(128 days)
Not Found
No
The summary describes standard pulse oximetry sensors and their intended use, with no mention of AI or ML in the device description, performance studies, or key metrics. The testing described is standard clinical validation for pulse oximetry accuracy.
No.
The device is a pulse oximeter sensor, which is used for monitoring (non-invasive spot-checking and/or continuous monitoring) of patients' oxygen saturation and pulse rate. It does not provide therapy or treatment.
Yes
The device, a pulse oximeter sensor, is indicated for "non-invasive spotchecking and/or continuous monitoring of patients," which involves observing and measuring physiological parameters to identify deviations from normal and potentially inform diagnosis.
No
The device description explicitly states that the devices are "Pulse Oximeter Sensors" which are hardware components intended for use with a separate system. The summary describes physical sensors (disposable and reusable, finger clip and ear clip) and their intended use for non-invasive monitoring, not software performing a medical function on its own.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The text describes the devices as "Pulse Oximeter Sensors" that are used for "non-invasive spotchecking and/or continuous monitoring of patients". They are applied to the finger or earlobe.
- Method of Operation: Pulse oximetry is a non-invasive method of measuring oxygen saturation in the blood. It works by shining light through the tissue and measuring the amount of light absorbed. This is done on the patient's body, not on a sample taken from the body.
Therefore, since the device performs measurements directly on the patient's body and does not involve testing samples taken from the body, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 Ib; 6100CP: pediatrics > 10 kg / 22 1b ; 6100CI: infants > 2 kg / 4 1b; and 6100CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 1b ; 6101CI: infants > 2 kg / 4 1b; and 6101CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 Ib; 6102CP: pediatrics > 10 kg / 22 1b ; 6102C1: infants > 2 kg / 4 1b; and 6102CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. The recommended application site is the earlobe.
Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. The recommended application site is the earlobe.
Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or ing of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. The recommended application site is the earlobe.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DPZ
Device Description
The Model 6100C Series, Model 6101C Series and Model 6102C Series Pulse Oximeter Sensors are single-patient use, non-sterile disposable pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Pulse Oximeter Sensors are reusable, non-sterile pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The proposed and predicate sensors utilize Nonin's PureLight® technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Model 6100C Series, 6101C Series, 6102C Series: 6100CA, 6101CA, 6102CA: adults > 30 kg / 66 lb; 6100CP, 6101CP, 6102CP: pediatrics > 10 kg / 22 lb; 6100CI, 6101CI, 6102CI: infants > 2 kg / 4 lb; and 6100CN, 6101CN, 6102CN: neonates 30 kg / 66 lb.
Model 8100AA, 8101AA, 8102AA: adult and pediatric patients (> 30 kg / 66 lb).
Model 8100AP, 8101AP, 8102AP: pediatric patients (8 – 60 kg / 18 – 132 lb).
Model 8100Q2, 8101Q2, 8102Q2: adult and pediatric patients (> 40 kg / 88 lb).
Intended User / Care Setting
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, 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 Safety Testing:
The Nonin Model 6100C Series, Model 6101C Series, Model 6102C Series, Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Series sensors are supported by electrical safety, electromagnetic compatibility, device performance, and clinical testing to ensure appropriate functionality and to demonstrate substantial equivalence to the predicate devices. The devices were tested with the Nonin's Medical Model X-100 SenSmart Universal Oximetry System.
Results show compliance to recognized standards (IEC 60601-1, EN 1789, IEC 60601-1-2, ISO 80601-2-61, IEC 60601-1-6, IEC 62304, ANSI/AAMI EC13, ISO 14155, ISO 10993-1, ISO 10993-5, ISO 10993-10) with all tests passing.
Clinical Testing: SpO2 Accuracy testing
- Models 6100CA, 6101CA, 6102CA, 6100CP, 6101CP, 6102CP, 6100Cl, 6101Cl and 6102Cl
- Study type: SpO2 accuracy testing
- Sample size: Healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
- Data source: Independent research laboratory.
