(380 days)
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas. The RT236 is used for flow rates between 0.3 and 4 L/min, and the RT235 is for flow rates greater than 4 L/min, for infant patients.
The RT138 and RT141 dual heated neonatal 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 minimises the formation of condensate. The RT138 is for gas flows of 0.3 - 4 L/min and the RT141 is for gas flows greater than 4 L/min.
This document describes a 510(k) premarket notification for the Fisher & Paykel Healthcare RT138 and RT141 Dual Heated Neonatal Breathing Circuits. The core of the submission revolves around demonstrating substantial equivalence to predicate devices (RT130 and RT131 Neonatal Breathing Circuits) rather than presenting a novel device with extensive performance studies against acceptance criteria in the typical sense of a diagnostic AI product.
Therefore, the requested information cannot be fully populated as it applies more directly to a diagnostic AI device's performance evaluation. However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance (Inferred from conclusions) |
|---|---|---|
| Materials Biocompatibility | Bio-compatibility according to ISO 10993-1, or prior use in a predicate device, or justification for minimal testing. | All materials either evaluated per ISO 10993-1, previously used in predicate, or justification provided. |
| Inspiratory and Expiratory Limb Performance | Meet design and functional requirements for gas flow, temperature maintenance, and condensate minimization. (Specific metrics not provided). | Meets design and performance functional requirements. |
| Electrical and Thermal Safety | Compliance with relevant electrical and thermal safety standards. (Specific standards not provided). | Meets design and performance functional requirements. |
| Intended Use Equivalence | Capable of delivering humidified breathing gases for infant patients, consistent with predicate devices. | Intended use is the same as the predicate devices. |
| Safety and Effectiveness Equivalence | Equivalent to or better than predicate devices in terms of safety, effectiveness, and performance. | RT138 and RT141 are equivalent to or better than the predicate devices in terms of safety, effectiveness and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "testing" which would imply a test set, but it's focused on engineering and material performance rather than clinical data. It's likely that a small number of physical devices were tested for each category.
- Data Provenance: Not specified, but given the manufacturer is based in New Zealand, the testing would likely have been conducted internally or within a testing facility in New Zealand or a collaborating country. The data is most likely prospective in the sense that the tests were conducted specifically for this submission on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this submission. The "ground truth" here is established through engineering and material testing against predefined specifications and standards, not through expert clinical consensus on patient data. The "experts" would be engineers, materials scientists, and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data reviews (e.g., expert reads of medical images). This document describes engineering and material testing.
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
No. This is not an AI or diagnostic imaging device, and therefore, an MRMC comparative effectiveness study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI or diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation is primarily:
- Engineering Specifications and Standards: The device's performance (e.g., gas flow, temperature, electrical safety) is measured against predetermined design specifications and relevant international standards (e.g., ISO 10993-1 for biocompatibility).
- Predicate Device Performance: The RT138 and RT141 are compared to the performance characteristics of the previously cleared RT130 and RT131. In areas like the inspiratory limb, being "identical in all aspects" to the predicate acts as a form of ground truth.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
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1/12/05
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
Summary of safety and effectiveness 1.3
| Contact person | Adele Bindon |
|---|---|
| Date prepared | '22 December 2003 |
| Trade name | RT138 Dual Heated Neonatal Breathing CircuitRT141 Dual Heated Neonatal Breathing Circuit |
| Common name | Heated Breathing Circuit |
| Classification name | Breathing System Heater (21 CFR 868.5270) |
| Predicate device | RT130 Neonatal Breathing Circuit K020332RT131 Neonatal Breathing Circuit K020332 |
12.3
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Description of device:
The RT138 and RT141 dual heated neonatal 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 minimises the formation of condensate.
The RT138 is for gas flows of 0.3 - 4 L/min and the RT141 is for gas flows greater than 4 L/min.
Intended use:
The RT138 and RT141 neonatal 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.
This 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.
Technological characteristics summary:
The RT138 and RT141 are dual-heated breathing circuits, compared to the predicate devices (RT130 and RT131) which are single-heated breathing circuits. 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 has different performance characteristics to that of the predicate, reflecting the addition of a heater wire.
The intended use of the RT138 and RT141 is the same as the predicate devices.
Summary of testing:
The following testing has been performed on the RT138 and RT141:
-
. Materials
All materials used in the RT138 and RT141 have either been evaluated according to tests outlined in ISO 10993-1; or have been previously used in a predicate device; or a justification for minimal testing has been provided -
. Inspiratory and expiratory limb performance
-
. Electrical and thermal safety
{2}------------------------------------------------
Conclusions demonstrating safety, effectiveness and performance:
The testing carried out for the RT138 and RT141 indicates that it meets design and performance functional requirements.
This information indicates that the RT138 and RT141 are equivalent to or better than the predicate devices in terms of safety, effectiveness and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains an image of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the perimeter of the circle.
Public Health Service
JAN 1 2 2005
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Ms. Adele Bindon Regulatory Affairs Engineer Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place, East Tamaki PO Box 14 348, Panmure Auckland, New Zealand
Re: K034026
Trade/Device Name: RT236 and RT235 Dual Heated Neonatal Breathing Circuits Regulation Number: 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE Dated: December 23, 2004 Received: December 28, 2004
Dear Ms. Bindon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Bindon
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chi-Lien, Ph.D.
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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1.2 Indications for use statement
K034026 510(k) Number
Respiratory Humidifier Device Name
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas. The RT236 is used for flow rates between 0.3 and 4 L/min, and the RT235 is for flow rates greater than 4 L/min, for infant patients.
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)
Page 1 of 1
§ 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).