(232 days)
The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen qas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.
The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%/21%) and oxygen mixing valve with an integral battery operated oxygen concentration analyzer and user adjustable alarms.
Here's a breakdown of the acceptance criteria and study information for the Heliox Low Flow Sentry Blender, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists performance requirements and indicates that the device met these requirements. No specific quantitative acceptance values are given for most criteria, only a "Pass" status. The table below paraphrases the descriptions as presented in the document.
| Acceptance Criteria (Description) | Reported Device Performance |
|---|---|
| Dimensional Envelope | Pass |
| Weight | Pass |
| Interface (gas inlets and outlets) | Pass |
| Nominal Supply Pressure | Pass |
| Normal Operating Pressure | Pass |
| Environmental Withstand | Pass |
| % O2 Control | Pass |
| Flow Characteristics | Pass |
| Blender Safety Features | Pass |
| Monitor Display | Pass |
| Oxygen Range, Resolution, & Accuracy | Pass |
| Low O2 Alarm Set point | Pass |
| High O2 Alarm Set point | Pass |
| "%" Flashing during calibration | Pass |
| Locked Indicator | Pass |
| Attach Sensor | Pass |
| Low Battery Indicator | Pass |
| On/Off Switch (Monitor Controls) | Pass |
| Lock/Unlock Switch (Monitor Controls) | Pass |
| Calibrate Button (Monitor Controls) | Pass |
| High Set Button (Monitor Controls) | Pass |
| Low Set Button (Monitor Controls) | Pass |
| Alarm Silence Button (Monitor Controls) | Pass |
| Hi O2 Concentration (Alarm/Alert Indications) | Pass |
| Low O2 Concentration (Alarm/Alert Indications) | Pass |
| Alarm Silence (Alarm/Alert Indications) | Pass |
| Alarm Loudness (Alarm/Alert Indications) | Pass |
| Monitor Power Source | Pass (Specified by Manufacturer) |
| Oxygen Sensor | Pass (Specified by Manufacturer) |
| Oxygen Blender Performance | Pass |
| Monitor/Analyzer Performance | Pass |
| Display, Controls, Alarms | Pass |
| System Accuracy | Pass |
| Labeling | Pass |
| Shipping Container | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 4 units were used for the majority of verification tests.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a medical device by Cardinal Health 207, Inc., in Yorba Linda, CA, the testing likely occurred internally or by a contracted lab within the United States. The document describes "Non-clinical Testing," implying laboratory or engineering tests rather than clinical human data. The testing is retrospective in relation to the submission date.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests appear to be objective engineering/performance verification tests against predefined specifications (ER3348 sections). There's no mention of human experts establishing "ground truth" in the context of diagnostic interpretation, as this is a device for blending gases, not an imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described is performance verification of a device against specifications, not a diagnostic task requiring adjudication of human performance or expert consensus.
5. 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
An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists). The Heliox Low Flow Sentry Blender is a physical device for gas blending and monitoring, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The device itself is a standalone blender, but the "standalone performance" term usually refers to the performance of an AI algorithm without human involvement in a diagnostic or interpretive task. The "performance testing" described in the document is effectively a standalone test of the device's technical specifications.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests was defined by the device's own performance requirements and specifications as outlined in "ER3348" (Verification Test Protocol Reference Number) and potentially other internal design history files (e.g., "Sentry Blender DHF" for Environmental Withstand). For example, "Oxygen Range, Resolution, & Accuracy" would have specific numerical targets against which the device's output was measured.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a mechanical/electronic medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of device.
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APR - 2 2010
510(K) Summary
510 (K) Summary as required by 21 CFR 807.92
| 510 (K) Submitter: | Cardinal Health 207, Inc.Yorba Linda, CA 92887(714) 283 - 2228 |
|---|---|
| Contact Person: | Monther Abushaban(714) 919 - 3660Monther.Abushaban@CardinalHealth.com |
| Establishment Registration Number: | 2050001 |
| Date Prepared: | April 1, 2010 |
| Name of the Device: | Heliox Low Flow Sentry Blender |
| Common/ usual name: | Oxygen Blender for Helium/Oxygen Mixtures |
| Classification: | The Heliox Low Flow Sentry Blender is classified asa class II device under the following classificationcode |
| Product code | CFR Section | Panel |
|---|---|---|
| 73 BZR | 21 CFR 868.5330 | Anesthesiology |
Predicate Device: The predicate devices are:
Sentry air/oxygen microblender (K911962) Low Flow air/oxygen blender (K883038) Helio2 Blender (K090781)
Device Description: The helium/oxygen and oxygen blender/monitor combines a precision helium/oxygen (79%/21%) and oxygen mixing valve with an integral battery operated oxygen concentration analyzer and user adjustable alarms.
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Intended Use:
The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen gas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.
Modifications to the predicate device:
The Heliox Low Flow Sentry Blender is the same device as the Sentry air/oxygen microblender (K911962). Modifications to Heliox Low Flow Sentry Blender are associated with this submittal are as follows:
- Intended use: Changed the gas mixture from air/oxygen to He- 02/oxygen . mixture.
- . The orifice of the poppet has been changed to address the differences in density of the helium/oxygen mixture from the density of air.
- . The dial knob label artwork has been changed from analog numbers to a amplitude range.
