← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K052829 # WRISTOX MODEL 3100 PULSE OXIMETER (K052829) _Nonin Medical, Inc. · DQA · Nov 10, 2005 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K052829 ## Device Facts - **Applicant:** Nonin Medical, Inc. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Nov 10, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric ## Indications for Use 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 of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients during both no motion and motion conditions, and for patients who are well or poorly perfused. ## Device Story Wrist-worn pulse oximeter; utilizes electro-optical sensor to measure light absorption of functional arterial hemoglobin. Provides continuous data collection/recording or spot-check measurements of SpO2 and pulse rate. Operates automatically upon finger sensor placement; powers off upon removal. Compatible with 8000AA-WO articulated finger clip or 8000J-WO flex sensors. Stores up to 33 hours of data; integrates with nVision® data management software for analysis. Used in clinical or home settings; operated by clinicians or patients. Output allows healthcare providers to monitor patient oxygenation status and pulse rate, facilitating clinical decision-making regarding respiratory or cardiovascular health. ## Clinical Evidence Bench and clinical testing performed to demonstrate functional characteristics and substantial equivalence to the predicate device. No specific performance metrics (e.g., sensitivity, specificity) provided in the summary. ## Technological Characteristics Wrist-worn pulse oximeter; electro-optical sensing principle. Compatible with articulated finger clip or flex sensors. Memory capacity for 33 hours of data. Connectivity via nVision® data management software. Software-based data storage and processing. ## Regulatory 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. ## Predicate Devices - Model 3100 WristOx® ([K030668](/device/K030668.md)) ## Reference Devices - nVision® data management software ([K033307](/device/K033307.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ NOV 1 0 2005 NOV 16 2005 510(k) Summary K052829 | Submitter: | Nonin Medical, Inc. | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Lori Roth
Clinical/Regulatory Specialist
Nonin Medical, Inc.
13700 1st Ave. North
Plymouth, MN 55441-5443 | | Date Prepared: | October 3, 2005 | | Trade Name: | Model 3100 WristOx® Pulse Oximeter | | Classification Name:
and Number: | Class II, 21 CFR 870.2700 | | Product Code: | 74 DQA | | Predicate Device(s): | Model 3100 WristOx® is substantially equivalent to
the Model 3100 WristOx® (K030668), which is also
manufactured by Nonin Medical. | | Device Description: | The Nonin Model 3100 WristOx® is a small wrist-
worn pulse oximeter. It has an electro-optical sensor
that determines the light absorption of functional
arterial hemoglobin. It is used to spot check patients,
or it can be used to provide continuous data collection
and recording of patients in situations where alarms
are not required. The device turns on automatically
when the sensor is placed on the finger and turns off
when the finger is removed. It may be used with
Nonin's 8000AA-WO articulated finger clip sensor or
the 8000J-WO flex sensor. The WristOx is also
memory capable in conjunction with nVision® data
management software (K033307). It is capable of
storing up to 33 hours of SpO2 and pulse rate data. | | Intended Use: | 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 of adult and pediatric patients. It is intended for
spot-checking and / or data collection and recording | | | of patients during both no motion and motion
conditions, and for patients who are well or poorly
perfused. | | Functional and
Safety Testing: | Nonin's Model 3100 WristOx® 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: | Nonin's Model 3100 WristOx® Pulse Oximeter is
identical in everyway to the predicate device not with
standing the changes specified in the labeling. | | | This conclusion is based upon the fact that the Model
3100 WristOx® Pulse Oximeter is substantially
equivalent to the predicate device in terms of
functional design and principles of operation. | {1}------------------------------------------------ ・ . {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 features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with three parallel lines extending from its head, resembling feathers or wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 0 2005 Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 154 Avenue North Plymouth, Minnesota 55441-5443 Re: K052829 Trade/Device Name: Model 3100 WristOx® Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: October 1, 2005 Received: October 13, 2005 Dear Ms. Roth: 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 - Ms. Roth 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 (240) 276-0120. 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/industry/support/index.html. Sincerely yours, Chiu-Lin Liu, 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 {4}------------------------------------------------ ## Indications for Use Statement | 510(k)
Number
(if known) | | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Nonin Medical, Inc. Model 3100 WristOx® Pulse Oximeter | | Indications
for Use | 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 of adult and pediatric patients. It is
intended for spot-checking and / or data collection and recording
of patients during both no motion and motion conditions, and for
patients who are well or poorly perfused. | Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) Quir, Siliom on San-Qif) of Anesthesiology, General Hospital, otion Control, Dental Devices Number: K552 829 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K052829](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K052829) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com