(37 days)
Not Found
No
The description focuses on standard pulse oximetry technology, wireless connectivity (Bluetooth), and basic alarm/display features. There is no mention of AI, ML, or any advanced data processing that would suggest their use.
No
The device measures and displays physiological parameters (oxygen saturation and pulse rate) and does not directly provide a therapeutic effect or treatment.
Yes
Explanation: The device measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description clearly outlines hardware components including a tabletop display unit, a wrist-worn patient module, LEDs, batteries, and an AC adapter. It is a system that includes both hardware and software.
Based on the provided information, the Nonin® Avant® Model 4000 Digital Pulse Oximetry System 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 Avant 4000 system measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate non-invasively through a sensor placed on the patient's body (likely a finger or other extremity, although not explicitly stated, this is the standard for pulse oximetry). It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring and displaying physiological parameters directly from the patient.
Therefore, the device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA, DQA
Device Description
The Avant Model 4000 Digital Pulse Oximetry System is a wireless pulse oximeter that includes a portable, tabletop display unit (Avant 4000) and a wrist-worn patient module Avant (4100). The System is designed for spot-checking and / or continuous noninvasive measuring and displaying of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate.
The Avant 4000 System is intended for use with adult, pediatric, and infant patients.
The Avant 4000 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Avant 4000 can be powered with a 12 VDC AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Avant 4100 patient module is powered with two 1.5 volt AA batteries.
The Avant 4000 System includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, event markers, real-time and print-on-demand data outputs.
Incorporating Bluetooth® Technology in the Avant 4000 eliminates the connection from the wrist worn oximeter module to the display unit giving patients increased ability to move freely without being hindered by cables.
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
adult, pediatric, and infant patients
Intended User / Care Setting
Not Found
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)
Nonin's Avant 4000 Pulse Oximetry System has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices.
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
JUN - 9 2004
Image /page/0/Picture/1 description: The image contains a handwritten word that appears to be "Ko41156". The writing is in black ink on a white background. The style of writing is cursive, with some letters connected to each other.
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | John R. Dalpee |
| Director of Regulatory Affairs | |
| Nonin Medical, Inc. | |
| 2605 Fernbrook Lane N. | |
| Plymouth, MN 55447-4755 | |
| Date Prepared: | April 30, 2004 |
| Trade Name: | Avant® Model 4000 Digital Pulse Oximetry System |
| Classification Name: | |
| and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | Nonin's Avant® Model 4000 is substantially equivalent to |
| the Avant® Model 2120 Pulse Oximeter manufactured by | |
| Nonin Medical, Inc. that was cleared by the FDA under | |
| K013319 on 1/03/02, and the Wireless Medicine | |
| LifeSync™ System (K030765). | |
| Device Description: | The Avant Model 4000 Digital Pulse Oximetry System is a |
| wireless pulse oximeter that includes a portable, tabletop | |
| display unit (Avant 4000) and a wrist-worn patient module | |
| Avant (4100). The System is designed for spot-checking | |
| and / or continuous noninvasive measuring and displaying | |
| of functional oxygen saturation of arterial hemoglobin | |
| (SpO2), and pulse rate. |
The Avant 4000 System is intended for use with adult,
pediatric, and infant patients.
The Avant 4000 display uses light-emitting diodes (LED)
components to present patient's SpO2 and pulse rate values,
as well as alarm limit and volume settings. The Avant 4000
can be powered with a 12 VDC AC adapter or with an
integral sealed 7.2-volt rechargeable NiMH battery pack.
The Avant 4100 patient module is powered with two 1.5
volt AA batteries. |
| | The Avant 4000 System includes adjustable audible and
visual pulse rate, oxygen saturation, and perfusion alarms.
It also includes a variety of advanced features, including
low battery alarms, event markers, real-time and print-on-
demand data outputs. |
| | Incorporating Bluetooth® Technology in the Avant 4000
eliminates the connection from the wrist worn oximeter
module to the display unit giving patients increased ability
to move freely without being hindered by cables. |
| Intended Use: | The Nonin® Avant® Model 4000 Digital Pulse Oximetry
System is indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate of adult, pediatric, and infant patients. It is
indicated for spot-checking and / or continuous monitoring. |
| Functional and
Safety Testing: | Nonin's Avant 4000 Pulse Oximetry System has
successfully undergone both bench and clinical testing in
order to demonstrate that it has appropriate functional
features and is substantially equivalent to the predicate
devices. |
| Conclusion: | Nonin's Avant Model 4000 is substantially equivalent to
the Avant® Model 2120 Pulse Oximeter manufactured by
Nonin Medical, Inc. and cleared by the FDA under
K013319 on 1/03/02. |
| | Previously cleared Bluetooth predicate device: Wireless
Medicine LifeSync™ System (K030765). |
1
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, representing the department's focus on health-related matters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
Mr. John R. Dalpee Director of Regulatory Affairs Nonin Medical, Incorporated 2605 Fernbrook Lane N. Plymouth, Minnesota 55447-4755
Re: K041156
Trade/Device Name: Avant® Model 4000 Digital Pulse Oximetry System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 30, 2004 Received: May 3, 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 approvisions 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 (1 wr 1, it is a 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.
3
Page 2 - Mr. 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 complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Free of arryly 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 premiance noticate 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), 11 you dontact the Office of Compliance at (301) 594-4646. 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 maj somal 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 vours,
Culs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(K) Number: __
KO41156
Device Name:
Nonin Medical, Inc. Avant® Model 4000
Indications for Use:
The Nonin® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in The Norm - Avail@ Model 1900 Digixianal oxygen saturation of arterial hemoglobin (SpO2) and measuring and ulsplaying funchenal ofty getients. It is indicated for spot-checking and / or continuous monitoring.
Cindyschum
(Division Sign Off) Division of Anesthesiology. General Hospital Infection Control, Dental Device 510(k) Number.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)