The Broncus Coagulation Electrode System consists of a catheter, a RF generator, and a commercially available patient return electrode. The RF generator produces RF power in a monopolar mode. The catheter delivers RF energy to the desired target site and relays temperature and other feedback to the RF generator. The patient return electrode is used to complete the return path for the electrical current.

AI/ML Overview

The provided document is a 510(k) summary for the Broncus™ Coagulation Electrode System, dated January 17, 2000. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, this document focuses on establishing substantial equivalence to predicate devices based on intended use and non-clinical performance and biocompatibility testing. It lacks the specifics of clinical study design, sample sizes for training or test sets, expert qualifications, ground truth establishment, or specific performance metrics that would be expected for a detailed AI/ML device submission.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Acceptance Criteria	Reported Device Performance
Functional testing	Passed
Electrical testing	Passed
Biocompatibility	Proven biocompatibility

Note: The document states that the "Coagulation Electrode System has undergone and passed functional and electrical testing designed to assess the performance of the catheter and the RF generator" and "The materials used in the Coagulation Electrode have proven biocompatibility." However, it does not specify the quantitative acceptance criteria (e.g., specific voltage ranges, tissue temperature limits, or mechanical strength thresholds) for these tests, nor does it provide detailed numerical results beyond "passed."

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

Not Available: The document does not mention any clinical test sets, human subject data, or data provenance. The testing described is non-clinical (functional, electrical, and biocompatibility).

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/Available: As no clinical test set or human subject data is mentioned, there is no discussion of experts establishing ground truth for such data.

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

Not Applicable/Available: No clinical test set is discussed.

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 a medical instrument (coagulation electrode system), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant to this submission.

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

Not Applicable: This is a physical medical device, not an algorithm.

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

Not Applicable/Available: For the non-clinical tests described, the "ground truth" would be engineering specifications and standards for functional and electrical performance, and established biocompatibility standards for materials. These are not explicitly detailed in the summary.

8. The sample size for the training set

Not Applicable/Available: This is a hardware device, not an AI/ML algorithm that requires a training set.

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

Not Applicable/Available: No training set is relevant for this device.

Summary

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JAN 2 8 2000

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K993700

Applicant Information:

Date Prepared:

January 17, 2000

Name: Address: Broncus Technologies, Inc. 1400 N. Shoreline Boulevard Building A. Suite 8 Mountain View, CA 94043

Contact Person: Phone Number: Fax Number:

John D'Angelo (650) 428-1600 ext. 312 (650) 428-1542

Device Information:

Classification	Class II
Trade Name:	Broncus™ Coagulation Electrode System
Classification Name:	Bronchoscope and Accessories 21 CFR 874.4680

Equivalent Devices:

The subject device is substantially equivalent in intended use and/or method of operation to the following predicate devices:

Broncus Technologies, Inc.	Broncus™ Bronchial Catheter System
Olympus America Inc.	Coagulation Electrode
Valleylab, Inc.	Force 2 Electrosurgical Generator

Description:

Intended Use:

The Broncus Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree.

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510(k) Summary of Safety and Effectiveness, continued

Comparison to Predicate Devices:

The Broncus Coagulation Electrode System is substantially equivalent in intended use and/or method of operation to the named predicate devices.

Non-Clinical Test Results:

Performance

The Coagulation Electrode System has undergone and passed functional and electrical testing designed to assess the performance of the catheter and the RF generator.

Biocompatibility

The materials used in the Coagulation Electrode have proven biocompatibility.

Summary of Substantial Equivalence:

Based on the intended use and the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2000

Mr. John D'Angelo President and CEO Broncus Technologies, Inc. 1400 N. Shoreline Blvd. Building A, Suite 8 Mountain View, CA 94043

Re: K993900

Trade Name: Coagulation Electrode, Model 2000; Radiofrequency Generator Regulatory Class: Class II Product Code: 874.4680, 77EOQ and 878.4400, 79GEI Dated: November 15, 1999 Received: November 16, 1999

Dear Mr. D'Angelo:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) 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.

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Page 2 -- Mr. John D'Angelo

· 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) 594-4613. 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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K493900

Device Name:

Broncus™ Coagulation Electrode System

Indications for Use:

The Broncus™ Coagulation Electrode System is intended for coagulation or hemostasis in the tracheobronchial tree.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over- The Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Karen A. Bohr

(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number 2493470

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.