(68 days)
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
The filter is comprised of a female (22 mm) filter housing, filter media and male (22 mm) filter housing. The filter media is a depth-type, electrostatic, hydrophobic media which traps microbiological and particulate matter. The filter media is held in place between the female and male filter housings. Both the female and male filter housings have standard 22 mm diameter connectors which have been designed to comply with ISO 5356-1.
Here's a summary of the acceptance criteria and study information for the RT016 Inspiratory Filter, based on the provided text:
Acceptance Criteria and Device Performance Study for the RT016 Inspiratory Filter
This submission focuses on establishing substantial equivalence to a predicate device, the RT019 Inspiratory/Expiratory Filter (K050927), rather than defining new acceptance criteria and proving the device meets them in a standalone study. The key argument is that the RT016 shares identical critical components and performance characteristics with the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly the performance specifications of the predicate device, which the RT016 is claimed to match due to identical components and design in critical functions.
| Performance Characteristic | Acceptance Criteria (from predicate/shared components) | Reported Device Performance (RT016) |
|---|---|---|
| Bacterial Filtration Efficiency | >99.9997% | >99.9997% |
| Viral Filtration Efficiency | >99.99% | >99.99% |
| Filtration Efficiency (Salt Test) | 98.17% | 98.17% |
| Resistance to flow @ 15 L/min | 0.35 ± 0.06 cmH2O | 0.35 ± 0.06 cmH2O |
| Resistance to flow @ 30 L/min | 0.71 ± 0.12 cmH2O | 0.71 ± 0.12 cmH2O |
| Internal volume | 38 mL | 38 mL |
| Compliance | 0.13 mL/cmH2O | 0.13 mL/cmH2O |
| Gas leakage | <5 mL/min at 70 ± 3.5 cmH2O | <5 mL/min at 70 ± 3.5 cmH2O |
Note: The submission asserts "The filtration of the two devices shows that the filtration performance is identical," meaning the RT016 is expected to perform identically to the predicate device for these critical features.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for the test set. The language used refers to "performance testing" and "results of the performance testing" without detailing the number of units tested. The data provenance is presumed to be from the manufacturer (Fisher & Paykel Healthcare) and conducted in their facilities or contracted labs, likely within New Zealand (country of origin of the submitter). The testing is retrospective in the sense that it relies heavily on the established performance of the predicate device's components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device performance study (bench testing) for filtration and physical characteristics, not a diagnostic imaging study requiring expert interpretation or ground truth establishment by clinical experts.
4. Adjudication Method for the Test Set
Not applicable for this type of technical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (breathing circuit bacterial filter). This device does not involve human reader interpretation or diagnostic effectiveness that an MRMC study would assess.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a "standalone" physical filter, in the context of typical AI/software device terminology, this question refers to algorithmic performance. Since the RT016 is a physical filter and not a software algorithm, this question is not applicable. The performance described is the inherent physical filtration and flow characteristics of the device.
7. The Type of Ground Truth Used
The ground truth used for performance validation is based on standard engineering and microbiology test methods for filters (e.g., measuring bacterial and viral filtration efficiency, resistance to flow, internal volume, compliance, and gas leakage according to recognized standards like BS EN ISO 23328-1:2008 for the salt test). The "ground truth" for the RT016's expected performance is derived directly from the previously established and accepted performance of its identical filter media and components from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This refers to a physical medical device. There is no "training set" in the context of an AI/machine learning model. The device's design is based on established engineering principles and materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI model, there is no ground truth established in that sense. The device's performance is validated through physical and microbiological bench testing against industry standards and comparisons to its predicate.
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510(k) Notification 5-1
510(k) Summary 5
FEB - 5 2014
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15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person/submitter | Elizabeth Goldstein |
|---|---|
| Date prepared | 27 November 2013 |
| Contact details | Address: 15 Maurice Paykel PlacePaykel BuildingEast TamakiAuckland 2013, New ZealandTelephone: +64 9 574 0100Fax: +64 9 574 0148 |
| Trade name | RT016 Inspiratory Filter |
| Common name | Breathing circuit bacterial filter |
| Classification name | Breathing circuit bacterial filterClass II (21 CFR §868.5260)Product code CAH (Filter, Bacterial, Breathing-Circuit) |
| Predicate device | RT019 Inspiratory/Expiratory Filter (K050927) |
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5.1 Device Description
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
The filter is comprised of a female (22 mm) filter housing, filter media and male (22 mm) filter housing. The filter media is a depth-type, electrostatic, hydrophobic media which traps microbiological and particulate matter. The filter media is held in place between the female and male filter housings. Both the female and male filter housings have standard 22 mm diameter connectors which have been designed to comply with ISO 5356-1.
