The 7.0 Fr. Endobronchial Blocker is intended for use to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures which require one-lung ventilation.

Device Description

The catheter contains a balloon at its distal tip. The proximal end of the catheter is made up of a Y-fitting. One port of the Y-fitting is connected to a pilot balloon assembly. This balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The other port of the Y-fitting connects to the through lumen of the catheter which incorporates a removable looped guide wire that is used to help traverse the catheter along the length of a previously positioned bronchoscope. When the balloon catheter has been advanced to either the right or left bronchus, the guide loop is removed and discarded leaving the through lumen open.

AI/ML Overview

The provided text describes a medical device submission, specifically a 510(k) premarket notification for the 7.0 Fr. Endobronchial Blocker. It details the device's description, indications for use, and a comparison to predicate devices for substantial equivalence. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in reports for AI/ML-driven devices or complex diagnostic systems.

The "Test Data" section only generally states:

The 7.0 Fr. Endobronchial Blocker was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

Performance Testing

Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an Endobronchial Blocker.

This is a high-level summary and does not provide the specific quantitative acceptance criteria or detailed study outcomes that would typically be presented for performance evaluation. The device described is a physical medical device (a catheter with a balloon), not an AI/ML software or diagnostic tool that would typically have the kind of performance metrics (sensitivity, specificity, AUROC, etc.) and associated study methodologies requested in the prompt.

Therefore, I cannot populate the table and answer the subsequent questions based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed clinical performance study with acceptance criteria for a novel diagnostic or AI-assisted function.

To answer your request, here's what would be provided if the document contained the information:

(Hypothetical/Illustrative Table - Not based on the provided text)

Acceptance Criteria (e.g., Performance Metric Threshold)	Reported Device Performance (e.g., Achieved Metric Value)
Accuracy: > 90% in detecting [condition]	92.5%
Sensitivity: > 85% for [condition]	88.1%
Specificity: > 90% for [condition]	93.2%
Positive Predictive Value: > 80%	84.7%
Negative Predictive Value: > 95%	96.0%
Agreement with expert: Kappa > 0.8	Kappa = 0.85
Mean inference time: < 5 seconds	3.2 seconds

Hypothetical/Illustrative Answers to Questions (based on how such a study would be reported, not on the provided text):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: (e.g., 500 cases)
- Data Provenance: (e.g., Retrospective, multi-center data from hospitals in the USA, UK, and Germany)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: (e.g., 3 independent experts)
- Qualifications: (e.g., Board-certified Radiologists, 10+ years of experience in chest imaging, specializing in [relevant area])
Adjudication method for the test set:
- Adjudication Method: (e.g., 2+1; if two experts agreed, that was the ground truth. If they disagreed, a third senior expert adjudicated the final ground truth. Or, Majority vote if more than 2 experts disagreed).
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:
- MRMC Study Done: (e.g., Yes)
- Effect Size: (e.g., Human readers showed a statistically significant increase in diagnostic accuracy of 8% (e.g., from 75% to 83%) when using AI assistance compared to without AI assistance, with a 95% CI of [5%, 11%]).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study Done: (e.g., Yes, the performance metrics in the table above represent standalone algorithm performance.)
The type of ground truth used:
- Ground Truth Type: (e.g., Expert consensus as described in point 4, confirmed by pathology reports for a subset of cases.)
The sample size for the training set:
- Training Set Sample Size: (e.g., 10,000 cases)
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: (e.g., Established by consensus of 2 junior radiologists, verified by a senior radiologist for a random 10% subset, supplemented with metadata from electronic health records including pathology and operative reports.)

Summary

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AUG 1 4 2002 021920

Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 750 Daniels Way P.O. Box 489 Bloomington, In 47402 (812) 339-2235

Device:
Trade Name:	7.0 Fr. Endobronchial Blocker
Proposed Classification Name:	Tracheal/Bronchial Differential Ventilation Tube

Predicate Devices or Legally Marketed Devices:

Cook Bronchial Blocker	Marketed & Distributed byCOOK INCORPORATED
Arndt Pediatric EndobronchialBlocker	Marketed & Distributed byCOOK INCORPORATED
Univent Tube	Marketed & Distributed byVitaid, LTD

Device Description

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Indications for Use

The 7.0 Fr. Endobronchial Blocker is intended for use to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures which require one-lung ventilation.

Substantial Equivalence

The 7.0 Fr. Endobronchial Blocker is similar to the Cook Bronchial Blocker (D.C. #K962167), The Arndt Pediatric Endobronchial Blocker (D.C. #K002288) and the Univent Tube D.C. #K894337). The 7.0 Fr. Endobronchial Blocker is a modification of the Arndt Pediatric Endobronchial Blocker and the Cook Bronchial Blocker manufactured and marketed by Cook. The Univent Tube was cleared under Premarket Notification #K894337. The similar indications for use and technological characteristics of the 7.0 Fr. Endobronchial Blocker as compared to the predicate devices support a determination of substantial equivalency.

Test Data

The 7.0 Fr. Endobronchial Blocker was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

·Performance Testing · Biocompatibility Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an Endobronchial Blocker.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850

AUG 1 4 2002

Ms. April Lavender Vice President, Regulatory Affairs Cook, Incorporated P.O. Box 489 Bloomington, Indiana 47402

Re: K021920

Trade/Device Name: 7.0 Fr Endobronchial Blocker Regulation Number: 21 CFR 868.5740; and 21 CFR 868.5720 Regulation Name: Tracheal/bronchial differential ventilation tube; and Bronchial tube Regulatory Class: II Product Code: CBI and BTS Dated: July 12, 2002 Received: July 15, 2002

Dear Ms. Lavender:

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.

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Page 2 – Ms. April Lavender

. . . . .

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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,

Qur Ls/or
Timothy A. Uhlrich

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Premarket Notification 7.0 Fr. Endobronchial Blocker Cook Incorporated .

Enclosure

510(k) Number (if known): K021920

Device Name:

Indications for Use:

The 7.0 Fr. Endobronchial Blocker is intended for use to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures which require one lung ventilation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
Use(Per 21 CFR 801.109)

	OR		Over-the-Counter
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(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices

510(k) Number
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Regulation Number and Section

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).