← Product Code [CAH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH) · K230483 # Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (K230483) _Passy-Muir, Inc. · CAH · Sep 16, 2023 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K230483 ## Device Facts - **Applicant:** Passy-Muir, Inc. - **Product Code:** [CAH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH.md) - **Decision Date:** Sep 16, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5260 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Pediatric, 3rd-Party Reviewed ## Indications for Use To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses. ## Device Story Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, single-patient use filter for non-mechanically ventilated tracheostomy patients. Device attaches to 15mm tracheostomy tube hub via twist motion. Filtration uses electrostatic charges in polypropylene media to capture microbes from inspiratory/expiratory gases. Used in clinical settings (hospital, sub-acute, pre-hospital, home) by patients or caregivers. Output is filtered air; helps reduce patient exposure to viral/bacterial particulates. Benefits include airway protection during spontaneous breathing. ## Clinical Evidence Bench testing only. Testing included: ISO 5356-1 connector compliance; leak testing (0 ml/min at 1 psi); dead space (6 ml); biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization, ISO 10993-23 irritation); ISO 18562-2/3/4 particulate/VOC/leachables testing; ASTM F2299 particle filtration efficiency (99.0% at 0.1 µm); ASTM F2101 bacterial/viral filtration efficiency (>99.9%); and ASTM 1980 accelerated aging. All results met pre-determined acceptance criteria. ## Technological Characteristics Materials: Polypropylene filter media, medical grade ABS housing. Principle: Electrostatic charge attraction. Form factor: 15mm conical connector (ISO 5356-1). Dead space: 6 ml. Flow resistance: <1.7 cmH2O @ 60 LPM. Single-patient use, non-sterile, 24-hour duration. No software or electronic components. ## Regulatory Identification A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. ## Predicate Devices - Altera Filter [K192713](/device/K192713.md) (Filter Only) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 16, 2023 Passy-Muir, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K230483 Trade/Device Name: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing circuit bacterial filter Regulatory Class: Class II Product Code: CAH Dated: September 14, 2023 Received: September 14, 2023 Dear Prithul Bom: 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. 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 located 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. # Bifeng Qian -S Bifeng Qian, M.D., Ph.D. Assistant Director Division of Infection Control and Plastic and Reconstructive Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K230483 #### Device Name Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) #### Indications for Use (Describe) For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healtheare provider or caregiver, where filtration of inspired gases is desired. Use up to 24 hours. Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients. | 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Passy Muir. The logo consists of the name "Passy Muir" in a stylized, cursive font in purple. To the right of the name is a purple square containing a white silhouette of a person's head and neck, with sound waves emanating from the mouth. #### 510(K) SUMMARY #### K230483 - DATE PREPARED: September 16, 2023 - Passy-Muir, Inc. APPLICANT: 4521 Campus Dr., PMB 273 Irvine, CA 92612 - MANUFACTURER: Passy-Muir, Inc. 4521 Campus Dr., PMB 273 Irvine, CA 92612 - Donna Malter (RA/QA Manager) CONTACT PERSON: Email: dmalter@passymuir.com Tel: (949) 833-8255 - PROPRIETARY NAME: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) - Filter, bacterial, breathing-circuit COMMON NAME: REGULATION NUMBER: 21 CFR 868.5260 - PRODUCT CODE: CAH - Class II DEVICE CLASS: - REVIEW PANEL: General Hospital Premarket Review: Surgical and Infection Control Devices (OHT4) Infection Control and Plastic Surgery Devices (DHT4B) - PREDICATE DEVICE: Altera Filter K192713 (Filter Only) by Meditera Tibbi Malzeme, San. ve Tic. A.S. DEVICE DESCRIPTION: The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion. PRINCIPLE OF OPERATION: Filtration is via the principle of electrostatic charges that attract and capture microbes in the media. {4}------------------------------------------------ INTENDED USE: To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses. ## INDICATIONS FOR USE: For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours. Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients. # Technological Characteristics Comparison # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: | Description | Subject Device | Predicate Device (K192713) | Comparison | |----------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------| | Device | Passy Muir Tracheostomy
Viral & Bacterial Airway
Protection Filter (PM-APF15) | Altera Filter - K192713 (Filter
