Validation (under simulated use) | Functional validation | |
| The Tenex Health TX System has been designed to conform to the following Voluntary Standards: | ||
| EMC and General Electrical Safety | IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests | |
| Performance | IEC 61847 Ultrasonic – Surgical systems – Measurement and declaration of the basic output characteristics | |
| Biocompatibility | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | |
| Sterilization | ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products | |
| • ISO 11737-2 Sterilization of medical devices – Microbiologicalmethods - Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilization process | ||
| Packaging | • ISO 11607-1 Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems andpackaging systems• ISO 11607-2 Packaging for terminally sterilized medical devices– Part 2: Validation requirements for forming, sealing andassembly processes | |
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807.92(b)(3) – Conclusions drawn from non-clinical and clinical data
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.
lt has been shown in this 510(k) submission that the difference between the Tenex Health TX System and the predicate device, the TX1 Tissue Removal System, does not raise any questions regarding its safety and effectiveness. The Tenex Health TX System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.
N/A