(101 days)
Not Found
No
The summary describes a regional oximetry sensor that measures hemoglobin oxygen saturation. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on functional, safety, and accuracy testing based on the sensor's optics technology, which is stated to be unchanged from the predicate devices.
No.
The device is described as an "adjunct monitor of trends in regional hemoglobin oxygen saturation," indicating it is used for monitoring and diagnostic purposes, not for treating a condition.
No
The device is described as an "adjunct monitor of trends in regional hemoglobin oxygen saturation" or "absolute real-time adjunct monitor of regional hemoglobin oxygen saturation," indicating it supports other diagnostic processes rather than providing a stand-alone diagnosis.
No
The device description explicitly states that the devices are "single-patient use, non-sterile disposable regional (tissue saturation) sensors," indicating they are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a "regional oximetry sensor" that monitors "regional hemoglobin oxygen saturation of blood underneath the sensor." This is a non-invasive measurement taken directly from the patient's body, not from a sample in a lab.
- Intended Use: The intended use describes monitoring trends and absolute real-time values of oxygen saturation in vivo (within the living body).
- Device Description: The device is a sensor that interacts directly with the patient's skin.
Therefore, the device falls under the category of a medical device used for patient monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Product codes (comma separated list FDA assigned to the subject device)
MUD
Device Description
The SenSmart Model 8203CA Regional Oximetry Sensor (Model 8203CA) and SenSmart Model 8204CA Regional Oximetry Sensor (Model 8204CA) are single-patient use, non-sterile disposable regional (tissue saturation) sensors intended for use with the Nonin Medical Model X-100 SenSmart Regional Oximetry System (Model X-100). The proposed devices are also compatible with the Nonin Model 7600 Regional Oximeter (Model 7600).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Underneath the sensor
Indicated Patient Age Range
Adult or pediatric patients weighing greater than 88 pounds (40 kilograms).
Intended User / Care Setting
Operating room, surgical recovery, critical care, emergency room, long-term care, 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
Testing: The Nonin Model 8203CA and Model 8204CA sensors are supported by 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 Model X-100 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: Electrical Safety, Reference: IEC 60601-1, Result: Pass
Test: Temperature and Humidity, Reference: IEC 60601-1, EN 1789, Result: Pass
Test: Atmospheric Pressure (Altitude), Reference: IEC 60601-1, Result: Pass
Test: Electromagnetic Immunity and Emissions, Reference: IEC 60601-1-2, Result: Pass
Test: Performance, Reference: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6; IEC 60601-1-12, IEC 62304, ANSI/AAMI EC13, ISO 14155-1; ISO 14155-2, Result: Pass
Test: Ingress Protection, Reference: ISO 80601-2-61, Result: Pass
Test: Diaphoretic related ingress, Reference: Internal performance characterization, Result: Pass
Test: Mechanical Durability, Reference: IEC 60601-1, ISO 80601-2-61, ISTA 2A, ASTM D-4169, Result: Pass
Test: Biocompatibility, Reference: ISO 10993-1, Result: Biocompatible
rSO2 Accuracy testing: the critical sensor optics technology of the proposed devices remains unchanged from the predicate devices. rSO2 accuracy is demonstrated through detailed device comparison, analysis and testing.
Clinical testing: the critical sensor optics technology of the proposed devices remains unchanged from the predicate devices. Thus prior clinical testing provided in K102715 is applicable for the proposed Model 8203CA and Model 8204CA sensors.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing conclusion: the proposed Model 8203CA and Model 8204CA sensors meet all acceptance criteria. Based on test results, analysis and comparison to the legally marketed predicates, the Model 8203CA and Model 8204CA sensors 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nonin Medical Inc. Laura Lind Sr. Regulatory Affairs Specialist 13700 1st Avenue North Plymouth, Minnesota 55441
Re: K151305
Trade/Device Name: SenSmart Model 8203CA Regional Oximetry Sensor, SenSmart Model 8204CA Regional Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: July 30, 2015 Received: July 31, 2015
Dear Laura Lind:
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.
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
1
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 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.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151305 - Page 1 of 1
Device Name
SenSmart™ Model 8203CA Regional Oximetry Sensor SenSmart™ Model 8204CA Regional Oximetry Sensor
Indications for Use (Describe)
Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, 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) |
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3
Image /page/3/Picture/0 description: The image shows the word "NONIN" in blue, with a small diamond above the "I". To the left of the word is an orange geometric shape. The word "NONIN" is written in a stylized font, with the letters slightly slanted to the right. The overall impression is of a logo or brand name.
Image /page/3/Picture/1 description: The image contains three parallelograms of different colors. The first parallelogram is orange, the second is blue, and the third is gray. The parallelograms are arranged in a row, with each one slightly overlapping the previous one.
