The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation. Patient population: Patients requiring one lung isolation. Environment of use: Hospitals - OR and ICU.

Device Description

The EZ-Blocker is a double lumen endobronchial tube made of polymer materials and inks. The distal part of the tube ends in a "y" shape with distal extensions for each branch of the lung. The extensions are symmetrical and colored differently (blue and yellow) for identification purposes. The device is supplied with an adapter for connection to a ventilator device. The symmetrical design facilitates introduction and positioning of the device in both main stem bronchi. When properly positioned, the cuff in the main stem branches of the non-ventilated lung can be inflated and lung isolation is achieved.

AI/ML Overview

The provided text describes the EZ-Blocker, a tracheal/bronchial differential ventilation tube, and its submission for 510(k) clearance. The focus of the submission is to demonstrate substantial equivalence to a predicate device (Cook Inc. Endobronchial Blocker, K021920) rather than presenting a study where specific performance metrics are defined as acceptance criteria and then proven through a clinical or stand-alone algorithm study.

Therefore, the information requested regarding acceptance criteria for device performance, study details, sample sizes, expert involvement, and ground truth establishment primarily focuses on the physical and functional characteristics of the device as tested in a laboratory setting, and the biocompatibility tests, rather than a performance study involving a specific outcome measure like accuracy, sensitivity, or specificity.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 requirements	Cytotoxicity, Sensitization, Irritation - PASS; Confirmed safe under ISO 10993-1 biocompatibility requirements.
Assembly Function	Validated for proper function	Validated for function.
Assembly Leakage	No leakage detected	Validated for leakage.
Assembly Bond Strength	Adequate bond strength	Validated for bond strength.
Balloon Verification Test	Pass tests for resting diameter, leakage, collapsing, burst	CMI performed Balloon Verification Test No. ECO-00967-002 consisting of: checking of resting diameter, leakage, collapsing of balloon, and burst test. (Implied: Passed all aspects).
Gas Barrier Property (Balloon)	Retain gas without significant volume changes up to 6 hours	CMI has verified by testing that the balloon retains gas without significant changes in volume up to 6 hours after inflation.
Shelf Life	Maintained for a specified period	2 years expiration dated. (Implied: Material integrity, sterility, and function maintained for 2 years).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test (biocompatibility, function, leakage, bond strength, balloon verification, gas barrier). These are typically bench tests performed on a representative sample of manufactured devices.
Data Provenance: The tests appear to be conducted by the manufacturer or a contracted lab ("CMI performed Balloon Verification Test"). The source of the data is the device manufacturer, EZ-Blocker B.V. The data is prospective for these engineering and lab tests, done specifically for the 510(k) submission. There is no mention of country of origin for test data, except for the manufacturing company (The Netherlands).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to the type of studies presented. These are engineering and bench tests, not clinical studies involving expert interpretation of medical data (e.g., images). The "ground truth" for these tests are objective measurements and pass/fail criteria based on engineering standards and regulatory requirements.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like "2+1" are used in studies involving subjective assessment (e.g., by multiple readers of diagnostic images). These laboratory and engineering tests have objective outcomes (e.g., a burst pressure, a leakage rate, a pass/fail for cytotoxicity).

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 is not a study of an AI or diagnostic imaging device. It's an invasive medical device for lung isolation during surgery.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" for the device's characteristics are objective measurements against established engineering and biocompatibility standards.
- Biocompatibility: ISO 10993-1 standards (e.g., cell viability in cytotoxicity tests).
- Function, Leakage, Bond Strength: Manufacturer's internal specifications and performance requirements validated through testing.
- Balloon Verification: Measurement of physical properties like diameter, and observable events like leakage, collapsing, and burst, against defined acceptance criteria.
- Gas Barrier Property: Measurement of gas volume over time.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is a series of bench testing and laboratory evaluations conducted by the manufacturer (EZ-Blocker B.V.) and a testing facility (CMI) to demonstrate the physical and biological characteristics of the EZ-Blocker. These tests were performed to show that the device meets safety and performance requirements, primarily for demonstrating substantial equivalence to a predicate device.

The document states: "The EZ-Blocker has been tested and confirmed safe under ISO 10993-1 biocompatibility requirements. The assembly is validated for function, leakage, and bond strength. The device is confirmed safe and effective as a device used in standard medical practice."

This implies that for each specified characteristic (biocompatibility, function, leakage, bond strength, balloon integrity, gas retention, shelf life), individual tests were performed, and the results met predetermined internal or industry-standard acceptance criteria. The specific details of these test protocols (e.g., number of units tested per batch for quality control, specific numerical thresholds for "passing" a burst test) are not provided in this summary, but the overall conclusion is that the device "passed."

Summary

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121462

510(k) Summary

Submitted by:
EZ-Blocker B.V. Delftechpark 26 Delft 2628 XH The Netherlands
Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279
9-14-2012 Date Prepared:

Product: EZ-Blocker

Classification Name: Tracheal/bronchial differential ventilation tube, Product Code CBI Regulation Number 868.5740
Intended Use: The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation.

Technological Characteristics:

8 2012

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Substantial Equivalence:

Feature	Cook Inc. EndobronchialBlocker, K021920	EZ-Blocker®This submission
Indication for Use	The 7.0 Fr. EndobronchialBlocker is intended for use todifferentially intubate a patient'sbronchus in order to isolate theleft or right lung for procedureswhich require one-lungventilation.	The EZ-Blocker is indicated foruse to intubate the patient'sbronchi in order to differentiallyisolate the left or right lung forprocedures which require one-lung ventilation, lung separation.
Company	Cook Inc.	EZ-Blocker B.V.
Distal Tip	Single	Double
Average InflationVolume Range	2.0 cc – 12.0 cc	Max 12.0 cc (recommended)
Balloon	Low-pressure, high-volumeSpherical or Elliptical	Low-pressure, high-volume
Lengths	50, 65, 78 cm	Tubing 69 cmOverall length 75 cm
Materials	Unknown	Silicone, Polyurethane
Biocompatibility	Performed but not specified	Cytotoxicity, Sensitization,Irritation - PASS
Testing for verifyingcharacteristics of thecuff	- Analysis of cuff pressure atvarious inflation volumes- Analysis of balloon cuffinflation retention	CMI performed BalloonVerification Test No. ECO-00967-002 consisting of:checking of resting diameter,leakage, collapsing of balloon,and burst test.
Gas Barrier property	Unknown	CMI has verified by testing thatthe balloon retains gas withoutsignificant changes in volume upto 6 hours after inflation.
Packaging	Pouch	Pouch
Shelf Life	Unknown	2 years expiration dated

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Test Data:

The EZ-Blocker has been tested and confirmed safe under ISO 10993-1 biocompatibility requirements. The assembly is validated for function, leakage, and bond strength. The device is confirmed safe and effective as a device used in standard medical practice.

The EZ-Blocker is substantially equivalent to the Cook Inc. Endobronchial Blocker K021920 based on the performance data.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

EZ-Blocker B.V. C/O Mr. Lewis Ward President L.W. Ward And Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301

Re: K121462

Trade/Device Name: EZ-Blocker® Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: September 14, 2012 Received: September 17, 2012

Dear Mr. Ward:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2- Mr. Ward

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

hh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: EZ-Blocker®

Indications for Use:

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

y. Schulten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121467

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).