(151 days)
Not Found
No
The description mentions electromagnetic tracking and predicting the future path based on spatial relationships, but this appears to be based on deterministic calculations from sensor data, not AI/ML algorithms. There is no mention of training data, test data, or AI/ML specific performance metrics.
Yes
The device is indicated for "coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids," which are therapeutic actions.
No
The device is an ablation system used for treating symptomatic uterine fibroids, not diagnosing them. It uses ultrasound for visualization and guidance during the ablation procedure.
No
The device description explicitly lists numerous hardware components including a console, RF ablation system, ultrasound visualization system, guidance system, foot pedal, cables, pads, handpiece, transducer, and field generator. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, the Acessa Pro Vu System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Acessa Pro Vu System Function: The Acessa Pro Vu System is used for treating conditions within the body (in vivo). It uses radiofrequency ablation to coagulate and ablate soft tissue, specifically uterine fibroids. It also provides real-time ultrasound visualization and guidance during the procedure.
The system's purpose is to directly intervene and treat a medical condition within the patient's body, not to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.
Product codes (comma separated list FDA assigned to the subject device)
HFG, OEW, IYO, ITX
Device Description
The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:
- RF Ablation System
- Ultrasound Visualization System
- Guidance System
The following accessories connect to the console:
- Dual Foot pedal (one for RF ablation and one for coagulation)
- Video Cable
- Power Cord
- Acessa Pads and Acessa Pad Cable
- Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
- Acessa Transducer, either:
- Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve ● (embedded with sensor), or
- Acessa ProVu Transducer with (embedded) sensor
- Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator
- Monitor (hospital-owned accessory monitor, not provided by Acessa)
The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.
The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Soft tissue, including uterine fibroids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals
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 bench testing was conducted to support the subject device.
- Biocompatibility Testing
- Use Life Testing of Transducers
- Electrical Safety and Electromagnetic Compatibility testing per:
- ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012 .
- IEC 60601-2-2: 2017
- IEC 60601-1-2: 2014
- IEC 60601-2-37: 2015
- Software Validation and Verification Testing per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Acessa ProVu Console and Guidance System Level Testing
- Benchtop Ablation Testing to validate that the ablations created by the subject device are substantially equivalent to the predicate.
- Acessa ProVu Handpiece Performance Testing to qualify and quantify the mechanical and functional properties of the Handpiece.
- Acessa Pads Performance Testing to qualify and quantify the mechanical and functional properties of the Pads.
- Acessa ProVu Transducer Performance Testing, including Acoustical and Thermal Measurement, in conformance with IEC 60601-2-37
- Acessa ProVu Transducer Sleeve Testing to qualify and quantify the mechanical and functional properties of the Transducer Sleeve.
Key Results: The performance data demonstrate that the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±10 mm (for Guidance Functionality)
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.
K132744 Acessa Guidance System, K121858 The Acessa System, K163121 Telemed SmartUS Ultrasound System
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
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2018
Acessa Health, Inc. Kim Rodriguez President & CEO 7004 Bee Cave Road, Bldg. 3, Suite 200 Austin, TX 78746
Re: K181124
Trade/Device Name: Acessa ProVu System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HFG, OEW, IYO, ITX Dated: August 31, 2018 Received: August 31, 2018
Dear Kim Rodriguez:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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.
1
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 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 (QS) 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 mediation-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,
Sharon M. Andrews -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181124
Device Name Acessa ProVu System
Indications for Use (Describe)
The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.
| 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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3
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Acessa ProVu System is provided below.
