(97 days)
No
The description focuses on the mechanical and ultrasonic functions of the device, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in surgical procedures, debridement of wounds, and provides sharp debridement of soft and hard tissue in wounds, which directly treats medical conditions.
No
Explanation: The device is an ultrasonic surgical instrument used for fragmentation, emulsification, and aspiration of tissue, as well as debridement of wounds. It performs therapeutic procedures rather than diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a console, ultrasonic MicroTip, inflation cuff, foot pedal, and supply kit. While the console has a graphical user interface, the device is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for fragmentation, emulsification, aspiration, and debridement of tissue during surgical procedures and wound treatment. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a system that physically interacts with tissue within the body (or on a wound) using ultrasonic energy and aspiration. It's a surgical tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) to diagnose a condition, monitor a disease, or determine a patient's health status.
- Performance Studies: The performance studies focus on the device's ability to fragment, emulsify, aspirate, and debride tissue, as well as its safety and usability in a surgical context. These are not studies related to diagnostic accuracy or performance.
In summary, the Tenex Health TX System with the TXP MicroTip is a surgical device used for tissue manipulation and removal, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
LFL
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 do 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Tenex Health TX System with the TXP MicroTip is intended for use in an office-based setting, clinical environment or hospital environment.
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
The following non-clinical performance tests were conducted to evaluate the differences noted above and to demonstrate substantial equivalence to the predicate device:
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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.
Key Results: 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.
Key Metrics
Not Found
Predicate Device(s)
Ultrasonic Surgical Aspirator System Model FS 1000 RF (K062471), AUSS-6 Ultrasonic Surgical Aspirator System and Accessories (K050776)
Reference Device(s)
The Tenex Health TX System (K153299)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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)
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.
| 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)
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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 Terrace | |
| Lake Forest, CA 92630 | |
| Phone: 949-454-7500 | |
| Fax: 949-580-1270 | |
| Official Correspondent: | David Vancelette |
| Vice President of Quality Assurance & Regulatory Affairs | |
| Phone: 949-238-8220 | |
| Email: dvancelette@tenexhealth.com | |
| Type of Submission: | Traditional 510(k). The Tenex Health TX System with the TXP MicroTip |
| is 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 regard | |
| to the device assembly process and technological characteristics. |
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
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.
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 do 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.
Indications for Use:
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.
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 Device
Tenex Health TX
System with the
TXP MicroTip | Predicate Device
Ultrasonic Surgical
Aspirator System
FS1000RF (K062471) | Predicate Device
AUSS-6 Ultrasonic
Surgical Aspirator
System (K050776) | Reference Device
Tenex Health TX
System (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 Device
Tenex Health TX
System with the
TXP MicroTip | Predicate Device
Ultrasonic Surgical
Aspirator System
FS1000RF
(K062471) | Predicate Device
AUSS-6 Ultrasonic
Surgical Aspirator
System (K050776) | Reference Device
Tenex Health TX
System (K153299) | Comments |
| Power
delivery | Constant (user
selected duty cycles
of low, medium,
and high) | Variable - user
controlled | Variable - user
controlled | Same as subject
device | Electronic
console is
identical to that
of reference
device K153299 |
| Irrigation
flow control | Forced, via air
pressurization of an
inflation cuff (for
external saline bag) | Forced, via
peristaltic pump,
