The TUNA System Product Family, including Precision Plus TUNA Office System, Precision TUNA Office System, and PROVu TUNA System is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Device Description

Each system of the TUNA system product family consists of an RF generator, sterile single-use cartridge, reusable handle, reusable telescope, sterile single-use tubing set, single-use return electrode, and other accessories.

AI/ML Overview

This 510(k) summary (K021804) describes a premarket notification for adding a contraindication to the labeling of the TUNA System product family. As such, the submission does not contain a study demonstrating device performance against specific acceptance criteria. The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices given a labeling change, not to introduce a new or modified device with new performance claims requiring clinical validation.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or addressed in this type of submission.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Not applicable. This 510(k) is to add a contraindication to the labeling of an existing device family, demonstrating substantial equivalence to the same devices without the added contraindication. There are no new performance claims or associated acceptance criteria being evaluated in this submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission does not involve a test set for evaluating device performance against acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission does not involve a test set requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This submission does not involve adjudication of a test set.

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 generator and accessories, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. This submission does not involve ground truth for performance evaluation.

8. The sample size for the training set

Not applicable. This submission does not involve a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. This submission does not involve a training set for an algorithm.

Summary

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510(k) SUMMARY

May 30, 2002

COMPANY AND CONTACT PERSON

Julie Goode, Product Regulation Manager Medtronic Gastroenterology/Urology 800 53rd Ave Minneapolis, MN 55421 (763) 514-7247

TRADE NAME

Precision Plus TUNA Office System Precision TUNA Office System PROVu TUNA System

COMMON NAME

Electrosurgical Generator and Accessories

CLASSIFICATION NAME

Electrosurgical Cutting and Coagulation Devices and Accessories

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Precision Plus TUNA Office System, K014224 Precision TUNA Office System, K002583 PROVu TUNA System, K965061

DESCRIPTION OF DEVICE

STATEMENT OF INTENDED USE

Each system of the TUNA system product family is indicated for the treat of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This premarket notification 510(k) change being effected is being submitted to add a contraindication regarding the use of the TUNA System on patients implanted with neurostimulators to the labeling of the TUNA System product family.

The TUNA systems previously cleared by FDA, and currently marketed include:

. PROVu TUNA System (510(k): K965061); was deemed substantially equivalent on January 28, 1997.
. Precision TUNA Office System (510(k): K002583); was deemed substantially equivalent on February 13, 2001.
. Precision Plus TUNA Office System (510(k): K014224); was deemed substantially equivalent on January 23, 2002.

In determining substantial equivalence, the decision-making process follows the 510(k) "Substantial Equivalence" flow diagram as follows:

. The TUNA System product family with the added contraindication is being compared to the following Marketed Device:
Precision Plus TUNA Office System (510(k): K014224) Precision TUNA Office System (510(k): K002583) PROVu TUNA System (510(k): K965061)
The TUNA System product family with the added contraindication has the same intended use as the:
Precision Plus TUNA Office System (510(k): K014224) Precision TUNA Office System (510(k): K002583) PROVu TUNA System (510(k): K965061)
The TUNA System product family with the added contraindication has thesame . technological characteristics as the:
Precision Plus TUNA Office System (510(k): K014224) Precision TUNA Office System (510(k): K002583) PROVu TUNA System (510(k): K965061).

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo is circular in shape, with the words "U.S. Human Services - USA" written around the top half of the circle and "Department of" written around the bottom left. In the center of the circle is a stylized symbol that resembles a person with their arms outstretched. The symbol is made up of three curved lines that overlap each other.

AUG 2 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Julie Goode Product Regulation Manager Medtronic, Inc. 800 53rd Avenue N.E. MINNEAPOLIS MN 55421-1200 Re: K021804

Trade/Device Name: SEE ATTACHMENT Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Product Code: 78 KNS Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and Coagulation device and accessories Product Code: 79 GEI Regulatory Class: II Dated: May 30, 2002 Received: June 3, 2002

Dear Ms. Goode:

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. Iisting 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 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

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K021804 ATTACHMENT

Trade/Device Name: TUNA® System Product Family, including Precision™ Plus TUNA® Office System (Model 6900 Cartridge, Model 6198 Handle, and Model 7900 Generator), Precision™ TUNA® Office System (Model 6800 Cartridge, Model 6198 Handle, and Model 7800 Generator), and PROVu™ TUNA® System (Model 6199 Cartridge, Model 6198 Handle, and Model 7600 Generator)

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INDICATIONS FOR USE

K021804 510(k) Number:

Precision Plus TUNA Office System Device Name: Precision TUNA Office System PROVu TUNA System

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	/
(Per 21 CFR 801.109)

Over-The-Counter-Use
----------------------	--

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K021804
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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.