(315 days)
No
The description details standard pulse oximetry and oscillometric NIBP technology, with no mention of AI or ML algorithms for data analysis or interpretation. The analysis is based on direct measurements and established physiological principles.
No
The device is described as a monitor that measures and displays various physiological parameters (SpO2, pulse rate, NIBP); it does not provide any treatment or therapy.
Yes
This device is identified as a "Pulse Oximeter and NIBP Monitor" which measures and displays physiological parameters (SpO2, pulse rate, and blood pressure) to assess a patient's health status, which is characteristic of a diagnostic device. The "Intended Use" explicitly states it's for "measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure," which are all diagnostic measurements.
No
The device description explicitly details hardware components like an internal electric pump, valves, and sensors (for pulse oximetry), indicating it is a physical device with integrated software, not a software-only medical device.
No, 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. They are used outside of the body (in vitro).
- Device Function: The Nonin® Model Avant™ 2120 Pulse Oximeter and NIBP Monitor measures physiological parameters directly from the patient's body.
- Pulse Oximetry measures oxygen saturation and pulse rate by passing light through perfused tissue.
- NIBP measures blood pressure by inflating a cuff on the arm.
- No Sample Analysis: The device does not analyze samples taken from the patient. It is a non-invasive monitoring device.
Therefore, based on the provided information, the device is a patient monitoring device and not an IVD.
N/A
Intended Use / Indications for Use
The NONIN® Model Avant™ 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 pulse oximeter is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.
Pulse Oximeter Intended Use:
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pcdiatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused.
Blood Pressure Monitor Intended Use:
The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking.
The Model 2120 should be used for patients with arm circumferences of 18-42 cm.
Product codes
74 DQA, 74 DXN
Device Description
The Model Avant™ 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.
Pulse Oximetry
The NONIN® Model Avant™ 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by mcasuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.
Blood Pressure Measurement
The NONIN® Model Avant™ 2120 NIBP uses an oscillometric stcp deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model Avant™ 2120 has the ability to make blood pressure measurcments at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for Pulse Oximetry), Arm (for Blood Pressure)
Indicated Patient Age Range
Adult, pediatric, infant, and neonatal patients for pulse oximeter.
Adult and pediatric patients for blood pressure monitor. Not intended for use with neonates for blood pressure.
Intended User / Care Setting
Hospitals, medical facilities, and subacute 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Special 510(k): Device Modification
MAR 2 2 2004
Attachment 4
510(k) Summary
Nonin Medical, Inc.
Model 2120 Avant™ Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor
510(k) Summary
9 May 2003
(1) Submitter information
| Name: | Nonin Medical, Inc. |
|---|---|
| Address: | 2605 Fernbrook Lane North |
| Plymouth, MN 55447-4755 | |
| Telephone: | 763-553-9968 |
| Registration Number: | 2183646 |
| Contact person: | Richard P. Bennett (Official Correspondent) |
| Nonin Medical, Inc. | |
| 2605 Fernbrook Lane North | |
| Plymouth, MN 55447-4755 | |
| Tel: 763-577-3166 | |
| Fax: 763-553-7807 | |
| Date prepared: | 9 May 2003 |
(2) Name of Device
| Device Trade Name: | NONIN® Model Avant™ 2120 Pulse Oximeter and
Noninvasive Blood Pressure (NIBP) Monitor |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common /
Classification Name: | Pulse Oximeter with Noninvasive Blood Pressure |
| Device Class: | Class II; 74 DQA, 870.2700; 74 DXN, 870.1130.
No performance standards have been established
under Section 514 of the Food, Drug and Cosmetic
Act for Pulse Oximeters. |
(3) Legally-marketed predicate devices
Model Avant™ 2120 Pulse Oximeter and NIBP, K013319, clearance date January 3, 2002, by Nonin Medical, Inc.
1
Special 510(k): Device Modification
Model N-395 Pulse Oximeter with Extension of Motion Performance Claims to cover three additional oximetry sensors, K993637, clearance date November 24, 1999 made by Nellcor Puritan Bennett.
Masimo SET® Radical Pulse Oximeter, K013792, clearance date December 11, 2001, made by Masimo Corporation.
The NONIN® Model Avant™ 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor is substantially equivalent to these devices.
(4) Description
The Model Avant™ 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.
Pulse Oximetry
The NONIN® Model Avant™ 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by mcasuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.
Blood Pressure Measurement
The NONIN® Model Avant™ 2120 NIBP uses an oscillometric stcp deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model Avant™ 2120 has the ability to make blood pressure measurcments at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.
(5) Intended Use
Indications for Use:
The NONIN® Model Avant™ 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 pulse oximeter is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.
2
Special 510(k): Device Modification
Pulse Oximeter Intended Use:
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pcdiatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused.
Blood Pressure Monitor Intended Use:
The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking.
The Model 2120 should be used for patients with arm circumferences of 18-42 cm.
(6) Conclusion
The NONIN® Model Avant™ 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor is equivalent in safety and efficacy to the legally marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Nonin Medical, Inc. c/o Mr. John R. Dalpee Director of Regulatory Affairs 2605 Fernbrook Lane North Plymouth, MN 55447-4755
Re: K031487
Trade Name: Model 2120 Avant™ Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: February 16, 2004 Received: February 19, 2004
Dear Mr. Dalpee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 -- Mr. John R. Dalpee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna R. LaClair
GBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K03i487/S2
Indications for Use
510(K) Number: K031487
Device Name: Model 2120 Avant™ Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor
Indications for Use:
The Nonin® Model Avant™ 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its functions may be used separately or simultaneously.
Prescription Use
(Per 21 CFR 801.109)
✓
Over-The-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Duna R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 31487