The CareGuide™ 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 CareGuide displays the most recent value of SmO2, as well as a graphical trend of previous SmO2 measurements. The CareGuide System should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the CareGuide™ Oximeter has not been demonstrated in disease states.

Device Description

The CareGuide sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The CareGuide Display is an all-in-one touch screen off-the-shelf computer. The display contains the user interface software, the algorithms that calculate SmQ2 from collected spectra, displays the current SmO2 result and trends previous results. The CareGuide 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 CareGuide display. The sensor contains 3 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject and (3) a microprocessor to control the optical components. The CareGuide Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.

AI/ML Overview

The provided text describes the CareGuide™ Oximeter, an oximeter that uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The submission aims to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity) or a detailed study proving the device meets these criteria with quantitative results.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will provide what can be extracted.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical format that would typically be found in a performance study. It broadly states: "The test results in this submission demonstrate that the CareGuide Oximeter meets the expected performance requirements for an Oximeter, and is therefore equivalent to the predicates relative to safety and mechanical properties."

Acceptance Criteria	Reported Device Performance
Not specified in document	Met expected performance requirements for an Oximeter. Demonstrated accuracy against a laboratory co-oximeter in an animal study. Demonstrated ability to measure tissue oxygen saturation in subjects with different skin color in a clinical environment.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified.
Data Provenance:
- An "isolated perfused animal limb GLP study" for accuracy against a laboratory co-oximeter. The location is not specified, but GLP (Good Laboratory Practice) implies a controlled environment.
- A "clinical environment" study for the ability to measure tissue oxygen saturation in subjects with different skin color (pigmentation). The location and other details are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The ground truth for the animal study was a "laboratory co-oximeter." For the clinical environment study, how the ground truth for pigment measurement was established is not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified. The document does not describe any adjudication process for establishing ground truth or evaluating device performance.

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 an oximeter, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, implicitly. The studies mentioned (animal, clinical environment) appear to evaluate the device's (including its algorithms) performance in measuring SmO2 directly, without a human-in-the-loop component for interpretation or assistance that would be typical in AI-assisted diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For accuracy: "laboratory co-oximeter" (considered a gold reference standard).
For skin color study: Not explicitly stated, but implies a measure of tissue oxygen saturation from the device compared to a reference or evaluated for consistency across different skin pigmentations.

8. The sample size for the training set

Not applicable. The device described uses NIRS technology and algorithms; it is not presented as a machine learning system requiring a distinct "training set" in the common sense of AI models. The algorithms are likely based on biophysical models of light absorption and scattering.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for machine learning.

Summary

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K113656

Reflectance Medical, Inc. 510(k) Premarket Notification Submission: CareGuide™ Oximeter

JUL 26 2012

SECTION 5 510(k) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS FOR CareGuide™ Oximeter

Submitter Information

Name:	Reflectance Medical, Inc. (RMI)
Address:	116 Flanders Road, Suite 1000Westborough, 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:	July 26, 2012
Device Name
Device Trade Name:	CareGuide™ Oximeter
Device Common Name:	Oximeter
Classification:	Sec 870.2700 Oximeter
Product Code:	MUD
Classification Panel:	Cardiovascular Device Panel
Predicate Devices

Device Trade Name:	Invos™ Somatic Oximeter
Device Common Name:	Oximeter
Classification:	Sec 870.2700 Oximeter
510(k) Number:	K051274
Product Code:	MUD

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Reflectance Medical, Inc. 510(k) Premarket Notification Submission: CareGuide™ Oximeter

Device Trade Name:	Hutchinson InSpectra™ StO2 Monitor
Device Common Name:	Oximeter
Classification:	Sec 870.2700 Oximeter
510(k) Number:	K012759
Product Code:	MUD
Device Trade Name:Device Common Name: OximeterClassification:510(k) Number:Product Code:	Hutchinson SpotCheck™ StO2 MonitorSec 870.2700 OximeterK103613MUD
Device Trade Name:	Spectros T-Stat™ Oximeter
Device Common Name:	Oximeter
Classification:	Sec 870.2700 Oximeter
510(k) Number:	K040684
Product Code:	MUD

Device Description

The CareGuide sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2).

