The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

Device Description

The DX-4100 Series Pulse Oximeter Monitors is a modification to the Philips VM-1 (K081937) SpQz/CO₂ Monitor. The Monitor uses the same picoSAT IP44 SpO₂ engine as the VM-1, the same power supply, battery and technically the same display (same resolution as used in the VM-1) and has the same intended use as the VM-1 (Pulse Oximetry only). The Monitors will use the Dixtal (FDA cleared: K100020) Pulse Oximetry DX Series SpO2 Sensors. A second version of the DX-4100 Series Pulse Oximeter is equipped with the Philips receptacle thereby providing direct connection to the full line of sensors as indicated for the VM-1. Accuracy testing included with the sensor submission was performed with the Philips VM-1 monitor.

AI/ML Overview

The provided text describes a 510(k) summary for the Dixtal DX-4100 Series Pulse Oximeter where substantial equivalence is claimed based on performance data from the predicate device (Philips Sure Signs Monitor, Model VM-1) and previously cleared sensors (Dixtal DX Series SpO2 Sensors). The information regarding the specific acceptance criteria and detailed study supporting device performance is somewhat fragmented and relies heavily on cross-referencing previous submissions.

Here's an attempt to extract and synthesize the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly listed in a table format with numerical targets. Instead, the document states that the conclusion of the risk assessment and performance data is that the device is "safe and effective for its intended use" and "substantially equivalent to the predicate devices." The core performance metric for pulse oximeters is accuracy in measuring oxygen saturation (SpO2).

Acceptance Criteria (Inferred)	Reported Device Performance
Pertaining to SpO2 Accuracy: - Device provides continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2).	- "Controlled de-Sat (Accuracy) Testing was performed with the Dixtal DX Series sensors and the VM-1." - "This data was initially submitted in support of the recently cleared Premarket Submission for the Dixtal DX Series Sensors (K100020)." - Implied to meet accuracy standards required for substantial equivalence, as the device uses the same SpO2 engine as the predicate and cleared sensors. - Predicate device (VM-1) post-market data indicates a low failure rate and no reportable events, suggesting good performance.
Pertaining to Pulse Rate Accuracy: - Device provides continuous, non-invasive monitoring of pulse rate.	- "Pulse rate is calculated by measuring the time interval between the peaks of the infrared light waveform." - Implied to meet accuracy standards required for substantial equivalence.
Safety and Effectiveness: - Device is safe and effective for its intended use.	- "The Risk Assessment concluded the device is safe and effective for its intended use." - "Post Market Data specific (only) to the VM-1...indicates less than 0.5% failure rate with no reportable events."
Biocompatibility of Components: - Materials in contact with patient are biocompatible.	- "The DX-4100 Series Pulse Oximeter Monitors is a bedside monitor that is not intended for contact with patients." - "The sensors intended for use with the monitor have been previously tested to assure biocompatibility for skin contact devices." - Listing of sensor materials (silicone, PBT, polycarbonate, PVC, polyurethane) and assertion of no latex, DEHP, or Phthalates.

Study Details:

