The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).

The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits.

The OxiPen features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator for visual assessment of pulsation. Additional indicators include a signal quality LED and heart symbol which show pulsation, a sensor symbol for disconnection alert, and a battery capacity symbol.

Like the referenced predicate device, the OxiPen provides an audible pulse tone which varies with saturation level, as well as audible and visual alerts for conditions like sensor disconnect and power-off. The LCD display may be backlit by briefly pressing any key.

The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout.

The EnviteC OxiPen Pulse Oximeter and accessory sensors employ the same technological characteristics as the predicate device and other oximeters to determine functional 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 resultant electrical signal is amplified, digitized, and analyzed to determine the functional oxygen saturation and pulse rate. The information is displayed on a liquid crystal display with pulse bar graph and audible pulse tone.

The OxiPen utilizes a two-layer architecture in which the oximeter-specific functions are managed by a dedicated subsystem (ChipOx) and the monitor functions including power management, display, and user interface are controlled separately.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance Study for EnviteC OxiPen Pulse Oximeter

The document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements for safety and efficacy. While it states that clinical tests were performed to validate accuracy claims, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy range for SpO2 or pulse rate) in a table format. Instead, it broadly states that the device "passed all of the tests" and "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2."

Therefore, the table below reflects what can be inferred or directly stated from the provided text regarding performance. Specific numerical acceptance criteria are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Accuracy of SpO2 measurement (70-100% SaO2)	Clinical test results support the stated accuracy claims for the specified range. (Specific numerical accuracy not provided in this document)
Accuracy of Pulse Rate measurement	The monitor and accessory sensors were tested for pulse rate with a listed simulator. The device passed all of the tests. (Specific numerical accuracy not provided in this document)
Electrical Safety (Applicable standards)	The device passed all tests.
Electromagnetic Compatibility (Applicable standards)	The device passed all tests.
Environmental Operation and Storage (Applicable standards)	The device passed all tests.
Resistance to Moisture Ingress (Applicable standards)	The device passed all tests.
Shock and Vibration (Applicable standards)	The device passed all tests.
Software Verification and Validation	Verified to requirements and validated to meet intended use by software and system level performance testing.
Biocompatibility of Patient Contact Materials	Meet applicable standards for biocompatibility.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of subjects or cases used in the clinical testing. It only states, "Clinical testing was performed... All testing was performed under an institutionally approved protocol with subject confidentiality and informed consent."
Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a German company, so it is plausible it could be European or international.
Retrospective or Prospective: Not explicitly stated, but the phrase "Clinical testing was performed... under an institutionally approved protocol with subject confidentiality and informed consent" strongly suggests a prospective study.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

No adjudication method is described in the provided text.

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

No MRMC comparative effectiveness study is mentioned. The study described focuses on standalone device performance against cooximetry.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The clinical testing "validated the performance and accuracy of the EnviteC OxiPen Pulse Oximeter and accessory sensors under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry." This is a direct measure of the device's accuracy without human interpretation influencing the measurement itself.

7. Type of Ground Truth Used

Expert Consensus: Not explicitly stated.
Pathology: Not applicable for SpO2 measurement.
Outcomes Data: Not applicable for SpO2 measurement.
Other: Cooximetry was used as the ground truth for arterial oxygen saturation (SaO2). The document states, "...versus arterial oxygen saturation as determined by cooximetry."

8. Sample Size for the Training Set

The document does not describe a machine learning model or a training set. It refers to "Embedded software in the device," but this would typically involve traditional software development and verification/validation, not a machine learning training process.

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

Not applicable, as no machine learning training set is described.

Summary

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K070193

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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: k.huebner@envitec.com
	Contact Person:	Mr. Klaus Huebner, Ph.D.
	Position/Title:	Manager of R & D
	Date of Preparation:	April 4, 2007
(2)	Trade Name:	EnviteC OxiPen Pulse Oximeter and Accessories
	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
	K963707	NBP 40 Handheld PulseOximeter	Nellcor Puritan Bennett(TYCO)
	Reason for Submission:	New device

(4) Description of Device:
The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits.

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The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout.

(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. The OxiPen device has no alarms or settable alarm limits and is intended for spot checking.

Indications for Use:

The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spotcheck measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).

The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.

Prescription device.

(6) Technological Characteristics:

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

The monitor and accessory sensors were tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, environmental operation and storage conditions, resistance to moisture ingress, and shock and vibration. The device passed all of the tests.

The monitor and accessory sensors were tested for pulse rate with a listed simulator. The device passed all of the tests.

Embedded software in the device was verified to requirements and validated to meet intended use by software and system level performance testing.

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 OxiPen Pulse Oximeter and accessory sensors under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry. All testing was performed under an institutionally approved protocol with subject confidentiality and 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, the EnviteC OxiPen Pulse Oximeter and accessory sensors perform in a manner equivalent to the predicate device as substantiated by parameter, bench, and clinical testing. Device safety is substantiated by compliance testing to applicable standards 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 and Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.

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

MAY - 2 2007

Re: K070193

Trade/Device Name: EnviteC OxiPen® Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 6, 2007 Received: April 10, 2007

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 (OS) 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 yours,

Chiu Lin, Ph.D.

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 OxiPen® Pulse Oximeter

Indications for use:

The monitor is intended for use on adult and pediatric 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)

Chellda

on Sign-Off) Collaion of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: K070193

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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).