The Valleylab G3000 Electrosurgical Device is a single-use device intended for use in open surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The G3000 Electrosurgical Device is intended for use with the Valleylab ForceTriad™ Electrosurgical Generator and conventional monopolar electrosurgical electrodes, such as blade, needle, ball, LLETZ loop, and arthroscopic electrodes.

Device Description

The G3000 Electrosurgical Device is a handheld, single-use device designed to deliver monopolar RF electrosurgical energy to a surgical site to cut and/or coagulate tissue. The G3000 Electrosurgical Device is designed for use only with the Valleylab ForceTriad™ Electrosurgical Generator (510(k) application submitted), and has a connector that will only fit into the ForceTriad™ generator. The G3000 connector is a "smart connector" that allows the ForceTriad™ generator to verify the device type. The device body incorporates "soft touch" material to improve the surgeon's grip. The surgeon activates the desired electrosurgical mode from the sterile field by using one of three push buttons on the device. Three electrosurgical modes are available: Cut, Hemostasis with Division, and Coaq. The surqeon can also control the power settings of the electrosurgical generator from the sterile field using a slider control on the device. The G3000 Electrosurqical Device uses conventional electrosurgical electrodes. such as coated and uncoated blade, needle, ball, LLETZ loops, and arthroscopy electrodes, with a 2.4mm (3/32 inch) shaft diameter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Valleylab G3000 Electrosurgical Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing efficacy through clinical trials with specific acceptance criteria and ground truth. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert involvement, and ground truth methodologies, is not detailed in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it states:

Acceptance Criteria (Implied)	Reported Device Performance
Device functions as intended and meets design specifications.	"Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications."
Substantially equivalent to predicate devices.	"Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices..."
Meets safety and effectiveness criteria.	"...and meets safety and effectiveness criteria."
Specific functional characteristics (e.g., button functionality, grip).	The document describes features like "soft touch" material for grip, "push buttons on the device" for mode selection (Cut, Hemostasis with Division, Coag), and a "slider control on the device" for power settings, implying these functionalities were tested to meet design intent. The G3000 connector is a "smart connector" that allows the ForceTriad™ generator to verify the device type, suggesting testing for compatibility and proper identification.

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

Sample Size: Not specified. The document globally refers to "Performance testing" and "Sufficient data," but does not quantify the number of devices tested or the amount of data collected.
Data Provenance: Not specified, but generally, 510(k) performance testing is conducted internally by the manufacturer using laboratory or bench testing. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical setting. Given it's a device for surgical use, in vivo testing (animal or human) might have been part of "performance testing," but no details are provided.

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

This information is not applicable to a 510(k) submission for this type of device. The "ground truth" for a device like an electrosurgical device typically revolves around its mechanical, electrical, and functional performance, verified against engineering specifications and industry standards, not against expert consensus on clinical outcomes in the same way an AI diagnostic tool would be.

4. Adjudication Method for the Test Set

Not applicable. As no expert-based ground truth or comparative clinical study is described, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned or described. This type of study is relevant for diagnostic devices (especially imaging) where human reader performance is a key metric. The G3000 is an electrosurgical tool, not a diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The G3000 is a physical electrosurgical device, not an algorithm. Its performance is inherent to its physical and electrical characteristics and its interaction with the electrosurgical generator.

7. Type of Ground Truth Used

The ground truth for this device would primarily be:

Engineering Specifications: Testing to ensure the device performs according to its design requirements (e.g., button actuation force, electrical insulation, material integrity, connector compatibility).
Industry Standards: Compliance with relevant electrical safety and performance standards for electrosurgical devices.
Bench Testing / In Vitro Models: Verification of tissue cutting and coagulation characteristics in controlled experimental settings.
In Vivo (Animal or Pre-clinical) Testing: Potentially, testing in animal models to confirm functional performance in a biological environment, if required.

The document states "Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications," indicating the ground truth was tied to these internal design specifications and anticipated function.

