Who is the manufacturer of SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES?

Nonin Medical, Inc. filed the 510(k) submission for SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES (K093853).

What is the FDA product code for SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES?

510(k) clearance (submission type: Special).

What are the predicate devices for SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES?

Model 7500 (K07128); Model LS1-9R LifeSense (K063752); Model 9600 (K023044); Model 2500A (K050056); Model 2500 (K002690); 7000X sensor (K093853).

Who can help prepare an FDA 510(k) submission like SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES

K093853 · Nonin Medical, Inc. · DQA · Jun 4, 2010 · Cardiovascular

Device Facts

Record ID	K093853
Device Name	SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
Applicant	Nonin Medical, Inc.
Product Code	DQA · Cardiovascular
Decision Date	Jun 4, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2700
Device Class	Class 2
Attributes	Pediatric

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 (<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 Story

Disposable transmittance pulse oximeter sensors; 6000CX series uses woven cloth material for improved fit/comfort; 7000X series uses microfoam. Sensors incorporate transparent envelope over optics to improve performance. Input: optical signals from patient appendices (fingers/foot). Output: raw signals processed by compatible Nonin-branded pulse oximeters to determine oxygen saturation and pulse rate. Used by clinicians or patients in clinical/home environments. Benefits: non-invasive monitoring of perfusion status; reduced cross-contamination risk via single-patient use.

Clinical Evidence

Bench and clinical testing performed to demonstrate compliance with ISO 9919:2005 (accuracy of operating data) and IEC 60601-1:1998 (biocompatibility per ISO 10993-1:2003).

Technological Characteristics

Transmittance pulse oximeter sensors. Materials: woven cloth (6000CX) or microfoam (7000X). Optical: Red (660 nm, 0.8 mW max) and Infrared (910 nm, 1.2 mW max). Non-sterile, single-patient use. Compatible with Nonin-branded pulse oximeters. Operating temp: -5 to +40 C.

Indications for Use

Indicated for non-invasive spot-checking or continuous monitoring of SpO2 and pulse rate in neonates, infants, pediatric, and adult patients (weight range >2kg to >30kg depending on model). Used in OR, recovery, critical care, ER, long-term care, home, and mobile settings.

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

Model 7500 (K07128)
Model LS1-9R LifeSense (K063752)
Model 9600 (K023044)
Model 2500A (K050056)
Model 2500 (K002690)
7000X sensor (K093853)

Submission Summary (Full Text)

{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 55441-5443 | JUN - 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 (<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. 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 | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product | 7000X 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 concern | 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. | | | 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 (<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. | | Sensor Application Site: | Fingers/Foot | Same | | Patient Use/Reuse: | Single-Use Disposable | Same | | Sterility: | Non-sterile | Same | | Measurement Technique: | Transmittance sensor | Same | | 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 Name | Nonin Medical, Inc. Model 6000CX and 7000X Sensor Series | | | | 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 (<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. | | | | | <table><tr><td>Prescription Use X (Part 21 CFR 801 Subpart D)</td><td>Over-The-Counter-Use (21 CFR 807 Subpart C)</td></tr></table> | 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: _______________________________________________________________________________________________________________________________________________________________

SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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