(172 days)
The Hudson RCI Gas Sampling Oxygen Nasal Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate.
The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery through both nasal prongs while allowing sampling of the patient's exhaled gas from both nasal prongs. Oxygen is delivered to the Cannula during all phases of ventilation through the base of the cannula and is directed through the lower halves of each nasal pronq into the nasal pharynx. During exhalation, oxygen continues to flow into the nasal pharynx through these lower pronq halves. When the gas sampling line is connected to an expiratory gas monitor, a small amount of gas is continuously withdrawn from the nasal pharynx through the upper halves of both nasal prongs. Part of this gas exits one side of the cannula and is routed via a small-bore gas sampling line to the expired gas monitor.
The provided document is a 510(k) summary for the Hudson RCI CO2, Oxygen Nasal Cannula, which is a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. Therefore, it focuses on comparing the new device to existing devices rather than presenting extensive new study data to establish performance criteria against a set benchmark in the way you might find for a novel device.
The document does not contain the information requested regarding acceptance criteria and a study proving those criteria are met for the Hudson RCI CO2, Oxygen Nasal Cannula itself.
Specifically, the document lacks the following information for the Hudson RCI device:
- A table of acceptance criteria and the reported device performance: This information is not provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics and acceptance thresholds for the new device.
- Sample size used for the test set and the data provenance: Not applicable, as no specific performance test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device for gas sampling and oxygen delivery, not an AI software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Predicate Device: SALTLER LABS Oxygen Delivery - CO2 Sampling Nasal Cannula (K892406 and K863883).
- Device Description: The Hudson RCI cannula provides bifurcated nares for oxygen delivery through both nasal prongs and simultaneous sampling of exhaled gas from both nasal prongs. Oxygen flows through the lower halves of each prong, and gas is sampled through the upper halves.
- Intended Use: Adjunct to oxygen therapy, delivering low flow oxygen while providing a means to sample expired gas, for monitoring ventilatory rate. No difference in intended use from the predicate device.
- Patient Population: Infant to adult patients requiring low flow oxygen therapy and expired gas monitoring. No difference in patient population from the predicate device.
- Comparison of Technological Characteristics: The main difference from the predicate device is that the Hudson RCI cannula performs both oxygen delivery and CO2 sampling through each nasal prong, whereas the predicate delivers oxygen through one and samples CO2 from the other. However, both operate in a similar manner. The document asserts no difference in technological characteristics that would affect safety or effectiveness compared to the predicate.
- Conclusion: Hudson RCI believes the device is substantially equivalent to the SALTER LABS Oxygen Delivery CO2 Sampling Cannula.
In essence, this document demonstrates substantial equivalence to an existing legally marketed device, which is the primary "acceptance criterion" for a 510(k) submission. It relies on the assumption that if the new device is substantially equivalent to one previously cleared, it is by extension "safe and effective." It does not present new performance data in the structured way implied by your questions, which are more relevant to a novel device or a device with new performance claims.
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Image /page/0/Picture/0 description: The image shows a logo for Hudson RCI. The logo is a stylized, geometric design with horizontal lines. The text "HUDSON RCI" is written below the geometric design. The "RCI" has a registered trademark symbol next to it.
SEPT 10 .
SUMMARY OF SAFETY AND EFFECTIVENESS
March 21, 1996
Hudson Respiratory Care Inc. 27711 Diaz Road, P.O. Box 9020 Temecula, California 92589-9020
Tel: (909) 676-5611 Fax: (909) 676-1578
| Official Contact: | Arden Morley |
|---|---|
| Director of Regulatory Affairs | |
| Proprietary or Trade Name: | CO2 , Oxygen Nasal Cannula |
| Common/Usual Name: | Cannula |
| Intended Device: | CO2 , Oxygen Nasal Cannula |
Predicate Device:
SALTER LABS Oxygen Delivery - CO2 Sampling Nasal Cannula K 892406 and K 863883
Device Description
The Hudson RCI nasal cannula with gas sampling port has bifurcated nares that channel oxygen delivery through both nasal prongs while allowing sampling of the patient's exhaled gas from both nasal prongs. Oxygen is delivered to the Cannula during all phases of ventilation through the base of the cannula and is directed through the lower halves of each nasal pronq into the nasal pharynx. During exhalation, oxygen continues to flow into the nasal pharynx through these lower pronq halves. When the gas sampling line is connected to an expiratory gas monitor, a small amount of gas is continuously withdrawn from the nasal pharynx through the upper halves of both nasal prongs. Part of this gas exits one side of the cannula and is routed via a small-bore gas sampling line to the expired gas monitor.
