The Y-Adapter is a device that provides a passage through which fluids can be delivered via the instrument channel of a bronchoscope without requiring the removal of bronchoscopic accessories from the instrument channel. The Y-Adapter attaches to the instrument channel port, and provides two ports to the channel: one for use with a catheter or other bronchoscopic accessory and one for use in the delivery of fluids.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the Asthmatx Y-Adapter, does not detail a study involving human readers or AI assistance. The device is a bronchoscope accessory, and the performance verification focuses on technical and material compliance rather than diagnostic accuracy. As such, information regarding AI performance, human reader improvement with AI, expert adjudication of ground truth for AI, MRMC studies, or standalone algorithm performance is not applicable or available in this document.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance

The "Performance Verification" section outlines categories of characteristics that will be verified prior to marketing, rather than presenting results from an already conducted study. Therefore, the "Reported Device Performance" column reflects the planned verification, as specific results are not included in this summary.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Planned Verification)
Biocompatibility	Compliance with ISO 10993-1:2003 (Biological evaluation of medical devices – Part 1: Evaluation and testing) and "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1)"	Will be formulated to comply with FDA-recognized biocompatibility standard ISO 10993-1:2003.
Sterilization	Compliance with ISO 11137-1:2006 (Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices) and "Updated 510(k) Sterility Review Guidance, August 30, 2002 (K90-1)"	Conformance to the requirements.
Packaging	Compliance with ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)	Conformance to the requirements.
Physical Dimensions	Not specifically defined, but implies meeting design specifications.	Will be verified.
Compatibility with Common Bronchoscopes	Not specifically defined, but implies functional fit and performance.	Will be verified.
Compatibility with Common Fluids	(e.g., saline, lidocaine solution)	Will be verified.
Maintenance of Vacuum	Not specifically defined, but implies preventing air leakage.	Will be verified.
Prevention of Leaks	Not specifically defined, but implies maintaining fluid integrity.	Will be verified.

Study Information:

Sample size used for the test set and the data provenance: Not applicable. The document describes a "Performance Verification" plan for a medical device (Y-Adapter) that does not involve a diagnostic algorithm or a test set of data in the common sense for AI/ML evaluation. The verification focuses on the device's physical and functional properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., diagnostic labels) is not relevant to the performance verification of this bronchoscope accessory.
Adjudication method for the test set: Not applicable.
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 bronchoscope accessory, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For the physical and functional characteristics, the "ground truth" would be established through engineering specifications, validated test methods, and compliance with industry standards (e.g., ISO, FDA guidance). It doesn't involve clinical outcomes, pathology, or expert consensus in the diagnostic sense.
The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Asthmatx. The logo consists of a stylized letter "A" made up of three thick lines, followed by the word "Asthmatx" in a simple, sans-serif font. A small registered trademark symbol is placed near the base of the "A".

OCT 20 2008

7.0 510(k) Summary

Applicant: Asthmatx, Inc. 888 Ross Drive, Suite 100 Sunnyvale, CA 94089 T: 408.419.0100 F: 408.419.0101
Contact: Carter Navarro Manager, Regulatory Affairs T: 408.419.0105 F: 408.419.0101 E: cnavarro@asthmatx.com
Date: September 30, 2008
Trade name: Y-Adapter Common name: Y-Adapter

Classification

Classification Name:	Bronchoscope accessory
Regulation Number:	21 CFR 874.4680
Product Code:	KTI
Class:	II
Classification Panel:	Ear Nose & Throat

Predicate Device: Olympus Single-use Biopsy Valve (Component of the Olympus EVIS EXERA II 180 System, cleared via K061313 on August 30, 2006)

Description

It's about breathing.®

Asthmatx, Inc. 888 Ross Drive, First Floor Sunnyvale, CA 94089 T 408-419-0100 F 408-419-0101 www.asthmatx.com

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082174

Premarket Notification (510(k)) for Y-Adapter

Intended Use

The Y-Adapter is intended for use in the delivery of fluids via the instrument channel of a bronchoscope.

Technological Characteristics

The Y-Adapter provides two ports through which the instrument channel can be accessed. The fluid delivery interface of each port of the Y-Adapter is comparable to that of the predicate device.

The Y-Adapter is manufactured from polyethylene and silicone rubber. Both materials in the Y-Adapter are widely used in medical applications and will be formulated to comply with the FDA-recognized biocompatibility standard ISO 10993-1:2003. The predicate device is manufactured from materials that are not specified in the available labeling.

Performance Verification

The Y-Adapter will conform to the requirements of the following guidance documents and FDA-recognized standards prior to marketing of the device:

. Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 (G95-1)
. Updated 510(k) Sterility Review Guidance, August 30, 2002 (K90-1)
. ISO 10993-1:2003 – Biological evaluation of medical devices – Part 1: Evaluation and testing
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: . Requirements for development, validation, and routine control of a sterilization process for medical devices
. ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

In addition, the following design and functional characteristics will be verified prior to marketing of the Y-Adapter:

. Physical dimensions
. Compatibility with common bronchoscopes
Compatibility with common fluids (e.g., saline, lidocaine solution) .
Maintenance of vacuum .
Prevention of leaks .

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K08 2174

Premarket Notification (510(k)) for Y-Adapter

Conclusion

The intended use, technological characteristics, and planned performance verification and conformance to recognized standards of the Y-Adapter indicate that it is as safe and effective as, and is substantially equivalent to, the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Asthmatx, Inc. c/o Carter Navarro 888 Ross Drive Sunnyvale, CA 94089

OCT 20 2008

Re: K082174

Trade/Device Name: Y-Adapter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: KTI Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Navarro:

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. 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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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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina Eggleston, us

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6.0 Indications for Use

K082174 510(k) Number (if known): _

Device Name: Y-Adapter

Indications for Use:

For use in the delivery of fluids via the instrument channel of a bronchoscope. .
For single use only. .

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

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen Baker

Nose and Throat De

510(k) Number: K082174

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.