8. Sample Size for the Training Set

Not applicable. This device is not an AI model or a system that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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K 051627

SUMMARY OF SAFETY AND EFFECTIVENESS G3000 Electrosurgical Device

Page 1 of 2

1. Submitter Information

Valleylab, a Division of Tyco Healthcare Group LP 5920 Lonabow Drive Boulder, CO 80301 Contact: Herbert Vinson Telephone: 303-530-6469

Date summary prepared: June 17, 2005

2. Name of Device

Trade or Proprietary Name: Valleylab G3000 Electrosurgical Device

Common Name: Monopolar electrosurgical device

Classification Name: Class II, 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories, Panel 79, General and Plastic Surgery

3. Predicate Devices

The G3000 Electrosurgical Device is substantially equivalent in function and intended use to the Valleylab E2516 Electrosurgical Pencil (K813071) and the Valleylab E2517 Power Control Pencil (K861112). All three devices are used for monopolar electrosurgery, allowing the surgeon to actuate the electrosurgical generator from the sterile field using push button controls on the device. All devices are used with conventional electrosurgical electrodes with a 2.4mm (3/32 inch) shaft diameter, such as coated and uncoated blade, needle, ball, LLETZ loop, and arthroscopy electrodes.

4. Device Description

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K 051627

Page 2 of 2

The surgeon activates the desired electrosurgical mode from the sterile field by using one of three push buttons on the device. Three electrosurgical modes are available:

Cut cuts tissue with minimal coagulation / hemostasis .
Hemostasis with Division divides tissue with controlled hemostasis .
Coaq coaqulates bleeding vessels to provide hemostasis .

The surqeon can also control the power settings of the electrosurgical generator from the sterile field using a slider control on the device.

The G3000 Electrosurqical Device uses conventional electrosurgical electrodes. such as coated and uncoated blade, needle, ball, LLETZ loops, and arthroscopy electrodes, with a 2.4mm (3/32 inch) shaft diameter. Valleylab initially intends to market the G3000 Electrosurgical Device with Valleylab coated blade electrodes (K955836, K962044), 10 and 15 foot cord lengths, and Valleylab disposable safety holsters (K791639). Alternate configurations with other electrodes are anticipated in the future.

5. Intended Use

The G3000 Electrosurgical Device is a single-use device intended for use in surgical procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic, arthroscopic) where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The G3000 Electrosurgical Device is intended for use with the Valleylab ForceTriad™ Electrosurgical Generator and conventional monopolar electrosurgical electrodes, such as coated and uncoated blade, needle, ball, LLETZ loop, and arthroscopic electrodes,

There are no specific contraindications associated with the G3000 Electrosurgical Device. General contraindications and warnings related to the use of electrosurgery. as outlined in the user instructions for Valleylab electrosurgical generators, apply to the G3000 Electrosurqical Device.

6. Summary of Technological Characteristics

The G3000 Electrosurgical Device has the same basic technological characteristics as the predicate devices noted above.

7. Performance Data

Performance testing was performed to ensure that the G3000 Electrosurgical Device functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2005

Valleylab, a Division of Tyco Healthcare Group LP c/o Mr. Herbert Vinson Senior Regulatory Associate . . . . 5920 Longbow Drive Boulder, Colorado 80301

Re: K051627

Trade/Device Name: Valleylab G3000 Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 17, 2005 Received: June 20, 2005

Dear Mr. Vinson:

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 (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.

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Page 2 -- Mr. Herbert Vinson

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter witi anow you to oegin manitoing your antial equivalence of your device to a legally premaired predicated on: "The Pressification 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 If you desire specific at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Compuner and (21 the Part 807.97). You may obtain Missuralium Uy Terefono to premainsvillities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octisa.http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ech

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): _ _ O 5 / 6 2 7

Device Name: Valleylab G3000 Electrosurgical Device

Indications For Use:

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Evelyn A. Roth

vision Sign-Off) vision of General, Restorative d Neurological Devices

Kos1627

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.