(480 days)
The RT265 and RT266 infant breathing circuits are intended to deliver humidified breathing gases for administration to an infant patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidifies gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways, for example use of an endotracheal tube.
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.
The RT265 and RT266 dual heated infant breathing circuits are classified as 'Breathing System Heater' according to 21 CFR §868.5270.
Infant breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimise the formation of condensate.
The RT265 and RT266 are dual-heated breathing circuits, unchanged from the predicate devices (RT235 and RT236). This means that there is a heater wire in both the inspiratory and expiratory limb.
The inspiratory limb is identical in all aspects to that of the predicate device. The expiratory limb is of a different design to that of the predicate, reflecting the change in material.
This document is a 510(k) summary for the Fisher & Paykel Healthcare RT265 and RT266 Dual Heated Infant Breathing Circuits. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way typically expected for AI/ML devices. Instead, it demonstrates substantial equivalence to a predicate device through non-clinical testing.
Therefore, many of the requested categories are not applicable to this document. However, I can extract the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Non-Clinical Tests) |
|---|---|
| Pneumatic performance equivalent to predicate | Testing performed; showed substantial equivalence |
| Single fault and fire prevention equivalent to predicate | Testing performed; showed substantial equivalence |
| Patient leakage current equivalent to predicate | Testing performed; showed substantial equivalence |
| Performance equivalent to predicate | Testing performed; showed substantial equivalence |
| Duration of use equivalent to predicate | Testing performed; showed substantial equivalence |
| Overall safety and effectiveness for intended purpose | Demonstrated to be at least as safe and effective as predicate |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in terms of number of units tested, but comparative performance testing was conducted.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by Fisher & Paykel Healthcare Limited. This is a retrospective comparison against the characteristics of their existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a non-clinical device performance comparison, not an expert-driven ground truth assessment.
4. Adjudication method for the test set
- Not applicable. This is a non-clinical device performance comparison.
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 is not an AI device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used
- Not applicable in the context of AI/ML ground truth. The "ground truth" here is the established performance and safety characteristics of the predicate device (RT235 and RT236), which the new devices (RT265 and RT266) are compared against through physical and functional testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
510(k) Summary 5 K 10376"
APR 1 6 2012
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, with a large ampersand between the two words. The word "HEALTHCARE" is on the second line in a similar font, but slightly smaller, and underlined.
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki
P O Box 14 348, P O Box 14 348, Panmure Telephone: +64 9 574 0100
Facsimile: +64 9 574 0158 Website: www.fphcare.com
. .
| Contact person | Stéphanie Elvin |
|---|---|
| Date prepared | 21 December 2010 |
| Trade name | RT265 and RT266 Dual Heated Infant Breathing Circuits1 |
| Common name | Heated Breathing Circuit |
| Classification name | Breathing System HeaterClass II (21 CFR § 868.5270), product code BZE |
| Predicate device | K034026 Fisher & Paykel Healthcare RT235 and RT236 Dual HeatedNeonatal Breathing Circuits2 |
1 Referred to throughout this document as RT265 and RT266
2 Referred to throughout this document as RT235 and RT236
{1}------------------------------------------------
Description 5.1
The RT265 and RT266 dual heated infant breathing circuits are classified as 'Breathing System Heater' according to 21 CFR $868.5270.
Infant breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimise the formation of condensate.
5.2 Intended use
The RT265 and RT266 infant breathing circuits are intended to deliver humidified breathing gases for administration to an infant patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidifies gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways, for example use of an endotracheal tube.
Indications for use 5.3
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.
Technological characteristics comparison 5.4
The RT265 and RT266 are dual-heated breathing circuits, unchanged from the predicate devices (RT235 and RT236). This means that there is a heater wire in both the inspiratory and expiratory limb.
The inspiratory limb is identical in all aspects to that of the predicate device. The expiratory limb is of a different design to that of the predicate, reflecting the change in material.
The intended use of the RT265 and RT266 is the same as the predicate devices.
Non-clinical tests 5.5
Comparative performance testing of the RT265 and RT266 with the predicate breathing circuits RT235 and RT236, such as pneumatic testing, single fault and fire prevention, patient leakage current, performance and duration of use testing were performed. Testing showed that the relevant features of each predicate are substantially equivalent.
Conclusion 5.6
The RT265 and RT266 are substantially equivalent to the RT235 and RT236 breathing circuits. The comparison of features, performance, materials and intended use demonstrate that the RT265 and RT266 are at least as safe and effective for their intended purpose.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human form with three arms reaching upwards. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Petry Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place PO Box 14648 Auckland, New Zealand 1071
APR 1 6 2012
Re: K103767
Trade/Device Name: RT265 and RT266 Dual Heated Infant Breathing Circuits Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing system heater. Regulatory Class: II Product Code: BZE Dated: April 10, 2012 Received: April 11, 2012
Dear Mr. Petry:
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.
{3}------------------------------------------------
Page 2- Mr. Petry
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement 4
510(k) Number
Device Name
Fisher & Paykel Healthcare RT265 and RT266 Dual Heated Infant Breathing Circuits
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
L. Schultheis
(Division Sign-Off) (Division Sigil-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103767
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).