(110 days)
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use between a ventilator and a breathing circuit. 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. It is not directional in terms of flow and is a single use device.
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is classified as a The Fisher & Tayker Ticannoure N1009-12-1 CFR §868.5260. It is intended to be Blaced at the machine end of a ventilator breathing circuit, to remove microbiological and particulate matter from the gases in a breathing circuit. The RT019 filter has a dual-walled translucent thermoplastic enclosure with aligned connector ports and perpendicular filter media. Its total length is 78 mm (3.1 in) with a maximum cross section diameter of 67 mm (2.6 in), and a mass of 23 g (0.81 oz). It has maximuli Cross scetton Giameer of 07 mm (1:40 conical tapers. The filter uses an electrostatic, hydrophobic, depth-type filter media.
The provided text does not describe the acceptance criteria and the study that proves a device meets them in the way requested. Instead, it is a 510(k) summary for a medical device (Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance acceptance criteria and a study to meet them.
Here's an analysis of why the requested information cannot be extracted from the provided text:
- No detailed acceptance criteria or performance data: The document states, "No additional tests were performed on the RT019 filter as it is identical to the predicate device (RT020). A change in the indications for use does not affect the filter's safety, efficacy or performance." This means there's no specific study for the RT019 presented, nor are there explicit acceptance criteria for its performance.
- Focus on substantial equivalence: The core argument is that the RT019 is "identical to the predicate device in every physical aspect" and therefore shares "the same technological characteristics" and "safety, effectiveness and performance."
- Lack of AI/algorithm specific information: The device described is a physical filter, not an AI or algorithm-based system. Therefore, questions related to test sets, data provenance, ground truth, experts, adjudication methods, MRMC studies, standalone performance, or training sets are not applicable to this document.
In summary, the provided text does not contain the information necessary to fulfill the request as it describes a physical medical device asserting substantial equivalence to a predicate device, rather than an AI/algorithm-driven device with performance studies against acceptance criteria.
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AUG 1 - 2005
Fisher & Paykel Healthcare Limited 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
510(k) Summary of Safety and Effectiveness 1.4
Reneta Money Contact person
30 March 2005 Date prepared
RT019 Inspiratory/Expiratory Filter Trade name
Breathing Circuit Bacterial Filter Common name
Breathing Circuit Bacterial Filter (21 CFR 868.5260) Classification name
RT020 End Expiratory Filter K002839 Predicate device
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Description of device 1.4.1
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is classified as a The Fisher & Tayker Ticannoure N1009-12-1 CFR §868.5260. It is intended to be Blaced at the machine end of a ventilator breathing circuit, to remove microbiological and particulate matter from the gases in a breathing circuit.
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The RT019 filter has a dual-walled translucent thermoplastic enclosure with aligned connector ports and perpendicular filter media. Its total length is 78 mm (3.1 in) with a maximum cross section diameter of 67 mm (2.6 in), and a mass of 23 g (0.81 oz). It has maximuli Cross scetton Giameer of 07 mm (1:40 conical tapers. The filter uses an electrostatic, hydrophobic, depth-type filter media.
1.4.2 Intended use
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use The Tisher & I ayker Hounteaus reservit. Its function is to remove microbiological and between a venthator and a breating and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.
Technological characteristics summary 1.4.3
As the RT019 is identical to the predicate device in every physical aspect, it shares the same technological characteristics.
Summary of testing: 1.4.4
No additional tests were performed on the RT019 filter as it is identical to the predicate device (RT020). A change in the indications for use does not affect the filter's safety, efficacy or performance.
Conclusions demonstrating safety, effectiveness and performance 1.4.5
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is identical to the predicate device in every aspect including safety, effectiveness and performance.
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Image /page/2/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 symbol is placed to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 - 2005
Fisher & Paykel Healthcare, Limited c/o Reneta Money 15 Maurice Paykel Place P.O. Box 14-348, Panmure East Tamaki, Auckland NEW ZEALAND
Re: K050927
Trade/Device Name: RT019 Inspiratory/Expiratory Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: July 18, 2005 Received: July 21, 2005
Dear Ms. Money:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boodetermined 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 eonimer to Provision of Hay 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For ( 100) was the device, subject to the general controls provisions of the Act. The I ou may, diereleve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can may or sations to back as a sateral 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. Money
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a based on a suith other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination and regulations administered by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CrK Fart 807), laocing (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Dections over device as described in your Section 510(k) I mis letter will anow you to begin manicemly your antial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acvice for your access to the regulation of the regulation entitled, Conder the Oriece of Compuners in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 1011 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. L.
Chiu Lin, Ph.D, Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 1.2
KUSO927 510(k) Number:
RT019 Inspiratory/Expiratory Filter Device Name:
The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Indications For Use: Filter is intended for use between a ventilator and a breathing circuit. 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. It is not directional in terms of flow and is a single use device.
Prescription Use
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aunf Sulean Koso927
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev
510(k) Number: K050427
§ 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).