EndoWindow™ High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

Device Description

EndoWindow™ is a sterile, single-use, disposable bipolar device that is intended to cauterize tissue in the esophagus. EndoWindow fits around a flexible endoscope and contains electrodes located distally on the exterior surface of the device. When positioned and activated, the electrodes deliver electrical current to cauterize tissue. Cauterization of tissue manifests as a white coagulum and occurs in full view of the user in the narrow rectangular window located between the electrodes. The inner diameter of EndoWindow is designed to accommodate an endoscope having a maximum diameter of 8.7mm.

AI/ML Overview

The provided Special 510(k) summary for the EndoWindow™ High Frequency Electrocautery Device (K021266) does not contain the detailed information necessary to answer all the posed questions regarding acceptance criteria and the specific study that proves the device meets them.

This document is a summary of safety and effectiveness, and typically, detailed study protocols, acceptance criteria, and comprehensive results are found in the full 510(k) submission, which is not publicly available in this format.

However, based on the provided text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated	Laboratory and animal testing: Performed to verify performance and safety. Biocompatibility: Conducted in accordance with ISO 10993-1 with satisfactory results. Substantial Equivalence: Deemed substantially equivalent to the predicate device (Microvasive Gold Probe).

Explanation of Limitations: The document states that "Laboratory and animal testing was performed to verify performance and safety" and "A biocompatibility assessment was conducted in accordance with ISO 10993-1 with satisfactory results." However, it does not list specific acceptance criteria (e.g., "device must coagulate tissue within X seconds at Y power level with Z tissue damage depth") nor does it provide the quantitative reported device performance against such criteria. The primary "performance" mentioned is the device's substantial equivalence to a predicate.

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

Sample Size: Unknown. The document mentions "Laboratory and animal testing" but does not specify the number of animals or the number of tests performed.
Data Provenance: Undisclosed. It only states "Laboratory and animal testing was performed." The location (country) or whether it was retrospective or prospective is not mentioned.

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

Number of Experts: Unknown.
Qualifications of Experts: Unknown.

4. Adjudication Method for the Test Set

Adjudication Method: Unknown.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The EndoWindow™ is an electrocautery device, not a diagnostic one. The performance data focuses on its function (cautery) and safety, not on human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the context of AI. This question typically applies to AI/ML software as a medical device. The EndoWindow™ is a physical surgical device, and its "performance" is inherently "standalone" in how it functions to cauterize tissue. There is no AI algorithm or human-in-the-loop component to evaluate here.

7. The Type of Ground Truth Used

For Performance and Safety: Based on the description, the ground truth was likely established through direct observation during laboratory and animal testing. For instance, the "cauterization of tissue manifests as a white coagulum," which would be a direct visual ground truth for efficacy. Safety would be evaluated by observing adverse events, tissue damage, etc., during these tests.
For Biocompatibility: Ground truth was established by adherence to ISO 10993-1 standards and the satisfactory results of the assessments.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" mentioned refers to traditional medical device performance and safety testing.

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

Not applicable. As above, there is no AI/ML training set for this device.

Summary of what the document does provide:

Device Description: A sterile, single-use, disposable bipolar device for transendoscopic electrocautery in the upper GI tract, specifically for Barrett's esophagus.
Predicate Device: Microvasive Gold Probe.
Performance Data Mentioned: Laboratory and animal testing to verify performance and safety, and a biocompatibility assessment per ISO 10993-1 with satisfactory results.
Conclusion: The device is substantially equivalent to the predicate, and safety and effectiveness are assured for its intended use.

In conclusion, for a traditional medical device like the EndoWindow™ High-Frequency Electrocautery Device, the concept of "acceptance criteria" and "study proving it meets criteria" is typically demonstrated through a combination of engineering specifications, performance tests (bench and animal), safety assessments (biocompatibility, electrical safety), and comparison to a legally marketed predicate device. The provided 510(k) summary only offers a high-level overview of these activities without the granular details requested by many of the questions.

Summary

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K021266

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510(k) Summary of Safety and Effectiveness Information

Company	Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, OH 45242
Contact	Ken Charak, MBA, RACManager Regulatory AffairsTelephone: (513) 337-7987Fax: (513) 337-1444Email: kcharak@eesus.jnj.com
Date Prepared	April 18, 2002
Device Name	Trade Name: EndoWindowTM High Frequency Electrocautery DeviceClassification Name: Electrosurgical Device
Predicate Device	Microvasive Gold Probe

Device Description

Indications for Use

EndoWindow High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

Technological Characteristics

While the basic design of EndoWindow is different than Gold Probe, a comprehensive assessment of the differences versus Gold Probe does not raise any new issues relating to safety and effectiveness.

Performance Data

Laboratory and animal testing was performed to verify performance and safety. A biocompatibility assessment was conducted in accordance with ISO 10993-1 with satisfactory results.

Conclusion

EndoWindow is substantially equivalent to Gold Probe. The information provided in this submission provides assurance that EndoWindow will meet the requirements for its intended use.

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Image /page/1/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 perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2002

Re: K021266

Trade/Device Name: EndoWindow™ High-Frequency Electrocautery Device Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: July 31, 2002 Received: August 1, 2002

Dear Mr. Charak:

Mr. Ken Charak

4545 Creek Road

Manager of Regulatory Affairs

CINCINNATI OH 45242-2839

Ethicon Endo-Surgery, Inc.

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 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.

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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 vour 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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Indications for Use Statement

510 (k) Number (if known): _____________________________

EndoWindow™ High Frequency Electrocautery Device Device Name:

Indications for Use:

EndoWindow™ High Frequency Electrocautery Device is indicated for the transendoscopic electrocautery of tissue in the upper gastrointestinal tract such as Barrett's esophagus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Optional Format 3-10-98)

David A. Ayres

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).