(132 days)
Not Found
No
The description focuses on standard RF ablation technology with a GUI for parameter selection and monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for "coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids," which are therapeutic actions. The clinical trials also demonstrate its effectiveness in reducing menstrual blood loss, decreasing fibroid symptoms, and improving quality of life, further indicating a therapeutic purpose.
No
This device is an electrosurgical system designed for coagulation and ablation of soft tissue, specifically for treating symptomatic uterine fibroids. Its purpose is therapeutic, not diagnostic. While it uses laparoscopic ultrasound guidance, the ultrasound itself is the diagnostic tool, not the Acessa System.
No
The device description explicitly lists multiple hardware components (Generator, Handpiece, Handpiece Cable, Pads, Pad Cable, Power Cord, Foot Pedal) that are part of the Acessa System. While it includes software for the GUI and control, it is not solely software.
Based on the provided information, the Acessa System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The components listed (Generator, Handpiece, Pads, Cables, etc.) are all designed to deliver and control radiofrequency energy for tissue ablation. They are not designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing blood, urine, tissue samples, or any other biological material outside of the body.
In summary, the Acessa System is a therapeutic device used for surgical intervention, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Acessa System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
Product codes
HFG
Device Description
The Acessa System includes the following system components:
Generator (Model Number 1000): Provides RF energy to the Handpiece through the Handpiece Cable.
Handpiece (Model Number 2000): Consisting of a disposable handle with a trocar-pointed shaft and 7 deployable needle electrodes. For use only disposable electrosurgical devices provided by Halt Medical, Inc.
Handpiece Cable (Model Number 4200): Connects Handpiece to the Generator. This extension cable is provided with the Generator.
Pads (Model Number 3000): A disposable set of 2 units, providing the return path for the RF energy applied by the Handpiece. Use only the Pads provided by Halt Medical, Inc.
Pad Cable (Model Number 4300): Connects the Pads to the Generator. This extension cable is provided with the RF Generator.
Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Generator. The Power cord is provided with the Generator.
Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing used to turn RF energy on and off. The Foot Pedal with tubing is provided with the Generator.
The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the 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 Generator. 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.
NOTE: The Acessa System must be used under laparoscopic ultrasound guidance. Laparoscopic ultrasound equipment is not included with the Acessa System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
laparoscopic ultrasound
Anatomical Site
soft tissue, uterine fibroids
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
The Acessa System was subjected to a battery of electrical, mechanical, and software validation testing, as well as applicable safety requirements (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2). The system passed all testing. EMC and safety testing were completed on the device as a whole and per component as required within EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2. A series of tests were performed to qualify and quantify the mechanical and functional properties of the device including shelf-life or service life testing. Ablation output and safety features were evaluated for the Generator and its accessories. Retention forces and ultrasound visibility was evaluated for the Handpiece. Fluid adherence, separation, and pull tests were completed to evaluate the Pads. The software and hardware for the Generator has been developed, verified and validated to evaluate the graphical user interface (GUI), alerts, communication between components, real-time feedback to the user via the device's sensors, power control, and software/hardware interface. A full system verification was completed to ensure safety is met in all related areas required by internal specifications, guidance documents, and standards.
A series of biocompatibility testing also demonstrated that the device materials are safe, suitable, and appropriate for their intended use and in compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Animal and bench ablation testing also successfully demonstrates that the Acessa System performs as intended and per specifications. The ablation capability was confirmed and the radiofrequency ablation provides a reproducible, discretely demarcated zone of tissue necrosis which was surrounded by normal tissue perfused with blood.
The Acessa System has undergone an IDE clinical trial under G080163 with identifier NCT00874029 under clinicaltrials.gov.
Clinical trials results demonstrated that radiofrequency volumetric ablation with the Acessa System effectively reduced the amount of menstrual blood loss, decreased the severity of fibroid symptoms, and improved health-related quality of life for up to 12 and 24 months post-treatment. The results also demonstrated the Acessa System's safety profile is acceptable with a high benefits to low risk ratio. Treatment with this device provides an outpatient minimally invasive option that allows rapid recovery and that avoids the risks, costs, and discomfort of major surgery.
- Peri-hysterectomy feasibility study was conducted to evaluate the device . for acute procedural and device safety. Various fibroid locations and types were encountered during this study. Pathology reports of the ablation zones were correlated per patient, per fibroid, with procedure documentation. From these data, it is shown that the ex vivo bench testing ablation results are predictive of the ablations in fibroid tissue invivo. There were no device-related adverse events in this study.