5. "510(k) Summary" as required by section 807.92(c)
| Submitter: | Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax: | 763-553-9968
763-553-7807 |
| Contact Person: | Laura Lind
Senior Regulatory Affairs Specialist |
| Date Prepared: | May 15, 2015 |
| Trade Names: | SenSmart™ Model 8203CA Regional Oximetry Sensor
SenSmart™ Model 8204CA Regional Oximetry Sensor |
| Common Name:
Classification Name:
Regulation Number: | Regional oximetry sensor
Oximeter, Tissue Saturation
Class II, 21 CFR 870.2700 (Oximeter) |
| Product Code, Panel: | MUD, Cardiovascular |
| Predicate Device(s): | The Nonin SenSmart Model 8203CA and Model 8204CA Regional
Oximetry Sensors are predicated on the Nonin SenSmart Model
8003CA and Model 8004CA Regional Oximetry Sensors cleared
under K102715 (December 17, 2010.) |
| Device Description: | The SenSmart Model 8203CA Regional Oximetry Sensor (Model
8203CA) and SenSmart Model 8204CA Regional Oximetry
Sensor (Model 8204CA) are single-patient use, non-sterile
disposable regional (tissue saturation) sensors intended for use
with the Nonin Medical Model X-100 SenSmart Regional Oximetry
System (Model X-100). The proposed devices are also compatible
with the Nonin Model 7600 Regional Oximeter (Model 7600). |
| Intended Use: | Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable
sensor is intended for use as an adjunct monitor of trends in
regional hemoglobin oxygen saturation of blood underneath the
sensor of adult or pediatric patients weighing greater than 88
pounds (40 kilograms). The sensor may be repositioned or
replaced with another 8203CA sensor without baseline re-
establishment. It is intended for use in environments including the
operating room, surgical recovery, critical care, emergency room,
long-term care, and mobile environments. |
4
Image /page/4/Picture/0 description: The image shows the logo for Nonin. The logo consists of an orange geometric shape on the left and the word "NONIN" in blue on the right. The geometric shape is made up of several squares that are nested inside each other. The word "NONIN" is written in a sans-serif font, and the letters are all capitalized.
Image /page/4/Picture/1 description: The image shows three parallelograms of different colors. The first parallelogram is orange, the second is blue, and the third is gray. The parallelograms are arranged side by side.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care. emergency room, long-term care, and mobile environments.
Testing: The Nonin Model 8203CA and Model 8204CA sensors are supported by 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 Model X-100 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 14155-1; ISO 14155-2 | Pass | |
| Ingress Protection | ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance | |
| characterization | Pass | |
| Mechanical Durability | IEC 60601-1 | |
| ISO 80601-2-61 | ||
| ISTA 2A | ||
| ASTM D-4169 | Pass | |
| Biocompatibility | ISO 10993-1 | Biocompatible |
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Image /page/5/Picture/0 description: The image shows the word "NONIN" in blue, with a stylized square logo in orange to the left of the word. The word "NONIN" is written in a sans-serif font, with the "O" in the word having a small white square inside of it. The stylized square logo is made up of two squares, one inside the other, with the inner square being slightly offset from the outer square.
| | rSO2 Accuracy testing: the critical sensor optics technology of
the proposed devices remains unchanged from the predicate
devices. rSO2 accuracy is demonstrated through detailed device
comparison, analysis and testing. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinical testing: the critical sensor optics technology of the
proposed devices remains unchanged from the predicate devices.
Thus prior clinical testing provided in K102715 is applicable for the
proposed Model 8203CA and Model 8204CA sensors. |
| | Testing conclusion: the proposed Model 8203CA and Model
8204CA sensors meet all acceptance criteria. Based on test
results, analysis and comparison to the legally marketed
predicates, the Model 8203CA and Model 8204CA sensors
perform equivalently to the predicate sensors for their intended
use. |
| Summary of
Substantial
Equivalence: | The Model 8203CA and Model 8204CA sensors have the
following similarities to the predicate devices:
Identical indications for use Identical intended use environments Identical patient population Same primary mode of operation Identical critical sensor optics technology Used with the same systems in same manner Perform equivalently to the same specifications Similar construction and materials |
| Conclusion: | No new questions of safety and effectiveness were raised. Based
on the results of the above referenced testing, the same critical
optics technology, results from safety and performance testing
and analysis, and risk management assessment, Nonin Medical
has determined that the proposed SenSmart Model 8203CA
Regional Oximetry Sensor and SenSmart Model 8204CA
Regional Oximetry Sensor are substantially equivalent to the
predicate Nonin SenSmart Model 8003CA Regional Oximetry
Sensor and SenSmart Model 8004CA Regional Oximetry Sensor |
and the proposed devices are safe for their intended use.
Image /page/5/Picture/2 description: The image contains three trapezoidal shapes arranged horizontally. The first shape is orange, the second is light blue, and the third is gray. The shapes appear to be part of a larger design or diagram, but the context is unclear due to the limited view.