EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments. Prescription device.

Device Description

The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above. EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission: A finger clip with rigid halves positioned by mild spring force, An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable, I A soft rubber finger sensor with unitary sealed tube type construction. A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta). Each sensor type includes the following features: r Connector pin-outs specific for the manufacturer type, Component specifications specific for the manufacture type. Each sensor clearly specifies the manufacturer type with two compatibility statements: One printed on or attached to the sensor r, 트 One on the instructions for use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: EnviteC Reusable SpO2 Sensors

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the clinical study (e.g., a specific SpO2 accuracy range with a defined root mean square error (RMSE) or bias/precision). Instead, it states that the clinical test results "support the stated accuracy claims for the specified range of 70% to 100% SaO2."

However, based on regulatory expectations for SpO2 devices, the general acceptance criteria for accuracy are often inferred from standards like ISO 80601-2-61 (which might not have been fully in effect or the exact version used at the time of this filing in 2009 for the clinical study). A common requirement for pulse oximeters is an accuracy of ±2% or ±3% across the specified range.

Therefore, the table below reflects what can be inferred rather than explicitly stated.

Acceptance Criterion (Inferred from regulatory standards)	Reported Device Performance (Summary from clinical study)
Accuracy of SpO2 measurement across a range of 70% to 100% SaO2 must be clinically acceptable. (Typically, SpO2 accuracy within ±2% or ±3% compared to co-oximetry reference.)	Clinical test results "support the stated accuracy claims for the specified range of 70% to 100% SaO2."
Device must be compatible with predicate oximeter manufacturers.	Device validated for compatibility with predicate oximeter manufacturers.
Compliance with electrical safety and electromagnetic compatibility (EMC) standards.	Device "passed all of the tests" for electrical safety and EMC.
Biocompatibility of patient contact materials.	Patient contact materials "meet applicable standards for biocompatibility."
Accurate pulse rate measurement.	Tested for pulse rate with a listed simulator and sensor electro-optical parameters were measured and compared to predicate devices; passed all tests.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "patients" and "subjects" but does not provide a specific number for the cohort involved in the clinical testing.
Data Provenance:
- Country of Origin: Not explicitly stated whether the clinical study was conducted in a specific country. However, the manufacturer is German (EnviteC-Wismar GmbH, Germany), and the 510(k) submission is to the FDA in the USA, implying potential international or US-based studies.
- Retrospective or Prospective: The study was prospective. This is indicated by the statement: "All testing was performed under an institutionally approved protocol with subject informed consent." This implies a planned, ethics-committee-approved study with new data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated, though "co-oximetry" is the gold standard for measuring SaO2 in these types of studies, typically performed by trained laboratory personnel or medical professionals. The interpretation of the co-oximetry results themselves does not usually require "experts" in the sense of physicians reviewing images, but rather proper execution and interpretation of laboratory-based physiological measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not mentioned. The ground truth for SpO2 studies is typically a direct physiological measurement (co-oximetry), which does not usually involve multi-reader adjudication as seen in image-based diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The EnviteC device is a sensor for direct physiological measurement (SpO2 and pulse rate), not an imaging device requiring human interpretation of output data for primary diagnosis.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Standalone Performance Study: Yes, a standalone performance study was performed. The clinical testing described directly assesses the accuracy of the EnviteC Reusable SpO2 Sensors (the algorithm/device only) against a reference standard (co-oximetry) under controlled conditions. This is the primary method for evaluating pulse oximeter accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used was co-oximetry. The text states: "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO₂ Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." Co-oximetry is considered the gold standard for measuring fractional hemoglobin oxygen saturation.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not mentioned. The document describes a medical device sensor, not an AI/ML algorithm that typically undergoes a distinct training phase with a dedicated dataset. The "validation" studies are for performance evaluation, not algorithm training. If there were internal iterative design/development tests, those datasets (and their sizes) are not detailed here.

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

How Ground Truth for Training Set was Established: Not applicable/not mentioned, as there is no indication of a distinct "training set" for an AI/ML algorithm. The device's underlying technology relies on established pulse oximetry principles and sensor design rather than a trainable model.

Summary

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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

Submitted by: EnviteC-Wismar GmbH by Honeywell Alter Holzhafen 18 Wismar 23966 Germany Tel.: +49-38 41 360 221 Fax: +49-38 41 360 222 Marcus.Lindenlaub@Honeywell.com Contact Person: Marcus Lindenlaub Position/Title: Managing Director

Date of Preparation:

(2) Trade Name: EnviteC Reusable SpO2 Sensors

Common/Classification Name: OXIMETER; EAR OXIMETER

Product Code(s):

DQA; 21 CFR §870.2700 DPZ; 21 CFR §870.2710

Class:

(a)

(1)

Class II

June 10, 2009

Predicate Device(s): (3)

Substantial Equivalence to:

K Number	Model	Manufacturer
K062605	Philips Reusable SpO2 Sensors,Models M1196A and M1196T(Finger Clip Sensors)	Philips Medical Systems(formerly HP)
K030973	Philips picoSAT II Sp02 PulseOximetry Module	Philips Medical Systems(formerly HP)
K053419	PULSOX-300, 300i	Konica Minolta Sensing, Inc.

Reason for Submission:

New Device(s)

Description of Device: (4)

The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above.

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EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission:

A finger clip with rigid halves positioned by mild spring force .
An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable
I A soft rubber finger sensor with unitary sealed tube type construction

A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta).

Each sensor type includes the following features:

r Connector pin-outs specific for the manufacturer type
Component specifications specific for the manufacture type

Each sensor clearly specifies the manufacturer type with two compatibility statements:

One printed on or attached to the sensor r
트 One on the instructions for use.

(5) Intended use:

The measurement of functional oxygen saturation of arterial hemoglobin (SpO2) has been a standard of care in the USA for 20 years. Applications for oximetry include monitoring in the anesthesia, recovery, and critical care environments, as well as transport monitoring and home care.

Indications for Use:

EnviteC Reusable SpO2 Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.

Prescription device.

(6) Technological Characteristics:

The EnviteC Reusable SpO2 Sensors employ the same technological characteristics as the predicate devices to determine arterial oxygen saturation: arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time

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varying absorbance of the tissue is measured from a photodiode light sensor. This method is characteristic of all pulse oximeter sensors which are the subject of this submission as well as the predicate devices.

(b) (1) Non-Clinical Tests Submitted:

The sensors were tested in accordance with current applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The sensors (with predicate device monitors) were tested for pulse rate with a listed simulator. Sensor electro-optical parameters were measured and compared to predicate devices. The sensors passed all of the tests.

Sensor patient contact materials meet applicable standards for biocompatibility.

(2) Clinical Tests Submitted:

Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO₂ Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. All testing was performed under an institutionally approved protocol with subject informed consent. Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.

(3) Conclusions from Tests:

As described in (b)(1) and (b)(2) above, EnviteC Reusable SpO2 Sensors are equivalent to predicate sensors as substantiated by parameter, bench, and clinical testing. Device safety is substantiated by testing to applicable standards and by biocompatibility of patient contact materials.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EnviteC-Wismar GmbH C/O Mr. Stephen H. Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119

JUL 2 4 2009

Re: K090438

Trade/Device Name: EnviteC Reusable SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: June 23, 2009 Received: June 24, 2009

Dear Mr. Gorski:

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.

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. Gorski

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runner, D.D.S., M.A. Acting 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):

K090438

Device Name:

EnviteC Reusable SpO2 Sensors

Indications for use:

EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediation (excluding neonatal and infant) patients in hospital-type facilities, mobile units and home environments.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

y Schulten

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

510(k) Number: K090438

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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).