5.2 Indications for Use
The Fisher & Paykel Healthcare RT016 Inspiratory Filter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
5.2.1 Indications for Use Comparison
The indications for Use Statements of the subject device, RT016 Inspiratory Filter, and the predicate device. RT019 Inspiratory/Expiratory Filter (K050927), are identical with the exception of the following:
- The placement of the filter with a ventilator system, where: :
- o The subject device, RT016 Inspiratory Filter, is intended to be connected to the ventilator inspiratory port only.
- The predicate device, RT019 Inspiratory/Expiratory Filter (K050927), may be o connected to the ventilator inspiratory and/or the ventilator expiratory port.
This change in configuration does not raise any new questions of safety or effectiveness for the following reasons:
- . The placement of the RT016 Inspiratory Filter on the ventilator inspiratory port is also an approved configuration for the predicate device.
- The RT016 Inspiratory Filter labelling clearly identifies the device as an . inspiratory filter and shows the RT016 Inspiratory Filter connected to the ventilator inspiratory port.
Refer to Table 5.1 on the following page for a side-by-side comparison of the Indications for Statements of the subject and predicate devices.
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| Design/technologicalcharacteristic forcomparison | Subject device(RT016 Inspiratory Filter) | Predicate device(RT019Inspiratory/ExpiratoryFilter, K050927) | Comments |
|---|---|---|---|
| Indications for use | • The Fisher & PaykelHealthcare RT016Inspiratory Filter isintended for use betweena ventilator and breathingcircuit. | • The Fisher & PaykelHealthcare RT019Inspiratory/ExpiratoryFilter is intended for usebetween a ventilator andbreathing circuit. | Identical |
| • Its function is to removemicrobiological andparticulate matter fromgases entering a breathingcircuit. The RT016 isintended to be connectedto the ventilatorinspiratory port. | • Its function is to removemicrobiological andparticulate matter fromgases entering and/orexiting a breathing circuit.The RT019 is intended tobe connected to theventilator inspiratoryand/or expiratory ports. | IdenticalThe function of thesubject device andpredicate device isidentical.However the subjectdevice is intended tobe connected to theventilator inspiratoryport only, whereasthe predicate devicemay be connected tothe ventilatorinspiratory and/orexpiratory ports. | |
| • It is not directional interms of flow and is asingle use device. | • It is not directional interms of flow and is asingle use device. | Identical | |
| • Availability: prescriptionuse (Part 21 CFR 801Subpart D) | • Availability: prescriptionuse (Part 21 CFR 801Subpart D) | Identical |
Table 5.1 A comparison of the Indications for Use of the subject and predicate devices
5.3 Technological Characteristics Comparison
The subject device, RT016 Inspiratory Filter, is identical to the predicate device, RT019 Inspiratory/Expiratory Filter (K050927), with respect to the following technological characteristics:
- Function, i.e. to remove microbiological and particulate matter from gases, as per the . Indications for Use.
- Reusability (i.e. single use) and sterility (i.e. non-sterile). .
- . Design:
- o All components of the RT016 Inspiratory Filter are identical to the corresponding components of the RT019 Inspiratory Expiratory Filter, including materials and processing;
- Performance (i.e. filtration efficiency). .
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The subject device, RT016 Inspiratory Filter, differs from the predicate device, RT019 Inspiratory/Expiratory Filter (K050927), in that:
- The predicate device, RT019 Inspiratory/Expiratory Filter (K050927), has insulation . housing to reduce condensation when used on the ventilator expiratory port (i.e. used with gases which are warm and humid), whereas the RT016 Inspiratory Filter does not have an insulation case as it is used on the ventilator inspiratory port only (i.e. on gases which are dry).
