(161 days)
Not Found
No
The description focuses on standard pulse oximetry technology, signal processing, and alarm features, with no mention of AI or ML.
No.
The device is a pulse oximeter used for measuring and displaying physiological parameters (SpO2 and pulse rate), not for treating a disease or condition. While the data it provides can be used to inform therapeutic decisions, the device itself is for monitoring, not therapy.
Yes
The device measures and displays functional oxygen saturation and pulse rate, which are used to assess a patient's physiological state and identify potential issues, thereby aiding in diagnosis.
No
The device description clearly outlines a physical handheld pulse oximeter with hardware components like a display (LEDs), battery operation, and sensors for measuring light absorption. It is not solely software.
Based on the provided information, the Nonin® Model 2500A Pulse Oximeter with Alarms is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The Model 2500A Pulse Oximeter measures oxygen saturation and pulse rate by shining light through perfused tissue on the body (typically a finger, toe, or earlobe). This is an in vivo measurement.
- The description clearly states it measures "functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate" by "measuring the absorption of red and infrared light passing through perfused tissue." This is a non-invasive, external measurement.
Therefore, the Model 2500A Pulse Oximeter is a medical device, but it falls under a different classification than IVD devices.
N/A
Intended Use / Indications for Use
The Nonin® Model 2500A Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate for adult, pediatric, and neonatal patients. It is intended for spot-checking and / or continuous monitoring of patients during motion and no motion conditions, and for patients who are well or poorly perfused.
Product codes
74 DQA, DQA
Device Description
The Model 2500A PalmSAT® with Alarms is a digital handheld pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate using one of a range of Nonin compatible oxygen sensors. It features an easy-to-read display that presents patient data and status information. The display features light-emitting diodes (LED) that show the SpO2, pulse rate values, tricolor pulse quality indicator, alarm bar, alarm silence indicator, and low battery indicator.
New Features
• Patient-specific audible and visual high priority alarms.
• Equipment-specific audible and visual medium priority alarms.
User selectable high and low alarm limits for SpO2 and pulse rate. The ability to review and recall previous alarm limits and volumes. Variable pitch audible pulse beep indicator with an adjustable volume Visual and audible (adjustable volume) alarms. An alarm silence feature: silences audible alarms for the first 2 minutes of normal operation and on-demand. Enhanced signal processing
The Model 2500A will typically operate for 60 hours continuously between alkaline battery replacements, or for 40 hours with the Model 2500B Rechargeable NiMH (Nickel Metal Hydride) Battery Pack (optional). The 2500A requires no routine calibration or maintenance other than replacement of the alkaline batteries or recharging the optional battery pack.
The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.
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, pediatric, and neonatal patients
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 2500A Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
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
Kosoosb
JUN 2 1 2005
Attachment 6
510(k) Summary
| Submitter: | Nonin Medical, Inc. | |
|---|---|---|
| Contact Person: | Lori Roth | |
| Clinical/Regulatory Specialist | ||
| Nonin Medical, Inc. | ||
| 13700 1st Ave North | ||
| Plymouth, MN 55441-5443 | ||
| Date Prepared: | January 7, 2005 | |
| Trade Name: | Model 2500A PalmSAT® Pulse Oximeter | |
| Classification Name: | ||
| and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | 74 DQA | |
| Predicate Device(s): | The predicate devices are the Model 2500 PalmSAT® | |
| Pulse Oximeter, K001930, cleared on July 22, 2000 | ||
| and the Model 2500 PlamSAT® Pulse Oximeter with | ||
| 2500C and 2500B, K002690, cleared on October 11, |
-
| |
| Device Description: | The Model 2500A PalmSAT® with Alarms is a digital
handheld pulse oximeter that displays numerical
values for functional oxygen saturation of arterial
hemoglobin (SpO₂) and pulse rate using one of a
range of Nonin compatible oxygen sensors. It
features an easy-to-read display that presents patient
data and status information. The display features
light-emitting diodes (LED) that show the SpO2, pulse
rate values, tricolor pulse quality indicator, alarm bar,
alarm silence indicator, and low battery indicator.