- Key results: The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy was measured over the SaO2 range of 70-100% in motion and non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
- Models 6100CN, 6101CN and 6102CN
- Study type: SpO2 accuracy testing
- Sample size: Male and female, light to dark-skinned subjects up to 30 days of age.
- Data source: Children's Hospital.
- Key results: The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy was measured over the SaO2 range of 70-100% in non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
- Models 8100AA, 8101AA, 8102AA, 8100AP, 8101AP and 8102AP
- Study type: SpO2 accuracy testing
- Sample size: Healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
- Data source: Independent research laboratory.
- Key results: The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy was measured over the SaO2 range of 70-100% in motion and non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
- Models 8100Q2, 8101Q2 and 8102Q2
- Study type: SpO2 accuracy testing
- Sample size: Healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older.
- Data source: Independent research laboratory.
- Key results: The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy was measured over the SaO2 range of 70-100% in non-motion. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.
Conclusion: The proposed sensors meet all acceptance criteria and perform equivalently to the predicate sensors for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
Nonin Medical, Inc. Ms. Nancy DeAngelo Senior Regulatory Affairs Specialist 13700 1st Ave. North Plymouth, Minnesota 55441
Re: K160865
Trade/Device Name: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CL, 6100CN) Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CL, 6101CN) Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CL, 6102CN) Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor Model 810202 Reusable, Ear Clip Pulse Oximeter Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: July 5, 2016 Received: July 6. 2016
Dear Ms. DeAngelo:
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.
1
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.
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K160865
Device Name
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CN) Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CN)
Indications for Use (Describe)
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 Ib; 6100CP: pediatrics > 10 kg / 22 1b ; 6100CI: infants > 2 kg / 4 1b; and 6100CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.
Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 1b ; 6101CI: infants > 2 kg / 4 1b; and 6101CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K160865
Device Name
Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CN) Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor
Indications for Use (Describe)
Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spotchecking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 Ib; 6102CP: pediatrics > 10 kg / 22 1b ; 6102C1: infants > 2 kg / 4 1b; and 6102CN: neonates 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.
Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K160865
Device Name
Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor
Indications for Use (Describe)
Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healtheare environments, and mobile environments.
Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 - 60 kg / 18 - 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities. Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K160865
Device Name
Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor
Indications for Use (Describe)
Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments.
The recommended application site is the earlobe.
Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or ing of adult and pediatric patients (> 40 kg / 88 1b) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, and mobile environments.
The recommended application site is the earlobe.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
"510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Phone: | |
| Fax: | 13700 1st Ave. North |
| Plymouth, MN 55441-5443 | |
| 763-553-9968 | |
| 763-553-7807 | |
| Contact Person: | Nancy DeAngelo |
| Senior Regulatory Affairs Specialist | |
| Date Prepared: | March 24, 2016 |
| Trade Names: | Model 6100C Series Single-Patient Use, Disposable Pulse |
| Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, | |
| 6100CN) | |
| Model 6101C Series Single-Patient Use, Disposable Pulse | |
| Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, | |
| 6101CN) | |
| Model 6102C Series Single-Patient Use, Disposable Pulse | |
| Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, | |
| 6102CN) | |
| Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter | |
| Sensor | |
| Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter | |
| Sensor | |
| Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter | |
| Sensor | |
| Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor | |
| Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor | |
| Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor | |
| Common Name: | Pulse oximeter sensor |
