(68 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the device, with no mention of AI or ML.
No
The device is an inspiratory filter intended to remove microbiological and particulate matter from gases in a breathing circuit, which is a supportive function rather than directly providing therapy.
No
This device is an inspiratory filter designed to remove microbiological and particulate matter from gases for a ventilator. Its function does not involve diagnosing medical conditions.
No
The device description clearly outlines physical components (filter housing, filter media) and its function is based on physical filtration, not software processing.
Based on the provided information, the Fisher & Paykel Healthcare RT016 Inspiratory Filter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to filter gases entering a breathing circuit from a ventilator, removing microbiological and particulate matter. This is a function related to the delivery of medical gas to a patient, not the analysis of biological samples from the human body.
- Device Description: The description details a physical filter with specific components and materials designed for gas filtration. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on filtration efficiency (bacterial, viral, salt), resistance to flow, volume, compliance, and gas leakage. These are all parameters relevant to the performance of a gas filter in a breathing circuit, not to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RT016 filter does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Tests:
Not applicable - no clinical testing was performed with respect to the RT016 Inspiratory Filter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency: >99.9997%
Viral filtration efficiency: >99.99%
Filtration efficiency as per the salt test method (NaCl): 98.17%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Notification 5-1
510(k) Summary 5
FEB - 5 2014
Image /page/0/Picture/5 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. The word "HEALTHCARE" is on the second line, also in a bold, sans-serif font.
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 Place |
| Paykel Building | |
| East Tamaki | |
| Auckland 2013, New Zealand |
Telephone: +64 9 574 0100
Fax: +64 9 574 0148 |
| Trade name | RT016 Inspiratory Filter |
| Common name | Breathing circuit bacterial filter |
| Classification name | Breathing circuit bacterial filter
Class II (21 CFR §868.5260)
Product code CAH (Filter, Bacterial, Breathing-Circuit) |
| Predicate device | RT019 Inspiratory/Expiratory Filter (K050927) |
1
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.
2
| Design/technological
characteristic for
comparison | Subject device
(RT016 Inspiratory Filter) | Predicate device
(RT019
Inspiratory/Expiratory
Filter, K050927) | Comments |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | • The Fisher & Paykel
Healthcare RT016
Inspiratory Filter is
intended for use between
a ventilator and breathing
circuit. | • The Fisher & Paykel
Healthcare RT019
Inspiratory/Expiratory
Filter is intended for use
between a ventilator and
breathing circuit. | Identical |
| | • Its function is to remove
microbiological and
particulate matter from
gases entering a breathing
circuit. The RT016 is
intended to be connected
to the ventilator
inspiratory port. | • Its function is to remove
microbiological and
particulate matter from
gases entering and/or
exiting a breathing circuit.
The RT019 is intended to
be connected to the
ventilator inspiratory
and/or expiratory ports. | Identical
The function of the
subject device and
predicate device is
identical.
However the subject
device is intended to
be connected to the
ventilator inspiratory
port only, whereas
the predicate device
may be connected to
the ventilator
inspiratory and/or
expiratory ports. |
| | • It is not directional in
terms of flow and is a
single use device. | • It is not directional in
terms of flow and is a
single use device. | Identical |
| | • Availability: prescription
use (Part 21 CFR 801
Subpart D) | • Availability: prescription
use (Part 21 CFR 801
Subpart 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). .
3
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/technological
characteristic for
comparison | Subject device
(RT016 Inspiratory Filter) | Predicate device
(RT019
Inspiratory/Expiratory
Filter, K050927) | Comments |
|----------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Configuration | Connected to the
ventilator inspiratory
port | Connected to the
ventilator inspiratory
port Connected to the
ventilator expiratory
port | Identical
As per the Indications
for use, the subject
device is intended to
be connected to the
ventilator inspiratory
port only. |
| Reusability | Single use only | Single use only | Identical |
| Components | Female (22 mm) filter
housing; Filter media; Male (22 mm) filter
housing | Female (22 mm) filter
housing; Filter media; Male (22 mm) filter
housing; Male insulation casing; Female insulation
casing | Identical
All components used
in subject device are
identical to the
corresponding
components used in
the predicate device,
including identical
materials and
processing.
The subject device
does not include the
male or female
insulation casing
components. |
| Connectors | Standard 22 mm
connectors Designed to comply
with
ISO 5356-1:2004 | Standard 22 mm
connectors Designed to comply
with
ISO 5356-1:2004 | Identical |
4
| Design/technological
characteristic for
comparison | Subject device
(RT016 Inspiratory Filter) | Predicate device
(RT019
Inspiratory/Expiratory
Filter, 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 |
| Technical
specifications | 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: 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.
5
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).
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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.
7
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
8
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.