Sample size used for the test set and the data provenance:
- The document states: "Controlled de-Sat (Accuracy) Testing was performed with the Dixtal DX Series sensors and the VM-1. This data was initially submitted in support of the recently cleared Premarket Submission for the Dixtal DX Series Sensors (K100020)."
- Specific sample size for the "Controlled de-Sat (Accuracy) Testing" is NOT provided in this document. It refers to a previous submission (K100020).
- Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for the de-saturation study. However, the mention of "Post Market Data" for the predicate device (VM-1) covers "April 2009 through June 2010" and mentions ">380 units distributed domestically," implying retrospective real-world data from the US for the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly mentioned in this summary. The "Controlled de-Sat (Accuracy) Testing" refers to a physiological challenge study where subjects' oxygen saturation is lowered. Ground truth in such studies typically comes from arterial blood gas analysis performed by clinical staff, rather than "experts" establishing ground truth in the typical diagnostic imaging sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This type of adjudication method is usually relevant for studies requiring subjective interpretation (e.g., image reading), which is not the primary method for validating pulse oximetry accuracy.
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:
- No, an MRMC study was NOT done. This device is a standalone medical device (pulse oximeter) that directly measures physiological parameters like SpO2 and pulse rate. It does not involve human "readers" or AI assistance in the way, for example, an AI-powered diagnostic imaging tool would.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance was assessed. The "Controlled de-Sat (Accuracy) Testing" inherently evaluates the device's (pulse oximeter with its sensors and internal algorithms) ability to accurately measure SpO2 against a reference standard (arterial blood gas) without human interpretation affecting the primary measurement. The DX-4100 series itself is described as a "stand-alone Pulse Oximeter monitor."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "Controlled de-Sat (Accuracy) Testing" for pulse oximeters typically uses arterial blood gas analysis as the gold standard (ground truth) for actual arterial oxygen saturation. This is inferred from the industry standard for such studies.
The sample size for the training set:
- Not applicable/Not mentioned. Pulse oximeters are typically based on well-established biophysical principles (light absorption at different wavelengths) and calibrated using laboratory standards and human de-saturation studies. The term "training set" is more commonly associated with machine learning or artificial intelligence models, which this device does not appear to utilize in the context of its core SpO2/PR measurement.
How the ground truth for the training set was established:
- Not applicable. As "training set" for a machine learning model is not relevant here. The ground truth for the performance evaluation (test set) is inferred to be arterial blood gas analysis, as described above.

Summary

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(SPECIAL) 510(k) SUMMARY

JUL 2 5 2011

K103285.

Submitter's Name and Address

(Device Sponsor and Manufacturer) Dixtal Medical, Inc. 101 N. Plains Industrial Road Bldg 2 Wallingford, CT 06492

Contact Person

Robert H. Schiffman, R.A.C. (EU) Quality Assurance Manager (203) 269-1112, Ext. 240 (203) 269-1760 (facsimile) robert.schiffman@philips.com

3006891479 Establishment Registration Number:

September 24, 2010 Date the Summary was Prepared:

Device/Trade Name/Common Name/Classification

Device Names (Proprietary/Trade Names):	Dixtal DX-4100 Series Pulse Oximeter
Device Name (Common Name):	Pulse Oximeter Monitor
Classification:	Class II, 21CFR 870.2700/74DQA

Legally Marketed Predicate Devices

Legally marketed predicate devices to the Dixtal DX-4100 Series Pulse Oximeter:

Philips Sure Signs Monitor, Model VM-1 (K082280) .
Philips picoSat II Pulse Oximeter engine (K081937) .

Description of the Subject Device

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Statement of Intended Use

The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpQ₂) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

Environments of Use

The Dixtal DX-4100 Series Pulse Oximeter monitors is intended for use in healthcare environments including but not limited to, respiratory therapy, anesthesia, the intensive care unit (ICU), neonatal (NICU) and pediatric (PICU) intensive care units, hospital transport, and other environments where pulse oximetry is required.

Technological Characteristics

The Dixtal DX-4100 Series is a stand-alone Pulse Oximeter monitor. The device uses the same Pulse Oximetry engine as the predicate device (Philips Sure Signs Monitor, Model VM-1: K082280) as well as the same power supply and battery. The display is similar to the predicate device providing the same resolution as available with the VM-1. The Monitor has been designed to use the Dixtal (FDA cleared: K100020) Pulse Oximetry DX Series SpQ Sensors. A second version of the monitor will be equipped with the Philips receptacle and for use the Philips SpQ2 sensors.

Performance Data

Non-Clinical data

Biocompatibility, Cleaning and Disinfection

The DX-4100 Series Pulse Oximeter Monitors is a bedside monitor that is not intended for contact with patients and is only momentarily in contact with the clinical personnel. Therefore the monitor does not meet the criteria for Biocompatibility testing. The sensors intended for use with the monitor have been previously tested to assure biocompatibility for skin contact devices. SpO2 sensors are labeled for reuse and can be cleaned to achieve a low level disinfection. The monitor can be wiped down for low level disinfection and cleaning.