New Features
• Patient-specific audible and visual high priority
alarms.
• Equipment-specific audible and visual medium
priority alarms. | |
| User selectable high and low alarm limits for SpO2 and pulse rate. The ability to review and recall previous alarm limits and volumes. Variable pitch audible pulse beep indicator with an adjustable volume Visual and audible (adjustable volume) alarms. An alarm silence feature: silences audible alarms for the first 2 minutes of normal operation and on-demand. Enhanced signal processing | | |
| The Model 2500A will typically operate for 60 hours continuously between alkaline battery replacements, or for 40 hours with the Model 2500B Rechargeable NiMH (Nickel Metal Hydride) Battery Pack (optional). The 2500A requires no routine calibration or maintenance other than replacement of the alkaline batteries or recharging the optional battery pack. | | |
| The pulse oximeter determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. | | |
| Indications for Use: | The Nonin® Model 2500A Pulse Oximeter with Alarms is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. It is intended for spot-checking and / or continuous monitoring of patients during motion and no motion conditions, and for patients who are well or poorly perfused. | |
| Functional and
Safety Testing: | Nonin's 2500A Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm | |
:
1
Confidential
conformance to accuracy and precision specifications.
2
Conclusion:
Nonin's Model 2500A Pulse Oximeter is substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of accuracy, functional nesults do not raise new operation: '. ' safety and effectiveness when compare to the legally marketed devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and four human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.
Public Health Service
JUN 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori Roth Clinical/Regulatory Specialist Nonin Medical, Incorporated 13700 1st Avenue North Plymouth, Minnesota 55441-5443
Re: K050056
K050030
Trade/Device Name: Model 2500A Palmsat Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 27, 2005 Received: May 31, 2005
Dear Ms. Roth:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaled by (2) the device is substantially equivalent (for the referenced above and have determined the actived in the enclicate devices marketed in indications for use stated in the cherosal 7, to engactment date of the Medical Device interstate collinitietee proc to thay 20, 1978, car casified in accordance with the provisions of Amendinents, on to devices mat nave obot (Act) that do not require approval of a premarket the rederal Pood, Drug, und Ocomonov, therefore, market the device, subject to the general approval apprication (1 Mill). I reason controls provisions of the Act include controls provisions of the rica. "Insting 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 II your device is classified (500 additional controls. Existing major regulations affecting (FMA), it may of subject to back adam adem f Federal Regulations, Title 21, Parts 800 to 898. In your device can oc round in the Seas nouncements concerning your device in the Federal Register.
4
Page 2 - Ms. Roth
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a saosaans. Systems with other requirements
mean that FDA has made a determination that your device the stars in annual mean that FDA has made a decommance and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seciential of the Act or any rederal statutes and regulations, but not limited to: registration in the studies You must comply with an the Act 3 requirements interest and listing (21 CFR I all 807), laooling (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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 5 10(k) I his letter will anow you to ocgin manceans your alence of your device to an premarket notification. The PDA miding of successions of the more of the may of the your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), a If you desire specific advice for your de res at (240) 276-0120. Also, please note the regulation please contact the Office of Comphanes are (210) - 11 CFR Part 807,97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 807, 100 entitled, "Misoranumig by reference to premation on your responsibilities under the act its tall f may obtain offer general miormation on Job 2 and Consumer Assistance at its toll-free Division of Bina8-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, 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
Enclosure
5
Attachment 2
Indications for Use Statement
| 510(k)
Number
| (if known) | K050056 |
|---|---|
| Device Name | Nonin Medical, Inc. Model 2500A |
| Indications | |
| for Use | The Nonin® Model 2500A Pulse Oximeter with Alarms is |
| indicated for use in measuring and displaying functional oxygen | |
| saturation of arterial hemoglobin (SpO₂) and pulse rate for adult, | |
| pediatric, and neonatal patients. It is intended for spot-checking | |
| and / or continuous monitoring of patients during motion and no | |
| motion conditions, and for patients who are well or poorly | |
| perfused. | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Anesthesiology, General HospitalDivision of anestnestology, General Hospital, Infection Control, Dental Devic
510(k) Number: Kosm56
.
: