The Multi-Parameter Mobile CareGuide™ 4100 Oximeter 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. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party or Reflectance supplied device, which would interface with the Multi-Parameter Mobile CareGuide 4100 Oximeter via a powered USB connection. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional inside and outside a hospital. The Multi-Parameter Mobile CareGuide 4100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 4100 Oximeter 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 4100 Oximeter has not been demonstrated in disease states.

Device Description

The Multi-Parameter Mobile CareGuide 4100 is a noninvasive optical sensor that determines two separate medical parameters and reports them out for display to the user in real-time. Light sources in the sensor illuminate the skin with near infrared (NIR) light passes through the skin and fat with only some loss to be primarily absorbed by small blood vessels in the muscle tissue. Light which is not absorbed is scattered back and analyzed by the spectroscopic detector, also contained in the sensor. The microprocessor in the sensor converts the reflected light to an absorbance spectrum which is then analyzed by two separate algorithms, also stored in the sensor's microprocessor. The two algorithms calculate muscle oxygen saturation (Sm22), and muscle pH (pHm).

The sensor is attached to the patient using the CareGuide Disposable. One Disposable is used per patient, but the CareGuide Sensor is reusable. To use, the adhesive liner is removed from the Disposable and, with the sensor clipped into the Disposable, is adhered to the patient's skin over either the deltoid, calf or thigh muscle.

When the sensor is first placed on the patient, software checks to make sure the LEDs are functioning properly and then the sensor automatically performs an optimization routine which sets up the spectral data collection parameters for the individual patient. Once conditions are established the sensor begins collecting spectra and reporting parameter values.

The Multi-Parameter Mobile CareGuide 4100 measures and provides for output of SmO2 and pHm data. The Multi-Parameter Mobile CareGuide 4100 communicates with either a 3ª party display or monitoring device, or RMI-supplied tablet, which is compliant with the Mobile CareGuide communications protocol. Sm02 and pHm values suitable for display and trending are sent via the Mobile CareGuide communications protocol to the display device as well as error information and device states.

AI/ML Overview

The provided text describes the Multi-Parameter Mobile CareGuide 4100 Oximeter and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

Instead, the document focuses on demonstrating that the new device operates on the same technological principles, has similar components, and identical intended use as previously cleared predicate devices. It lists several standards and internal tests that were conducted to ensure safety and effectiveness, but it does not provide quantitative performance data for these tests against specific acceptance criteria.

Therefore, I cannot populate the table or answer most of the requested questions directly from the provided text.

Here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance:

Parameter/Test	Acceptance Criteria	Reported Device Performance
Accuracy, functionality, and safety as an Oximeter	Not explicitly stated (implied to be equivalent to predicate devices and meeting standards)	"The accuracy, functionality and safety of the Multi-Parameter Mobile CareGuide 4100 Oximeter is the equivalent to the predicate device."
IEC60825-1 Ed 2.0 (2007) - Laser Safety	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
IEC 60601-1-1: 2005 - Medical Electrical Equipment Safety	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
IEC 60601-1-2: 2007-03 - EMC	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
ISO 10993-5 2009 - In vitro cytotoxicity	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
ISO 10993-10 2010 - Irritation and delay-type hypersensitivity	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
AAMI TIR 12:2010 - Reprocessing	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
AAMI TIR 30:2003 - Cleaning reusable medical devices	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
ISTA 1A - Packaging	(Assumed compliance)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter"
Internal Tests (Vibration & shock, Auto-start, Sensor optimization, algorithm updates)	(Assumed internal criteria)	Test results demonstrate that the device "meet[s] the expected performance requirements for an Oximeter" and verify minor updates to the algorithm.

