(80 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a simple mechanical adapter, with no mention of AI or ML.
No
The device is a Y-Adapter used for delivering fluids through a bronchoscope, facilitating the process rather than directly providing a therapeutic effect. Its function is to allow simultaneous fluid delivery and accessory use, not to treat a condition itself.
No
The device is described as facilitating the delivery of fluids and allowing access for bronchoscopic accessories. There is no mention of it being used for the purpose of diagnosis or providing diagnostic information.
No
The device description clearly describes a physical Y-Adapter that attaches to a bronchoscope and has two ports. The performance studies also focus on physical characteristics and material compatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of fluids via the instrument channel of a bronchoscope." This describes a device used during a medical procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a physical adapter that connects to a bronchoscope to facilitate fluid delivery and accessory use. This is a mechanical device for procedural use.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information based on test results
The device is clearly intended for use in a clinical setting during a bronchoscopy procedure to manage fluid delivery and accessory use, which falls under the category of a medical device used for treatment or procedural support, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Y-Adapter is intended for use in the delivery of fluids via the instrument channel of a bronchoscope.
For use in the delivery of fluids via the instrument channel of a bronchoscope.
For single use only.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
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
1
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 .
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
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.
4
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
5
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