Only) by Meditera Tibbi
Malzeme, San. Ve Tic. A.S. | N/A | | Model | Passy Muir Tracheostomy
Viral & Bacterial Airway
Protection Filter (PM-APF15) | Not available | N/A | | Classification | Class II Device, CAH - Filter,
Bacterial, Breathing-Circuit
(21 CFR 868.5260) | Class II Device, CAH - Filter,
Bacterial, Breathing-Circuit
(21 CFR 868.5260) | Same | | Intended Use | To filter a patient's
inspiratory and expiratory
respiratory gasses to remove
bacteria and viruses. | To filter a patient's inspiratory
and expiratory respiratory
gasses to remove bacteria and
viruses. | Same | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Passy Muir logo. The logo is purple and features the company name in a stylized font. To the right of the name is a purple square with rounded corners, inside of which is a white silhouette of a person's head and neck with sound waves coming from their mouth. | Indications for Use | For non-mechanically
ventilated tracheostomy
patients who are awake and
alert or monitored by a
trained healthcare provider or
caregiver, where filtration of
inspired and/or expired gases
is desired. Use up to 24
hours.
Environment of use - clinical
settings including hospital,
sub-acute, pre-hospital, and
home. For adults with Tidal
Volumes >300 ml and
pediatrics with Tidal
Volumes >80 ml. Do not use
on neonate or infant patients. | [Filter Device] For use with
ventilators, anesthesia
machines and open flow
systems where filtration of
inspired and/or expired gases
is desired. Use up to 24 hours.
[HME Device] N/A
Environment of use - clinical
settings including hospital,
sub-acute, pre-hospital and
home or patients with Tidal
Volumes >300 ml | Similar
-Second
device in
K192713 is an
HME and not
relevant to this
submission | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Principle of Operation | Filtration is via the principle
of electrostatic charges that
attract and capture microbes
in the media. | Filtration is via the principle of
electrostatic charges that
attract and capture microbes in
the media. | Same | | Patient Population | Adults Tidal Volume
>300 ml
Pediatrics Tidal Volume
>80 ml. Do not use on
neonate or infant patients. | Adults Tidal Volume >300ml | Similar | | Anatomical Site | Breathing gas pathway | Breathing gas pathway | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Passy Muir. The logo consists of the name "Passy Muir" in a stylized, cursive font, with a registered trademark symbol next to it. To the right of the name is a purple square with rounded corners, inside of which is a white silhouette of a person's head and neck, with sound waves emanating from the mouth. | Description | Subject Device | Predicate Device (K192713) | Comparison | |-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Environments of Use | Hospitals, sub-acute,
pre-hospital, and home | Hospitals, sub-acute,
pre-hospital, and home | Same | | Compatibility with
environment and other
devices | Intended for use with open
tracheostomy tube with a
15mm conical connector | Intended for use with
ventilators, anesthesia gas
machines and open flow
systems that utilize a 15mm or
22mm conical connector | Similar | | Prescriptive | Yes | Yes | Same | | Packaging | Non-sterile | Non-sterile | Same | | Single patient use,
disposable | Yes, up to 24 hours | Yes, up to 24 hours | Same | | Filter Media | Media -polypropylene media | Media –polypropylene media | Similiar | | Housing Material | Medical grade ABS | Unknown | N/A | | Biocompatibility | Externally Communicating,
Tissue, Limited
Cytotoxicity
Sensitization Irritation
Leachable and Extractables
with TRA
Acute Systemic Toxicity
Volatile Organic Compound
Testing
Particulate Matter Testing | Externally Communicating,
Tissue, Limited
Cytotoxicity
Sensitization Irritation
Leachable and Extractables
with TRA
Acute Systemic Toxicity
Volatile Organic Compound
Testing
Particulate Matter Testing | Same | | Performance Testing | Flow Resistance
<1.7 cmH2O @ 60 LPM
Leakage - 0 ml/min | Flow Resistance
<1.7 cmH2O @ 60 LPM
Leakage - 0 ml/min | Similar | | Dead space | 6 ml | 45 ml | Different | | Particulate Filtration
Efficiency ASTM
F2299 @ 0.1 µm (PFE) | >99.0% | Not available | N/A | | Bacterial Filtration
Efficiency (BFE)* | >99.9% | 99.998% | Similar | | Viral Filtration
Efficiency (VFE)* | >99.9% | 99.96% | Similar | | Connector | 15mm conical connector ISO
5356-1 | 15mm and 22mm conical
connectors ISO 5356-1 | 15mm conical
connector
same
22mm N/A | | Shelf Life | Unknown | 3 years | N/A | *ASTM F2100. Bacterial and Viral Filtration Efficiency test method adapted from ASTM F2101. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for Passy Muir. The logo features the name "Passy Muir" in a stylized, cursive font in purple. To the right of the name is a purple square containing a white silhouette of a person's head and neck, with sound waves emanating from the mouth, suggesting speech or communication. # NON-CLINICAL TESTING OF SUBJECT DEVICE: | Test Method | Test Performed | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------| | FDA Recognized
Consensus Standard No.
