(165 days)
No
The summary describes a standard spirometer and pulse oximeter with data management software. There is no mention of AI, ML, or any features that would typically utilize these technologies for analysis or interpretation. The device relies on a digital volume transducer and standard physiological measurements.
No
The device measures lung function and oxygen saturation, which are diagnostic and monitoring functions, not therapeutic interventions.
Yes
A diagnostic device is used for diagnosing, preventing, or treating a disease or condition. The MicroLab/MicroLoop spirometer is used to measure lung function and oxygen saturation, which provides information for diagnosing respiratory conditions.
No
The device description explicitly states it is a "mains/battery operated desktop spirometer" and mentions hardware components like a "Digital Volume Transducer" and an "integral thermal printer." While it includes optional software ("Spirometry PC software"), the core device is a physical piece of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MicroLab / MicroLoop spirometer measures lung function (volume and flow of air) and pulse oximetry (oxygen saturation and pulse rate). These measurements are taken directly from the patient's body (breathing and finger), not from a sample taken from the body.
- Intended Use: The intended use describes measuring physiological parameters directly from the patient.
- Device Description: The description details how the device interacts with the patient's breath and finger, not with biological samples.
Therefore, while this is a medical device used for diagnosis and monitoring, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.
Product codes
BZG, DQA
Device Description
The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen.
Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin Ipod® SpO2 sensor can be connected to the MicroLab / MicroLoop.
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
Pediatric (4 to 17 years) and adult (18 to 99 years) patients.
For pulse oximetry measurements, adult patients.
Intended User / Care Setting
Hospitals, physician offices, laboratories and occupational health testing 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)
Non-clinical tests were conducted for determination of substantial equivalence, including:
- Basic Safety: IEC 60601-1. Results: The proposed device passes the applicable tests and standards.
- EMC Compatibility: IEC 60601-1-2. Results: The proposed device passes the applicable tests and standards.
- Risk Management: ISO 14971. Results: The proposed device passes the applicable tests and standards.
- Usability: EN 62366. Results: The proposed device passes the applicable tests and standards.
- Software life cycle: ISO 62304. Results: The proposed device passes the applicable tests and standards.
- Biocompatibility: ISO 10993-1. Results: The proposed device passes the applicable tests and standards.
- ATS / ERS: Standard of lung function testing. Results: The proposed device passes the applicable tests and standards.
- Accuracy Testing: Measurement accuracy for the new oximetry module. Results: The proposed device passes the applicable tests and standards.
Summary Discussion of Bench Performance Data: The CareFusion MicroLab / MicroLoop passed all specified test requirements. The validation and verification testing confirmed this device meets user needs and design inputs for pulmonary function and oximetry system. Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above. These standards address electrical safety, emc, risk, usability, software life cycle and biocompatibility. All testing which have been performed demonstrate substantial equivalence to the predicate devices.
Clinical tests were not performed with this device.
Conclusion: The Carefusion MicroLab / MicroLoop meets the functional claims and intended use as described in the product labeling. The performance are substantially equivalent to the K031102 MicroLab and K092324 SpiroPro described in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an emblem of an abstract stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2014
CareFusion Germany 234 GmbH Mr. Elmar Niedermeyer Leibnizstrasse 7 Hoechberg, Bavaria, Germany 97204
Re: K141936
Trade/Device Name: MicroLab MicroLoop Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG, DQA Dated: 11/24/204 Received: 11/28/2014
Dear Mr. Niedermeyer,
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. 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
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MicroLab / MicroLoop
Indications for Use (Describe)
The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Deepika A. Lakhani -A
2014.12.29 11:18:21 -05'00'
for Dr. James Lee Acting Branch Chief/ RPDB
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Image /page/3/Picture/1 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a yellow accent on the top left. To the right of the circle is the word "CareFusion" in gray text.
