The Multi-Parameter Mobile CarcGuide™ 3100 Oximeter with Tablet is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has not been demonstrated in disease states.

Device Description

The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses Near Infrared (NIR) Spectroscopy to calculate muscle oxygen saturation (SmO2) and muscle pH (pHm) and displays those parameters as real-time values and historical trends on a tablet device. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to an Android tablet with display software through a proprietary protocol. The Android tablet (qualified models Acer A500 and Asus Google Nexus 7) contains 3d party software that locks down the tablet so that only the CareGuide software may run and no other application or operating software can be modified. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet 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 a USB connection to the Android tablet. The sensor is identical to the predicate (K130079) Multi-parameter Mobile CareGuide 3100 Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses the same disposable element as the Multi-Parameter Mobile CareGuide 3100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by integrating an Android tablet as a display component.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

No specific clinical study comparing the new device's performance against detailed quantitative acceptance criteria is presented. The safety and effectiveness claim is based on demonstrating substantial equivalence to predicate devices because the core measurement technology and algorithms for SmO2 and pHm remain unchanged. The primary change is the integration of a dedicated Android tablet for display.

Instead of a new clinical study with performance metrics, the submission relies on the established performance of the predicate device and extensive bench and software testing to ensure the new display integration does not compromise the device's functionality.

1. Table of Acceptance Criteria and Reported Device Performance

As there isn't a new clinical study with specific quantitative acceptance criteria for this 510(k) submission, the table below reflects what can be inferred from the "Rationale for Substantial Equivalence." The "acceptance criteria" here refer to maintaining the established performance and features of the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (as stated in submission)
Principle of Operation: Identical to predicate devices (NIR spectroscopy)	"The principle of operation... is identical to that of the predicate CareGuide devices. They use the exact same NIR spectroscopic platform to measure tissue oxygen saturation and muscle."
Algorithms: Same software quantitative algorithm for SmO2 and pHm as predicate	"The same software quantitative algorithm for SmO2 and pHm is used in both devices."
Reusable Components: Identical sensor hardware to predicate (CPU board, battery, optical board, USB interfaces, housing, cables)	"The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is equivalent to the ● Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in reusable components. Both devices use the exact same sensor hardware: main sensor CPU board, battery, optical board (light sources, spectrometer and microprocessor), USB interfaces, plastic housing and cables."
Disposable Components: Identical disposable sheath and sensor check device to predicate	"The Multi-Parameter Mobile CareGuide 3100 Oximeter with Table is equivalent to the Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in disposable components. Both devices use the exact same disposable sheath ('Ray') and disposable sensor check device ('Cradle')."
Light Source: Identical underlying LED light source and wavelength range (700-900 nm) to predicate	"The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has the identical underlying LED light source as the CareGuide predicates, with the exact same range of wavelength (700-900 nm)."
Display Functionality: Dedicated Android tablet is functionally equivalent to predicate's display, showing real-time parameters and historical trends.	"The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet and the predicated CareGuide 1100 Oximeter are equivalent. The CareGuide 1100 System includes a Monitor display while the CareGuide 3100 {subject of this 510(k)} includes a dedicated Android display. Both displays are functionally equivalent. Both CareGuide 1100 and 3110 displays are tools that interface with the CareGuide oximeter and display real-time parameters and historical trends per their cleared indications for use."
Compatibility: New device with tablet supports specified communications protocol.	"The predicate Multi-Parameter Mobile CareGuide 3100 Oximeter is compatible with any USB-connected display device that supports the specified communications protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet {subject of this 510(k)} now includes such a USB-connected display device (i.e. dedicated Android tablet), supporting that specified communications protocol."
Safety and Effectiveness: Meets relevant consensuses and FDA recognized standards.	"Bench testing demonstrates that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is safe and effective, meeting all relevant consensuses and FDA recognized standards. The bench and software test results in this submission demonstrate that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet meets the expected performance requirements for an Oximeter."