flow rate control
knob | Forced, via
peristaltic pump,
flow rate control
knob | Same as subject
device | Same
functionality |
| Irrigation
flow rates | Free-flow (in excess
of 30 cc/min) with a
full 1000cc saline
irrigation bag. | Variable: 2-25
cc/min | Variable: 0-300
mL/min | Free-flow (in
excess of 30
cc/min) with a full
500cc saline
irrigation bag. | |
| Aspiration
flow control | Vacuum pump,
solenoid pinch
valves, 3 user
selectable levels on
a touchscreen GUI | Vacuum pump,
valves, pressure
level readout | Vacuum pump,
valves, pressure
level readout | Same as subject
device | |
| Aspiration
flow rates | Constant (user
selectable levels of
10cc/20cc/30cc/
min) | Variable, limited by
irrigation flow rate
during operation, 2-
25 cc/min | Variable, limited by
irrigation flow rate
during operation | Same as subject
device | |
| Aspiration
potential
(vacuum
pressure) | Adjustable: 100
mmHg, 300 mmHg
or 500 mmHg | Adjustable: 75-585
mmHg | Variable: 75-508
mmHg | Same as subject
device | |
| Aspiration
Waste
Container | 1000cc sterile
collection bag
integrated into the
MicroTip (affixed
to cartridge) | 2 liter sterile fluid
containment bag | 2 liter sterile fluid
containment bag | 500cc sterile
collection bag
integrated into the
MicroTip (affixed
to cartridge) | |
| Frequency | 26.5 ± 1.5kHZ | 22.5kHz±500Hz | 22.5kHz±500Hz | Same as subject
device | |
| MicroTip
Case Nose | Polycarbonate over-
molded stainless
steel sheath | Polycarbonate front
housing component | Polycarbonate front
housing component | Same as subject
device | |
| Character-
istic | Subject Device
Tenex Health TX
System with the
TXP MicroTip | Predicate Device
Ultrasonic Surgical
Aspirator System
FS1000RF
(K062471) | Predicate Device
AUSS-6 Ultrasonic
Surgical Aspirator
System (K050776) | Reference Device
Tenex Health TX
System (K153299) | Comments |
| MicroTip
Horn/Needle | One-piece, stainless
steel, 14 gage
needle, 1.6mm ID | Various sizes of
stainless steel or
titanium tips,
including 1.1mm
and 1.6mm ID
needle tips and a
1.8mm ID bone
shaving tip.
Separate stainless
steel horn internal to
the handpiece. | Various sizes of
stainless steel or
titanium tips.
Separate stainless
steel horn internal to
the handpiece. | Two stainless steel
pieces brazed
together, 18 gage
needle, 0.8mm ID | Various size
needle tips are
appropriate for
soft and hard
tissue. K062471
includes 3
comparably sized
tips. The single
horn/needle
assembly
provides an
equivalent final
construction. |
| Tip length | 1.29" | Variable: 3" - 11.8" | Variable: 3" - 11.8" | 1.74" | Longer tips are
for laparoscopic
application, not
applicable to
subject device's
indications. |
| Distal Tip
shape | Cylindrical | Cylindrical | Various, including
Cylindrical | Same as subject
device | |
| Tip sheath | Stainless steel
sheath | Silicone rubber
sheath | Various, depending
on probe tip | Same as subject
device | Both sheaths
provide
contained
channel for
irrigation.
Subject device
has a durable
hard plastic
sheath for
percutaneous
application |
| Reusable
System
Components | Console (generator),
saline inflation cuff | Console,
(generator),
handpiece,
handpiece front
housing and
wrenches | Console,
(generator),
handpiece,
handpiece front
housing and
wrenches | Same as subject
device | |
| Character-
istic | Subject Device
Tenex Health TX
System with the
TXP MicroTip | Predicate Device
Ultrasonic Surgical
Aspirator System
FS1000RF
(K062471) | Predicate Device
AUSS-6 Ultrasonic
Surgical Aspirator
System (K050776) | Reference Device
Tenex Health TX
System (K153299) | Comments |
| Single-Use,
Sterile
Components | TX-Plus MicroTip
(tip, integrated
sheath, handpiece
and tube set), fluid
containment bag
and Supply Kit
Components | Probe tip, sheath,
tube set and fluid
containment bag | Probe tip, sheath,
tube set and fluid
containment bag | Same as subject
device | |
| MicroTip
Supply Kit | Commercially
available medical
supplies
manufactured by
other manufacturers | None provided | None provided | Same as subject
device | Supply Kit is
identical to that
of reference
device 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:
-
- 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
-
- 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.
-
- 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
-
- 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
-
- 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
-
- 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.
-
- 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.
- 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.
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.