Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

{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) | |----------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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. 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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<br>Viral & Bacterial Airway<br>Protection Filter (PM-APF15) | Altera Filter - K192713 (Filter<br>Only) by Meditera Tibbi<br>Malzeme, San. Ve Tic. A.S. | N/A | | Model | Passy Muir Tracheostomy<br>Viral & Bacterial Airway<br>Protection Filter (PM-APF15) | Not available | N/A | | Classification | Class II Device, CAH - Filter,<br>Bacterial, Breathing-Circuit<br>(21 CFR 868.5260) | Class II Device, CAH - Filter,<br>Bacterial, Breathing-Circuit<br>(21 CFR 868.5260) | Same | | Intended Use | To filter a patient's<br>inspiratory and expiratory<br>respiratory gasses to remove<br>bacteria and viruses. | To filter a patient's inspiratory<br>and expiratory respiratory<br>gasses to remove bacteria and<br>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<br>ventilated tracheostomy<br>patients who are awake and<br>alert or monitored by a<br>trained healthcare provider or<br>caregiver, where filtration of<br>inspired and/or expired gases<br>is desired. Use up to 24<br>hours.<br>Environment of use - clinical<br>settings including hospital,<br>sub-acute, pre-hospital, and<br>home. For adults with Tidal<br>Volumes >300 ml and<br>pediatrics with Tidal<br>Volumes >80 ml. Do not use<br>on neonate or infant patients. | [Filter Device] For use with<br>ventilators, anesthesia<br>machines and open flow<br>systems where filtration of<br>inspired and/or expired gases<br>is desired. Use up to 24 hours.<br>[HME Device] N/A<br>Environment of use - clinical<br>settings including hospital,<br>sub-acute, pre-hospital and<br>home or patients with Tidal<br>Volumes >300 ml | Similar<br>-Second<br>device in<br>K192713 is an<br>HME and not<br>relevant to this<br>submission | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Principle of Operation | Filtration is via the principle<br>of electrostatic charges that<br>attract and capture microbes<br>in the media. | Filtration is via the principle of<br>electrostatic charges that<br>attract and capture microbes in<br>the media. | Same | | Patient Population | Adults Tidal Volume<br>>300 ml<br>Pediatrics Tidal Volume<br>>80 ml. Do not use on<br>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,<br>pre-hospital, and home | Hospitals, sub-acute,<br>pre-hospital, and home | Same | | Compatibility with<br>environment and other<br>devices | Intended for use with open<br>tracheostomy tube with a<br>15mm conical connector | Intended for use with<br>ventilators, anesthesia gas<br>machines and open flow<br>systems that utilize a 15mm or<br>22mm conical connector | Similar | | Prescriptive | Yes | Yes | Same | | Packaging | Non-sterile | Non-sterile | Same | | Single patient use,<br>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,<br>Tissue, Limited<br>Cytotoxicity<br>Sensitization Irritation<br>Leachable and Extractables<br>with TRA<br>Acute Systemic Toxicity<br>Volatile Organic Compound<br>Testing<br>Particulate Matter Testing | Externally Communicating,<br>Tissue, Limited<br>Cytotoxicity<br>Sensitization Irritation<br>Leachable and Extractables<br>with TRA<br>Acute Systemic Toxicity<br>Volatile Organic Compound<br>Testing<br>Particulate Matter Testing | Same | | Performance Testing | Flow Resistance<br><1.7 cmH2O @ 60 LPM<br>Leakage - 0 ml/min | Flow Resistance<br><1.7 cmH2O @ 60 LPM<br>Leakage - 0 ml/min | Similar | | Dead space | 6 ml | 45 ml | Different | | Particulate Filtration<br>Efficiency ASTM<br>F2299 @ 0.1 µm (PFE) | >99.0% | Not available | N/A | | Bacterial Filtration<br>Efficiency (BFE)* | >99.9% | 99.998% | Similar | | Viral Filtration<br>Efficiency (VFE)* | >99.9% | 99.96% | Similar | | Connector | 15mm conical connector ISO<br>5356-1 | 15mm and 22mm conical<br>connectors ISO 5356-1 | 15mm conical<br>connector<br>same<br>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<br>Consensus Standard No.<br>1-62, ISO 5356-1 Third<br>Edition 2004-05-15 | Conical Connector<br>Compliance | Meet the Standard | Met the Standard | | Pre-determined<br>Acceptance Criteria | Leak Testing | No leak at 1 psi for 2<br>minutes | Leakage -<br>0 ml/min | | Pre-determined<br>Acceptance Criteria | Dead Space | Better than predicate<br>(45 ml) | 6 ml | | FDA Recognized<br>Consensus Standard No.<br>2-245, ISO 10993-5 Third<br>edition 2018-08 | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | | FDA Recognized<br>Consensus Standard No.<br>2-296, ISO 10993-10<br>Fourth Edition 2021-11 | Skin Sensitization | Not a contact skin<br>sensitizer | Not a contact<br>skin sensitizer | | FDA Recognized<br>Consensus Standard No.<br>2-291, ISO 10993-23 First<br>Edition 2021-11 | Irritation | Non-Irritant | Non-Irritant | | FDA Recognized<br>Consensus Standard No.<br>1-135, ISO 18562-2 First<br>Edition 2017-03 | Particulate Matter Testing | <12 micrograms / m3PM | <12 micrograms<br>/ m³PM | | FDA Recognized<br>Consensus Standard No.<br>1-136, ISO 18562-3 First<br>Edition 2017-03 | Volatile Organic<br>Compounds (VOC)<br>Testing | Identify and confirm<br>VOCs within safe levels | Identified and<br>confirmed<br>VOCs within<br>safe levels | | FDA Recognized<br>Consensus Standard No.<br>1-137, ISO 18562-4 First<br>Edition 2017-03 | Leachables in Condensate<br>Testing | Meet Standard | Met Standard | | ASTM F2299/F2299M | Particle Filtration<br>Efficiency | Particle efficiency ≥ 99%<br>0.1 µm (PFE) for 0.1<br>micron particle | 99.0% 0.1 µm<br>(PFE) for 0.1<br>micron particle | | ASTM F2299/F2299M | Flow Resistance | <1.7 cmH2O @ 60 LPM<br>Leakage - 0 ml/min | <1.7 cmH2O @<br>60 LPM<br>Leakage -<br>0 ml/min | | Test Method | Test Performed | Acceptance Criteria | Results | | ASTM F2101 | Viral Filtration Efficiency<br>(VFE) % | Viral filtration efficiency<br>is equivalent to predicate | >99.9% | | ASTM F2101 | Bacterial Filtration<br>Efficiency (BFE) % | Bacterial filtration<br>efficiency is equivalent to<br>predicate | >99.9% | | FDA Recognized<br>Consensus Standard No.<br>14-497, ASTM 1980-16 | Accelerated Aging | Device meets its<br>performance<br>specifications post-<br>conditioning | Device met its<br>performance<br>specifications<br>post-<br>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.