(97 days)
Not Found
No
The description mentions "algorithms that calculate SmO2 from collected spectra" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML development (training sets, test sets, etc.). The focus is on standard signal processing and calculation from NIRS data.
No.
The device is described as an "adjunct, non-invasive monitor" and its intended use states it "should not be used as the sole basis for diagnosis or therapy," indicating it is a diagnostic/monitoring device, not a therapeutic one.
Yes
The device is described as an "adjunct, non-invasive monitor" and provides "SmO2 data," which is used by a healthcare professional. Although it states it "should not be used as the sole basis for diagnosis or therapy," it contributes data that would be part of a diagnostic process.
No
The device description explicitly details hardware components including light sources, a spectroscopic detector, microprocessors, communication components, and a battery, all contained within a reusable sensor. It also mentions a disposable sleeve. This is not a software-only device.
Based on the provided information, the Mobile CareGuide™ 2100 Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Mobile CareGuide 2100 Oximeter's Function: The Mobile CareGuide 2100 Oximeter is a non-invasive device that uses Near Infrared Spectroscopy (NIRS) to measure muscle oxygen saturation (SmO2) in vivo (within the living body) by placing a sensor on the skin. It does not analyze specimens taken from the body.
Therefore, because it operates by directly measuring a physiological parameter within the body rather than analyzing a specimen outside the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mobile CareGuide™ 2100 Oximeter is intended for use as an adjunct. non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.
Product codes
MUD
Device Description
The Mobile CareGuide 2100 Oximeter sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2).
The Mobile CareGuide 2100 Oximeter is a self-contained, medical oximeter. The sensor contains algorithms that calculate SmO2 from collected spectra and communicates the current SmO2 result to a 310 party display or patient monitor through a proprietary protocol. The Mobile CareGuide 2100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 30 party display/patient monitor. The sensor contains 6 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Mobile CareGuide 2100 Oximeter Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near Infrared Spectroscopy (NIRS)
Anatomical Site
Skeletal muscle tissue beneath the sensor, sensor may be positioned on pigmented skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professional in a hospital.
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
Testing demonstrates that the Mobile CareGuide 2100 Oximeter is a safe and effective oximeter meeting all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the Mobile CareGuide 2100 Oximeter meets the expected performance requirements for an Oximeter, and is therefore equivalent to the predicate relative to safety and mechanical properties. The accuracy and safety of the Mobile CareGuide 2100 Oximeter is the same as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Reflectance Medical, Inc. 510(k) Premarket Notification Submission: Mobile CareGuide™ 2100 Oximeter
SECTION 5
DEC 5 2012
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR Mobile CareGuide™ 2100 Oximeter
Submitter Information
| Name: | Reflectance Medical, Inc. (RMI) |
|---|---|
| Address: | 116 Flanders Road, Suite 1000 Westborough, MA 01581 USA |
| Telephone Number: | 508.366.4700 |
| Registration Number: | NA (RMI will apply for registration number following 510(k) clearance, prior to commencement of commercial shipment.) |
| Contact Person: | Dr. Babs Soller |
| Telephone Number: | 508.366.4700, Ext 223 |
| Fax Number: | 508.366.4770 |
| Email: | Babs.Soller@reflectancemedical.com |
| Date Prepared: | November 20, 2012 |
| Device Name | |
| Device Trade Name: | Mobile CareGuide™ 2100 Oximeter |
| Device Common Name: | Oximeter |
| Classification: | Sec 870.2700 Oximeter |
| Product Code: | MUD |
| Classification Panel: | Cardiovascular Device Panel |
| Predicate Devices |
| Device Trade Name: | CareGuide™ Oximeter |
|---|---|
| Device Common Name: | Oximeter |
| Classification: | Sec 870.2700 Oximeter |
| 510(k) Number: | K113656 |
| Product Code: | MUD |
1
Reflectance Medical, Inc. 510(k) Premarket Notification Submission: Mobile CareGuide™ 2100 Oximeter
Device Description
The Mobile CareGuide 2100 Oximeter sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2).
