(168 days)
No
The description focuses on standard RF ablation technology with user-controlled parameters and safety features based on monitoring measured parameters against predefined limits. 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, which directly treats the tissue and fits the definition of a therapeutic device.
No
The device is an ablation system used for coagulating and ablating soft tissue, which is a therapeutic function, not a diagnostic one. It delivers RF energy to destroy tissue, rather than to identify or analyze a condition.
No
The device description clearly lists multiple hardware components including a generator, probe, cables, electrode pads, power cord, and foot pedal. While it includes software for control and display, it is an integrated hardware-software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The components listed (generator, probe, cables, pads, foot pedal) are all designed for delivering energy to tissue within the body for therapeutic purposes.
- Mechanism of Action: The device uses radiofrequency energy to ablate or coagulate tissue. This is a physical process applied to the body, not a diagnostic test analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is a therapeutic device used for tissue ablation and coagulation, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
Product codes
GEI
Device Description
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System includes the following system components:
• Halt 2000GI Radiofrequency Generator (RF Generator): that provides RF energy to the RF Probe
• Disposable RF Probe (Tulip™, TU 1000), a hand piece with a trocar-pointed shaft and 7 deployable RF needle electrodes.
• RF Probe Extension Cable that connects the RF Probe to the RF Generator.
• Dispersive Electrode Pads (TSP 115) Set that provides the return path for the RF energy applied by the RF Probe. (Use only Dispersive Electrode Pads provided by Halt Medical, Inc.)
• Dispersive Electrode Pad Set Extension Cable (TSPCBL) that connects the Dispersive Electrode Pad Set to the RF Generator.
• Power Cord that is a medical grade power cord providing AC power to the RF Generator.
• Foot Pedal that is a pneumatic foot pedal with tubing used to turn RF energy on and off.
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation 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 RF probe 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 RF 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.
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
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation 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, ANSI/AAMI HF-18). The system passed all testing.
Animal and bench testing also successfully demonstrates that the Halt RF Ablation 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Rita Model 1500 (K993944), Rita Model 1500X (K032149)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "K094009" at the top. Below the text is a horizontal line. Under the line is the word "Halt" in a stylized font, with the word "MEDICAL" in smaller letters below it.
JUN 1 4 2010
01 (3)
t Ti
510(K) SUMMARY
As Required By 21 CFR 807.92
| Date of Summary Preparation | June 7, 2010 |
|---|---|
| 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 |
| Director of RA/QA, Halt Medical, Inc. | |
| Office: (925) 271-0626 | |
| e-mail: ctate@haltmedical.com | |
| Trade Name | Halt 2000GI™ Electrosurgical Radiofrequency |
| Ablation System | |
| Common/Classification Name | Electrosurgical, cutting and coagulation device |
| and accessories | |
| Classification | Class II |
| Product Code | GEI |
| Classification Panel | General and Plastic Surgery |
| Classification Regulation | 21 CFR §878.4400 |
| Legally Marketed Device to | |
| which substantial equivalence is | |
| claimed | Rita Medical Systems - Electrosurgical RF |
| Generator and accessories: | |
| • Rita Model 1500 (K993944) | |
| • Rita Model 1500X (K032149) | |
| Intended Use | The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System |
| is indicated for use in percutaneous, laparoscopic, and intraoperative | |
| coagulation and ablation of soft tissue. | |
| Device | |
| Description | The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System |
| includes the following system components: |
• Halt 2000GI Radiofrequency Generator (RF Generator): that
provides RF energy to the RF Probe |
. .
1
Image /page/1/Picture/0 description: The image shows the number 2094009 at the top, followed by a horizontal line. Below the line is the word "Halt" in a stylized font, with the word "MEDICAL" in smaller letters below and to the right of "Halt". The word "Halt" is written in a cursive style, with the "H" and "t" connected by a curved line.
Page 2 of 3
- Disposable RF Probe (Tulip™, TU 1000), a hand piece with a . trocar-pointed shaft and 7 deployable RF needle electrodes.
- RF Probe Extension Cable that connects the RF Probe to the . RF Generator.
- Dispersive Electrode Pads (TSP 115) Set that provides the . return path for the RF energy applied by the RF Probe. (Use only Dispersive Electrode Pads provided by Halt Medical, Inc.)
- Dispersive Electrode Pad Set Extension Cable (TSPCBL) that ● connects the Dispersive Electrode Pad Set to the RF Generator.
- Power Cord that is a medical grade power cord providing AC . power to the RF Generator.
- Foot Pedal that is a pneumatic foot pedal with tubing used to � turn RF energy on and off.
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation 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 RF probe 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 RF 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.
Technological Characteristics Compared to Predicate Devices
The design features and principal modes of operation of the Halt 2000GI™ System is equivalent to commercially available RF Ablation Systems specifically the predicate devices listed above.
Substantial equivalence is established with respect to similar intended use, principal design, type of energy used or delivered, materials, performance and safety requirements.
The key similarities and differences of the Halt RFA System to the legally marketed RITA RF Ablation Systems are summarized below:
- . Both Utilizes RF energy at equivalent frequencies (approximately 450 kHz), sinusoidal waveforms and
2
Image /page/2/Picture/0 description: The image shows the number K094009 written in black ink, with a line underneath it. Below the line is the word "Halt" in a stylized font, with the word "Medical" in smaller letters underneath. The word "Halt" has a design element that looks like an arrow going through the "t".
Page 3 of 3
equivalent power levels (150 – 250 Watts)
| Both incorporates the same surgical and technical concepts for the in situ delivery and control of RF energy through deployable array needle electrodes with impedance and temperature feedback under visual control. | |
|---|---|
| Halt RF Probe (Tulip) features seven deployable needle electrodes, a live trocar tip, and provides real-time simultaneous feedback from all seven temperature sensors while RITA® Probe features nine deployable needle electrodes, a hollow shaft with a needle tip, and provides real-time temperature feedback from five independent temperature sensors within the array. | |
| Halt RF Probe (Tulip) is designed to create single ablations up to 6 cm in size while RITA Probe is up to 5 cm. Both can also be used to ablate the needle track. | |
| Both the RF Probes use similar medical grade metal alloys and plastic polymers (i.e. Nitinol®, surgical grade Stainless Steel and PEEK). | |
| Performance | |
| Testing | The Halt 2000GI™ Electrosurgical Radiofrequency Ablation 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, ANSI/AAMI HF-18). The system passed all testing. |
| Animal and bench testing also successfully demonstrates that the Halt RF Ablation 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. | |
| 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. | |
| Conclusion | The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System with its indication for use, is substantially equivalent to the legally marketed medical device as demonstrated by the technological characteristics comparison and performance testing completed for this device. |
ે વ
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Halt Medical. Inc. % Mr. Russ DeLonzor President & COO 131 Sand Creek Road, Suite B Brentwood, California 94513
JUN 14 2010
Re: K094009
Trade/Device Name: Halt 2000GI Electrosurgical Radiofrequency Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI
Dated: April 13, 2010 Received: April 15, 2010
Dear Mr. DeLonzor:
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 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
...
4
Page 2 - Mr. Russ DeLonzor
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/ucrn1 i 800 .html or 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 (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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millikin
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 Form
510(k) Number (if known): K094009
Device Name: Halt 2000GI™ Electrosurgical Radiofrequency Ablation System
Indications for Use:
The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (
Diagnostic Devices (OVD)
on Sign-Off (Divisi Division of Surgical Orthopedic, and Restorative Devices
510(k) Number K094009
Evaluation and Safety
Division Sign-Off
510(k)
Office of In Vitro Diagnostic Device
Page 1 of 1