Risks to Health

The Risk Assessment associated with the use of Pulse Oximeters and their sensors has been conducted and is documented and included in the Design Control Activities section of this submission. The Risk Assessment concluded the device is safe and effective for its intended use.

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(SPECIAL) 510(k) SUMMARY

Oxygen Saturation Sensors-Materials

Y-Sensor:

Sensor heads: silicone Cable: silicone Connector: PBT (thermoplastic polyester)

· ·· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

Finger Sensor:

Shell: Polycarbonate Bladder: PVC Foam spring: Silicone Cable: Polyurethane Connector: PBT (thermoplastic polyester)

Note - There is not any latex or natural rubber (which contains trace levels of latex), DEHP or Phthalates in these devices.

Performance Data

Clinical data

Controlled de-Sat (Accuracy) Testing was performed with the Dixtal DX Series sensors and the VM-1. This data was initially submitted in support of the recently cleared Premarket Submission for the Dixtal DX Series Sensors (K100020).

Literature review has been conducted, summarized and is presented in the design control section of this submission. The report includes Post Market data obtained from review of the FDA Maude database as well as from the scientific literature available from various publication sources.

Post Market Data specific (only) to the VM-1 (the picoSat IP45 engine is included in many of the Philips SureSigns VM and VS products) from April 2009 through June 2010 (>380 units distributed domestically) indicates less than 0.5% failure rate with no reportable events.

Conclusion: Jn compliance with Guidance documents, accepted Industry Standards and Design Control requirements, the documented results of verification and validation testing and hypoxia studies; establish the Dixtal DX Series 4100 Pulse Oximeter is substantially equivalent to the predicate devices.

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(SPECIAL) 510(k) SUMMARY

Pulse Oximetry-Background

Pulse Oximeters to which these sensors are connected measures oxygen saturation and pulse rate with sensors that contain red and infrared light sources. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.

The light energy is beamed through a sample cell- a pulsating vascular bed, the patient's finger or toe for example. The remaining light energy not absorbed by the sample cell reaches a photodiode, on the of the sensor. The signal received by the photodiode is split into its red and infrared components, sampled, software filtered and displayed as a numerical value for oxygen saturation and as a waveform, the Plethysmogram.

Functional oxygen saturation is defined as: percentage saturation given by the oxyhaemoglobin concentration (cO2Hb) divided by the sum of the oxyhaemoglobin concentration and the deoxyhaemoglobin concentration (cHHb)

Fractional oxyhaemoglobin FO2Hb: oxyhaemoglobin concentration cO2Hb divided by the total

haemoglobin concentration, ctHb where

cO2Hb is the concentration of oxyhaemoglobin;

ctHB is the concentration of total haemoglobin.

This is sometimes reported as a percentage (multiplying the fraction by 100).

Finctional saturation represents the amount of oxyhemoglobin as a percentage of the hemoglobin that can be oxygenated. Dysfunctional hemoglobin (COHb and METHb) are not included in the measurement of functional saturation.

Image /page/3/Figure/11 description: This image shows a graph with two curves plotted on it. The x-axis ranges from 500 to 1,000, while the y-axis ranges from 10 to 20,000. There are two vertical dashed lines, one labeled "Red 660nm" and the other labeled "Infrared 940 nm."

Pulse Oximetry - Extinction Coefficients vs. wavelength (nm)

Pulse rate is calculated by measuring the time interval between the peaks of the infrared light waveform.

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

Mr. Robert H. Schiffman Quality Assurance Manager Dixtal Medical, Incorporated 101 North Plains Industrial Road Wallingford, Connecticut 06492

JUL 2 5 2011

Re: K103285

Trade/Device Name: Dixtal DX-4100 Series Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 20, 2011 Received: July 21, 2011

Dear Mr. Schiffman:

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 - Mr. Schiffman

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/CentersOffic es/CDRH/CDRHOffice s/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 yours.

Anthony Dim-

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name: Dixtal DX-4100 Series Pulse Oximeter

Indications for use: The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

Prescription Use

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulta

Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

K.103285

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).