1-62, ISO 5356-1 Third
Edition 2004-05-15 | Conical Connector
Compliance | Meet the Standard | Met the Standard | | Pre-determined
Acceptance Criteria | Leak Testing | No leak at 1 psi for 2
minutes | Leakage -
0 ml/min | | Pre-determined
Acceptance Criteria | Dead Space | Better than predicate
(45 ml) | 6 ml | | FDA Recognized
Consensus Standard No.
2-245, ISO 10993-5 Third
edition 2018-08 | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | | FDA Recognized
Consensus Standard No.
2-296, ISO 10993-10
Fourth Edition 2021-11 | Skin Sensitization | Not a contact skin
sensitizer | Not a contact
skin sensitizer | | FDA Recognized
Consensus Standard No.
2-291, ISO 10993-23 First
Edition 2021-11 | Irritation | Non-Irritant | Non-Irritant | | FDA Recognized
Consensus Standard No.
1-135, ISO 18562-2 First
Edition 2017-03 | Particulate Matter Testing | <12 micrograms / m3PM | <12 micrograms
/ m³PM | | FDA Recognized
Consensus Standard No.
1-136, ISO 18562-3 First
Edition 2017-03 | Volatile Organic
Compounds (VOC)
Testing | Identify and confirm
VOCs within safe levels | Identified and
confirmed
VOCs within
safe levels | | FDA Recognized
Consensus Standard No.
1-137, ISO 18562-4 First
Edition 2017-03 | Leachables in Condensate
Testing | Meet Standard | Met Standard | | ASTM F2299/F2299M | Particle Filtration
Efficiency | Particle efficiency ≥ 99%
0.1 µm (PFE) for 0.1
micron particle | 99.0% 0.1 µm
(PFE) for 0.1
micron particle | | ASTM F2299/F2299M | Flow Resistance | <1.7 cmH2O @ 60 LPM
Leakage - 0 ml/min | <1.7 cmH2O @
60 LPM
Leakage -
0 ml/min | | Test Method | Test Performed | Acceptance Criteria | Results | | ASTM F2101 | Viral Filtration Efficiency
(VFE) % | Viral filtration efficiency
is equivalent to predicate | >99.9% | | ASTM F2101 | Bacterial Filtration
Efficiency (BFE) % | Bacterial filtration
efficiency is equivalent to
predicate | >99.9% | | FDA Recognized
Consensus Standard No.
14-497, ASTM 1980-16 | Accelerated Aging | Device meets its
performance
specifications post-
conditioning | Device met its
performance
specifications
post-
conditioning | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Passy Muir. The logo consists of the name "Passy Muir" in a stylized, cursive font in purple. To the right of the name is a purple square containing a white silhouette of a person's head and neck, with sound waves emanating from the mouth, suggesting speech or communication. # CONCLUSION: The conclusions drawn from the non-clinical performance testing demonstrate that the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is as safe, as effective, and perform as well as or better than the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K230483](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94therapeutic-devices/CAH/K230483) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com