Missing Information/Not Applicable based on the text:

2. Sample size used for the test set and the data provenance: Not mentioned. The document primarily discusses technical equivalence and compliance with standards, not a specific clinical performance study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
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 tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states the device "automatically performs an optimization routine" and "begins collecting spectra and reporting parameter values." This implies a standalone algorithm for measurement, but no specific performance metrics are provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated. For oximeters, ground truth typically involves comparison to a reference standard (e.g., co-oximetry of arterial blood samples), but this detail is not provided in this submission summary. The phrase "The accuracy, functionality and safety... is the equivalent to the predicate device" suggests reliance on the predicate's established performance rather than a new full-scale ground truth study.
8. The sample size for the training set: Not mentioned. No specific training set for an algorithm is described, though the document refers to "two separate algorithms" stored in the sensor's microprocessor.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

The document serves as a 510(k) summary focused on demonstrating substantial equivalence to previously cleared predicate devices. The primary argument for meeting acceptance criteria is that the Multi-Parameter Mobile CareGuide 4100 Oximeter utilizes identical technology (NIR spectroscopy hardware and software), has similar components, and the same intended use as its predicates. Compliance with various safety, electrical, biological, and packaging standards is listed as evidence of safety and effectiveness, but no quantitative performance data from a specific clinical study with defined acceptance criteria is provided.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol associated with the department.

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

August 22, 2014

Reflectance Medical, Inc. % Nandini Murthy Regulatory Consultant 116 Flanders Road, Suite 1000 Westborough, Massachusetts 01581

Re: K141496

Trade/Device Name: Multi-parameter Mobile Careguide 4100 Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD. CBZ Dated: June 4, 2014 Received: June 6, 2014

Dear Nandini Murthy,

This letter corrects our substantially equivalent letter of August 4, 2014.

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.

{1}------------------------------------------------

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 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

sincerely yours,

[signature]

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

Enclosure

{2}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

Indications for Use Form

Indications for Use

510(k) Number (if known):

Multi-Parameter Mobile CareGuide™ 4100 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 of

{3}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

SECTION 5 510(k) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS FOR Multi-Parameter Mobile CareGuide™ 4100 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:	August 1, 2014

Device Name

Trade name of New Device:	Multi-Parameter CareGuide™ Oximeter
Model Number:	4100
510(k) Holder/Submitter:	Reflectance Medical, Inc. (RMI)
510(k) Number:	N/A
Applicable product codes:	MUD, 21 CFR 870.2700 Oximeter andCBZ, 21 CFR 868.1170 Analyzer, Hydrogen-Ion(Ph)
Classification Panel:	Cardiovascular

Predicate Devices

Predicate Device #1:	CareGuide Oximeter
Trade name of Device:	CareGuide™ Oximeter
Model #:	1100
510(k) holder/Submitter:	Reflectance Medical, Inc.

{4}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

510(k) Number:	K113656
Predicate Device #2:	CareGuide Oximeter
Trade name of Device:	Mobile CareGuide™ Oximeter
Model #:	2100
510(k) holder/Submitter:	Reflectance Medical, Inc.
510(k) Number:	K122645
Predicate Device #3:	CareGuide Oximeter
Trade name of Device:	Multi-Parameter Mobile CareGuide™ Oximeter
Model #:	3100
510(k) holder/Submitter:	Reflectance Medical, Inc.
510(k) Number:	K130079
Predicate Device #4:	CareGuide Oximeter
Trade name of Device:	Multi-Parameter Mobile CareGuide™ Oximeter
Model #:	3100 with Tablet
510(k) holder/Submitter:	Reflectance Medical, Inc.
510(k) Number:	K133923

Device Description

The Multi-Parameter Mobile CareGuide 4100 has the following technical characteristics in common with the CareGuide family of predicate devices.

Characteristics	Reflectance Medical Multi-Parameter Mobile CareGuide 4100Oximeter
Principle of Operation	NIR spectroscopy
Components	Monitor with reusable sensor and disposable pad
Light Source	LEDs
Parameters Measured	Tissue oxygen saturation (SmO2) and muscle pH (pHm)

{5}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

detector, also contained in the sensor. The microprocessor in the sensor converts the reflected light to an absorbance spectrum which is then analyzed by two separate algorithms, also stored in the sensor's microprocessor. The two algorithms calculate muscle oxygen saturation (Sm22), and muscle pH (pHm).

