(27 days)
None
No
The provided text describes a disposable expiratory filter/water trap for a ventilator. There is no mention of AI, machine learning, or any computational or analytical functions that would suggest the presence of an AI model. The device's function is purely mechanical filtration and water trapping.
No
The device is described as an expiratory filter and water trap for a ventilator, which is a component of a therapeutic system but not a standalone therapeutic device itself. Its primary function is to filter and trap water, rather than directly treat a medical condition.
No
Explanation: The device is described as an expiratory filter and water trap for a ventilator. Its function is to filter and trap water, which are therapeutic or supportive functions, not diagnostic. There is no indication that it analyzes patient data or provides information for disease detection or diagnosis.
No
The device is a physical component, a "disposable expiratory filter/water trap," designed for use with a ventilator. It is described as having physical performance metrics (e.g., flow resistance, flow leakage, filtration efficiency) and undergoes biocompatibility testing. This clearly indicates it is a hardware medical device, not a software-only device.
No.
The device is a filter and water trap for a ventilator, which is used to support breathing and does not perform in vitro diagnostic testing on specimens derived from the human body.
N/A
Intended Use / Indications for Use
The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.
It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.
It should be operated by properly trained clinical personnel, under the direction of a physician.
Product codes
CBK
Device Description
The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.
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
adult, pediatric, and neonatal patients
Intended User / Care Setting
properly trained clinical personnel, under the direction of a physician.
institutional healthcare environment (e.g., hospitals).
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)
Bench testing: Testing was not listed in K081837. Performance as listed on labeling: VFE / BFE 99.999% DOP / POA efficiency 99.97% Flow resistance -
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - AVEA Disposable Expiratory Filter/Water Trap
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 8, 2025
Telesair Inc.
℅ Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
Saint Petersburg, Florida 33704
Re: K251133
Trade/Device Name: AVEA disposable expiratory filter/water trap (11790)
Regulation Number: 21 CFR 868.5895
Regulation Name: Continuous Ventilator
Regulatory Class: Class II
Product Code: CBK
Dated: April 11, 2025
Received: April 11, 2025
Dear Paul Dryden:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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K251133 - Paul Dryden Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K251133 - Paul Dryden Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251133
Device Name: AVEA Disposable Expiratory Filter/Water trap
Indications for Use (Describe)
The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.
It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.
It should be operated by properly trained clinical personnel, under the direction of a physician.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Telesair 510(k) Summary
Page 1 of 4
Date Prepared: 23-Apr-25
Sponsor: Telesair Inc.
199 Technology Drive, Suite 110
Irvine, CA 92618
Tel - 949-570-3553
Sponsor Contact: Don Lin, Ph.D. - Founder and CEO
Submission Correspondent: Paul Dryden
ProMedic Consulting LLC
Proprietary or Trade Name: AVEA disposable expiratory filter/water trap
Common/Usual Name: Ventilator, continuous, facility use
Classification Name: Continuous Ventilator
21 CFR 868.5895
Product Code: CBK
Proprietary or Trade Name: AVEA disposable expiratory filter/water trap
Common/Usual Name: Ventilator, continuous, facility use
Classification Name: Continuous Ventilator
21 CFR 868.5895
Product Code: CBK
Device Description: The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.
Indications for Use: The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.
It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.
It should be operated by properly trained clinical personnel, under the direction of a physician.
Page 6
Telesair 510(k) Summary
Page 2 of 4
Table of Comparison of Subject vs. Predicate
| Predicate Vyaire AVEA Disposable Expiratory Filter/ Water Trap | Subject device AVEA Disposable Expiratory Filter/ Water Trap | Comparison | |
|---|---|---|---|
| K# | K081837 | TBD | |
| Product Code | CBK | CB | Identical |
| CFR | 868.5895 | 868.5895 | Identical |
| Indications for Use | The AVEA Ventilator is intended to provide continuous respiratory support in an institutional healthcare environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician. This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use. | The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator. It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician. | Clarified the indications to be specific for the filter as an accessory to the Avea ventilator. Otherwise similar. |
| Fundamental scientific technology | Filtration media with integral water trap | Filtration media with integral water trap | Identical to K081837 |
| Bench testing | Testing was not listed in K081837 | Identical to K081837 | Identical to K081837 |
| Performance as listed on labeling | VFE / BFE 99.999% DOP / POA efficiency 99.97% Flow resistance - |