(228 days)
Not Found
No
The summary describes a standard pulse oximeter that measures and stores data. There is no mention of AI, ML, or any advanced data processing that would suggest the use of these technologies.
No.
The device is a pulse oximeter used for measuring, displaying, and storing physiological data (SpO2 and pulse rate), not for treating a condition.
Yes
The device measures and displays physiological parameters (SpO2 and pulse rate) which are used for monitoring a patient's health status in various medical settings. These measurements provide information that aids healthcare professionals in assessing and diagnosing conditions, even if the device itself doesn't provide a diagnosis.
No
The device description explicitly states it is a "small, wrist worn pulse oximeter" and uses an "electro-optical sensor," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Nonin Model 3100 WristOx™ Pulse Oximeter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nonin Model 3100 WristOx™ is a pulse oximeter. It measures oxygen saturation and pulse rate noninvasively by placing a sensor on the skin (typically a finger or wrist). It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring and displaying physiological parameters directly from the patient.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
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 and pediatric patients
Intended User / Care Setting
hospitals, medical facilities, ambulatory, subacute and sleep study 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Model 2500 PalmSat® Hand Held Pulse Oximeter (K002690)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 7 2003
Summary and Certification
510 Summary, K030668 A
| Submitter: | Nonin Medical Inc. |
|---|---|
| Contact Person: | John R. Dalpee |
| Director, Regulatory Affairs | |
| Nonin Medical Inc. | |
| 2605 Fernbrook Lane N. | |
| Plymouth, MN 55447-4755 | |
| Date Prepared: | 150October, 2003 |
| Trade Name: | WristOx TM Pulse Oximeter, Model 3100 |
| Classification Name | |
| And 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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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
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
Concurrence of CDRH, Office of Device Evaluation
Signature
Wision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KO30668 510(k) Number: _