Intended Use
The Hudson RCI Cannula is an adjunct to oxygen therapy with its primary function being that of delivering low flow oxygen to a patient while providing a means to sample expired gas. It is intended for use in patients requiring oxygen therapy to improve blood oxygen levels while monitoring expired gas to determine ventilatory rate. No difference in intended use between the Hudson RCI and Salter Labs product has been identified.
Patient Population
The Cannula may be used on patient populations ranging from infant to adults that require low flow oxygen therapy and expired gas monitoring. No difference in patient population between the Hudson RCI and Salter Labs product has been identified.
Image /page/0/Picture/16 description: The image shows two logos for the ARC award. The first logo on the left has the text "11TH ARD 1992" below the ARC letters. The second logo on the right has the text "ZENITH AWARD 1989" below the ARC letters. Both logos have a mountain range design above the letters ARC.
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DSMA - Summary of Safety and Effectiveness for Hudson RCI ETCO2 , Oxygen Nasal Cannula Page 2 of 2
Comparison of Technological Characteristics
The Cannula is a modification of feature and design of the SALTER LABS Oxygen Delivery/CO2 Sampling Cannula. The main difference between the Cannula and the predicate device is that the latter delivers oxygen through one nasal prong and samples CO2 from the other prong while the Hudson RCI Cannula will perform both functions through each nasal prong. However, the Hudson RCI Cannula and predicate device Cannula operate in a similar manner in that they each deliver a gas, usually oxygen, while providing a means to sample exhaled gas. No difference in technological characteristics between the Hudson RCI and Salter Labs product that would affect safety or effectiveness has been identified.
Conclusion
Hudson RCI has designed and manufactured the Cannula to objective criteria and believes that it is substantially equivalent to the SALTER LABS Oxygen Delivery CO2 Sampling Cannula which has been identified as a legally marketed predicate device.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three parallel lines that curve upwards, resembling a bird in flight or a stylized representation of the human spirit.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2001 JUN 5
Ms. Sheryl Saenz Hudson Respiratory Care, Inc. 27711 Diaz Road P.O. Box 9020 Temecula, CA 92589
Re: K961150
Trade/Device Name: Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula Regulation Number: 868.1400 Regulatory Class: II (two) Product Code: 73 CCK
Dear Ms. Saenz:
This letter corrects our substantially equivalent letter of September 10, 1996, regarding the Double Lumen Oxygen Delivery Gas Sampling Nasal Cannula. Our letter identified the product code as 73 CAT. This is in error; the correct product code is 73 CCK as indicated above.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory
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Page 2 - Ms. Sheryl Saenz
action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
unk Dake Teth
mes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
K961150 ·
Device Name:
Hudson RCI Gas Sampling Oxygen Nasal Cannulae
Indications for Use:
The Hudson RCI Gas Sampling Oxygen Nasal Cannula is an adjunct o oxygen therepy with The Huuson Holl Cas Sampling Oxygon Naoa. Bannalize en to a patient while providing a lls pinnal y lunction being that or deliveling to in nuse in patients requiring oxygen therapy to means to sample expired gas. It is internete for determine ventilatory rate.
Laut Mulos 6-21-96
TINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRIDE SHOW-OHIS LINE Division of Cardiovascular, Respiratory
and Neurological Devices
510(k) Number SIO(K) Number of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).