| Classification Name: | Oximeter |
| Regulation Number: | Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | DQA, Anesthesiology |
| DPZ, Anesthesiology | |
| Predicate Device(s): | The Nonin Model 6100C Series (Models 6100CA, 6100CP, |
| 6100CI, 6100CN), Model 6101C Series (Models 6101CA, | |
| 6101CP, 6101CI, 6101CN), Model 6102C Series (Models | |
| 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP, |
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Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and 8102Q2 Pulse Oximeter Sensors are predicated on Nonin's disposable cloth SpO2 Model 6000CX Series sensors (Models 6000CA, 6000CP, 6000Cl and 6000CN), Nonin Model 8100S(X) Series Soft Pulse Oximetry Sensors (Models 8100SS, 8100SM and 8100SL) and Nonin Model 8000Q2 Ear Clip Sensor cleared under K09853 (June 4, 2010), K132402 (February 21, 2014) and K080255 (May 23, 2008), respectively. The proposed and predicate sensors utilize Nonin's PureLight® technology. Device Description: The Model 6100C Series, Model 6101C Series and Model 6102C Series Pulse Oximeter Sensors are single-patient use. non-sterile disposable pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). The Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Pulse Oximeter Sensors are reusable, non-sterile pulse sensors intended for use with the Nonin Medical Model X-100 SenSmart Universal Oximetry System (Model X-100). Intended Use: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors Nonin's Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6100CA: adults > 30 kq / 66 lb; 6100CP: pediatrics > 10 kg / 22 lb.; 6100Cl: infants > 2 kg / 4 lb; and 6100CN: neonates 30 kg / 66 Ib), who are well or poorly perfused, during both motion and nonmotion conditions. It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments. Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors Nonin's Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 lb.; 6101Cl: infants > 2 kg / 4 lb; and 6101CN: neonates 30 kg / 66 Ib), who are well or poorly perfused, during both motion and nonmotion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
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Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors
Nonin's Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 lb; 6102CP: pediatrics > 10 kg / 22 lb.; 6102Cl: infants > 2 kg / 4 lb; and 6102CN: neonates 30 kg / 66 Ib), who are well or poorly perfused, during both motion and nonmotion conditions.
lt is intended for use hospitals, medical facilities. Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 - 60 kg / 18 - 132 lb) who are well or poorly perfused. during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
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Model 8102AA/8102AP Reusable, Finger Clip Pulse Oximeter Sensor
The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Model 8100Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8100Q2 reusable, ear clip sensor is indicated for noninvasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
Model 8101Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8101Q2 reusable, ear clip sensor is indicated for noninvasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kq / 88 lb) who are well or poorly perfused. during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
Model 8102Q2 Reusable, Ear Clip Pulse Oximeter Sensor
The Model 8102Q2 reusable, ear clip sensor is indicated for noninvasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
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| Testing: | The Nonin Model 6100C Series, Model 6101C Series, Model
6102C Series, Model 8100AA/8100AP, Model 8101AA/8101AP,
Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and
Model 8102Q2 Series sensors are supported by electrical safety,
electromagnetic compatibility, device performance, and clinical
testing to ensure appropriate functionality and to demonstrate
substantial equivalence to the predicate devices. The devices
were tested with the Nonin's Medical Model X-100 SenSmart
Universal Oximetry System. |
| ---------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Functional and Safety Testing:
The results of the testing demonstrate equivalency with the predicate devices and compliance to recognized standards. Table 1 summarizes test results for the proposed devices, which met the relevant requirements of the applicable recognized standards.
| Table 1 | ||
|---|---|---|
| Test | Reference | Result |
| Electrical Safety | IEC 60601-1 | Pass |
| Temperature and Humidity | IEC 60601-1 | |
| EN 1789 | Pass | |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Electromagnetic Immunity and | ||
| Emissions | IEC 60601-1-2 | Pass |
| Performance | ISO 80601-2-61 | |
| IEC 60601-1 | ||
| IEC 60601-1-6; IEC 60601-1-12 | ||
| IEC 62304 | ||
| ANSI/AAMI EC13 | ||
| ISO 14155 | Pass | |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance | |
| characterization | Pass | |
| Mechanical Durability | IEC 60601-1 | |
| ISO 80601-2-61 | Pass | |
| Biocompatibility | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-10 | Pass |
Note: The results reflected in the table above are representative for all sensors covered within this submission.
