(205 days)
To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses.
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.
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.
The provided document is a 510(k) summary for the Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15). It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Conical Connector Compliance | Meet the Standard (FDA Recognized Consensus Standard No. 1-62, ISO 5356-1 Third Edition 2004-05-15) | Met the Standard |
| Leak Testing | No leak at 1 psi for 2 minutes | 0 ml/min |
| Dead Space | Better than predicate (45 ml) | 6 ml |
| Cytotoxicity | Non-cytotoxic (FDA Recognized Consensus Standard No. 2-245, ISO 10993-5 Third edition 2018-08) | Non-cytotoxic |
| Skin Sensitization | Not a contact skin sensitizer (FDA Recognized Consensus Standard No. 2-296, ISO 10993-10 Fourth Edition 2021-11) | Not a contact skin sensitizer |
| Irritation | Non-Irritant (FDA Recognized Consensus Standard No. 2-291, ISO 10993-23 First Edition 2021-11) | Non-Irritant |
| Particulate Matter Testing | <12 micrograms / m³PM (FDA Recognized Consensus Standard No. 1-135, ISO 18562-2 First Edition 2017-03) | <12 micrograms / m³PM |
| Volatile Organic Compounds (VOC) Testing | Identify and confirm VOCs within safe levels (FDA Recognized Consensus Standard No. 1-136, ISO 18562-3 First Edition 2017-03) | Identified and confirmed VOCs within safe levels |
| Leachables in Condensate Testing | Meet Standard (FDA Recognized Consensus Standard No. 1-137, ISO 18562-4 First Edition 2017-03) | Met Standard |
| Particle Filtration Efficiency (PFE) | Particle efficiency ≥ 99% 0.1 µm (PFE) for 0.1 micron particle (ASTM F2299/F2299M) | 99.0% 0.1 µm (PFE) for 0.1 micron particle |
| Flow Resistance | <1.7 cmH2O @ 60 LPM (ASTM F2299/F2299M) | <1.7 cmH2O @ 60 LPM |
| Leakage | 0 ml/min (ASTM F2299/F2299M) | 0 ml/min |
| Viral Filtration Efficiency (VFE) % | Viral filtration efficiency is equivalent to predicate (ASTM F2101) | >99.9% |
| Bacterial Filtration Efficiency (BFE) % | Bacterial filtration efficiency is equivalent to predicate (ASTM F2101) | >99.9% |
| Accelerated Aging | Device meets its performance specifications post-conditioning (FDA Recognized Consensus Standard No. 14-497, ASTM 1980-16) | Device met its performance specifications post-conditioning |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (N per test) for each performance test. It only states the acceptance criteria and results. The data provenance is non-clinical, likely laboratory testing, and no geographic origin is specified for these tests. All tests appear to be prospective, laboratory-based evaluations of the device's physical and filtration properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study described is non-clinical performance testing of a physical filter device, not a study involving human or image interpretation by experts. Ground truth is established by measurable physical and chemical properties according to recognized standards (e.g., ISO, ASTM).
4. Adjudication method for the test set
Not applicable, as this is non-clinical performance testing, not a study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive filtration device, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on pre-defined physical and chemical standards and objective measurements. For example:
- Conical Connector Compliance: Measured against ISO 5356-1 standard.
- Filtration Efficiency (BFE/VFE/PFE): Measured objectively against ASTM F2101 and ASTM F2299 standards.
- Leakage/Dead Space/Flow Resistance: Directly measured physical properties.
- Biocompatibility (Cytotoxicity, Sensitization, Irritation): Assessed according to ISO 10993 series standards, which involve laboratory assays and observations against established biological safety criteria.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is involved.
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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.
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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
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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) |
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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.