510(k) Summary
GENERAL INFORMATION
5.1 Type of Submission
Traditional 510(k) Submission
Submission date: 07/04/2014
5.2 Submitter
- Name: CareFusion Germany 234 GmbH
Address: Leibnizstrasse 7 D-97204 Hoechberg Germany
Contact person in Germany:
| (Official Correspondent) | Elmar Niedermeyer |
|---|---|
| Address: | CareFusion Germany 234 GmbH |
| Leibnizstrasse 7, 97204 Hoechberg | |
| Germany | |
| Phone: | +49 931 49 72 - 361 |
| FAX: | +49 931 49 72 - 62361 |
| elmar.niedermeyer@carefusion.com |
| Contact person in the U.S.: | |
|---|---|
| (U.S. Agent) | Donald Sherratt |
| Address | CareFusion |
| 22745 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Phone: | 714-919-3349 |
| Fax: | 714-283-8420 |
| E-mail: | donald.sherratt@carefusion.com |
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5.3 Establishment Registration Number 9615102
5.4 Common Name or Classification Name
Spirometer, Diagnostic (CFR 868.1840, Product Code BZG) Oximeter (CFR 870.2700, Product Code DQA)
5.5 Trade Name
MicroLab / MicroLoop
5.6 Device Classification
This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868 Code BZG 74 Cardiovascular Part 870 Code DQA
5.8 Reason for Premarket Notification
- . modification to existing MicroLab K031102
- SPIDA5 software will be superseded by SPCS (Spirometry PC Software) ●
- new housing & display, optional also without integrated printer available .
- new option SpO2 with Nonin Ipod® sensor ●
5.9 Legally predicate marketed devices
5.10 Predicate Device Company
- . CareFusion
- Viasys (now CareFusion)
5.11 Device Description
Description & function:
The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen.
5
Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin lpod® SpO2 sensor can be connected to the MicroLab / MicroLoop.
Scientific Concept:
The scientific concept which forms the basis of the MicroLab / MicroLoop is the CareFusion Digital Volume Transducer, a stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.
Significant physical & performance characteristics:
Performance (lung function measurements) VC, FEV.75, FEV1, FEV3, FEV6, FVC, PEF, FEV.75/VC, FEV.75/FVC, FEV1/VC, FEV1/FVC, FEV3/VC, FEV.75/FEV6, FEV1/FEV6, FEF25 (MEF75), FEF50 (MEF50), FEF75 (MEF25), FEF25-75 (MMEF), FEF50/VC, FEF50/FVC, MVV, FIV1, FIVC, PIF, FIV1/FIVC, FIF25, FIF50, FIF75, FEF50/FIF50, MET2575, FET, TV, ERV, IRV, IC, EVC, IVC, FR, Ti, Te, Ti/Ttot, TV/Ti Performance (option SpO2) SpO2 (%), Pulse Rate, Recording Time, Valid Sample Duration
Dimensions (MicroLab) 255 x 120 x 35mm 123 x 82 x 23mm (MicroLoop) Dimensions Transducer 50 x 60 x 90mm Weight 630g (MicroLab) (MicroLoop) 191g Weight Dockingstation 124g (MicroLoop) Transducer tvpe CareFusion Bidirectional Digital Volume Display Colour 1/4 VGA LCD touch screen Power supply unit Input 100 to 240V, 50 to 60Hz Output 12V 2.5A (Class1) (MicroLab) Output 5V 2.0A (Class1) (MicroLoop) Battery Pack Rechargeable NiMH 8.4V 1A-hours (MicroLab) Rechargeable Lithium Polymer 3.7V 1600mA-hours (MicroLoop)
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5.12 Intended Use Statement
The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.
5.13 Required Components
- MicroLab (with internal printer) or MicroLoop (without internal printer) .