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a specific clinical test set in terms of sample size or data provenance for this 510(k) submission. The submission relies on "Bench testing" and "software test results" to demonstrate that the new device (with the integrated tablet) performs as expected and is equivalent to the predicate. The performance of the underlying oximetry and pHm measurements would have been established in previous 510(k) clearances for the predicate devices (K130079 and K113656).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission does not detail a new clinical study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool for human readers. It is a medical device for direct physiological measurement and display.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's core functionality is standalone in terms of generating SmO2 and pHm values from collected spectra using internal algorithms. The 510(k) mainly addresses the display mechanism. "Bench testing" and "software test results" were performed to confirm that the entire system (including the new display component) functions correctly. Therefore, the performance evaluated was the standalone device's ability to measure and display parameters accurately, consistent with the predicate.

7. The Type of Ground Truth Used

For the current 510(k), the "ground truth" for proving substantial equivalence was primarily:

Engineering specifications and design documents: Demonstrating identical hardware, software algorithms, and principle of operation to the predicate devices.
Bench testing standards: Adherence to "relevant consensuses and FDA recognized standards" for oximeters, confirming the overall system functions as expected.

For the original clearance of the oximetry (SmO2) and pHm features (in the predicate devices K130079 and K113656), the ground truth would have been established through methods appropriate for physiological measurements, likely involving:

Reference standard instruments: Comparing SmO2 and pHm measurements against established, more invasive, or laboratory-based reference methods.
Induced physiological changes: Studies where oxygen saturation and pH are systematically varied in subjects to test the device's accuracy across a range of values.

8. The Sample Size for the Training Set

Not applicable for this 510(k) submission. This is not an AI/ML device that requires a distinct training set for its algorithms. The core algorithms were established and validated during the previous clearance of the predicate devices.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no new training set is described. The ground truth for the underlying algorithms of the predicate devices would have been established through a combination of physiological research, established oximetry principles, and potentially in-vivo and in-vitro studies comparing the device's measurements to reference standards.

Summary

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K133923

Reflectance Medical, Inc.

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

APR 1 2014

SECTION 5

510(k) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS FOR Multi-Parameter Mobile CareGuide™ 3100 Oximeter, with Tablet

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:	12/19/2013

Device Name

Trade name of New Device:	Multi-Parameter CareGuide™ Oximeter with Tablet
Model Number:	3100
510(k) Holder/Submitter:	Reflectance Medical, Inc. (RMI)
510(k) Number:	N/A
Product codes:	21 CFR § 870.2700, 21 CFR 868.1170
Classification Panel:	Cardiovascular

Predicate Devices

Predicate Device #1:	Mobile CareGuide
Trade Name of Device:	Multi-Parameter Mobile CareGuide Oximeter
Model #:	3100 :
510(k) Holder/Submitter:	Reflectance Medical Inc.
510(k) Numbers:	K130079, CareGuide 3100
Product codes:	MUD, 21 CFR 870.2700, CardiovascularCBZ, 21 CFR 868.1170, Anesthesiology

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510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

Predicate Device #2:	CareGuide
Trade Name of Device:	CareGuide Oximeter
Model #:	1100
510(k) Holder/Submitter:	Reflectance Medical Inc.
510(k) Numbers:	K113656, CareGuide 1100
Product code:	MUD, 21 CFR 870.2700, Cardiovascular

Device Description

Characteristics
Reflectance Medical Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet
Principle of Operation	NIR spectroscopy
Components	Monitor with reusable sensor, disposable pad and display tablet
Light Source	LEDs
Parameters Measured	Tissue oxygen saturation (SmO2) and muscle pH (pHm)

The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is a multiple parameter oximeter. The sensor contains algorithms that calculate SmO2 and pHm from collected spectra and communicates the current SmO2 and pHm results to an Android tablet with display software through a proprietary protocol. The Android tablet (qualified models Acer A500 and Asus Google Nexus 7) contains 3d party software that locks down the tablet so that only the CareGuide software may run and no other application or operating software can be modified. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet 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 a USB connection to the Android tablet. The sensor is identical to the predicate (K130079) Multi-parameter Mobile CareGuide 3100 Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet uses the same disposable element as the Multi-Parameter Mobile CareGuide 3100 Oximeter, a disposable sleeve that isolates the sensor optical elements from the patient's skin.

