K Number
K092484
Device Name
HELIOX LOW FLOW SENTRY BLENDER
Date Cleared
2010-04-02

(232 days)

Product Code
Regulation Number
868.5330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a mechanical gas blender with an integrated oxygen analyzer and alarms. There is no mention of AI or ML in the device description, intended use, or performance studies.

Yes
The device is described as a medical device that provides continuous heliox/oxygen gas mixture to patients, indicating a direct therapeutic intervention by delivering a specific gas mixture for medical treatment.

No

This device is a blender/monitor for heliox and oxygen mixtures, designed to provide a continuous gas mixture to patients. It does not perform any diagnostic function.

No

The device description explicitly states it combines a mixing valve with an integral battery-operated oxygen concentration analyzer, indicating it is a hardware device with integrated software for monitoring and control.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is designed to provide a gas mixture to patients (infant, pediatric, and adult) for breathing. This is a direct interaction with the patient's respiratory system.
  • Device Description: The description details a blender and monitor for mixing and analyzing gases for delivery to a patient.
  • Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVDs are typically used to test blood, urine, tissue, or other samples in a laboratory or clinical setting to diagnose, monitor, or screen for diseases or conditions.

This device falls under the category of a medical device used for respiratory support and gas delivery to a living patient.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

73 BZR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

infant, pediatric, and adult patients

Intended User / Care Setting

qualified, trained personnel, under the direction of a physician, in institutional environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Tested 4 units for various performance metrics.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K911962, K883038, K090781

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

K092484

Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a simple, sans-serif font.

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 - 3660
Monther.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 as
a class II device under the following classification
code |

Product codeCFR SectionPanel
73 BZR21 CFR 868.5330Anesthesiology

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.

1

Image /page/1/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of three curved lines that converge at a point, resembling the wings of a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.

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.

2

Image /page/2/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic above the text "CardinalHealth". The graphic is composed of three curved lines that converge at a point, resembling a bird in flight or abstract wings.

91727 Rev AER 3348Pass or Fail
PRS Reference
NumbersDescriptionVerification Test Protocol
Reference NumberNumber of
Units for
Test
4.1.1Dimensional EnvelopeER3348 Section 4.1.14Pass
4.1.2WeightER3348 Section 4.1.14Pass
4.1.3Interface (gas inlets and outlets)ER3348 Section 4.1.14Pass
4.2.1Nominal Supply PressureER3348 Section 4.1.14Pass
4.2.2Normal Operating PressureER3348 Section 4.1.14Pass
4.3Environmental WithstandRefer to Sentry Blender
DHFN/APass
4.4.1% O2 ControlER3348 Sect. 5.24Pass
4.4.2Flow CharacteristicsER3348 Sect. 5.24Pass
4.4.4Blender Safety FeaturesER3348 Sect. 5.1, 5.34Pass
4.5.1Monitor DisplayER3348 Sect. 5.14Pass
4.5.1 aOxygen Range, Resolution, & AccuracyER3348 Sect. 5.14Pass
4.5.1 bLow O2 Alarm Set pointER3348 Sect. 5.14Pass
4.5.1 cHigh O2 Alarm Set pointER3348 Sect. 5.14Pass
4.5.1 d"%" Flashing during calibrationER3348 Sect. 5.14Pass
4.5.1 eLocked IndicatorER3348 Sect. 5.14Pass
4.5.1 fAttach SensorER3348 Sect. 5.14Pass
4.5.1 gLow Battery IndicatorER3348 Sect. 5.14Pass
4.5.2Monitor ControlsER3348 Sect. 5.14Pass
4.5.2 aOn/Off SwitchER3348 Sect. 5.14Pass
4.5.2 bLock/Unlock SwitchER3348 Sect. 5.14Pass
4.5.2.1Calibrate ButtonER3348 Sect. 5.14Pass
4.5.2.2High Set ButtonER3348 Sect. 5.14Pass
4.5.2.3Low Set ButtonER3348 Sect. 5.14Pass
4.5.2.4Alarm Silence ButtonER3348 Sect. 5.14Pass
4.5.3Alarm/Alert IndicatonsER3348 Sect. 5.34Pass
4.5.3 aHi O2 ConcentrationER3348 Sect. 5.34Pass
4.5.3 bLow O2 ConcentrationER3348 Sect. 5.34Pass
4.5.3 cAlarm SilenceER3348 Sect. 5.34Pass
4.5.3 dAlarm LoudnessER3348 Sect. 5.34Pass
4.5.4Monitor Power SourceSpecified by Manufacturer
(not tested)N/APass
4.5.5Oxygen SensorSpecified by Manufacturer
(not tested)N/APass
5.1Oxygen Blender PerformanceER3348 Sect. 5.24Pass
5.2Monitor/Analyzer PerformanceER3348 Sect. 5.34Pass
5.2.1Display, Controls, AlarmsER3348 Sect. 5.34Pass
5.2.2System AccuracyER3348 Sect. 5.34Pass
6.1LabelingER3348 Section 4.1.14Pass
6.2Shipping ContainerER3348 Section 4.1.14Pass

3

Image /page/3/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic appears to be a series of curved lines, possibly representing a bird in flight or a stylized medical symbol. The text "CardinalHealth" is written in a simple, sans-serif font.

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.

4

Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The graphic is made up of four curved lines that resemble the wings of a bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font.

.

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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.

6

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

7

Image /page/7/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a simple, sans-serif font, with the first letter capitalized.

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