(114 days)
No Reference Device(s) K/DEN number found.
No
The description focuses on the mechanical and electrical functions of an ultrasonic surgical aspirator and does not mention any AI or ML capabilities.
No
The device is used for surgical removal of tissue, not for therapeutic treatment of conditions or diseases.
No
The device is described as an "Ultrasonic Surgical Aspirator" intended for fragmenting, emulsifying, and aspirating soft tissue during surgical procedures. Its functions (irrigation, aspiration, cutting, coagulation) are all therapeutic, not diagnostic.
No
The device description clearly outlines multiple hardware components including a console, ultrasonic handpiece, and foot pedal, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the surgical removal of soft tissue through fragmentation, emulsification, and aspiration. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an ultrasonic surgical aspirator used to physically remove tissue during surgery. It involves a console, handpiece, and foot pedal for controlling surgical functions like irrigation, aspiration, cutting, and coagulation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue biopsies) to provide information about a person's health status. This device does not perform any such tests on samples. It is used for direct surgical intervention.
The device is clearly designed for use during surgical procedures on a patient, not for analyzing samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The TX1 Tissue Removal System is intended for use as an Ultrasonic Surgical Aspirator of soft tissue.
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.
Product codes (comma separated list FDA assigned to the subject device)
LFL, GEI
Device Description
The TX1 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.: PASS
- 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
15 of 82 | Regulatory Specialists, Inc.
MAR 2 0 2013
1
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.
2
( 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 |
3
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
4
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.
5
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
6
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
7
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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1 of 1 Regulatory Specialists, Inc.