AVEA disposable expiratory filter/water trap (11790)

K251133 · Telesair, Inc. · CBK · May 8, 2025 · Anesthesiology

Device Facts

• Record ID: K251133
• Device Name: AVEA disposable expiratory filter/water trap (11790)
• Applicant: Telesair, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: May 8, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Device is an expiratory filter and water trap accessory for the AVEA Ventilator; used in institutional healthcare environments (hospitals). Operated by trained clinical personnel under physician direction. Functions as a mechanical filtration component to trap moisture and particulates in the expiratory limb of the ventilator circuit. No electronic or software components; purely mechanical device.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and bench performance testing (VFE/BFE 99.999%, DOP/POA efficiency 99.97%, flow resistance < 1 cmH2O at 60 lpm, and flow leakage < 0.01 lpm at 140 cmH2O) compared to the predicate device.

Technological Characteristics

Mechanical expiratory filter with integral water trap. Dimensions: 9.7 cm diameter, 33 cm height. Internal volume: 500 ml (130 ml water trap). Biocompatibility tested per ISO 10993. No energy source or software.

Indications for Use

Indicated for use as an expiratory filter and water trap for the AVEA Ventilator in institutional healthcare settings for adult, pediatric, and neonatal patients.

Regulatory Classification

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.

Predicate Devices

• Vyaire AVEA Disposable Expiratory Filter/ Water Trap (K081837)

Reference Devices

• AVEA Ventilator (K013642)
• AVEA Ventilator (K022674)
• AVEA Ventilator (K062093)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

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.

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251133 - Paul Dryden
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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-

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K251133 - Paul Dryden
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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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. |

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510(k) Summary

Telesair

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 - < 1 cmH2O at 60 lpm Flow leakage - <0.01 lpm at 140 cmH2O internal pressure | VFE / BFE 99.999% DOP / POA efficiency 99.97% Flow resistance - < 1 cmH2O at 60 lpm Flow leakage - <0.01 lpm at 140 cmH2O internal pressure | Identical to K081837 |

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510(k) Summary
Telesair

| | Predicate Vyaire AVEA Disposable Expiratory Filter/ Water Trap | Subject device AVEA Disposable Expiratory Filter/ Water Trap | Comparison |
| --- | --- | --- | --- |
| Internal volume | 500 ml includes Water trap of 130 ml | 500 ml includes Water trap of 130 ml | Identical for K081837 |
| Dimensions | Diameter – 9.7 cm Height – 33 cm | Diameter – 9.7 cm Height – 33 cm | Identical to K081837 |
| Biocompatibility | Tested per ISO 10993 | Tested per ISO 10993 | Identical to K081837 |

## Substantial Equivalence Discussion

The subject and predicate devices are identical in all ways.

## Intended Use/ Indications for Use

The indications for use for the subject device have been updated to reflect this as an accessory to the AVEA ventilator only. Otherwise, the intended use is the same as AVEA disposable expiratory filter/water trap cleared under K081837.

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Telesair

510(k) Summary

Page 4 of 4

# Substantial Equivalence Conclusion

The subject device and the predicate – AVEA disposable expiratory filter/water trap – K081837 is substantially equivalent based upon identicality.