- . Prospective, non-randomized, longitudinal Phase II studies using the Acessa System were conducted at two separate centers to establish early safety and effectiveness data. Various fibroid types and locations were treated in this study. The patients were followed to 12 months using validated questionnaire for fibroid symptoms (UFS-QOL) as well as menstrual pad counts. The mean uterine volume at baseline was 204.4 cm3. At 6 months and 12 months post-treatment, the mean uterine volume was significantly reduced to 155.0 cm3 (p= 0.012) and 151.4 cm3 (p = 0.009), respectively. The percent of subjects demonstrating reduced uterine volume in contrast to baseline was 82.2%, 80.0%, and 79.3% at the 3-, 6-, and 12-month visits, respectively. At baseline, 77% of subjects reported heavy to very heavy bleeding prior to the treatment. After 12 months post-treatment, 3.5% (p=50% reduction in menstrual bleeding at 12 months post-treatment).
Cumulative reintervention rate
§ 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
510(k) Summary
As Required By 21 CFR 807.92
5 2012 NOV
As Required By 21 CFR 807.92
| Date of Summary Preparation | November 2, 2012 |
|---|---|
| Submitter and Owner's Name and Address | Halt Medical, Inc. |
| 131 Sand Creek Road, Suite B | |
| Brentwood, CA 94513 | |
| Main: (925) 634-7943 | |
| Fax: (925) 634-7841 | |
| Contact Person | Clarisa A. Tate |
| Senior Director of RA & QA, Halt Medical, Inc. | |
| Office: (925) 271-0626 | |
| e-mail: ctate@haltmedical.com | |
| Trade Name | The Acessa System |
| Common Name | The Acessa System |
| Classification Name | Unipolar endoscopic coagulator-cutter and accessories |
| Classification | Class II |
| Product Code | HFG |
| Classification Panel | Obstetrics and Gynecology |
| Classification Regulation | 21 CFR §884.4160 |
| Legally Marketed Device to which | |
| substantial equivalence is claimed | Halt 2000GITM Electrosurgical Radiofrequency Ablation |
| System (K094009) | |
| Intended Use | The Acessa System is indicated for use in percutaneous, laparoscopic coagulation |
| and ablation of soft tissue, including treatment of symptomatic uterine fibroids | |
| under laparoscopic ultrasound guidance. | |
| Device | |
| Description | The Acessa System includes the following system components: |
| Generator (Model Number 1000): Provides RF energy to the Handpiece | |
| through the Handpiece Cable. Handpiece (Model Number 2000): Consisting of a disposable handle | |
| with a trocar-pointed shaft and 7 deployable needle electrodes. For use | |
| only disposable electrosurgical devices provided by Halt Medical, Inc. Handpiece Cable (Model Number 4200): Connects Handpiece to the | |
| Generator. This extension cable is provided with the Generator. Pads (Model Number 3000): A disposable set of 2 units, providing the | |
| return path for the RF energy applied by the Handpiece. Use only the | |
| Pads provided by Halt Medical, Inc. Pad Cable (Model Number 4300): Connects the Pads to the Generator. | |
| This extension cable is provided with the RF Generator. Power Cord (Model Number 4110): A medical grade power cord that | |
| provides AC power to the Generator. The Power cord is provided with | |
| the Generator. Foot Pedal (Model Number 4100): Pneumatic foot pedal with tubing | |
| used to turn RF energy on and off. The Foot Pedal with tubing is | |
| provided with the Generator. | |
| The Acessa System is designed to deliver up to 200 W of RF power at 460 kHz in | |
| three operational modes: Temperature Control, Manual Control and Coagulation | |
| Mode. A touch screen with a graphical user interface (GUI) enables selection of | |
| operational parameters such as the mode of operation, the ablation time, the | |
| target temperature, and the power delivery level. With the 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 | |
| Generator. 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. |
NOTE: The Acessa System must be used under laparoscopic ultrasound
guidance. Laparoscopic ultrasound equipment is not included with the Acessa
System. |
| Intended Use
and
Technological
Characteristics
Compared to
Predicate
Devices | The Acessa System and the Halt 2000GI System do not have the same Indications
for Use statement, as the Acessa System includes the specific indication of
"treatment of symptomatic uterine fibroids."
