The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open. It consists of two parts: A power generator control unit with a Helium gas supply and an application probe. An ionised gas plasma flame is generated in a controlled Helium gas flow at the end of a 4mm PTFE application tube (the probe). This produces a corona-type flame issuing from the open end of the probe with a high electron temperature but low molecular temperature of about 20C. When the probe is brought close (within 3 mm) to a surface connected to earth - such as human tissue - the corona-type flame changes to an arc discharge flame with a temperature of approx. 800C. The inert Helium gas flow in which the discharge takes place protects the area of discharge and minimises oxidation. This plasma flame can be used to stop blood flow from damaged tissue by cauterisation. The electrical generator provides an alternating current at a fixed frequency in the kilo hertz range with a power supply range of between 2 and 30W. The new probe is the LTC. This is a cutting probe where the 4mm PTFE tube retracts, exposing the point which is approximately 8-10mm long. This probe works by using the Corona flame passing between the point and the tissue at the nearest point which could be on the side of the probe. The point area which is hot then cuts through the tissue and cauterises small blood vessels as it passes through.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Helica Laparoscopic Cutting & Cauterising (LTC) Probe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data or performance against detailed acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, and extensive performance metrics for a novel, standalone AI device (which this is not) is not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal acceptance criteria in the manner one would typically find for a new, innovative device requiring extensive clinical validation. Instead, the "acceptance" hinges on demonstrating substantial equivalence to the predicate device. The performance comparison focuses on qualitative characteristics and a single in-vitro comparison rather than quantitative metrics against predefined thresholds.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (from "Summary of Non Clinical Tests")
Equivalence in Indicated Use: Same intended use as predicate.	"The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open." This is the same as the predicate (Helica "TC" Laparoscopic Cauterising Probe, K972267), with the addition of the "cutting" function.
Equivalence in Operating Principle: Uses the same fundamental technology.	"use the same operating principle" (Helium gas electrosurgical cauterization, now with a cutting mechanism via a retracting sheath and exposed point).
Equivalence in Design: Similar overall construction.	"incorporate the same design" (basic Helica probe design, with modification to the handle for sheath retraction).
Equivalence in Materials: Made from similar components.	"incorporate the same materials"
Equivalence in Shelf Life: Similar stability over time.	"have the same shelf life"
Equivalence in Packaging: Similar packaging methods.	"are packaged using the same materials and processes"
Safety (qualitative comparison): Should be at least as safe, preferably safer, than the predicate.	The helium unit has "much better control of the depth of necrosis" than the Argon Beam Coagulator (ABC) (a competitor, not necessarily the predicate, but used for comparison). It implies "much lower power at point of application" than ABC, leading to a conclusion of being "safer" than ABC. While the comparison is with ABC, it supports the non-inferiority/safety argument for the new device.
Effectiveness (qualitative comparison): Should achieve similar therapeutic effects.	"similar results" to the ABC in terms of effect, implying effectiveness for the intended use.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: Not specified. The document mentions an "in vitro comparison." Typically, "in vitro" studies do not involve human subjects or a "test set" in the clinical trial sense. If there were tissue samples, the number is not provided.
Data Provenance: The study was an "in vitro comparison." No country of origin is specified for the data as it was likely laboratory-based. It is retrospective in the sense that it's a comparison study performed on existing technology principles, not a prospective human clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: One expert is named: "Dr. John Webb, Ph.D."
Qualifications: "Ph.D." The specific field of his Ph.D. or his medical specialization (e.g., surgeon, pathologist) is not stated. The context implies expertise in the technical aspects of electrosurgery.

4. Adjudication Method for the Test Set:

Not applicable. This was an in-vitro comparison, not a study requiring adjudication of expert interpretations of medical images or conditions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is an electrosurgical tool, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant or described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical electrosurgical device, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the in-vitro comparison appears to be macroscopic and microscopic assessment of tissue effects (depth of necrosis, width of effect) under controlled laboratory conditions, as observed and interpreted by Dr. John Webb. This would be a form of objective measurement and expert observation.

