The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device.

Device Description

Nonin's Model 4100 Bluetooth® - enabled wrist-worn Patient Oximeter Module measures and transmits SpO2, pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device. The patient module includes a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The 4100 Patient Oximeter Module is powered with two AA batteries, which last for approximately 120 hours when used continuously.

AI/ML Overview

The provided text is a 510(k) summary for the Nonin Model 4100 Patient Oximeter Module. It states that the device has undergone "both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." However, the document does not provide specific details about the acceptance criteria or the specific study results proving the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not specify any quantitative acceptance criteria for device performance, nor does it present reported device performance in a table. It only states that functional and safety testing was performed and that the device is "substantially equivalent" to a predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. It only mentions "clinical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is an oximeter, not an AI-powered diagnostic tool requiring human reader interpretation improvements. The document describes a traditional medical device (pulse oximeter).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an oximeter, not an AI algorithm. Its performance is inherent to its function of measuring SpO2 and pulse rate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly provided. For pulse oximeters, the ground truth for SpO2 measurements typically involves co-oximetry blood gas analysis, but the document does not confirm this.

8. The sample size for the training set

This is not applicable as the device is a hardware medical device (pulse oximeter) and does not inherently involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

K043359

JAN - 7 2005

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:	December 6, 2004
Trade Name:	Model 4100 Patient Oximeter Module
Classification Name:and Number:	Class II, 21 CFR 870.2700
Product Code:	74 DQA
Predicate Device(s):	Nonin's Model 4100 Patient Oximeter Module issubstantially equivalent to the Avant® Model 4000 PulseOximetry System manufactured by Nonin Medical, Inc.that was cleared by the FDA under K041156 on 6/09/04.
Device Description:	Nonin's Model 4100 Bluetooth® - enabled wrist-wornPatient Oximeter Module measures and transmits SpO2,pulse rate, and plethysmographic data to a compatibleBluetooth - enabled device. The patient module includes aclass II Bluetooth radio with a range of approximately 30feet (spherical range).The 4100 Patient Oximeter Module is powered with twoAA batteries, which last for approximately 120 hours whenused continuously.
Intended Use:	The Nonin® Bluetooth® - enabled Model 4100 PatientOximeter Module is indicated for use in measuring andtransmitting functional oxygen saturation of arterialhemoglobin (SpO2), pulse rate, and plethysmographic datato a compatible Bluetooth - enabled device.
Functional andSafety Testing:	Nonin's Model 4100 Patient Oximeter Module hassuccessfully undergone both bench and clinical testing inorder to demonstrate that it has appropriate functionalfeatures and is substantially equivalent to the predicatedevice.
Conclusion:	Nonin's Model 4100 Patient Oximeter Module issubstantially equivalent to the Avant® Model 4000 PulseOximetry System manufactured by Nonin Medical, Inc.and cleared by the FDA under K041156 on 6/09/04.

{1}------------------------------------------------

and the comments of the comments of the comments of

and the comments of the comments of

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Mr. John R. Dalpee Director of Regulatory Affairs Nonin Medical, Incorporated 2605 Fernbrook Lane North Plymouth, Minnesota 55447-4755

Re: K043359

Trade/Device Name: Model 4100 Patient Oximeter Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 6, 2004 Received: December 17, 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.

{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. 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) 594-0120. 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,

Sutte Michael ms.
Chiu Lin, Ph.D.

for DR. LIN 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

くなってい

510(K) Number:

K 04335

Device Name:

Nonin Medical, Inc. Model 4100 Patient Oximeter Module

Indications for Use:

Sia. G. Semilla
(Division Sign Off)
Division of Anesthesiology, General Hospital
Michael for

hesiology, General Hospital, on Control. Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nonin Medical Inc.

Model 4100 Traditional 510(K): Premarket Notification

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).