The difference between the Indications for Use statements of the Acessa System
and Halt 2000GI System does not alter the intended therapeutic effect of the
device. Like the Halt 2000GI System, the Acessa System uses coagulation or
ablation of soft tissue to achieve its therapeutic effect, (i.e., treatment of
symptomatic uterine fibroids).
The technological characteristics of the Acessa System are equivalent to
commercially available Halt 2000GITM System. It is the same product. |
| Performance
Testing | The Acessa System was subjected to a battery of electrical, mechanical, and
software validation testing, as well as applicable safety requirements (EN/IEC
60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-2). The system passed all testing.
EMC and safety testing were completed on the device as a whole and
per component as required within EN/IEC 60601-1, EN/IEC 60601-1-2,
EN/IEC 60601-2-2. A series of tests were performed to qualify and quantify the mechanical
and functional properties of the device including shelf-life or service life
testing. Ablation output and safety features were evaluated for the
Generator and its accessories. Retention forces and ultrasound visibility
was evaluated for the Handpiece. Fluid adherence, separation, and pull
tests were completed to evaluate the Pads. The software and hardware for the Generator has been developed,
verified and validated to evaluate the graphical user interface (GUI),
alerts, communication between components, real-time feedback to the
user via the device's sensors, power control, and software/hardware
interface. A full system verification was completed to ensure safety is met in all
related areas required by internal specifications, guidance documents,
and standards. |
1
2
A series of biocompatibility testing also demonstrated that the device materials are safe, suitable, and appropriate for their intended use and in compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Animal and bench ablation testing also successfully demonstrates that the Acessa System performs as intended and per specifications. The ablation capability was confirmed and the radiofrequency ablation provides a reproducible, discretely demarcated zone of tissue necrosis which was surrounded by normal tissue perfused with blood.
The Acessa System has undergone an IDE clinical trial under G080163 with identifier NCT00874029 under clinicaltrials.gov.
Clinical trials results demonstrated that radiofrequency volumetric ablation with the Acessa System effectively reduced the amount of menstrual blood loss, decreased the severity of fibroid symptoms, and improved health-related quality of life for up to 12 and 24 months post-treatment. The results also demonstrated the Acessa System's safety profile is acceptable with a high benefits to low risk ratio. Treatment with this device provides an outpatient minimally invasive option that allows rapid recovery and that avoids the risks, costs, and discomfort of major surgery.
- Peri-hysterectomy feasibility study was conducted to evaluate the device . for acute procedural and device safety. Various fibroid locations and types were encountered during this study. Pathology reports of the ablation zones were correlated per patient, per fibroid, with procedure documentation. From these data, it is shown that the ex vivo bench testing ablation results are predictive of the ablations in fibroid tissue invivo. There were no device-related adverse events in this study.
- . Prospective, non-randomized, longitudinal Phase II studies using the Acessa System were conducted at two separate centers to establish early safety and effectiveness data. Various fibroid types and locations were treated in this study. The patients were followed to 12 months using validated questionnaire for fibroid symptoms (UFS-QOL) as well as menstrual pad counts. The mean uterine volume at baseline was 204.4 cm3. At 6 months and 12 months post-treatment, the mean uterine volume was significantly reduced to 155.0 cm3 (p= 0.012) and 151.4 cm3 (p = 0.009), respectively. The percent of subjects demonstrating reduced uterine volume in contrast to baseline was 82.2%, 80.0%, and 79.3% at the 3-, 6-, and 12-month visits, respectively. At baseline, 77% of subjects reported heavy to very heavy bleeding prior to the treatment. After 12 months post-treatment, 3.5% (p Trade/Device Name: The Acessa System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HFG Dated: October 8, 2012 Received: October 24, 2012
Dear Ms. Tate:
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.
6
Page 2 – Ms. Clarisa Tate
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner
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
7
Indications for Use
510(k) Number (if known): K121858
Device Name: Acessa System
Indications For Use: The Acessa 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 System consists of the following components:
- Generator (Model Number 1000) .
- Handpiece (Model Number 2000)
- Handpiece Cable (Model Number 4200)
- Pads (Model Number 3000)
- Pad Cable (Model Number 4300)
- Power Cord Model Number (4110)
- Foot Pedal (Model Number 4100)
ਮ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K121858 |
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