- Digital Volume Transducer ●
- Transducer housing ●
- USB cable PC / Printer ●
- Dockingstation Cradle (only for MicroLoop) ●
- Instruction for Use ●
- PSU ●
- SPCS Software ●
- Accessories ●
- Carrying case ●
- SpO2 Nonin Ipod oximeter (optional) ●
5.14 Summary Table of Comparison
A. Pulmonary Function
| Pulmonary Function (comparison) | ||
|---|---|---|
| MicroLab K031102 | MicroLab / MicroLoop | |
| (with SpO₂) | ||
| Indications | ||
| for Use | The Microlab spirometer is intended, for prescription | |
| use only, to measure the maximal volume and flow of | ||
| air that can be moved in and out of a patient's lungs. | ||
| The system is intended for use with pediatric (4 to 17 | ||
| years) and adult (18 to 99 years) patients in hospitals, | ||
| physician offices, laboratories and occupational health | ||
| testing environments. | The Microlab / MicroLoop spirometer is intended, for | |
| prescription use only, to measure the maximal volume | ||
| and flow of air that can be moved in and out of a | ||
| patient's lungs and for pulse oximetry measurements. | ||
| The system is intended for use with pediatric (4 to 17 | ||
| years) and adult (18 to 99 years) patients in hospitals, | ||
| physician offices, laboratories and occupational health | ||
| testing environments. | ||
| The optional Nonin IPOD® Integrated Pulse Oximetry | ||
| Device is designed to measure pulse | ||
| rate and oxygen saturation in adult patients. The | ||
| sensor is designed for use on the fingers of | ||
| patients weighing more than 30 kilograms, where the | ||
| finger tissue is between 5 and 21 | ||
| millimeters. | ||
| Intended | ||
| patient | ||
| population | Pediatric (4 to 17 years) | |
| Adult (18 to 99 years) | similar | |
| Perfor- | ||
| mance | ||
| specifica- | ||
| tion | ||
| (spirometry | ||
| measure- | ||
| ment para- | ||
| meter) | VC, FEV75, FEV1, FEV3, FEV6, FVC, PEF, | |
| FEV75/VC, FEV75/FVC, FEV1/VC, FEV1/FVC, | ||
| FEV3/VC, FEV3/FVC, FEV75/FEV6, FEV1/FEV6, | ||
| FEF75, FEF50, FEF25, FEF25-75, FEF50/VC, | ||
| FEF50/FVC, MVV, FIV1, FIVC, PIF, FIV1/FIVC, | ||
| FIF25, FIF50, FIF75, FEF50/FIF50, MET 2575, FET, | ||
| TV, ERV, IRV, IC, EVC, IVC, FR, Ti, Te, Ti/Ttot, TV/TI | similar | |
| Principle of | ||
| operation | Air flow integration by bi-directional digital | |
| volume transducer | similar | |
| Material | ||
| Transducer | ||
| (breathing | ||
| path | ||
| contacting) | Turbine swirl plate (Polycarbonate) | |
| Turbine van | ||
| (Polyester type 427) | ||
| Turbine tube | ||
| (Clear Acrylic) | ||
| Pivot | ||
| (Nivapoint stainless steel) | ||
| Turbine Flow deflector (stainless steel) | ||
| Mouthpiece holder | ||
| (ABS Plastic) | similar | |
| Material | ||
| Transducer | ||
| housing | ||
| (patient skin | ||
| contacting) | Polyurethane "rubber feel" & black ABS | similar |
| Material | ||
| device | ||
| housing | PC/ABS Cycoloy C2950 | similar |
| Transducer | ||
| (type) | Type 36-TDX 1048 | |
| CareFusion Bi-Directional Digital Volume | similar | |
| Resolution | 0,01 liter | similar |
| Accuracy | +/- 3% to ATS Recommendations | similar |
| Volume | ||
| Range | 0.1 - 8 Litres | similar |
| Flow Range | 0.2 - 15 Litres/Second | similar |
| Sterilization | Turbine can be disinfected or cleaned | similar |
| Anatomical | ||
| sites | ||
| (Housing of | ||
| device and | ||
| Transducer) | 274 x 134 x 51,5 mm | |
| Weight: 820g | ||
| (with integral thermal printer) | MicroLab: | |
| 255 x 120 x 35 mm | ||
| Weight: 630g | ||
| (with integral thermal printer) | ||
| MicroLoop: | ||
| 123 x 82 x 23 | ||
| Weight: 191g | ||
| (without integral thermal printer) | ||
| Handle (transducer): | ||
| 50 x 60 x 90 | similar | |
| User input | ||
| type (no | ||
| patient contact) | 240 x 120 dot LCD Display & 26 Keypad | |
| switches | Colour 1½ VGA LCD touch screen | |