| Primary | Secondary | |
|---|---|---|
| Submitter's Name: | Acessa Health Inc. | Acessa Health Inc. |
| Submitter's Address: | 7004 Bee Cave Rd, | |
| Bldg. 3, Suite 200, | ||
| Austin, TX 78746 | 7004 Bee Cave Rd, | |
| Bldg. 3, Suite 200, | ||
| Austin, TX 78746 | ||
| Submitter's Telephone: | (877) 412-3828 | (877) 412-3828 |
| Submitter's Fax: | (925) 605-0327 | (925) 605-0327 |
| Contact Name: | Kim Rodriguez | Brian J. Bergeron |
| Date Summary was Prepared: | September 27, 2018 | |
| Trade or Proprietary Name: | Acessa ProVu System | |
| Common or Usual Name: | Radiofrequency Ablation System | |
| Primary Product Code: | HFG (coagulator, laparoscopic, unipolar (and | |
| accessories)) | ||
| Regulation Name and Number: | Class II per 21 CFR 884.4160: Unipolar Endoscopic | |
| Coagulator-Cutter and Accessories | ||
| Secondary Product Codes: | OEW, IYO, ITX | |
| Classification Panel: | Obstetrics and Gynecology | |
| Legally Marketed | ||
| (Unmodified) Devices to | ||
| Which Substantial Equivalence | ||
| is Claimed: | Primary Predicate: | |
| K132744 Acessa Guidance System | ||
| Secondary Predicates: | ||
| K121858 The Acessa System | ||
| K163121 Telemed SmartUS Ultrasound System | ||
| The predicate devices have not been subject to a design | ||
| related recall. |
4
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:
- RF Ablation System 1.
- Ultrasound Visualization System 2.
-
- Guidance System
5
The following accessories connect to the console:
- Dual Foot pedal (one for RF ablation and one for coagulation) O
- Video Cable O
- Power Cord O
- Acessa Pads and Acessa Pad Cable O
- O Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
- O Acessa Transducer, either:
- Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve ● (embedded with sensor), or
- Acessa ProVu Transducer with (embedded) sensor
- Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator O
- Monitor (hospital-owned accessory monitor, not provided by Acessa) O
The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.
The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.
6
INTENDED USE/INDICATIONS FOR USE
The Acessa ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.
The subject and predicate device have the same intended use.
| | Acessa ProVu
System
(K181124) | Acessa Guidance
System
(K132744) | The Acessa
System
(K121858) | SmartUS EXT-
1M/3M
(K163121) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| General Information | | | | |
| Classification
Regulation | 21 CRF §884.4160 | 21 CRF §884.4160 | 21 CRF §884.4160 | 21 CRF §892.1550 |
| Classification Name | Unipolar endoscopic
coagulator cutter and
accessories | Unipolar endoscopic
coagulator cutter and
accessories | Unipolar endoscopic
coagulator cutter and
accessories | Ultrasonic pulsed
doppler imaging
system |
| Product Code | HFG - coagulator,
laparoscopic, unipolar
(and accessories) | HFG - coagulator,
laparoscopic, unipolar
(and accessories) | HFG - coagulator,
laparoscopic, unipolar
(and accessories) | IYN |
| Secondary Product
Codes | OEW, IYO, ITX | OEW, IYO | N/A | ITX, IYO |
| Product Class | II | II | II | II |
| Intended Users | Health Care
Professionals | Health Care
Professionals | Health Care
Professionals | Health Care
Professionals |
| Classification Panel | Obstetrics and
Gynecology | Obstetrics and
Gynecology | Obstetrics and
Gynecology | Radiology |
| System Accessories | Field Generator
Ultrasound Transducer
RF Handpiece
Dual foot pedal
Single use pads
Handpiece Cable
Pad Cable
Power Cord | Field Generator
Ultrasound Transducer
RF Handpiece
Dual foot pedal
Single use pads
Handpiece Cable
Pad Cable
Power Cord | Field Generator
Ultrasound Transducer
RF Handpiece
Dual foot pedal
Single use pads
Handpiece Cable
Pad Cable
Power Cord | |
| RF Functionality | | | | |
| Operating Principle | Monopolar | Monopolar | Monopolar | |
| Max Power
Delivery | 200 W into 50-80 Ω | 200 W into 50-80 Ω | 200 W into 50-80 Ω | |
| Frequency | 460 kHz | 460 kHz | 460 kHz | |
| Wave Form | Sinusoidal | Sinusoidal | Sinusoidal | |
| Temperature
Display Range | 15 - 125°C | 15 - 125°C | 15 - 125°C | |
| Impedance Range | 0-511 Ohms | 0-511 Ohms | 0-511 Ohms | |
| Duration Range | 0.1 to 12 minutes | 0.1 to 12 minutes | 0.1 to 12 minutes | |
| Temperature
Display | Handpiece and Pad
thermocouples | Handpiece and Pad
thermocouples | Handpiece and Pad
thermocouples | |
