(819 days)
No
The description mentions a "microprocessor controlled" device, which is common in many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technologies. The device's function appears to be based on controlling power and gas flow based on pre-defined parameters, not learning from data or making complex decisions.
No.
The device is an electrosurgical coagulator used for surgical procedures, which is an interventional device, not a therapeutic device.
No
The device is described as an electrosurgical coagulator used for soft tissue surgery, which is a therapeutic function, not a diagnostic one. It uses helium gas and thermal coagulation to treat tissue.
No
The device description explicitly states it is a "microprocessor controlled Helium Thermal Coagulator" and mentions hardware components like power output, gas flow, and disposable probes. This indicates it is a hardware device with software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a "helium gas electrosurgical coagulator for use in all soft tissue surgery." This indicates a direct surgical intervention on living tissue within the body.
- Device Description: The description details a device that uses helium gas and electrosurgery to coagulate tissue. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to provide information about a disease or condition.
In summary, the device's function is to perform a surgical procedure (coagulation of soft tissue) directly on the patient, which is the opposite of an in vitro diagnostic that analyzes samples outside the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
Laparoscopic, Endoscopic, and open surgical procedures where Monopolar electrosurgery is normally used. Not intended for use on patients with right to left cardiac shunting.
The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and open.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The 'TC' is a microprocessor controlled Helium Thermal Coagulator. Working at 2 to 33 watts of power with Helium gas flows of 1 to 5 liters/minute depending on procedure and probe. The 'TC' automatically works with all of the flexible disposable probes. Models T, C, D, E, R, and S. (Size range 2.5mm to 4mm x 60 mm to 310mm)
In all cases probe is activated (foot control) in the gas-enhanced mode, A Helium plasma is created between the probe and the target tissue. This mode permits the user to coagulate tissue in a more controlled manner than with standard fulguration and the flow of inert gas produces the following additional beneficial effects: (1) The presence of inert gas at surgical site inhibits combustion with other gases (e.g., oxygen, nitrogen, etc.)
And the gas jet pushes any residual smoke or water vapor away from the site, thereby improving visibility, and (2) The gas jet pushes blood out of the way which significantly reduces the coagulation of blood on the surface of the tissue and provides the surgeon with improved visibility at surgical site.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Helica 'TC' due to its design and the use of Helium needs only very low gas pressure (does not exceed 1.5 psi at probe tip) and very low wattage to achieve excellent results. Published studies show that gas-enhanced electrosurgery is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K924918, K931028, K942579, K954229, K962690
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
§ 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
SUMMARY OF EQUIVALENCY OF SAFETY AND EFFECTIVENESS
HELICA 'TC', VALLEY LAB. APEC AND ERBE APC 300
HELICA 'TC'
VALLEY LAB. APEC
ERBE APC 300
INTENDED USE:
Laparoscopic, Endoscopic, and open surgical procedures where Monopolar electrosurgery is normally used. Not intended for use on patients with right to left cardiac shunting.
PRODUCT DESCRIPTION:
The 'TC' is a microprocessor controlled Helium Thermal Coagulator. Working at 2 to 33 watts of power with Helium gas flows of 1 to 5 liters/minute depending on procedure and probe. The 'TC' automatically works with all of the flexible disposable probes. Models T, C, D, E, R, and S. (Size range 2.5mm to 4mm x 60 mm to 310mm)
In all cases probe is activated (foot control) in the gas-enhanced mode, A Helium plasma is created between the probe and the target tissue. This mode permits the user to coagulate tissue in a more controlled manner than with standard fulguration and the flow of inert gas produces the following additional beneficial effects: (1) The presence of inert gas at surgical site inhibits combustion with other gases (e.g., oxygen, nitrogen, etc.)
Same
Same
Endoscopy
Unknown
Same
Use several generators Ranging from 40 to 120 Watts and Argon gas flows From 0.5 to 16 liters/minute .
Uses a number of hand sets Depending on procedure.
Does the same using Argon gas . Has both hand and foot controls. APC 300 generator Not specified Argon gas flows From 0.1 to 9 liters /minute.
Uses 3 specified Probes depending Type of operation.
Does the same Using Argon gas.
1
And the gas jet pushes any residual smoke or water vapor away from the site, thereby improving visibility, and (2) The gas jet pushes blood out of the way which significantly reduces the coagulation of blood on the surface of the tissue and provides the surgeon with improved visibility at surgical site.
SAFETY and PERFORMANCE
| The Helica 'TC' due to its design
and the use of Helium needs only
very low gas pressure (does not
exceed 1.5 psi at probe tip) and
very low wattage to achieve
excellent results. | Needs more gas pressure
And power due to Argon
Being a heavier gas and to
Design of the generator
Hand set. | Same. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------|
| Published studies show that gas-
enhanced electrosurgery is safe
effective. | Same. | Same. |
| BIOCOMPATABILITY | | |
| Selection of materials meet all
known standards. | Same. | Same. |
| ELECTRICAL | | |
| Meets or exceeds all applicable sections
of, IEC 601-1 (1988), Medical Electrical
Equipment Part 1: General Requirements
for Safety, IEC 601-2-2 (1991), Medical
Electrical Equipment Part 2: Particular
Requirements for the Safety of High
Frequency Surgical Equipment, and ANSI
/AAMI HF18 (1993), Electrosurgical Devices. | Same. | Same. |
| SUMMARY NUMBERS | K924918, K931028, K942579 | Unknown |
K924918. K931028. K942579. K954229, K962690
Unknown
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1999
John B. Webb. Ph.D. CEO Tenerco, Inc. 1020 West Bay Avenue Newport Beach, California 92661
Re: K972267 Trade Name: Helica TC (Thermal Coagulator) Regulatory Class: II Product Code: GEI Dated: August 25, 1999 Received: August 26, 1999
15
Dear Dr. Webb:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - John B. Webb, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address - 4 - 4 - - - -"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510 (k) Number: K972267
Device Name:
Helica TC (Thermal Coagulator)
Indications for Use: The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and open.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K9-72267 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________