| Material touch screen foil: | ||
| PC/ABS Cycoloy C 2950 | ||
| Energy | ||
| used | ||
| (battery) | 7,2V NiCad | |
| 600 mAh | MicroLab: | |
| 8,4V NiMH rechargeable | ||
| 1000 mAh | ||
| MicroLoop: | ||
| 3,7V Li-ion rechargeable | ||
| 1600 mA | ||
| Environ- | ||
| mental | ||
| specifi- | ||
| cations | Operating: | |
| 0 to +40 °C | ||
| 30% to 90% RH | ||
| Storage: | ||
| -20 to +70 °C | ||
| 10% to 90% RH | similar | |
| Accessory | ||
| (patient skin | ||
| or mucous | ||
| membrane | ||
| contacting) | VOL2104 Nose Clips (pack of 5) | |
| Body material: Polyacetal | ||
| Pad material: | ||
| Ethylene Vinyl Acetate | ||
| PSA1000 Adult Disposable Mouthpiece | ||
| (material: Polyethylene coated bleached kraft paper) | ||
| SST1250 One-way Safety Mouthpiece | ||
| (250 per box) | ||
| (material: Polyethylene coated bleached kraft paper / | ||
| Safety wheel & valve: Polystyrene & Rectaleen 8/170) | ||
| SST1000 One-way Safety Mouthpiece | ||
| (500 per box) | ||
| (material: Polyethylene coated bleached kraft paper / | ||
| Safety wheel & valve: Polystyrene & Rectaleen 8/170) | ||
| PSA1200 Paediatric Disposable | ||
| Mouthpiece | ||
| (material: Polyethylene coated bleached kraft paper) | ||
| PSA1100 Paediatric adapter | ||
| (Polypropylene co-polymer, natural Stamylan | ||
| P512MN10, colour UN0001 white) | similar | |
| Software | Spida 5 Software | SPCS Software |
| (Spirometry PC Software) |
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8
9
Summary of technological characteristics compared to the predicate device to the table "A" above:
- There is a new indication for MicroLab / MicroLoop. The Nonin Ipod® . Oximeter is used to measure SpO2 and pulse rate. The technological characteristics are the same as in the predicate devices.
- The housing of the MicoLab / MicroLoop has changed in size and a . LCD touchscreen has been used. The material used for the housing did not change compared to the predicate device.
- . Both devices use a rechargeable battery as energy source
- The Software of the device changed from the previous Spida 5 software . to the SPCS software.
| Oximetry Function (comparison) | ||
|---|---|---|
| SpiroPro K092324 | MicroLab / MicroLoop | |
| (with SpO2) | ||
| Oximeter | ||
| type | Nonin OEM oximeter module (Xpod) | Nonin OEM oximeter module (Ipod) |
| Principle of | ||
| operation | Non-invasive pulse and oxygen saturation | |
| measurement by red and infrared light | ||
| emitting technology | similar | |
| Intended | ||
| patient | ||
| population | Adults and children from 4 years on | Adult patients weighing more than 30 |
| kilograms, where the finger tissue is | ||
| between 5 and 21 millimeters. | ||
| Intended | ||
| application | ||
| site | patient's finger | similar |
| Performance | ||
| specification (SpO2 | ||
| parameter) | Accuracy SpO2 70-100%: |
- no motion (adults) +/- 2 to +/-3 digits
- motion (adults) +/-2 to +/- 3 digits
- low perfusion (adults) +/-2 to +/- 3 digits
each depending on the sensor used | Accuracy SpO2 70-100%: - no motion (adults) +/- 2 digits
- motion (adults) +/- 3 digits
- low perfusion (adults) +/- 3 digits
for the Ipod finger sensor |
| | Heart Rate: - no motion (adults)
(18 - 300 BPM) +/-3 digits - motion (adults)
(40 - 240 BPM) +/- 5 digits - low perfusion (adults)
(40 - 240 BPM) +/- 3 digits | similar |
| Safety
Specifications (SpO2
sensor) | Electrical: (patient isolation)
Meets IEC60601-1 dielectric withstand | similar |
| | Mechanical: (ruggedness)
shock - IEC 60068-2-27
Vibration IEC 60068-2-6, IEC 60068-2-64 | Mechanical: (ruggedness)
shock - IEC 60068-2-27
Vibration Mil-standard 810C, method 514-2 |
B. Oximetry Function
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| | Environment:
Operating temperature 0 to +50°C
Storage temperature -20 to +50°C
Operating humidity 10% to 90% non cond.