| Characteristics | Reflectance Medical Mobile CareGuide 2100 Oximeter |
|---|---|
| Principle of Operation | NIR spectroscopy |
| Components | Monitor with reusable sensor and disposable pad |
| Light Source | LEDs |
| Parameters Measured | Tissue oxygen saturation (SmO2) |
The Mobile CareGuide 2100 Oximeter is a self-contained, medical oximeter. The sensor contains algorithms that calculate SmO2 from collected spectra and communicates the current SmO2 result to a 310 party display or patient monitor through a proprietary protocol. The Mobile CareGuide 2100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 30 party display/patient monitor. The sensor contains 6 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Mobile CareGuide 2100 Oximeter Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.
Indications for Use
The Mobile CareGuide™ 2100 Oximeter is intended for use as an adjunct. non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.
2
Reflectance Medical, Inc.
510(k) Premarket Notification Submission: Mobile CareGuide™ 2100 Oximeter
Rationale for Substantial Equivalence
The Mobile CareGuide™ 2100 Oximeter is substantially equivalent to the Reflectance Medical CareGuideTM Oximeter (K113656).
The Mobile CareGuide 2100 Oximeter is substantially equivalent to the predicate by intended use and design.
- . The principle of operation of the Mobile CareGuide 2100 Oximeter is identical to that of the predicate device. They use the exact same NIR Spectroscopy to measure tissue oxygen saturation. The same software quantitative algorithm is used in both devices.
- The Mobile CareGuide 2100 Oximeter is equivalent to the predicates in components. . Both devices use the exact same optical board (light sources, spectrometer and microprocessor).
- . The Mobile CareGuide 2100 Oximeter has the identical underlying LED light source as the predicate, with the exact same ranges of wavelength (700-900 nm) and number of wavelengths.
- . The Mobile CareGuide 2100 Oximeter produces the same numeric data to be displayed on a 3rd party device as the predicate device.
- The Intended Use is identical to the predicate. Both are intended for use as oximeters, to . measure tissue oxygen saturation.
Summary of Safety and Effectiveness Data
Testing demonstrates that the Mobile CareGuide 2100 Oximeter is a safe and effective oximeter meeting all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the Mobile CareGuide 2100 Oximeter meets the expected performance requirements for an Oximeter, and is therefore equivalent to the predicate relative to safety and mechanical properties. The accuracy and safety of the Mobile CareGuide 2100 Oximeter is the same as the predicate device.
Conclusion
The Mobile CareGuide 2100 Oximeter is equivalent to predicate device in terms of technology (NIR Spectroscopy) and intended use. The Mobile CareGuide 2100 Oximeter, with its embedded microprocessor and supporting components, does not raise new questions of safety or effectiveness. as compared to the predicate. Therefore, the Mobile CareGuide 2100 Oximeter is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 5 2012
Reflectance Medical, Inc. c/o Nandini Murthy 116 Flanders Rd, Suite 1000 Westborough, MA 01581
Re: K122645
Trade/Device Name: Mobile CareGuide 2100 Oximeter Regulation Number: 21 CFR §870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: November 21, 2012 Received: November 27, 2012
Dear Ms. Murthy:
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.
4
Page 2 -- Ms. Nandini Murthy
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 (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 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/ReportalProblem/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 vours,
Mitchell J. Shein 2012.12.05 15:14:32 -05'00'
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Reflectance Medical, Inc.
510(k) Premarket Notification Submission: Mobile CareGuide™ 2100 Oximeter
Indications for Use Form
Indications for Use
510(k) Number (if known): K122645
Mobile CareGuide™ 2100 Oximeter Device Name:
Indications for Use:
The Mobile CareGuide™ 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF . NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Mitchell J. Shein
2012.12.05
15:13:33 -05'00'
Bram Zuckerman, M.D.
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