(84 days)
No
The description focuses on the mechanical and control aspects of an ultrasonic surgical aspirator, with no mention of AI or ML capabilities.
Yes
Explanation: The device is described as an ultrasonic surgical aspirator used in surgical procedures for fragmentation, emulsification, and aspiration of soft tissue, which directly treats or alters a physiological condition or body structure.
No
The device is described as an ultrasonic surgical aspirator for tissue removal, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines multiple hardware components including a console, ultrasonic handpiece, tube set, and foot pedal, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description details an "ultrasonic surgical aspirator" that physically removes tissue. It describes components like a handpiece, tube set, and foot pedal, all consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue samples. There is no mention of analyzing biomarkers, detecting diseases, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for tissue removal during a procedure.
N/A
Intended Use / 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.
Product codes
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, tube set, and foot pedal: The system has been designed to work with commercially available accessories and consumables including cautery pencils and forceps, ultrasonic handpiece tips, and silicone sleeves.
The console provides control over the four modes of operation including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console also 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. Two USB ports are available for loading software upgrades. An Ethernet port is also available for future system expandability.
The ultrasonic handpiece connects to the console for power. and to the tube set for both delivering irrigation fluid directly to the surgical site and for removing emulsified tissue. The handpiece is constructed from both 316L stainless steel and TiAl6V4 Titanium Alloy components, and can be sterilized by steam and reused multiple times.
The tube set employs an external tubing cartridge design that can be easily installed or removed in a single step. The tubing is made of biomedical grade silicone. The tube set can be sterilized by steam and reused multiple times.
Irrigation fluid is delivered under pressure to ensure adequate cooling of the ultrasonic tip, as well as adequate flushing of 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 of the system. Simple in design, it offers on/off functionality and is rated IPX5 for protection against liquids.
NOTE: The device is essentially the same device cleared to market under 510(k) K080803. with changes made to the frequency range, irrigation system, foot pedal, software, labeling, and console color.
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)
Independent, 3rd party electrical safety testing, adherence to U.S. FDA design control guidance, as well as thorough inhouse, non-clinical (bench) testing and software validation provide reasonable assurance that the TX1 Tissue Removal System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
510(k) Submitter/ Owner
Contact person
Date prepared
Trade name
Common name
Classification
Predicate device
Device description
American Optisurgical Inc. 25501 Arctic Ocean Lake Forest. CA 92630 Voice: (949) 580-1266 Fax: (949) 580-1270
David Salzberg Director of Regulatory Affairs American Optisurgical, Inc. Email: regulatory@optisurgical.com
06/02/10
TX1 Tissue Removal System
Ultrasonic Surgical Aspirator
Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code LFL)
K021989, Selector Integra Ultrasonic Surgical Aspirator
The TX1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, tube set, and foot pedal: The system has been designed to work with commercially available accessories and consumables including cautery pencils and forceps, ultrasonic handpiece tips, and silicone sleeves.
The console provides control over the four modes of operation including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console also 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. Two USB ports are available for loading software upgrades. An Ethernet port is also available for future system expandability.
AUG 27 2010
1
The ultrasonic handpiece connects to the console for power. and to the tube set for both delivering irrigation fluid directly to the surgical site and for removing emulsified tissue. The handpiece is constructed from both 316L stainless steel and TiAl6V4 Titanium Alloy components, and can be sterilized by steam and reused multiple times.
1
The tube set employs an external tubing cartridge design that can be easily installed or removed in a single step. The tubing is made of biomedical grade silicone. The tube set can be sterilized by steam and reused multiple times.
Irrigation fluid is delivered under pressure to ensure adequate cooling of the ultrasonic tip, as well as adequate flushing of 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 of the system. Simple in design, it offers on/off functionality and is rated IPX5 for protection against liquids.
NOTE: The device is essentially the same device cleared to market under 510(k) K080803. with changes made to the frequency range, irrigation system, foot pedal, software, labeling, and console color.
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.
The TX1 Tissue Removal System has similar technological characteristics as the predicate device cleared under 510(k) K021989. A summary is as follows:
Intended use
Technological characteristics
2
| Device
Characteristics | Subject Device
TX1 Tissue Removal System | Predicate Device
Selector® Integra Ultrasonic
Surgical Aspirator |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The TX1 is indicated for use in
surgical procedures where
fragmentation, emulsification,
and aspiration of soft tissue are
desirable. | The Selector® is indicated for
use in surgical procedures where
fragmentation, emulsification,
and aspiration of soft tissue are
desirable. |
| Display | Articulating, LCD Touch Screen | 7 segment, manual pushbutton |
| Power source | 100-240V 50/60Hz | 100-240V 50/60Hz |
| Method of tissue
emulsification | Ultrasonic energy | Ultrasonic energy |
| Frequency | 28 kHz | 24 kHz and 35 kHz |
| Tip Amplitude | Max 255µm | Max 24 kHz: 305µm
Max 35 kHz: 215µm |
| Method of
aspiration (vacuum) | Peristaltic pump | Venturi pump |
| Vacuum level | 100, 300, or 500 mmHg | 0 to 600 mmHg |
| Method of irrigation | Constant Pressure | Constant flow |
| Irrigation flow | 10, 20, or 30 cc/min | 0 to 50 cc/min |
| Material in contact
with tissue | TiAl6V4 Titanium Alloy | TiAl6V4 Titanium Alloy |
| Electrical safety
standards met | 60601-1
60601-1-2
60601-2-2 | 60601-1
60601-1-2
CSA 22.2 #601-1 |
Table II - Summary of Device Characteristics
Conclusion
Independent, 3rd party electrical safety testing, adherence to U.S. FDA design control guidance, as well as thorough inhouse, non-clinical (bench) testing and software validation provide reasonable assurance that the TX1 Tissue Removal System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Optisurgical, Inc. % Mr. David Salzberg Director of Regulatory Affairs 25501 Arctic Ocean Lake Forest, California 92630
AUG 2 7 2010
Re: K101561
Trade/Device Name: TX1 Tissue Removal System Regulatory Class: Unclassified Product Code: LFL, GEI Dated: June 02, 2010 Received: June 04, 2010
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. 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
4
Page 2 - Mr. David Salzberg
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 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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): V
Device Name: TX1 Tissue Removal System
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Neil R. Ogden
Brimm, Siwell
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101561
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