Storage humidity 10% to 95% non cond. | Environment:
Operating temperature -5 to +50°C
Storage temperature -40 to +70°C
Operating humidity 10% to 95% non cond.
Storage humidity 10% to 95% non cond. |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Display:
LCD display
Alarms:
no alarms
Mode:
short term continuous monitoring | similar |
Summary of technological characteristics compared to the predicate device to the table "B" above:
- The MicroLab / MicroLoop uses the Nonin Ipod whereby the predicate . device uses the Nonin Xpod. Both oximeters are interchangeable and thereby the proposed device is substantial equivalent to the predicate device SpiroPro.
- The MicroLab / MicroLoop oximeter is for adult patients this is a Nonin . IPOD sensor specific limitation. The technical limitation for the IPOD oximeter sensor is specified by the original sensor manufacturer Nonin. For the intended patient population the MicroLab / MicroLoop is substantial equivalent to the predicate device SpiroPro.
- The SpO2 accuracy is the same as for the Nonin Xpod wherby the ● SpO2 accuracy depends on the used sensors. Both devices are substantial equivalent.
- The difference in specification is the vibration test which has been done . according U.S. Mil-standard instead of IEC and a light changed environment range. The MicroLab / MicroLoop operates as intended in user environments and is substantial equivalent to the predicate SpiroPro.
5.15 Summary of Device Testing
| Characteristic | Standard/Test | Results Summary | |
|---|---|---|---|
| 1. | Basic Safety | IEC 60601-1 | The proposed device passes the applicable tests and standards |
| 2. | EMC Compatibility | IEC 60601-1-2 | The proposed device passes the applicable tests and standards |
| 3. | Risk Management | ISO 14971 | The proposed device passes the applicable tests and standards |
| 4. | Usability | EN 62366 | The proposed device passes the applicable tests and standards |
| 5. | Software life cycle | ISO 62304 | The proposed device passes the applicable tests and standards |
| 6. | Biocompatibility | ISO 10993-1 | The proposed device passes the applicable tests and standards |
| 7. | ATS / ERS | Standard of lung | |
| function testing | The proposed device passes the applicable tests and standards | ||
| 8. | Accuracy Testing | Measurement accuracy | |
| for the new oximetry | |||
| module | The proposed device passes the applicable tests and standards |
1. Non-clinical tests conducted for determination of substantial equivalence:
11
Summary Discussion of Bench Performance Data
The CareFusion MicroLab / MicroLoop passed all specified test requirements.
The validation and verification testing confirmed this device meets user needs and design inputs for pulmonary function and oximetry system.
Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above. These standards address electrical safety, emc, risk, usability, software life cycle and biocompatibility. All testing which have been performed demonstrate substantial equivalence to the predicate devices.
2. Clinical tests conducted for determination of substantial equivalence and/or of clinical information:
Clinical Performance Data/Information:
Clinical testing was not performed with this device.
3. Conclusion drawn from non-clinical and clinical data:
The Carefusion MicroLab / MicroLoop meets the functional claims and intended use as described in the product labeling. The performance are substantially equivalent to the K031102 MicroLab and K092324 SpiroPro described in the submission.
5.16 Conclusion
Based on the above, CareFusion concludes that the MicroLab / MicroLoop Spirometer is substantially equivalent to the legally marketed predicate devices and as safe as effective as the predicate.