Characteristics	Reflectance Medical CareGuide Oximeter
Principle of Operation	NIR spectroscopy
Components	Monitor with reusable sensor and disposable pad
Light Source	LEDs
Parameters Measured	Tissue oxygen saturation (SmO2)

The CareGuide Display is an all-in-one touch screen off-the-shelf computer. The display contains the user interface software, the algorithms that calculate SmQ2 from collected spectra, displays the current SmO2 result and trends previous results. The CareGuide 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 CareGuide display. The sensor contains 3 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject and (3) a microprocessor to

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Reflectance Medical, Inc.

510(k) Premarket Notification Submission: CareGuide™ Oximeter

control the optical components. The CareGuide Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.

Indications for Use

Rationale for Substantial Equivalence

The CareGuide™ Oximeter is substantially equivalent to the Somanetics Invos™ Somatic Oximeter (K051274), the Hutchinson InSpectra™ StO2 Monitor (K012759) and the Hutchinson Spot Check StO2 Monitor (K103613).

The CareGuide Oximeter is substantially equivalent to the predicates by intended use and design.

. The principle of operation of the CareGuide Oximeter is identical to that of the predicate devices. They all use NIR Spectroscopy to measure tissue oxygen saturation.
. The CareGuide Oximeter is identical to the predicates in components. All devices have a Monitor with a Sensor.
. The CareGuide Oximeter has the same underlying LED light source as the predicates. with the similar ranges of wavelength (700-900 nm between the three devices).
The CareGuide Oximeter and the predicates all display output as a numeric trend. .
The Intended Use is identical to the predicates. They are all intended for use as . oximeters, to measure tissue oxygen saturation.

Further, the CareGuide Oximeter has multiple number of wavelengths like the T-Stat predicate Oximeter

Summary of Safety and Effectiveness Data

Testing demonstrates that the CareGuide Oximeter is a safe and effective oximeter meeting all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the CareGuide Oximeter meets the expected performance requirements for an Oximeter, and is therefore equivalent to the predicates relative to safety and mechanical properties. The accuracy of the CareGuide Oximeter against the gold reference standard of a

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K113656

Reflectance Medical, Inc.

510(k) Premarket Notification Submission: CareGuide™ Oximeter

laboratory co-oximeter was demonstrated in an isolated perfused animal limb GLP study. The ability of the CareGuide Oximeter to measure tissue oxygen saturation in subjects with different skin color (pigmentation) has been demonstrated in the clinical environment.

Conclusion

The CareGuide Oximeter is equivalent to predicate devices in terms of technology (NIR Spectroscopy) and intended use. The CareGuide Oximeter, with its multiple source configuration to overcome the effect of skin pigmentation, does not raise new questions of safety or effectiveness, as compared to the predicates. Therefore, the CareGuide Oximeter is substantially equivalent to the predicate devices.

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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 & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

JUL 26 2012

Reflectance Medical, Inc. c/o Nandini Murthy Rgulatory Consultant, RMI 116 Flanders Road. Suite 100 Westborough. MA 01581

Re: K113656

Trade/Device Name: CareGuide Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter, tissue saturation Regulatory Class: Class II (two) Product Code: MUD Dated: July 20, 2012 Received: July 23, 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.

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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/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 your

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

Enclosure

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Reflectance Medical, Inc.

510(k) Premarket Notification Submission: CareGuide Oximeter

Indications for Use Form

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

CareGuide™ Oximeter Device Name:

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

(Division Sign-Ofm
Division of Cardiovascular Devices
510(k) Number 1413 650

CONFIDENTIAL

Page 1 of 1

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).