ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

K103584 · Shenzhen Envisen Industry Co. Limited · DQA · Jun 10, 2011 · Cardiovascular

Device Facts

• Record ID: K103584
• Device Name: ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
• Applicant: Shenzhen Envisen Industry Co. Limited
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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. Prescription Device

Device Story

Envisen Disposable and Reusable Oximeter Sensors are pulse oximetry accessories compatible with various third-party monitors. Reusable sensors feature finger clips with plastic shells and silicone pads; disposable sensors utilize adhesive medical tape assemblies. Both types incorporate LEDs (red and infrared) and a photodiode detector. Sensors connect to host monitors via manufacturer-specific cables. Operation involves illuminating arterial tissue with two light wavelengths and measuring transmission to calculate SpO2 and pulse rate. Used in clinical settings (anesthesia, ICU, recovery, surgery) and home/transport environments. Healthcare providers use the monitor's output to assess patient oxygenation status, facilitating clinical decision-making for respiratory or circulatory management. Benefits include non-invasive, continuous monitoring of patient oxygen saturation.

Clinical Evidence

Clinical hypoxia testing performed on human adult volunteers. Accuracy of SpO2 measurements validated against arterial oxygen saturation (SaO2) determined by co-oximetry. Results support accuracy claims across the specified saturation range.

Technological Characteristics

Dual-wavelength (red/infrared) LED light source; photodiode detector. Configurations: finger clip (plastic shell, silicone pads) or adhesive tape. Connectivity: manufacturer-specific cable connectors. Biocompatible patient contact materials. Compliant with electrical safety and EMC standards.

Indications for Use

Indicated for continuous non-invasive monitoring of functional oxygen saturation (SpO2) and pulse rate in adult, pediatric, and infant patients in hospital, mobile, and home environments.

Regulatory Classification

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.

Predicate Devices

• N-395 Pulse Oximeter (K993637)
• Nellcor Oximax pulse oximetery sensors (K052186)
• Single-patient use disposable sensor series (K093853)
• MODEL 7500A Palmsat Pulse Oximeter (K080255)
• Philips SpO2 Reusable Sensor, Model M1196A and M1196T (K062605)
• BCI WW1020 SPECTRO2 Pulse Oximeter (K083705)
• CSI 504-US Pulse Oximeter (K910770)
• Ohmeda 3800 Pulse Oximeter (K962127)
• Datex-Ohmeda Oxygen Saturation Module, M-OSAT and Accessories (K010463)

Submission Summary (Full Text)

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# 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 [phone] Fax [phone] E-mail: [e-mail] 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 oximetery<br>sensors | Nellcor Puritan Bennett, Inc. |
| K093853 | Single-patient use disposable<br>sensor series | Nonin Medical, Inc. |
| K080255 | MODEL 7500A Palmsat Pulse<br>Oximeter | Nonin Medical, Inc. |
| K062605 | Philips SpO2 Reusable Sensor,<br>Model M1196A and M1196T | Philips Medical Systems |
| K083705 | BCI WW1020 SPECTRO2 Pulse<br>Oximeter | Smiths Medical PM, Inc.<br>(formerly SIMS BCI) |
| K910770 | CSI 504-US Pulse Oximeter | Criticare Systems, Inc. |
| K962127 | Ohmeda 3800 Pulse Oximeter | GE Healthcare Finland Oy<br>(formerly Ohmeda Medical) |
| K010463 | Datex-Ohmeda Oxygen<br>Saturation Module, M-OSAT and<br>Accessories | GE Healthcare Finland Oy<br>(formerly Datex-Ohmeda,<br>Inc.) |

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### 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.

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.

### (5) Intended use:

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

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### Device Indications for Use:

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.

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.

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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.

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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/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 [phone] or [phone] 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

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## 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

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