Refer to Table 5.2 for a side-by-side comparison of the key technological characteristics of the subject device, RT016 Inspiratory Filter, and the predicate device, RT019 Inspiratory/Expiratory Filter (K050927).
| Design/technologicalcharacteristic forcomparison | Subject device(RT016 Inspiratory Filter) | Predicate device(RT019Inspiratory/ExpiratoryFilter, K050927) | Comments |
|---|---|---|---|
| Configuration | Connected to theventilator inspiratoryport | Connected to theventilator inspiratoryport Connected to theventilator expiratoryport | IdenticalAs per the Indicationsfor use, the subjectdevice is intended tobe connected to theventilator inspiratoryport only. |
| Reusability | Single use only | Single use only | Identical |
| Components | Female (22 mm) filterhousing; Filter media; Male (22 mm) filterhousing | Female (22 mm) filterhousing; Filter media; Male (22 mm) filterhousing; Male insulation casing; Female insulationcasing | IdenticalAll components usedin subject device areidentical to thecorrespondingcomponents used inthe predicate device,including identicalmaterials andprocessing.The subject devicedoes not include themale or femaleinsulation casingcomponents. |
| Connectors | Standard 22 mmconnectors Designed to complywithISO 5356-1:2004 | Standard 22 mmconnectors Designed to complywithISO 5356-1:2004 | Identical |
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| Design/technologicalcharacteristic forcomparison | Subject device(RT016 Inspiratory Filter) | Predicate device(RT019Inspiratory/ExpiratoryFilter, K050927) | Comments |
|---|---|---|---|
| Sterility | Supplied in a non-sterile state Non-sterile when used | Supplied in a non-sterile state Non-sterile when used | Identical |
| Filtration efficiency | Bacterial: >99.9997% Viral: >99.99% Salt test: 98.17% | Bacterial: >99.9997% Viral: >99.99% Salt test: 98.17% | Identical |
| Technicalspecifications | Resistance to flow:$0.35 \pm .06$ cmH2O at 15 L/min $0.71 \pm 0.12$ cmH2O at 30 L/min Internal volume (i.e. compressible volume): 38 mL Compliance: 0.13 mL/cmH2O Gas leakage: <5 mL/min at $70 \pm 3.5$ cmH2O | Resistance to flow:$0.35 \pm .06$ cmH2O at 15 L/min $0.71 \pm 0.12$ cmH2O at 30 L/min Internal volume (i.e. compressible volume): 38 mL Compliance: 0.13 mL/cmH2O Gas leakage: <5 mL/min at $70 \pm 3.5$ cmH2O | Identical |
Table 5.2 A comparison of the key technological characteristics of the subject and predicate devices
5.4 Non-Clinical Tests
The RT016 Inspiratory Filter and the predicate device, RT019 Inspiratory/Expiratory Filter (K050927), share the same filter media component and therefore the non-clinical tests summarized below are applicable to both devices.
The following performance characteristics of the filter media were tested:
- Bacterial filtration efficiency; .
- Viral filtration efficiency; and .
- Filtration efficiency as per the salt test method specified in BS EN ISO 23328-1:2008. .
The results of the performance testing are as follows:
- . Bacterial filtration efficiency: >99.9997%;
- . Viral filtration efficiency: >99.99%; and
- . Filtration efficiency as per the salt test method (NaCl): 98.17%.
The filtration of the two devices shows that the filtration performance is identical.
5.5 Clinical Tests
.
Not applicable - no clinical testing was performed with respect to the RT016 Inspiratory Filter.
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5.6 Conclusion
The comparison of the technological characteristics summarized above demonstrates that the subject device, RT016 Inspiratory Filter, is substantially equivalent to the predicate device, RT019 Inspiratory/Expiratory Filter (K050927). In addition, bench testing, as summarized above, supports both performance of the RT016 Inspiratory Filter in accordance with its intended use as well as substantial equivalence of the RT016 Inspiratory Filter to the RT019 Inspiratory/Expiratory Filter (K050927).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2014
Fisher & Paykel Healthcare Elizabeth Goldstein Regulatory Affairs Specialist 15 Maurice Paykel Place Paykel Building East Tamaki Auckland, New Zealand 14 348
Re: K133666
Trade/Device Name: RT016 Inspiratory Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: November 27, 2013 Received: November 29, 2013
Dear Ms. Goldstein:
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. 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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Page 2 - Ms. Elizabeth Goldstein
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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Erin Keith Acting Division Director Division of General Hospital, Respiratory, Anesthesiology Infectious Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name RT016 Inspiratory Filter
Indications for Use (Describe)
The Fisher & Paykel Healthcare RTD16 Inspiratory Fitter is intended for use between a ventilator and breathing circuit. Its function is to remove microbiological and particulate matter from gases entering a breathing circuit. The RT016 is intended to the ventilator inspiratory port. It is not directional in terms of flow and is a single use device.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CARDE OF COLLECTION OF FOR FDALUSE ONLY . STOREDAL CONSULT AND AND AND Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FDA
Anya C. Harry -S 2014.01.29 19:31:18 -05'00'
FORM FDA 3881 (9/13)
PSC Publishung Scrices (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 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).