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

Device Description

EnviteC's Reusable SoftTip Y sensors are a modification of EnviteC's Multi-Site Y SpO2 Sensors listed in K043463. The modification integrates the two Y-sensor housing tips into a single molded rubber tube which facilitates placement on a digit. This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors.

Like the Multi-site Y SpO2 sensors, EnviteC's SoftTip Y SpO2 sensors consist of a connector and a duplex cable which divides at the distal end to the LED light source and light sensitive photodetector.

The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors.

A unique SoftTip Y sensor exists for each manufacturer series, and each SoftTip 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

The provided text describes a 510(k) premarket notification for a medical device (EnviteC Reusable SoftTip Y SpO2 Sensors) and its substantial equivalence to a predicate device. The information primarily focuses on the device modification and why existing clinical data for the predicate device is sufficient.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Non-Clinical:
Meet applicable standards for medical device Electrical Safety, temperature, and Electromagnetic Compatibility.	"The modified sensors were tested in accordance with applicable standards for medical device Electrical Safety, temperature, and Electromagnetic Compatibility. The SoftTip Y SpO2 sensors passed all of the tests."
Maintain original optical geometry and specifications of the predicate Y-sensors.	"This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors." and "The optical geometry and electro-optical specifications of the unmodified Y-sensors are preserved in the SoftTip Y modifications."
Clinical:
Accuracy claims for the specified SaO2 range of 70% to 100%.	"Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2." (This is attributed to the predicate device's testing and deemed valid for the modified device).
Compatibility with same oximeter monitor manufacturers as Y-Sensors.	"The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors."

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

The document states that no new clinical testing was performed for the modified device. Instead, it relies on the clinical hypoxia testing performed for the predicate Y SpO2 Sensors.

Sample size: Not specified for the predicate device's clinical testing.
Data provenance: Not specified for the predicate device's clinical testing.
Retrospective/Prospective: Not specified for the predicate device's clinical testing.

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 applicable, as new clinical testing with ground truth establishment was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.

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

Not applicable, as new clinical testing with adjudication was not performed for this device. The document defers to prior clinical testing of the predicate device, for which this information is not provided.

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 sensor, not an AI-powered diagnostic tool. The concept of human readers improving with or without AI assistance does not apply.

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

Not applicable. This device is an oximeter sensor, not an AI algorithm.

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

For the predicate device, the clinical hypoxia testing would have likely used a co-oximeter or arterial blood gas (ABG) analysis as the reference standard (ground truth) for SaO2 measurements. However, the document does not explicitly state the specific type of ground truth used.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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K060675

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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		JUL 17 200
	Contact Person:	Bernd Lindner
	Position/Title:	Managing Director
	Date of Preparation:	December 2, 2005
(2)	Trade Name:	Reusable EnviteC SoftTipY® 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
		K043463	Reusable Multi-site Y SpO2Sensors	EnviteC-Wismar GmbH
	Reason for Submission:		Device Modification to Y-Sensors

(4) Description of Device:
EnviteC's Reusable SoftTip Y sensors are a modification of EnviteC's Multi-Site Y SpO2 Sensors listed in K043463. The modification integrates the two Y-sensor housing tips into a single molded rubber tube which facilitates placement on a digit. This modification preserves in its entirety the original optical geometry and specifications of the predicate Y-sensors.

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The EnviteC SoftTip Y SpO2 Sensors comprise a family of oximeter sensors designed and validated for compatibility with the same oximeter monitor manufacturers as the Y-Sensors.

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.

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 for oximetry include monitoring in the anesthesia, recovery, and critical care environments, as well as transport monitoring and home care.

Indications for Use:

Prescription device.

(6) Technological Characteristics:

The EnviteC SoftTip Y 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 varying absorbance of the tissue is measured from a photodiode light sensor. The optical geometry and electro-optical specifications of the unmodified Y-sensors are preserved in the SoftTip Y modifications.

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

Consistent with internal design control processes, a detailed risk analysis was performed to determine the impact of the housing change, and a

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compilation of tests performed has been provided. The modified sensors were tested in accordance with applicable standards for medical device Electrical Safety, temperature, and Electromagnetic Compatibility. The SoftTip Y SpO2 sensors passed all of the tests.

(2) Clinical Tests Submitted:

As determined by the risk analysis and specification comparison, the clinical hypoxia testing for the predicate Y SpO2 Sensors is valid for the SoftTip Y SpO2 sensors because of the narrow scope of the modifications. 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 SoftTip Y SpO2 Sensors are equivalent to the unmodified Y SpO2 Sensors as substantiated by parameter and bench testing determined by risk analysis of the modifications. Device safety is further substantiated by testing to applicable compliance standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2006

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

Re: K060675

Trade/Device Name: EnviteC Reusable SoftTip Y SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 6, 2006 Received: July 7, 2006

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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Syndie Y. Michailons.

Chiu Lin, Ph.D. 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: EnviteC Reusable SoftTip Y SpO2 Sensors

Indications for use:

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

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)

Cury J. Wilson

on of Anesthesiology, General Hospital, uon Control. Dental Dev

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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).