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510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

Indications for Use

The Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has not been demonstrated in disease states.

Rationale for Substantial Equivalence

The CareGuide 3100 device's oximetry feature has been already cleared under classification regulation 21 C.F.R § 870.2700, Oximeter. The device's pHm feature has been already cleared under classification regulation 21 C.F.R § 868.1170, Anesthesiology. This 510(k) is seeking clearance for use of the CareGuide 3100 with a dedicated Android Display device.

There is no change in how the User would use the information generated by the Multi-Parameter Care Guide 3100 with Tablet relative to the predicate devices. They are all intended for monitoring of respective parameters. Neither the Multi-Parameter CareGuide 3100 with Tablet nor any of the predicate devices identified by RMI provides diagnostic output.

The Multi-Parameter CareGuide 3100 with Tablet has the same technological characteristics as the previously cleared RMI devices, the CareGuide 1100 (K113656) and the Multi-Parameter Mobile CareGuide 2100 (K130079).

The principle of operation of the Multi-Parameter Mobile CareGuide 3100 Oximeter with . Tablet is identical to that of the predicate CareGuide devices. They use the exact same NIR spectroscopic platform to measure tissue oxygen saturation and muscle. The same software quantitative algorithm for SmO2 and pHm is used in both devices.
The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is equivalent to the ● Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in reusable components. Both devices use the exact same sensor hardware: main sensor CPU board, battery, optical board (light sources, spectrometer and microprocessor), USB interfaces, plastic housing and cables.
. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Table is equivalent to the Multi-Parameter Mobile CareGuide 3100 Oximeter predicate in disposable components. Both devices use the exact same disposable sheath ("Ray") and disposable sensor check device ("Cradle").

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510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet has the identical underlying LED light source as the CareGuide predicates, with the exact same range of wavelength (700-900 nm).
. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet and the predicated CareGuide 1100 Oximeter are equivalent. The CareGuide 1100 System includes a Monitor display while the CareGuide 3100 {subject of this 510(k)} includes a dedicated Android display. Both displays are functionally equivalent. Both CareGuide 1100 and 3110 displays are tools that interface with the CareGuide oximeter and display real-time parameters and historical trends per their cleared indications for use.
. The predicate Multi-Parameter Mobile CareGuide 3100 Oximeter is compatible with any USB-connected display device that supports the specified communications protocol. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet {subject of this 510(k)} now includes such a USB-connected display device (i.e. dedicated Android tablet), supporting that specified communications protocol.

Summary of Safety and Effectiveness Data

Bench testing demonstrates that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is safe and effective, meeting all relevant consensuses and FDA recognized standards. The bench and software test results in this submission demonstrate that the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet meets the expected performance requirements for an Oximeter. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is therefore equivalent to the predicates by indications for use and device features and functionality.

Conclusion

The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is equivalent to predicate device in terms of technology (NIR Spectroscopy) and intended use. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet does not raise new questions of safety or effectiveness, as compared to the predicate. Therefore, the Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2014

Reflectance Medical, Inc. Babs Soller Chief Executive Officer 116 Flanders Road, Suite 1000 Westborough, MA 01581 US

Re: K133923

Trade/Device Name: Multi-parameter Mobile CareGuide 3100 Oximeter with Tablet Regulation Number: 21 CFR 870.8700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: March 7, 2014 Received: March 13, 2014

Dear Dr. Soller,

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 r lease be actised may be notal your device complies with other requirements of the Act

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Page 2 - Dr. Babs Soller

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 devicerelated 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" (21 CFR 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,

Image /page/5/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, geometric design. There are lines drawn through the logo, which may indicate that it is not valid or has been rejected. The logo is black and white and appears to be a scanned image.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

Indications for Use Form

Indications for Use

510(k) Number (if known): K133923_

Device Name: Multi-Parameter Mobile CareGuide™ 3100 Oximeter with Tablet

Indications for Use:

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 of

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Page 21 of 361

Regulation Number and Section

§ 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).