K Number
K093853
Device Name
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
Date Cleared
2010-06-04

(170 days)

Product Code
Regulation Number
870.2700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult 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. Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 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. Nonin's Models 6000Cl and 70001 Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 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. Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 pounds (<2 kilograms) or adults weighing greater than 66 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 Description
The 6000CX are single-patient use disposable, cloth transmittance sensors. They are comprised of woven cloth material (like a Band-Aid) that allows the sensor to be applied to the patient's appendices with the ability to stretch the sensor material for improved position and comfort. The optical components are identical to the currently marketed Model 7000X single-patient use disposable sensor. The modification that was made to the currently marketed 7000X sensor series is a transparent envelope was added to the sensor optics to improve sensor performance. The sensors are compatible with all Nonin-branded pulse oximeters.
More Information

Not Found

No
The summary describes a pulse oximeter sensor, which is a hardware component for measuring oxygen saturation. There is no mention of software algorithms, data processing beyond basic signal acquisition, or any terms related to AI/ML. The modifications described are physical (adding a transparent envelope).

No
The device is a pulse oximeter sensor, which is indicated for monitoring and not for providing therapy.

No

This device is a pulse oximeter sensor used for non-invasive monitoring (spot-checking and continuous) of oxygen saturation and pulse rate, which are physiological parameters. While these measurements can contribute to a diagnosis, the device itself is a monitoring tool, not a diagnostic one that identifies or confirms a disease or condition. The text clearly states "monitoring" and "spot-checking", not "diagnosis."

No

The device description clearly states it is comprised of physical components like woven cloth material and optical components, indicating it is a hardware device.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the body (in vitro means "in glass"). This device is a pulse oximeter sensor that is applied to the body (specifically, the fingers or foot) to measure physiological parameters non-invasively.
  • The intended use is for non-invasive monitoring. The description clearly states "non-invasive spot-checking and/or continuous monitoring."
  • The device description focuses on the sensor's physical characteristics and optical components. It doesn't mention any reagents, test strips, or analysis of biological samples.
  • The performance studies mentioned are functional and safety testing, not analytical performance studies typical for IVDs.

Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult 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.

Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 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.

Nonin's Models 6000Cl and 7000I Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 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.

Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 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.

Product codes

74 DQA, DQA

Device Description

The 6000CX are single-patient use disposable, cloth transmittance sensors. They are comprised of woven cloth material (like a Band-Aid) that allows the sensor to be applied to the patient's appendices with the ability to stretch the sensor material for improved position and comfort. The optical components are identical to the currently marketed Model 7000X single-patient use disposable sensor. The modification that was made to the currently marketed 7000X sensor series is a transparent envelope was added to the sensor optics to improve sensor performance. The sensors are compatible with all Nonin-branded pulse oximeters.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingers/Foot

Indicated Patient Age Range

Adult pediatric patients, pediatric patients, infant patients, neonate/adult patients.

Intended User / Care Setting

operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional and Nonin's Model 6000CX and 7000X sensor series have Safety Testing: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Model 7500 (K07128), Model LS1-9R LifeSense (K063752), Model 9600 (K023044), Model 2500A (K050056), Model 2500 (K002690)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K093853". The characters are written in a cursive style, with some of the numbers being slightly distorted.

:

_

510(k) Summary

Submitter:Nonin Medical, Inc.
Contact Person:Lori M. Roth
Clinical/Regulatory Specialist
Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443JUN - 4 2010
Date Prepared:December 15, 2009, revised April 21, 2010, revised June 2,
2010
Trade Name:Model 6000CX and 7000X Sensor Series
Classification Name:
and Number:Class II, 21 CFR 870.2700
Product Code:74 DQA
Predicate Device(s):Nonin's 7000X sensor as cleared in the following 510(K)
submissions: Model 7500 (K07128 cleared on July 12, 2007),
Model LS1-9R LifeSense (K063752 cleared on May 4, 2007),
Model 9600 (K023044 cleared on July 23, 2003), Model 2500A
(K050056 cleared on June 21, 2005), and Model 2500
(K002690 cleared on October 11, 2000).
Device Description:The 6000CX are single-patient use disposable, cloth
transmittance sensors. They are comprised of woven cloth
material (like a Band-Aid) that allows the sensor to be applied
to the patient's appendices with the ability to stretch the
sensor material for improved position and comfort. The
optical components are identical to the currently marketed
Model 7000X single-patient use disposable sensor. The
modification that was made to the currently marketed 7000X
sensor series is a transparent envelope was added to the
sensor optics to improve sensor performance. The sensors
are compatible with all Nonin-branded pulse oximeters.
Intended Use:Nonin's Models 6000CA and 7000A Single-Patient Use
Disposable Pulse Oximeter Sensors are indicated for non-
invasive spot-checking and/or continuous monitoring of adult
pediatric patients who are well or poorly perfused, weighing
greater than 60 pounds (30 kilograms). It is intended for use

1

in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for noninvasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 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.

