SINGLE-PATIENT USE DISPOSABLE SENSOR

K093306 · Nonin Medical, Inc. · DQA · Mar 4, 2010 · Cardiovascular

Device Facts

• Record ID: K093306
• Device Name: SINGLE-PATIENT USE DISPOSABLE SENSOR
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Device Story

The 6500MA (wrap-around) and 6500SA (interlocking) are single-patient use disposable transmittance pulse oximeter sensors. They utilize optical components (red 660 nm, infrared 910 nm) to measure SpO2 and pulse rate when connected to Nonin-branded pulse oximeters. The sensors consist of a lamination of foams (polyurethane, polyester, polyethylene) and a malleable wire for positioning on a patient's finger. The device is operated by clinicians or patients in various settings, including ORs, critical care, and home environments. The oximeter monitor processes the optical signals to provide real-time SpO2 and pulse rate data. This output assists healthcare providers in assessing patient oxygenation status, enabling timely clinical interventions. The disposable nature of the sensors helps reduce the risk of cross-contamination.

Clinical Evidence

The device underwent bench and clinical testing to demonstrate compliance with ISO 9919:2005 (accuracy) and IEC 60601-1:1998/ISO 10993-1:2003 (biocompatibility). Clinical testing confirmed SpO2 accuracy of ±2 digits for both normal and low perfusion conditions, improving upon the predicate's ±3 digits.

Technological Characteristics

Fingertip transmittance sensor; optical components (660 nm red, 910 nm infrared); materials include polyurethane, cross-linked polyester foam, polyethylene, and polyester with adhesive. Compatible with Nonin-branded pulse oximeters. Non-sterile. Operating temperature 0 to +40°C.

Indications for Use

Indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients weighing >30 kg (60 lbs), regardless of perfusion status. Intended for use in clinical 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

• Nonin 7000 sensor (K07128, K063752, K023044, K050056, K002690)

Submission Summary (Full Text)

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K093306

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# 510(k) Summary

| Submitter: | Nonin Medical, Inc. | MAR - 4 2010 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Lori M. Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave. North<br>Plymouth, MN 55441-5443 | |
| Date Prepared: | October 22, 2009 | |
| Trade Name: | Oximeter Sensor | |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | 74 DQA | |
| Predicate Device(s): | Nonin's 7000 sensor as cleared in the following 510(K)<br>submissions: Model 7500 (K07128 cleared on July 12, 2007),<br>Model LS1-9R LifeSense (K063752 cleared on May 4, 2007), Model<br>9600 (K023044 cleared on July 23, 2003), Model 2500A (K050056<br>cleared on June 21, 2005), and Model 2500 (K002690 cleared on<br>October 11, 2000). | |
| Device Description: | The 6500MA (wrap-around model) and 6500SA (interlocking<br>model) are fingertip single-patient use disposable, transmittance<br>sensors. They are comprised of a lamination of two foams<br>(patient contact side and external side) with the optical<br>components and a malleable wire within the lamination. The<br>optical components are identical to the currently marketed Model<br>7000 single-patient use disposable sensor. The sensors are<br>compatible with all Nonin-branded pulse oximeters. | |
| Intended Use: | Nonin's Models 6500MA and 6500SA Single-Patient Use<br>Disposable Pulse Oximeter Sensors are indicated for non-invasive<br>spot-checking and/or continuous monitoring of adult and<br>pediatric patients who are well or poorly perfused, weighing<br>greater than 60 pounds (30 kilograms). It is intended for use in<br>environments including operating room, surgical recovery, critical<br>care, emergency room, long-term care, home use and mobile<br>environments. | |

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### Functional and Safety Testing:

Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility.

### Substantial Equivalence:

| | Predicate Device<br>Model 7000 Sensor Series | Subject Device<br>Model 6500 Sensor Series |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Patient Population: | Adult/Pediatric (weighing > 30<br>kilograms) | Same |
| Sensor Application Site: | Fingers | Same |
| Patient Use/Reuse: | Disposable | Same |
| Sterility: | Non-sterile | Same |
| Measurement Technique: | Fingertip transmittance sensor | Same |
| SpO2 Accuracy (Arms) (70-<br>100%): | $\pm$ 3 digits | $\pm$ 2 digits |
| SpO2 Low Perfusion Accuracy<br>(Arms) (70-100%): | $\pm$ 3 digits | $\pm$ 2 digits |
| Pulse Rate Accuracy (Arms)<br>(18-300 BPM): | $\pm$ 3 digits | Same |
| Low Perfusion Pulse Rate<br>Accuracy (Arms) (40-240<br>BPM): | $\pm$ 3 digits | Same |
| Red:<br>Infrared: | 660 nm @ 0.8 mW maximum<br>average power<br>910 nm @ 1.2 mW maximum<br>average power | Same |
| Operating: | 0 o to +40o C (32o F to 104o F) | Same |
| Storage/Transportation: | -30o to +50o C (-22o F to 122o F) | -30o to +70o C (-22o F to 158o F) |
| Operating:<br>Storage/Transportation: | 10 to 90% non-condensing<br>10 to 95% non-condensing | Same |
| Sensor Housing: | Microfoam | Polyurethane, cross-linked<br>polyester foam,<br>polyethylene/polyurethane,<br>polyester with adhesive |

#### Conclusion:

Nonin's Model 6500 sensor series is substantially equivalent to Nonin's Model 7000 sensors when used with Nonin-branded Pulse Oximeters monitors.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

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

Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 15t Avenue North Plymouth, Minnesota 55441

MAR - 4 2010

Re: K093306

Trade/Device Name: Model 6500 Sensor Series Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: February 1, 2010 Received: February 4, 2010

Dear Ms. Roth:

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 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 – Ms. Roth

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,

far

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 Statement

| 510(k) Number (if known) | K093306 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Nonin Medical, Inc. Model 6500 Sensor Series |
| Indications for Use | Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments. |

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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. Schultetus

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

510(k) Number: