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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Avant® Model 4000 Digital Pulse Oximetry System, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for the Avant® Model 4000 Digital Pulse Oximetry System in terms of accuracy (e.g., A
rms
value for SpO2 or pulse rate). It generally states that the device successfully underwent "both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate devices."

Therefore, I cannot populate a table with specific acceptance criteria and reported performance values based on the given text.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size used for the clinical testing. It only mentions "clinical testing."
Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Clinical testing generally implies prospective data collection, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide any information about the number of experts, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention or describe an MRMC comparative effectiveness study. Pulse oximeters are typically standalone measurement devices, and the concept of human readers improving with AI assistance does not directly apply in the same way it would for imaging diagnostics. The study aimed to demonstrate substantial equivalence, not to quantify human performance improvement with AI assistance.

6. Standalone Performance:

Yes, a standalone performance evaluation (algorithm only without human-in-the-loop performance) was implicitly done. For a pulse oximeter, "standalone performance" refers to the device's ability to accurately measure SpO2 and pulse rate independently. The document states "bench and clinical testing" was conducted to demonstrate functional features and substantial equivalence. This implies evaluating the device's measurements against a reference standard without human intervention adjusting the device's output.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. For pulse oximetry, the typical gold standard or ground truth involves:
* Co-oximetry: Blood samples analyzed by a co-oximeter for precise arterial oxygen saturation (SaO2).
* Controlled Desaturation Studies: Human subjects undergoing controlled desaturation (to vary SpO2) while the device's readings are compared to co-oximetry.

Given the context of pulse oximetry, it is highly probable that co-oximetry and/or controlled desaturation studies were used as the reference standard to establish ground truth.

8. Sample Size for the Training Set:

The document does not specify any sample size for a training set. Pulse oximeters, especially those submitted in 2004, typically rely on physiological models and signal processing rather than large-scale machine learning training sets in the modern sense. The "training" of such a device usually refers to the development and calibration against known physiological responses under various conditions.

9. How the Ground Truth for the Training Set was Established:

As there's no explicit mention of a "training set" in the context of machine learning, the document does not describe how ground truth for a training set was established. If we interpret "training" more broadly as the developmental process, the ground truth would have been established through extensive laboratory testing, physiological modeling, and potentially smaller-scale clinical studies during the device's design and calibration phases, likely using co-oximetry as the reference standard.

Summary

{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. DalpeeDirector of Regulatory AffairsNonin 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 tothe Avant® Model 2120 Pulse Oximeter manufactured byNonin Medical, Inc. that was cleared by the FDA underK013319 on 1/03/02, and the Wireless MedicineLifeSync™ System (K030765).
Device Description:	The Avant Model 4000 Digital Pulse Oximetry System is awireless pulse oximeter that includes a portable, tabletopdisplay unit (Avant 4000) and a wrist-worn patient moduleAvant (4100). The System is designed for spot-checkingand / or continuous noninvasive measuring and displayingof 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 4000can be powered with a 12 VDC AC adapter or with anintegral sealed 7.2-volt rechargeable NiMH battery pack.The Avant 4100 patient module is powered with two 1.5volt AA batteries.
	The Avant 4000 System includes adjustable audible andvisual pulse rate, oxygen saturation, and perfusion alarms.It also includes a variety of advanced features, includinglow battery alarms, event markers, real-time and print-on-demand data outputs.
	Incorporating Bluetooth® Technology in the Avant 4000eliminates the connection from the wrist worn oximetermodule to the display unit giving patients increased abilityto move freely without being hindered by cables.
Intended Use:	The Nonin® Avant® Model 4000 Digital Pulse OximetrySystem is indicated for use in measuring and displayingfunctional oxygen saturation of arterial hemoglobin (SpO2)and pulse rate of adult, pediatric, and infant patients. It isindicated for spot-checking and / or continuous monitoring.
Functional andSafety Testing:	Nonin's Avant 4000 Pulse Oximetry System hassuccessfully undergone both bench and clinical testing inorder to demonstrate that it has appropriate functionalfeatures and is substantially equivalent to the predicatedevices.
Conclusion:	Nonin's Avant Model 4000 is substantially equivalent tothe Avant® Model 2120 Pulse Oximeter manufactured byNonin Medical, Inc. and cleared by the FDA underK013319 on 1/03/02.
	Previously cleared Bluetooth predicate device: WirelessMedicine 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)

Regulation Number and Section

§ 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).