| | Acessa ProVu
System
(K181124) | Acessa Guidance
System
(K132744) | The Acessa
System
(K121858) | SmartUS EXT-
1M/3M
(K163121) |
| Set Power Display | Yes, coagulation only | Yes, coagulation only | Yes, coagulation only | |
| Duration of Energy
Delivery Displayed | Yes | Yes | Yes | |
| Control Modes | Temperature, Manual,
Coagulation | Temperature, Manual,
Coagulation | Temperature, Manual,
Coagulation | |
| Power Level
Controls | Yes, coagulation only | Yes, coagulation only | Yes, coagulation only | |
| Ablation Duration
Controls | Yes | Yes | Yes | |
| Maximum Ablation
Duration | 12 minutes at target
time | 12 minutes at target
time | 12 minutes at target
time | |
| Power Supply (PS) | 100-240 V, 50/60 Hz
switchable PS | 100-240 V, 50/60 Hz
switchable PS | 100-240 V, 50/60 Hz
switchable PS | |
| Peak Voltage | 230 V | 230 V | 230 V | |
| Manual Mode
Power Limit | 15 W | 10-15 W | 10-15 W | |
| Number of Serial
Communication
Ports | Single USB port | Single USB Port | Single USB Port | |
| Pump used with
Generator | None | None | None | |
| Display | Hospital-provided
Monitor | LCD/Touch Screen | LCD/Touch Screen | |
| User Control
Interface | System settings
controlled at the
Console. | System settings
controlled with the
handpiece buttons and
at the RF Generator
LCD/Touch Screen. | System settings
controlled with the
handpiece buttons and
at the RF Generator
LCD/Touch Screen. | |
| Guidance Functionality | | | | |
| Tracking
Technology | Electromagnetic | Electromagnetic | | |
| Accuracy | ±10 mm | ±10 mm | | |
| Views | Provide a
geometrically accurate
"3D" representation of
the Transducer and
Handpiece.
Display a 2D inset
view of the ultrasound
video, with the added
feature of the target
zone overlaid on it and
the laparoscopic
ultrasound transducer | Provide a
geometrically accurate
"3D" representation of
the Transducer and
Handpiece.
Display a 2D inset
view of the ultrasound
video and the
laparoscopic
ultrasound transducer | | |
| Tracking System | NDI V3 | NDI V2 | | |
| Ultrasound Functionality | | | | |
| Ultrasound System | Ultrasound beam
formers and drivers | Ultrasound beam
formers and drivers
(Off the shelf Aloka 6
Ultrasound system
K093488) | Ultrasound beam
formers and drivers
(Off the shelf Aloka 6
Ultrasound system
K093488) | Ultrasound beam
formers and drivers |
| Ultrasound
Transducer | Acessa ProVu
Transducer (Model
Number: 7500 or
7700) | Aloka UST 5526L-75
Transducer
(K040719) | Aloka UST 5526L-75
Transducer
(K040719) | Aloka UST 5526L-75
Transducer
(K040719) |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
7
8
The subject device is a combination system of the previously cleared devices that includes an RF ablation system (K121858), guidance control (K132744) and an OEM ultrasound component (K163121). As evidenced by the table above, there are differences in technological characteristics between the subject and predicate device. These differences do not raise different questions of safety and effectiveness.
SUMMARY OF PERFORMANCE DATA
To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the subject device. The specific types of non-clinical testing conducted are listed below.
- Biocompatibility Testing O
- Use Life Testing of Transducers o
- Electrical Safety and Electromagnetic Compatibility testing per: O
- ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012 .
- IEC 60601-2-2: 2017 ●
- IEC 60601-1-2: 2014
- . IEC 60601-2-37: 2015
- Software Validation and Verification Testing per FDA's Guidance for Industry and O FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
- Acessa ProVu Console and Guidance System Level Testing O
- Benchtop Ablation Testing to validate that the ablations created by the subject device O are substantially equivalent to the predicate.
- Acessa ProVu Handpiece Performance Testing to qualify and quantify the O mechanical and functional properties of the Handpiece.
- Acessa Pads Performance Testing to qualify and quantify the mechanical and O functional properties of the Pads.
- Acessa ProVu Transducer Performance Testing, including Acoustical and Thermal O Measurement, in conformance with IEC 60601-2-37
- Acessa ProVu Transducer Sleeve Testing to qualify and quantify the mechanical and O functional properties of the Transducer Sleeve.
CONCLUSION
The performance data demonstrate that the subject device is substantially equivalent to the predicate devices.