Clinical Testing: SpO2 Accuracy testing
Models 6100CA, 6101CA, 6102CA, 6100CP, 6101CP, 6102CP, 6100Cl, 6101Cl and 6102Cl
SpO2 accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The
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accuracy of the sensors in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in motion and non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
Models 6100CN, 6101CN and 6102CN
SpO2 accuracy testing was conducted at a Children's Hospital on male and female, light to dark-skinned subjects up to 30 days of age. The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
Models 8100AA. 8101AA. 8102AA. 8100AP. 8101AP and 8102AP
SpO2 accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in motion and non-motion. Accuracy data was calculated using the root-mean-squared (ARMs value) for all subjects.
Models 8100Q2, 8101Q2 and 8102Q2
SpO2 accuracy testing was conducted at an independent research laboratory on healthy, male and female, non-smoking, light to darkskinned subjects that were 18 years of age and older. The measured oxygen saturation value (SpO2) of the sensors was compared to simultaneous arterial blood samples as assessed by co-oximetry. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SaO2 range of 70-100% in non-motion. Accuracy data was calculated using the root-mean-squared (ARMS value) for all subjects.
Testing conclusion: the proposed Model 6100C Series, Model 6101C Series, Model 6102C Series, Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 Series sensors meet all acceptance criteria. Based on test results and comparison to the leqally marketed predicates, the Model the proposed sensors perform equivalently to the predicate sensors for their intended use.
Summary of Substantial Equivalence:
The Model 6100C Series, Model 6101C Series, Model 6102C Series, Model 8100AA/8100AP, Model 8101AA/8101AP, Model 8102AA/8102AP, Model 8100Q2, Model 8101Q2 and Model 8102Q2 sensors have the following similarities to their respective predicate devices:
- . Identical indications for use
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- Identical intended use environments ●
- ldentical patient population
- Same primary mode of operation .
- ldentical critical sensor optics technology (PureLight® Technology) ●
- Perform equivalently to the same specifications .
- . Similar construction and materials
The following lists the differences and the rationale for those differences between the proposed sensors and their respective predicate devices:
- . Model 6100C Series, Model 6101C Series and Model 6102C Series
- Contraindications the contraindication regarding the use of o device in MR environment was deemed more appropriate as a warning and the contraindication regarding defibrillation proof is no longer applicable due to verification testing according to IEC 60601-1:2005 when used with the X-100 System.
- SpO2 Motion Accuracy internal and clinical testing was O performed to verify the addition of accuracy claims in accordance with ISO 80601-2-61:2011.
- Pulse Rate Accuracy (Motion and Non-motion) internal and O clinical testing was performed to verify the change in motion claims and the addition of non-motion claims in accordance with ISO 80601-2-61:2011.
- New connector type the X-100 System, along with the о cleared SpO2 and rSO2 sensors for the system, utilize a Hirose connector with a Smart chip for authentication of the sensor to the system.
- Model 8100AA/8100AP, Model 8101AA/8101AP, and Model ● 8102AA/8102AP
- Contraindications the contraindication regarding the use of o device in MR environment was deemed more appropriate as a warning.
- Sensor Optic Housing Materials the direct patient contacting о materials used on the proposed sensors are the same as other cleared Nonin oximetry devices.
- Model 8100Q2. Model 8101Q2 and Model 8102Q2 ●
- Contraindications the contraindication reqarding the use of о device in MR environment was deemed more appropriate as a warning and the contraindication regarding defibrillation proof is no longer applicable due to verification testing according to IEC 60601-1:2005 when used with the X-100 System.
- SpO2 and Pulse Rate Low Perfusion internal and clinical O testing was performed to verify the addition of these claims in accordance with ISO 80601-2-61:2011.
- New connector type the X-100 System, along with the O cleared SpO2 and rSO2 sensors for the system, utilize a Hirose connector with a Smart chip for authentication of the sensor to the system.
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