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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 TracheostomyViral & Bacterial AirwayProtection Filter (PM-APF15) | Altera Filter - K192713 (FilterOnly) by Meditera TibbiMalzeme, San. Ve Tic. A.S. | N/A |
| Model | Passy Muir TracheostomyViral & Bacterial AirwayProtection 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'sinspiratory and expiratoryrespiratory gasses to removebacteria and viruses. | To filter a patient's inspiratoryand expiratory respiratorygasses to remove bacteria andviruses. | Same |
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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-mechanicallyventilated tracheostomypatients who are awake andalert or monitored by atrained healthcare provider orcaregiver, where filtration ofinspired and/or expired gasesis desired. Use up to 24hours.Environment of use - clinicalsettings including hospital,sub-acute, pre-hospital, andhome. For adults with TidalVolumes >300 ml andpediatrics with TidalVolumes >80 ml. Do not useon neonate or infant patients. | [Filter Device] For use withventilators, anesthesiamachines and open flowsystems where filtration ofinspired and/or expired gasesis desired. Use up to 24 hours.[HME Device] N/AEnvironment of use - clinicalsettings including hospital,sub-acute, pre-hospital andhome or patients with TidalVolumes >300 ml | Similar-Seconddevice inK192713 is anHME and notrelevant to thissubmission |
|---|---|---|---|
| Principle of Operation | Filtration is via the principleof electrostatic charges thatattract and capture microbesin the media. | Filtration is via the principle ofelectrostatic charges thatattract and capture microbes inthe media. | Same |
| Patient Population | Adults Tidal Volume>300 mlPediatrics Tidal Volume>80 ml. Do not use onneonate or infant patients. | Adults Tidal Volume >300ml | Similar |
| Anatomical Site | Breathing gas pathway | Breathing gas pathway | Same |
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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 withenvironment and otherdevices | Intended for use with opentracheostomy tube with a15mm conical connector | Intended for use withventilators, anesthesia gasmachines and open flowsystems that utilize a 15mm or22mm 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, LimitedCytotoxicitySensitization IrritationLeachable and Extractableswith TRAAcute Systemic ToxicityVolatile Organic CompoundTestingParticulate Matter Testing | Externally Communicating,Tissue, LimitedCytotoxicitySensitization IrritationLeachable and Extractableswith TRAAcute Systemic ToxicityVolatile Organic CompoundTestingParticulate Matter Testing | Same |
| Performance Testing | Flow Resistance<1.7 cmH2O @ 60 LPMLeakage - 0 ml/min | Flow Resistance<1.7 cmH2O @ 60 LPMLeakage - 0 ml/min | Similar |
| Dead space | 6 ml | 45 ml | Different |
| Particulate FiltrationEfficiency ASTMF2299 @ 0.1 µm (PFE) | >99.0% | Not available | N/A |
| Bacterial FiltrationEfficiency (BFE)* | >99.9% | 99.998% | Similar |
| Viral FiltrationEfficiency (VFE)* | >99.9% | 99.96% | Similar |
| Connector | 15mm conical connector ISO5356-1 | 15mm and 22mm conicalconnectors ISO 5356-1 | 15mm conicalconnectorsame22mm N/A |
| Shelf Life | Unknown | 3 years | N/A |
*ASTM F2100. Bacterial and Viral Filtration Efficiency test method adapted from ASTM F2101.
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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 RecognizedConsensus Standard No.1-62, ISO 5356-1 ThirdEdition 2004-05-15 | Conical ConnectorCompliance | Meet the Standard | Met the Standard |
| Pre-determinedAcceptance Criteria | Leak Testing | No leak at 1 psi for 2minutes | Leakage -0 ml/min |
| Pre-determinedAcceptance Criteria | Dead Space | Better than predicate(45 ml) | 6 ml |
| FDA RecognizedConsensus Standard No.2-245, ISO 10993-5 Thirdedition 2018-08 | Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| FDA RecognizedConsensus Standard No.2-296, ISO 10993-10Fourth Edition 2021-11 | Skin Sensitization | Not a contact skinsensitizer | Not a contactskin sensitizer |
| FDA RecognizedConsensus Standard No.2-291, ISO 10993-23 FirstEdition 2021-11 | Irritation | Non-Irritant | Non-Irritant |
| FDA RecognizedConsensus Standard No.1-135, ISO 18562-2 FirstEdition 2017-03 | Particulate Matter Testing | <12 micrograms / m3PM | <12 micrograms/ m³PM |
| FDA RecognizedConsensus Standard No.1-136, ISO 18562-3 FirstEdition 2017-03 | Volatile OrganicCompounds (VOC)Testing | Identify and confirmVOCs within safe levels | Identified andconfirmedVOCs withinsafe levels |
| FDA RecognizedConsensus Standard No.1-137, ISO 18562-4 FirstEdition 2017-03 | Leachables in CondensateTesting | Meet Standard | Met Standard |
| ASTM F2299/F2299M | Particle FiltrationEfficiency | Particle efficiency ≥ 99%0.1 µm (PFE) for 0.1micron particle | 99.0% 0.1 µm(PFE) for 0.1micron particle |
| ASTM F2299/F2299M | Flow Resistance | <1.7 cmH2O @ 60 LPMLeakage - 0 ml/min | <1.7 cmH2O @60 LPMLeakage -0 ml/min |
| Test Method | Test Performed | Acceptance Criteria | Results |
| ASTM F2101 | Viral Filtration Efficiency(VFE) % | Viral filtration efficiencyis equivalent to predicate | >99.9% |
| ASTM F2101 | Bacterial FiltrationEfficiency (BFE) % | Bacterial filtrationefficiency is equivalent topredicate | >99.9% |
| FDA RecognizedConsensus Standard No.14-497, ASTM 1980-16 | Accelerated Aging | Device meets itsperformancespecifications post-conditioning | Device met itsperformancespecificationspost-conditioning |
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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.
§ 868.5260 Breathing circuit bacterial filter.
(a)
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.(b)
Classification. Class II (performance standards).