- In summary, the Heliox Low Flow Sentry Blender described in this submission is, in our opinion, substantially equivalent to the predicate device(s).
Reason for the submission:
This is a modified device with a new intended use to be marketed by Cardinal Health 207, Inc.
Summary of Technological Characteristics of Device Compared to the Predicate Device:
The Heliox Low Flow Sentry Blender is substantially equivalent in safety and effectiveness to the legally marketed (predicate) currently in distribution.
Summary of Non-clinical Testing for the Device and Conclusions:
Performance testing verified that the Heliox Low Flow Sentry Blender meets it's performance requirements that this device is substantially equivalent to medical devices currently legally marketed in the United States.
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| 91727 Rev A | ER 3348 | Pass or Fail | ||
|---|---|---|---|---|
| PRS ReferenceNumbers | Description | Verification Test ProtocolReference Number | Number ofUnits forTest | |
| 4.1.1 | Dimensional Envelope | ER3348 Section 4.1.1 | 4 | Pass |
| 4.1.2 | Weight | ER3348 Section 4.1.1 | 4 | Pass |
| 4.1.3 | Interface (gas inlets and outlets) | ER3348 Section 4.1.1 | 4 | Pass |
| 4.2.1 | Nominal Supply Pressure | ER3348 Section 4.1.1 | 4 | Pass |
| 4.2.2 | Normal Operating Pressure | ER3348 Section 4.1.1 | 4 | Pass |
| 4.3 | Environmental Withstand | Refer to Sentry BlenderDHF | N/A | Pass |
| 4.4.1 | % O2 Control | ER3348 Sect. 5.2 | 4 | Pass |
| 4.4.2 | Flow Characteristics | ER3348 Sect. 5.2 | 4 | Pass |
| 4.4.4 | Blender Safety Features | ER3348 Sect. 5.1, 5.3 | 4 | Pass |
| 4.5.1 | Monitor Display | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 a | Oxygen Range, Resolution, & Accuracy | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 b | Low O2 Alarm Set point | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 c | High O2 Alarm Set point | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 d | "%" Flashing during calibration | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 e | Locked Indicator | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 f | Attach Sensor | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.1 g | Low Battery Indicator | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2 | Monitor Controls | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2 a | On/Off Switch | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2 b | Lock/Unlock Switch | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2.1 | Calibrate Button | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2.2 | High Set Button | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2.3 | Low Set Button | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.2.4 | Alarm Silence Button | ER3348 Sect. 5.1 | 4 | Pass |
| 4.5.3 | Alarm/Alert Indicatons | ER3348 Sect. 5.3 | 4 | Pass |
| 4.5.3 a | Hi O2 Concentration | ER3348 Sect. 5.3 | 4 | Pass |
| 4.5.3 b | Low O2 Concentration | ER3348 Sect. 5.3 | 4 | Pass |
| 4.5.3 c | Alarm Silence | ER3348 Sect. 5.3 | 4 | Pass |
| 4.5.3 d | Alarm Loudness | ER3348 Sect. 5.3 | 4 | Pass |
| 4.5.4 | Monitor Power Source | Specified by Manufacturer(not tested) | N/A | Pass |
| 4.5.5 | Oxygen Sensor | Specified by Manufacturer(not tested) | N/A | Pass |
| 5.1 | Oxygen Blender Performance | ER3348 Sect. 5.2 | 4 | Pass |
| 5.2 | Monitor/Analyzer Performance | ER3348 Sect. 5.3 | 4 | Pass |
| 5.2.1 | Display, Controls, Alarms | ER3348 Sect. 5.3 | 4 | Pass |
| 5.2.2 | System Accuracy | ER3348 Sect. 5.3 | 4 | Pass |
| 6.1 | Labeling | ER3348 Section 4.1.1 | 4 | Pass |
| 6.2 | Shipping Container | ER3348 Section 4.1.1 | 4 | Pass |
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Conclusion:
The summary above shows that there are no new questions of safety and effectiveness of the subject device (Heliox Low Flow Sentry Blender) as compared to predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Monther Abushaban Regulatory Affairs Manager Cardinal Health 207, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
APR - 2 2010
Re: K092484
Trade/Device Name: Heliox Low Flow Sentry Blender Regulation Number: 21CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: March 3, 2010 Received: March 31, 2010
Dear Mr. Abushaban:
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.
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Page 2 - Mr. Abushaban
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 (OS) 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 yours.
Th 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
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Indications for Use
Device Name: Heliox Low Flow Sentry Blender
Indications for Use:
The Heliox Low Flow Sentry Blender is designed to provide a continuous heliox/oxygen qas mixture to infant, pediatric, and adult patients. It is intended as a device to mix an 79% Helium / 21% Oxygen gas source with a 100% oxygen gas source to provide low flow mixtures containing 20% to 100% oxygen with the balance of the gas being Helium for patients who are spontaneously breathing. It is a medical device intended for use by qualified, trained personnel, under the direction of a physician, in institutional environments where the delivery and monitoring of helium/oxygen mixture is required.
X AND/ OR Prescription Use (Part 21CFR 801 subpart D)
Over the Counter Use: (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices
10(k) Number: K092484
Traditional 510(k) Submission for Heliox Low Flow Sentry Blender
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).