Indications for Use

The Multi-Parameter Mobile CareGuide™ 4100 Oximeter is intended for use as an adjunct, noninvasive 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 4100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party or Reflectance supplied device, which would interface with the Multi-Parameter Mobile CareGuide 4100 Oximeter via a powered USB connection. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional inside and outside a hospital. The Multi-Parameter Mobile CareGuide 4100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 4100 Oximeter 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 4100 Oximeter has not been demonstrated in disease states.

Rationale for Substantial Equivalence

The Multi-Parameter Mobile CareGuide 4100 Oximeter is substantially equivalent to the Reflectance Medical CareGuide predicate devices by intended use and design.

{6}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

. The Mobile CareGuide 4100 Oximeter is identical to the predicate family in technological optical principles. They all use the identical NIR Spectroscopy hardware and software, using multiple wavelengths in the range 700-900 nm to measure tissue oxygen saturation and pH.
The Multi-Parameter Mobile CareGuide 4100 Oximeter has a reusable sensor, disposable . and sensor check functionality equivalent to the predicates.
The Multi-Parameter Mobile CareGuide 4100 Oximeter provides identical data to be . displayed as numeric values or trend.
. The Intended Use is the same as the predicate.
. Therefore, the Multi-Parameter Mobile CareGuide 4100 Oximeter is substantially equivalent to the predicates in terms of the proposed intended use and technology.
There are no new or open questions of safety and effectiveness. ●

Summary of Safety and Effectiveness Data

Testing demonstrates that the Multi-Parameter Mobile CareGuide 4100 Oximeter is a safe and effective oximeter meeting all relevant FDA recognized standards and internal testing as listed in Table 1.

Standard #or InternalTest	Description
IEC60825-1Ed 2.0 (2007)	Safety of laser products - Part 1: Equipment classification, andrequirements
IEC 60601-1-1: 2005	Medical electrical equipment -- Part 1-1: General requirements for safety –Collateral standards: Safety requirements for medical electrical systems
IEC 60601-1-2: 2007-03	Medical Electrical Equipment - Part 1-2: General Requirements for basicsafety and essential performance – Collateral standard: ElectromagneticCompatibility – Requirements and tests
ISO 10993-52009	Biological evaluation of medical devices-Part 5: Test for in vitrocytotoxicity
ISO 10993-102010	Biological evaluation of medical devices-Part 10: Tests for irritation anddelay-type hypersensitivity
AAMI TIR12:2010	Designing, testing and labeling reusable medical devices for reprocessingin health care facilities: A guide for medical device manufacturers
AAMI TIR30:2003	A compendium of processes, materials, test methods, and acceptancecriteria for cleaning reusable medical devices

Table 1 Standards and Internal Testing

{7}------------------------------------------------

510(k) Premarket Notification Submission: Multi-Parameter Mobile CareGuide™ 4100 Oximeter

Standard #or InternalTest	Description
ISTA 1A	Series Non-Simulation Integrity Performance Test Procedure: Packaged-Products 150 lb (68 kg) or Less
Internal Tests	Device Verification and Validation tests such as Vibration and shock,Auto-start, Sensor optimization and background checks and verification ofminor updates to the CareGuide 4100 algorithm

The test results in this submission demonstrate that the Multi-Parameter Mobile CareGuide 4100 Oximeter meets the expected performance requirements for an Oximeter. The accuracy, functionality and safety of the Multi-Parameter Mobile CareGuide 4100 Oximeter is the equivalent to the predicate device.

Conclusion

The Multi-Parameter Mobile CareGuide 4100 Oximeter is equivalent to predicate devices in terms of technology (NIR Spectroscopy) and intended use. The Multi-Parameter Mobile CareGuide 4100 Oximeter does not raise new questions of safety or effectiveness, as compared to the predicate. Therefore, the Multi-Parameter Mobile CareGuide 4100 Oximeter is substantially equivalent to the predicate device.

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).