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

Device Description

The Envisen Disposable and Reusable SpO2 Sens ors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors.

Envisen Reusable Oximeter Sensors ar e finger clip type sensors with specifications validated to meet the requirements for compatibility with each specified manufacturer ser ies. Ea ch finger clip is comprised of a plastic shell with silic one pads which position the optical components to measure throught he finger, and a cable with manufacturer specific connector.

Envisen Disposable Oximeter Sensors consist of adhesive medical tape assemblies which are provide d in three different configurations for application on a dult, pediatric, and infant patients. Each sensor uses a cable with manufacturer specific connector.

sensors are labeled for c ompatibility for a specific All manufacturer/monitor series and includes the following elements:

트 Optical and electronic specifications specific to the monitor type
Connector configuration specific for the monitor type 트

Sensor labeling clearly specifies the manufacturer/monitor type with two compatibility statements:

. Compatibility label attached to the sensor cable
Compatibility information provided on the instructions for use. .

Both reusable and dispos able sensors utilize configurations (finger clip, adhesive tapes) which have wide industry and clinical acceptance.

AI/ML Overview

The provided text describes a 510(k) summary for the Envisen Disposable and Reusable Oximeter Sensors. While it states that clinical testing was performed to validate accuracy, it does not provide specific acceptance criteria or detailed results of that study.

Therefore, I cannot fulfill all parts of your request with the given information. I can, however, extract what is available regarding the study and what is missing.

Missing Information:
The document does not explicitly state the acceptance criteria for the device's performance. It only states that clinical hypoxia test results were obtained "to validate the accuracy" and that clinical test results "support device accuracy claims for the specified saturation range."

Here's what can be extracted and what is missing in relation to your request:

1. Table of acceptance criteria and reported device performance

Metric	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy	Not explicitly stated in the document.	"Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range." (No specific numerical accuracy values like bias, precision, or A_rms are provided).
Biocompatibility	Requirements for biocompatibility.	"Patient contact materials meet requirements for biocompatibility."
Electrical/Thermal Safety & EMC	Applicable standards for pulse oximeter sensors, including device electrical and thermal safety and EMC.	"All sensors have been tested to meet current applicable standards for pulse oximeter sensors, including device electrical and thermal safety and EMC (electromagnetic compatibility). All sensors were tested for pulse rate with a listed SpO2 simulator. The devices passed all of the tests."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: "human adult volunteers" - Specific number not provided.
Data Provenance:
- Country of Origin: Not explicitly stated for the clinical study, but the submitting company is Envisen Inc. in Shenzhen, China.
- Retrospective or Prospective: "Clinical testing has been performed under an approved protocol with subject informed consent." This phrasing strongly suggests a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable as the ground truth was "arterial oxygen saturation (SaO2) as determined by co-oximetry," not an expert reading.
Qualifications of Experts: N/A

4. Adjudication method for the test set

Adjudication method: Not applicable. The ground truth was objective measurement via co-oximetry, not subjective interpretation requiring adjudication.

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

MRMC Study: No. This device is an oximeter sensor, not an AI-assisted diagnostic imaging device requiring human reader interpretation. The clinical study focused on the device's standalone accuracy against a physiological gold standard.

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

Standalone Performance: Yes, implicitly. The clinical hypoxia test evaluated the "accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry." This is a direct measurement of the device's performance against a gold standard, without human interpretation as part of the primary measurement.

7. The type of ground truth used

Type of Ground Truth: Physiological measurement - "arterial oxygen saturation (SaO2) as determined by co-oximetry."

8. The sample size for the training set

Sample Size for Training Set: Not applicable. Oximeters are typically calibrated during manufacturing and their performance is based on established biophysical principles, not on a "training set" in the machine learning sense. The clinical study described is a validation, not a training activity.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set for this type of device.