8. The Sample Size for the Training Set:

Not applicable. This device did not involve machine learning or an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary

{0}------------------------------------------------

FEB - 4 2004

K032969 (pg 1 of 3)

510(k) Summary

Applicant Name, Address, Telephone, Fax, E-Mail:

Helica Instruments Inc. 200 E. Robinson St. Suite 500 Oralando, Florida 32801

Contact:

c/o Dr. John B. Webb Ph. D. 1020 W. Bay Ave Newport Beach, CA 92661-1015

Tel: (949) 673-0640 Fax: (946) 675-5730 E-Mail: tenerco@earthlink.net

Submission Date:

-/-/03

Trade Name:

Helica Laparoscopic Cutting & Cauterising (LTC) Probe

Common Name:

Helium Cutting Probe

Classification:

Class II

Legally Marketed Predicate Device Name:

Helica "TC" Laparoscopic Cauterising (IT) Probe, K972267

Description of Device:

"The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open"

{1}------------------------------------------------

K032969 (pg 2 of 3)

It consists of two parts:

A power generator control unit with a Helium gas supply. .
. An application probe.

An ionised gas plasma flame is generated in a controlled Helium gas flow at the end of a 4mm PTFE application tube (the probe). This produces a corona-type flame issuing from the open end of the probe with a high electron temperature but low molecular temperature of about 20C. When the probe is brought close (within 3 mm) to a surface connected to earth - such as human tissue - the corona-type flame changes to an arc discharge flame with a temperature of approx. 800C. The inert Helium gas flow in which the discharge takes place protects the area of discharge and minimises oxidation.

This plasma flame can be used to stop blood flow from damaged tissue by cauterisation.

The electrical generator provides an alternating current at a fixed frequency in the kilo hertz range with a power supply range of between 2 and 30W.

Referring to the application probe, which the model is the LT, the L is for Laparoscopic and the T is the length.

The new probe is the LTC. This is a cutting probe where the 4mm PTFE tube retracts, exposing the point which is approximately 8-10mm long. This probe works by using the Corona flame passing between the point and the tissue at the nearest point which could be on the side of the probe. The point area which is hot then cuts through the tissue and cauterises small blood vessels as it passes through.

Statement of Intended Use:

"The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery-laparoscopic ,endoscopic and open ".

Description of Modification:

The basic design of the Helica probe remains the same. However the handle of the LTC probe has been modified to allow the PTFE sheath to be retracted; this exposes the brass insert, which can then be used as a cutting instrument.

Summary of Non Clinical Tests:

In vitro comparison of the Helica thermal coagulator (HTC) and the argon beam coagulator (ABC); Dr. John Webb, Ph.D:

{2}------------------------------------------------

K032964 (pg 3 of 3)

The helium unit does have a much better control of the depth of necrosis than that of the ABC, but slightly less control over the width, perhaps due to the significantly greater power applied by the ABC to get the same effect. However, the judgement of effect of each of these unite while in use during surgery is visual and it will be easy to judge the spread of the effect and not easy to judge the depth.

It can therefore be concluded that the use of the HTC should be easier than the AB, even given similar results, and the HTC should be considered "safer" with its much lower power at point of application.

Substantial Equivalence:

The has the following similarities to those which previously received 510(k) clearance:

have the same indicated use, .
. use the same operating principle,
incorporate the same design, .
incorporate the same materials, .
have the same shelf life, .
and are packaged using the same materials and processes. .

In summary, described in this submission is substantially equivalent to the predicate device

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Helica Instruments, Inc. c/o John B. Webb. Ph.D. 1020 W. Bay Avenue Newport Beach, California 92661-1015

Re: K032969

Trade/Device Name: Helica "TC" Laparoscopic Cutting and Cauterising (LTC) Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Codc: GEI Dated: January 15, 2004 Received: January 21, 2004

Dear Dr. Webb:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - John B. Webb. Ph.D.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours.

Miriam C Provost

for Celia M. Witton, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K032969

Device Name: Helica "TC" Laparoscopic Cutting and Cauterising (LTC) Probe

Indications For Use:

"The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery- laparoscopic, endoscopic and open."

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

KU32969.

miriani C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. Holdiner Backed, Restorative

... Neurological Devices

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Regulation Number and Section

§ 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.