(170 days)
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.
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.
The provided text describes Nonin Medical, Inc.'s Model 6000CX and 7000X Sensor Series for pulse oximetry. However, the document does not contain specific acceptance criteria for performance metrics (like accuracy or precision of SpO2 measurements) nor a detailed study report proving the device meets said criteria.
Instead, it primarily focuses on:
- Substantial Equivalence: The document states that the new sensor series is "substantially equivalent to Nonin's currently marketed Model 7000X sensors" and lists predicate devices.
- Safety and Functional Testing: It mentions that the devices "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." However, the results of these tests and the specific acceptance criteria for "Accuracy of Operating Data" are not detailed.
- Comparison to Predicate: A table compares the new sensors (6000CX and 7000X) to the predicate 7000X sensor, highlighting similarities in indications for use, application site, patient use/reuse, sterility, and measurement technique. Differences are noted in operating/storage temperatures and sensor optic housing material (cloth for 6000CX vs. microfoam for 7000X).
Therefore, based solely on the provided text, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide answers to most of the study-related questions. The document implies that performance was evaluated against ISO 9919:2005 Clause 50, but it does not specify the numerical acceptance criteria or the reported performance values.
Unavailable Information:
The document does not provide:
- Specific numerical acceptance criteria for SpO2 accuracy (e.g., Accuracy Root Mean Square (ARMS) values).
- Reported device performance values for SpO2 accuracy.
- Details of the clinical study (sample size, data provenance, ground truth establishment, number/qualifications of experts, adjudication method).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Sample size for the training set or how its ground truth was established, as this device appears to be a hardware sensor, not an AI/software algorithm evaluated in the same manner.
Summary of what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 9919:2005 Clause 50) | Reported Device Performance |
|---|---|
| Specific numerical criteria not provided in text | Not detailed in text |
| Meeting requirements of ISO 9919:2005 Clause 50 (Accuracy of Operating Data) | "successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (clinical testing was performed, but details are not provided).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Not specified. For pulse oximetry accuracy studies, arterial blood gas analysis is typically the ground truth reference, performed by lab technicians or medical professionals, not experts in image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Ground truth for pulse oximetry is usually direct measurement (e.g., co-oximetry), not expert adjudication of subjective data.
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
- No. This is a hardware pulse oximeter sensor, not an AI/software device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware sensor. Its performance is measured directly, not as an algorithm's standalone output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document mentions "clinical testing" for "Accuracy of Operating Data" as per ISO 9919:2005 Clause 50. Standard practice for pulse oximetry accuracy testing involves comparing the device's SpO2 readings to reference SpO2 values obtained via arterial blood gas co-oximetry. This is the most likely ground truth used, though not explicitly stated in the document.
8. The sample size for the training set
- Not applicable. This is a hardware sensor, not a machine learning model requiring a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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510(k) Summary
| Submitter: | Nonin Medical, Inc. | ||
|---|---|---|---|
| Contact Person: | Lori M. RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave. NorthPlymouth, 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, clothtransmittance sensors. They are comprised of woven clothmaterial (like a Band-Aid) that allows the sensor to be appliedto the patient's appendices with the ability to stretch thesensor material for improved position and comfort. Theoptical components are identical to the currently marketedModel 7000X single-patient use disposable sensor. Themodification that was made to the currently marketed 7000Xsensor series is a transparent envelope was added to thesensor optics to improve sensor performance. The sensorsare compatible with all Nonin-branded pulse oximeters. | ||
| Intended Use: | Nonin's Models 6000CA and 7000A Single-Patient UseDisposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adultpediatric patients who are well or poorly perfused, weighinggreater than 60 pounds (30 kilograms). It is intended for use |
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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
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7000X sensors when used with Nonin-branded Pulse Oximeters monitors.
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| Sensor Comparison Chart | ||
|---|---|---|
| Product | 7000X Sensor(Predicate Device) | 6000CX and 7000X Sensors(Subject Devices) |
| Indications for Use: | Nonin's Model 7000A oximeter sensor isdesigned as a Single-Patient UseDisposable sensor for monitoring patientsweighing more than 30 kilograms. It isintended for use where little motion isexpected or cross-contamination is aconcern. | Nonin's Models 6000CA and 7000A Single-Patient Use Disposable Pulse OximeterSensors are indicated for non-invasive spot-checking and/or continuousmonitoring of adult pediatric patients who are well or poorly perfused, weighinggreater than 60 pounds (30 kilograms). It is intended for use in environmentsincluding 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 designedas a single patient use sensor formonitoring pediatric patients weighing 10to 40 kilograms. It is intended for usewhere moderate sensor motion isexpected or cross-contamination is aconcern | Nonin's Models 6000CP and 7000P Single-Patient Use Disposable Pulse OximeterSensors are indicated for non-invasive spot-checking and/or continuousmonitoring of pediatric patients who are well or poorly perfused, weighinggreater than 22 pounds (>10 kilograms). It is intended for use in environmentsincluding operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments. | |
| The NONIN Model 70001 Infant Flexi-FormII Pulse Oximeter Sensor is designed formonitoring infant patients (weighing 2 to20 kilograms) as a single patient usesensor. It is intended for use wheremoderate sensor motion is expected orcross-contamination is a concern. | Nonin's Models 6000CI and 70001 Single-Patient Use Disposable Pulse OximeterSensors are indicated for non-invasive spot-checking and/or continuousmonitoring of infant patients who are well or poorly perfused, weighing greaterthan 4 pounds (>2 kilograms). It is intended for use in environments includingoperating 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 designedas a single patient use sensor formonitoring neonatal patients weighing 2-10 kilograms. It is intended for use wheremoderate sensor motion is expected orcross-contamination is a concern. | Nonin's Models 6000CN and 7000N Single-Patient Use Disposable Pulse OximeterSensors are indicated for non-invasive spot-checking and/or continuousmonitoring of neonate/adult patients who are well or poorly perfused, weighingless than 4 pounds (<2 kilograms) or adults weighing greater than 66 pounds (>30kilograms) . It is intended for use in environments including operating room,surgical recovery, critical care, emergency room, long-term care, home use andmobile 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 averagepower | Same for all previously listed models |
| Infrared: | 910 nm @ 1.2 mW maximum averagepower | |
| 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 Same6000CX Cloth |
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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.
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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
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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. | |||
| 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: _______________________________________________________________________________________________________________________________________________________________
§ 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).