Summary

{0}------------------------------------------------

KIO3588

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

JUN 1 0 2011

Submitted by: Envisen Inc. Block 1, Zone A, Jian Long Industrial Complex Henggang, Longgang District Shenzhen 518115 China Tel +86 755 8882 7227 Fax +86 755 2865 1415 E-mail: feilu@envisen.com Dr. Fei Lu, Ph.D Contact Person: Position/Title: General Manager Date of Preparation: November 1, 2010 Trade Name: Envisen Disposable and Reusable Oximeter Sensors

Common/Classification Name:	Oximeter
Product Code:	DQA, 21 CFR §870.2700
Class:	Class II

(3) Predicate Device(s):

(a) (1)

510(k)	Device	Manufacturer
K993637	N-395 Pulse Oximeter	Nellcor Puritan Bennett, Inc.
K052186	Nellcor Oximax pulse oximeterysensors	Nellcor Puritan Bennett, Inc.
K093853	Single-patient use disposablesensor series	Nonin Medical, Inc.
K080255	MODEL 7500A Palmsat PulseOximeter	Nonin Medical, Inc.
K062605	Philips SpO2 Reusable Sensor,Model M1196A and M1196T	Philips Medical Systems
K083705	BCI WW1020 SPECTRO2 PulseOximeter	Smiths Medical PM, Inc.(formerly SIMS BCI)
K910770	CSI 504-US Pulse Oximeter	Criticare Systems, Inc.
K962127	Ohmeda 3800 Pulse Oximeter	GE Healthcare Finland Oy(formerly Ohmeda Medical)
K010463	Datex-Ohmeda OxygenSaturation Module, M-OSAT andAccessories	GE Healthcare Finland Oy(formerly Datex-Ohmeda,Inc.)

{1}------------------------------------------------

Reason for Submission:

New Device(s)

Description of Device: (4)

The Envisen Disposable and Reusable SpO2 Sens ors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors.

sensors are labeled for c ompatibility for a specific All manufacturer/monitor series and includes the following elements:

트 Optical and electronic specifications specific to the monitor type
Connector configuration specific for the monitor type 트

Sensor labeling clearly specifies the manufacturer/monitor type with two compatibility statements:

. Compatibility label attached to the sensor cable
Compatibility information provided on the instructions for use. .

Both reusable and dispos able sensors utilize configurations (finger clip, adhesive tapes) which have wide industry and clinical acceptance.

(5) Intended use:

SpO2 monitoring applications include anesthesia/intra-operative, recovery, ICU/critical care, day surgery, home/chronic care, and transport.

{2}------------------------------------------------

Device Indications for Use:

Prescription Device

(6) Technological Characteristics:

The EnviteC Disposable and Reusable SpO2 Sensors utilize the same measurement principles as the listed predicate devices: two wavelengths of light (red, infrared) from light emitting diodes (LED's) illuminate the patient's arterial tissue; and the light transmission through the tissue is measured using a photodiode light detector. The transmission properties vary with the patient's arterial blood saturation and pulse rate.

This method is fundamental to all pulse oximeter sensors and monitors for the non-invasive measurement of functional oxygen saturation (SpO2).

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

All sensors have been tested to meet current applicable standards for pulse oximeter sensors, including device electrical and thermal safety and EMC (electromagnetic compatibility). All sensors were tested for pulse rate with a listed SpO2 simulator. The devices passed all of the tests.

Patient contact materials meet requirements for biocompatibility.

(2) Clinical Tests Submitted:

Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Envisen Disposable and Reusable Oximeter Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.

(3) Conclusions from Tests:

As described in (b)(1) and (b)(2), testing above demonstrates that the Envisen Disposable and Reusable Oximeter Sensors are equivalent to predicate sensors as substantiated by laboratory and clinical testing.

Device safety is supported by compliance testing and by use of biocompatible patient contact materials.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

JUN 1 0 2011

Shenzhen Envisen Industry Company Limited C/O Mr. Stephen H. Gorski President Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119

Re: K103584

Trade/Device Name: Envisen Disposable and Reusable Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 20, 2011 Received: May 31, 2011

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. 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.

{4}------------------------------------------------

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/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,

for

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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Envisen Disposable and Reusable Oximeter Sensors Device Name:

Indications for use:

Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate for patients in hospitals, hospital-type facilities, mobile, 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)

L. Schultze

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

510(k) Number: K103584

Page 1 of 1 _

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).