Nonin's Models 6000Cl and 70001 Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for noninvasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 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.

Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for noninvasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 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.

Functional and Nonin's Model 6000CX and 7000X sensor series have Safety Testing: 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. A sensor comparison summary table is on page 3 of this Sensor Comparison Table summary. Nonin's Model 6000CX and 7000X sensor series are Conclusion: substantially equivalent to Nonin's currently marketed Model

2

7000X sensors when used with Nonin-branded Pulse Oximeters monitors.

3

Sensor Comparison Chart
Product7000X Sensor
(Predicate Device)6000CX and 7000X Sensors
(Subject Devices)
Indications for Use:Nonin's Model 7000A oximeter sensor is
designed as a Single-Patient Use
Disposable sensor for monitoring patients
weighing more than 30 kilograms. It is
intended for use where little motion is
expected or cross-contamination is a
concern.Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter
Sensors are indicated for non-invasive spot-checking and/or continuous
monitoring of adult 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.
The NONIN Model 7000P Pediatric Flexi-
Form II Pulse Oximeter Sensor is designed
as a single patient use sensor for
monitoring pediatric patients weighing 10
to 40 kilograms. It is intended for use
where moderate sensor motion is
expected or cross-contamination is a
concernNonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter
Sensors are indicated for non-invasive spot-checking and/or continuous
monitoring of pediatric patients who are well or poorly perfused, weighing
greater than 22 pounds (>10 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.
The NONIN Model 70001 Infant Flexi-Form
II Pulse Oximeter Sensor is designed for
monitoring infant patients (weighing 2 to
20 kilograms) as a single patient use
sensor. It is intended for use where
moderate sensor motion is expected or
cross-contamination is a concern.Nonin's Models 6000CI and 70001 Single-Patient Use Disposable Pulse Oximeter
Sensors are indicated for non-invasive spot-checking and/or continuous
monitoring of infant patients who are well or poorly perfused, weighing greater
than 4 pounds (>2 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.
The NONIN Model 7000N Neonatal Flexi-
Form II Pulse Oximeter Sensor is designed
as a single patient use sensor for
monitoring neonatal patients weighing 2-
10 kilograms. It is intended for use where
moderate sensor motion is expected or
cross-contamination is a concern.Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter
Sensors are indicated for non-invasive spot-checking and/or continuous
monitoring of neonate/adult patients who are well or poorly perfused, weighing
less than 4 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.
Sensor Application Site:Fingers/FootSame
Patient Use/Reuse:Single-Use DisposableSame
Sterility:Non-sterileSame
Measurement Technique:Transmittance sensorSame
Red:660 nm @ 0.8 mW maximum average
power
                                                                                                                                                                                                                                                        | Same for all previously listed models                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |

| Infrared: | 910 nm @ 1.2 mW maximum average
power | |
| Operating: | 0° to +40° C (32° F to 104° F) | -5° to +40° C (23° F to 104° F) |
| Storage/Transportation: | -30° to +50° C (-22° F to 122° F) | -30° to +70° C (-22°F to 158° F) for all previously listed models |
| Operating: | 10 to 90% non-condensing | Same for all previously listed models |
| Storage/Transportation: | 10 to 95% non-condensing | Same for all previously listed models |
| Sensor Optic Housing: | Microfoam | 7000X Same
6000CX Cloth |

·

:

:

.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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

Ms. Lori Roth RN, BSN Clinical / Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443

JUN - 4 2010

Re: K093853

Trade/Device Name: Model 6000CX and 7000X Sensor Series Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 21, 2010 Received: May 6, 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. 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.

5

Page 2- Ms. Lori 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony 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

6

Indications for Use Statement

510(k) Number (if known)
Device NameNonin Medical, Inc. Model 6000CX and 7000X Sensor Series
Indications for UseNonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult 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.
Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of pediatric patients who are well or poorly perfused, weighing greater than 22 pounds (>10 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.
Nonin's Models 6000Cl and 7000I Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of infant patients who are well or poorly perfused, weighing greater than 4 pounds (>2 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. Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of neonate/adult patients who are well or poorly perfused, weighing less than 4 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)Prescription Use X (Part 21 CFR 801 Subpart D)Over-The-Counter-Use (21 CFR 807 Subpart C)
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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign=Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________