(87 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities.
No
The device is a diagnostic tool that measures and displays vital signs (SpO2 and pulse rate); it does not treat or directly intervene in a patient's condition.
Yes
The device is indicated for "simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements used to assess a patient's physiological state and aid in diagnosis.
No
The device description explicitly states it is a "portable, tabletop device" with physical components like a display using LEDs, an AC adapter, a rechargeable battery pack, and connections for oxygen sensors. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Nonin® Avant™ 9600 Digital Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Avant™ 9600 clearly states it is a "portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients". This is a non-invasive measurement taken directly from the patient, not from a specimen.
- The intended use and device description focus on direct patient monitoring. The device measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using a sensor.
Therefore, the Avant™ 9600 is a non-invasive patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Nonin® Avant™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments. The Avant™ 9600 is intended for continuous monitoring and / or spot-checking of patients during both no motion and motion conditions, for patients who are well or poorly perfused.
Product codes
74 DQA
Device Description
The Avant™ 9600 Digital Pulse Oximeter is a portable tabletop device designed for continuous noninvasive measurement, display, and recording of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using one of a range of compatible oxygen sensors. The Avant™ 9600 is intended for prescription use with adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments.
The Avant™ 9600's 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™ 9600 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.
The Avant™ 9600 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, real-time and print-on-demand data outputs, a patient security mode, and nurse call options.
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, infant, and neonatal patients
Intended User / Care Setting
hospitals, medical facilities, home care, and subacute environments, patient transport, sleep laboratories, and EMS 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
Nonin's Avant™ 9600 Pulse Oximeter has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device.
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
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 shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then the number '4', another '0', the number '5', the number '8', and finally the number '9'. The characters are written in a cursive style, with some connections between the letters and numbers.
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: | May 24, 2004 |
| Trade Name: | Avant™ 9600 Pulse Oximeter |
| Classification Name: | |
| and Number: | Class II, 21 CFR 870.2700 |
| Product Code: | 74 DQA |
| Predicate Device(s): | The Avant™ 9600 is substantially equivalent to the Avant |
| 2120 (K031487), which is also manufactured by Nonin | |
| Medical. | |
| Device Description: | The Avant™ 9600 Digital Pulse Oximeter is a portable |
| tabletop device designed for continuous noninvasive | |
| measurement, display, and recording of functional oxygen | |
| saturation of arterial hemoglobin (SpO2) and pulse rate | |
| using one of a range of compatible oxygen sensors. The | |
| Avant™ 9600 is intended for prescription use with adult, | |
| pediatric, infant, and neonatal patients in hospitals, medical | |
| facilities, home care, and subacute environments. It may | |
| also be used in patient transport, sleep laboratories, and | |
| EMS environments. |
The Avant™ 9600's 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™ 9600 can be powered internally with a 12 VDC
1.5A AC adapter or with an integral sealed 7.2-volt
rechargeable NiMH battery pack.
The Avant™ 9600 includes adjustable audible and visual
pulse rate, oxygen saturation, and perfusion alarms. It also
includes a variety of advanced features, including low |
1
| | battery alarms, real-time and print-on-demand data outputs,
a patient security mode, and nurse call options. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Nonin® Avant™ 9600 Digital Pulse Oximeter is a
portable, tabletop device indicated for use in
simultaneously measuring, displaying, and recording
functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate of adult, pediatric, infant, and neonatal
patients in hospitals, medical facilities, home care, and
subacute environments. It may also be used in patient
transport, sleep laboratories, and EMS environments. The
Avant™ 9600 is intended for continuous monitoring and /
or spot-checking of patients during both no motion and
motion conditions, for patients who are well or poorly
perfused. |
| Functional and
Safety Testing: | Nonin's Avant™ 9600 Pulse Oximeter has successfully
undergone both bench and clinical testing in order to
demonstrate that it has appropriate functional
characteristics and is substantially equivalent to the
predicate device. |
| Conclusion: | The Avant™ 9600 Pulse Oximeter is substantially
equivalent to the predicate device in terms of functional
design and principles of operation. |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
T
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
Mr. John R. Dalpee Director Regulatory Affairs Nonin Medical, Incorporated 2605 Fernbrook Lane, North Plymouth, Minnesota 55447-4755
Re: K040589
R040389
Trade/Device Name: Modification for the Avant™ Model 9600 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 11, 2004 Received: May 12, 2004
Dear Mr. Dalpee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin be (27) be device is substantially equivalent (for the referenced above and have decemined are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conninetee proct to that have been reclassified in accordance with the provisions of Amendinents, or to devices that have oact (Act) that do not require approval of a premarket the Federal Pool, Drug, and Connelly , therefore, market the device, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the Fiel. "The girling 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 If your device is classified (500 above) was a controls. Existing major regulations affecting (PMA), it may of subjoct to sach adam feederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nonements 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 mean that 177A has made a deceminations administered by other Federal agencies. of the Act of ally I ecclai statutes and regar-seens, including, but not limited to: registration You must comply with an the Hotel Ing (21 CFR Part 801); good manufacturing practice and listing (21 CFR I at 807), laoomig (21 CFR (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Partitle A requirents as set form in the quality of 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) This icter will anow you to organ made of substantial equivalence of your device to a premits in the results in the Print mainly of 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), If you desire specific at the for for your 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 may outain 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,
Chiu, I-Ling, Ph.D.
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: 040589
Device Name:
Nonin Medical, Inc. Avant™ 9600
Indications for Use:
The Nonin® Avant™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated The Nomin - Availt - - 900 Digitary, displaying, and recording functional oxygen 101 ase in sifilultaneously measuring and pulse rate of adult, pediatric, infant, and saturation of arterial nemogloom (Bp of) allis post It may also be used in patient transport, sleep laboratories, and EMS environments. The n thay arso be used in patient aransports, and / or spot-checking of patients A valle - 7000 is intended for some conditions, for patients who are well of poorly perfused. હ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auu Sulom
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Prescription use AND/OR Over-The-Counter
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)