MODEL 3100 WRISTOX PULSE OXIMETER by NONIN MEDICAL, INC.

The Nonin Model 3100 WristOx™ Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.

Device Description

The Nonin Model 3100 WristOx is a small, wrist worn pulse oximeter. It uses an electro-optical sensor to noninvasively measure, display and store functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. The WristOx stores up to 33 hours of SpO2 and pulse rate data. Stored patient data may be downloaded to any data management software system using the nonproprictary communication protocol . Nonin's data management software system (nVISION™) is available as an accessory, but is not required to use the memory feature.

AI/ML Overview

The provided text is a 510(k) summary for the Nonin Model 3100 WristOx Pulse Oximeter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about the acceptance criteria or a study that explicitly proves the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods.

The document states:
"The Nonin Model 3100 WristOx has undergone Functional and Safety Testing: both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device."

While it mentions "clinical testing," it does not provide the specifics requested in your prompt. Therefore, I cannot fill in the table or answer most of your detailed questions based on the provided text.

Here's a breakdown of what can and cannot be answered from the provided text:

What can be inferred/answered from the text:

Device Name: WristOx Pulse Oximeter, Model 3100
Predicate Device: Model 2500 PalmSat® Hand Held Pulse Oximeter (K002690)
Type of Study (General): Functional and safety testing, including clinical testing, to demonstrate substantial equivalence.
Ground Truth for Substantial Equivalence: Comparison to a legally marketed predicate device (Model 2500 PalmSat® Hand Held Pulse Oximeter).
Regulation Number/Name/Class: Regulation Number: 870.2700, Regulation Name: Oximeter, Regulatory Class: II.
Application Type: 510(k) premarket notification.

What cannot be answered from the provided text:

Specific Acceptance Criteria: The document does not list quantitative acceptance criteria (e.g., accuracy +/- X%, precision Y%).
Reported Device Performance: No specific performance metrics (e.g., SpO2 accuracy, pulse rate accuracy) are reported.
Sample size used for the test set: Not mentioned.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. The device is an oximeter, not an AI-assisted diagnostic tool, so an MRMC study in the context of human reader improvement with AI is unlikely to be relevant here.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable as it's not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed beyond general clinical testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the clinical testing, the standard for oximeters usually involves comparing to a co-oximeter in an induced hypoxia study, but this is not specified in the provided text. The primary "ground truth" for the 510(k) summary is the predicate device's performance.
The sample size for the training set: Not applicable/not mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable/not mentioned.

Summary Table (with inferred/unavailable information):

Feature/Criterion	Acceptance Criteria (as per document)	Reported Device Performance (as per document)
Substantial Equivalence	Device is substantially equivalent to predicate device (Model 2500 PalmSat® Hand Held Pulse Oximeter, K002690).	The device was determined by the FDA to be substantially equivalent to the predicate device.
Functional Characteristics	Appropriate functional characteristics. (Specifics not provided)	Achieved "appropriate functional characteristics" to demonstrate substantial equivalence. (Specifics not provided)
Safety Testing	Expected to be safe. (Specifics not provided)	Underwent safety testing to demonstrate substantial equivalence. (Specifics not provided)
SpO2 Accuracy	Not specified in text (Typically +/- 2% or 3% for medical oximeters within a certain range, compared to co-oximetry).	Not reported in text
Pulse Rate Accuracy	Not specified in text (Typically +/- 1 to 3 bpm or % compared to ECG).	Not reported in text
Memory Function	Similar to predicate device.	Stores up to 33 hours of SpO2 and pulse rate data; similar to predicate.
Indications for Use	Measuring, displaying, and storing functional SpO2 and pulse rate; for adult and pediatric patients; in hospitals, medical facilities, ambulatory, subacute, and sleep study environments.	Meets stated indications for use.

Since the requested detailed information regarding specific study metrics, sample sizes, and expert details is not present in the provided document, I cannot complete those sections. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of clinical study results. A full 510(k) submission might contain such details, but they are not in this summary.

Summary

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OCT 1 7 2003

Summary and Certification

510 Summary, K030668 A

Submitter:	Nonin Medical Inc.
Contact Person:	John R. DalpeeDirector, Regulatory AffairsNonin Medical Inc.2605 Fernbrook Lane N.Plymouth, MN 55447-4755
Date Prepared:	150October, 2003
Trade Name:	WristOx TM Pulse Oximeter, Model 3100
Classification NameAnd Number:	Class II, 21 CFR Part 870.2700, Oximeter
Product Code:	DQA
Predicate Device:	Model 2500 PalmSat® Hand Held Pulse Oximeter(K002690)

Device Description: The Nonin Model 3100 WristOx is a small, wrist worn pulse oximeter. It uses an electro-optical sensor to noninvasively measure, display and store functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. The WristOx stores up to 33 hours of SpO2 and pulse rate data. Stored patient data may be downloaded to any data management software system using the nonproprictary communication protocol . Nonin's data management software system (nVISION™) is available as an accessory, but is not required to use the memory feature.

Indications for Use: The Nonin Model 3100 WristOx™ Pulse Oximeter is a small, wrist-worn device indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spotchecking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, subacute and sleep study environments.

The Nonin Model 3100 WristOx has undergone Functional and Safety Testing: both bench and clinical testing in order to demonstrate that it has appropriate functional characteristics and is substantially equivalent to the predicate device.

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Conclusion: The Nonin Model 3100 WristOx is substantially equivalent to the Model 2500 PalmSat Hand Held Pulse Oximeter (K002690), which employs a similar memory function. This conclusion is based on the fact that the subject device is substantially equivalent to the predicate device in terms of principals of operation, function, and indications for use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 17 2003

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

Re: K030668

Trade/Device Name: WristOx Pulse Oximeter, Model 3100 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 29, 2003 Received: July 30, 2003

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 vour 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.

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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 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) 594-4646. 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 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.

Patricia Cucentoffer

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

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Indications For Use

510(k) number Device Name;

K030668 WristOx Model 3100

Indications for Use

Concurrence of CDRH, Office of Device Evaluation

Signature

Wision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KO30668 510(k) Number: _

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).