(32 days)
No
The summary describes a standard pulse oximeter module that measures and transmits data via Bluetooth. There is no mention of AI, ML, or any advanced data processing beyond basic measurement and transmission.
No
The device is described as measuring and transmitting physiological data (SpO2, pulse rate, plethysmographic data), which are diagnostic or monitoring functions, not therapeutic. It does not mention treating, preventing, or curing a condition.
Yes
Explanation: The device is used to measure and transmit physiological data (oxygen saturation and pulse rate) which are used for diagnostic purposes. It is explicitly called a "Patient Oximeter Module", indicating its role in patient monitoring, which is a key aspect of diagnosis.
No
The device description explicitly states it is a "wrist-worn Patient Oximeter Module" and includes hardware components like a Bluetooth radio and batteries, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and transmit physiological data (SpO2, pulse rate, plethysmographic data) from a patient's body. This is a physiological measurement, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is a wrist-worn oximeter module that measures these physiological parameters directly from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or performing tests on biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device measures parameters directly from the patient's body.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DQA
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.
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
Not Found
Intended User / Care Setting
Not Found
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)
Nonin's Model 4100 Patient Oximeter Module has successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN - 7 2005
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | John R. Dalpee |
| Director of Regulatory Affairs | |
| Nonin 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 is |
| substantially equivalent to the Avant® Model 4000 Pulse | |
| Oximetry 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-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. |
| Intended Use: | 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. |
| Functional and
Safety Testing: | Nonin's Model 4100 Patient Oximeter Module has
successfully undergone both bench and clinical testing in
order to demonstrate that it has appropriate functional
features and is substantially equivalent to the predicate
device. |
| Conclusion: | Nonin's Model 4100 Patient Oximeter Module is
substantially equivalent to the Avant® Model 4000 Pulse
Oximetry System manufactured by Nonin Medical, Inc.
and cleared by the FDA under K041156 on 6/09/04. |
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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:
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.
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