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

Not recommended for use on the ear.

Prescription device.

Device Description

The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter sensors validated for compatibility with the predicate oximeter manufacturers listed above.

EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One housing contains a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various sites including the finger, thumb, toe, or foot, and are affixed by a medical grade tape.

A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).

Each sensor type includes the following unique features:

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

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

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EnviteC Reusable Multi-site Y SpO2 Sensors:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical results of the device's performance against such criteria. The clinical testing section broadly states:

Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.

This suggests that the device's accuracy within the 70% to 100% SaO2 range was deemed acceptable. However, specific performance metrics like Root Mean Square (RMS) difference, bias, or precision are not provided in this summary.

Detailed Study Information

A table of acceptance criteria and the reported device performance:
As mentioned above, a quantitative table is not present in this summary. The performance is broadly stated as supporting accuracy claims within 70-100% SaO2.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size (number of subjects/patients) used for the clinical testing.
- Data Provenance: The testing was "performed under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry" and "All testing was performed at a single institutionally approved protocol." This indicates the data was prospective and collected specifically for this study. The country of origin is not explicitly stated, but given the manufacturer's location (Germany) and the submission to the FDA (USA), the testing likely occurred in one of these regions or a location approved for such clinical trials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by "arterial oxygen saturation as determined by co-oximetry." Co-oximetry is a laboratory method, not typically relying on expert interpretation for its raw result. Therefore, there's no mention of experts needed to establish this specific ground truth. Clinical staff would have performed the blood draws and laboratory analysis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There is no mention of an adjudication method in the context of expert review for the test set. Given the ground truth method (co-oximetry), expert adjudication of the ground truth itself wouldn't be applicable in the same way it would be for an imaging study.
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:
- This is not applicable. The device is an SpO2 sensor, not an AI-powered diagnostic tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical testing describes the standalone performance of the SpO2 sensors in measuring oxygen saturation compared to co-oximetry (the "ground truth"). The device itself outputs a reading without a human interpreting an image or complex data for diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was arterial oxygen saturation as determined by co-oximetry. This is a direct, objective physiological measurement.
The sample size for the training set:
- The document does not provide information on a "training set" in the context of an algorithm. SpO2 sensors are typically calibrated during manufacturing and their performance is verified through clinical testing, rather than "trained" in the machine learning sense.
- If by 'training set' it refers to the data used during the R&D phase to refine the sensor's algorithms and hardware, this information is not disclosed in the 510(k) summary. The summary focuses on the formal verification and validation (V&V) testing.
How the ground truth for the training set was established:
- Not applicable as no "training set" in the machine learning context is described. For sensor calibration and development, manufacturers typically use a variety of controlled conditions and known oxygen saturation levels, often verified by co-oximetry or other reference methods, but this is part of the internal design and development process, not usually detailed in a 510(k) summary.

Summary

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FEB 11 2005
K043463

Page 1 of 3

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

(1)	Submitted by:	EnviteC-Wismar GmbHAlter Holzhafen 18Wismar 23966GermanyTel.: +49-38 41 360 221Fax: +49-38 41 360 222E-mail: b.lindner@envitec.com
	Contact Person:	Bernd Lindner
	Position/Title:	Managing Director
	Date of Preparation:	November 1, 2004
(2)	Trade Name:	EnviteC Reusable Multi-site Y SpO2 Sensors
	Common/Classification Name: OXIMETER
	Product Code(s):	DQA; 21 CFR §870.2700
	Class:	Class II
(3)	Predicate Device(s): Substantial Equivalence to:
	K Number	Model	Manufacturer
	K944760	Nellcor Dura-Y OxygenTransducer, Ear Clip	Nellcor Puritan Bennett, Inc.
	K962127	Ohmeda 3800 Pulse Oximeter	Datex-Ohmeda, Inc.
	K893877	Biochem 3100 Oximeter	BCI-Biochem International, Inc
	K910770	CSI 504-US Pulse Oximeter	CSI-Criticare Systems, Inc.
	K010463	Datex-Ohmeda S/5 OxygenSaturation Module, M-OSAT andAccessories	Datex-Ohmeda, Inc.
	K032979	Philips Reusable SpO2 Sensors	Philips Medizin AyatemeBöeblingen GmbH (formerly HP)
	K890033	Model 8700 Pulse Oximeter	Nonin Medical, Inc.
	K993979	Model 2001MARSpO2 PulseOximeter	Novametrix Medical Systems Inc.

Reason for Submission: New Device(s)

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Description of Device: (4)

The EnviteC Reusable Multi-site Y SpO2 Sensors are a family of oximeter THE ENTROS NOWBLOG Walidated for compatibility with the predicate oximeter manufacturers listed above.

EnviteC's Reusable Multi-site Y SpO₂ Sensors consist of a connector and a cable which divides at the distal end into two sensor housings. One a ouble white a dual LED light source, and the other contains a light sensitive photodetector. The housings may be positioned on various seristive proceded.org finger, thumb, toe, or foot, and are affixed by a medical grade tape.

A unique Y sensor exists for each manufacturer above, and each Y sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, CSI, etc.).

Each sensor type includes the following unique features:

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

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

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

Intended use: (5)

The measurement of functional oxygen saturation of arterial hemoglobin (SpO2) has been a standard of care in the USA for 20 years. Applications (opez) no both de monitoring in the anesthesia, recovery, and critical care environments, as well as transport monitoring and home care.

Indications for Use:

Not recommended for use on the ear.

Prescription device.

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Technological Characteristics: (6)

The EnviteC Reusable Multi-site Y SpO2 Sensors employ the same The "Envited" Nousable "Mail" 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 two wavelenging absorbance of the tissue is measured from a photodiode light time varying absorbands characteristic of all Y sensors which are the subject of this submission as well as the predicate devices.

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

The sensors were tested in accordance with applicable standards for medical device Electrical Safety and Electromagnetic Compatibility. The medical device monitors) were tested for pulse rate with a sensors (with prodicate dones ro-optical parameters were measured and Insted Simmator. " Conton" Store Y sensors passed all of the tests.

Sensor patient contact materials (housing and attachment tape) meet applicable standards for biocompatibility.

Clinical Tests Submitted: (2)

Clinical testing was performed to validate the performance and accuracy Official testing was perfect Multi-site Y SpO2 Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry. Trypoxia versus arterial oxygen-can institutionally approved protocol with All testing was porrormed consent. Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2.

Conclusions from Tests: (3)

As described in (b)(1) and (b)(2) above, EnviteC Reusable Multi-site Y SpO2 Sensors are equivalent to predicate sensors as substantiated by Spoz Sensoro and clinical testing. Device safety is substantiated by parameter, bother, and by biocompatibility of patient contact materials.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Envitec-Wismar GMBH Mr. Stephen Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119

Re: K043463

Trade/Device Name: EnviteC Reusable Multi-Site Y SpO2 Sensors Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 12, 2004 Received: December 15, 2004

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 such 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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Indications for Use

510(k) Number (if known):

EnviteC Reusable Multi-site Y SpO2 Sensors Device Name:

Indications for use:

Not recommended for use on the ear.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Prescription Use × (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)
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Cure Suleom

ion of Annsthesiology, General Hospital, Jution Control. Dental Devices

Number K043463

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).