(161 days)
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.
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.
This K050056 510(k) submission for the Nonin Model 2500A PalmSAT® Pulse Oximeter details the device's accuracy and performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but does not explicitly state specific numerical acceptance criteria or detail the reported device performance against those criteria. It generally concludes that the device is "substantially equivalent to the predicate devices in terms of accuracy."
However, based on typical pulse oximeter accuracy standards and the context of a 510(k) submission for a Class II device, common acceptance criteria would likely be related to the root mean square deviation (ARMS) of oxygen saturation measurements compared to a co-oximeter, across a specified saturation range. Without further details in the provided text, a precise table cannot be constructed.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for the Test Set: Not explicitly stated in the provided document. The document only mentions "Human oxygenation evaluations were conducted."
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but clinical trials involving human deoxygenation are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not explicitly stated in the provided document.
4. Adjudication Method for the Test Set:
Not explicitly stated in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:
This device is a pulse oximeter, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned in the document.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document refers to "human oxygenation evaluations" to confirm accuracy. For pulse oximeters, the "standalone" performance refers to the device's ability to accurately measure SpO2 and pulse rate without human interpretation of the algorithm's direct output (other than reading the displayed values). The accuracy studies for pulse oximeters intrinsically assess this standalone performance against a "gold standard" reference. Therefore, a standalone performance assessment was effectively conducted.
7. Type of Ground Truth Used:
The ground truth for pulse oximeter accuracy studies is typically established by co-oximetry measurements of arterial blood samples. While not explicitly stated as "co-oximetry" in the provided text, the phrase "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications" strongly implies this method, as it is the gold standard for SpO2 accuracy assessment.
8. Sample Size for the Training Set:
This device does not appear to utilize machine learning or AI in a way that requires a distinct "training set" in the conventional sense for a diagnostic algorithm. The pulse oximeter's algorithms are based on established biophysical principles of light absorption by oxyhemoglobin and deoxyhemoglobin. Therefore, a specific "training set" for an AI model is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI algorithm, this question is not applicable. The underlying scientific principles for pulse oximetry are well-established.
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Kosoosb
JUN 2 1 2005
Attachment 6
510(k) Summary
| Submitter: | Nonin Medical, Inc. | |
|---|---|---|
| Contact Person: | Lori RothClinical/Regulatory SpecialistNonin Medical, Inc.13700 1st Ave NorthPlymouth, 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, 2000and the Model 2500 PlamSAT® Pulse Oximeter with2500C and 2500B, K002690, cleared on October 11,2000. | |
| Device Description: | The Model 2500A PalmSAT® with Alarms is a digitalhandheld pulse oximeter that displays numericalvalues for functional oxygen saturation of arterialhemoglobin (SpO₂) and pulse rate using one of arange of Nonin compatible oxygen sensors. Itfeatures an easy-to-read display that presents patientdata and status information. The display featureslight-emitting diodes (LED) that show the SpO2, pulserate values, tricolor pulse quality indicator, alarm bar,alarm silence indicator, and low battery indicator.New Features• Patient-specific audible and visual high priorityalarms.• Equipment-specific audible and visual mediumpriority 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 andSafety 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 |
:
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Confidential
conformance to accuracy and precision specifications.
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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.
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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.
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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
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Attachment 2
Indications for Use Statement
| 510(k)Number(if known) | K050056 |
|---|---|
| Device Name | Nonin Medical, Inc. Model 2500A |
| Indicationsfor Use | The Nonin® Model 2500A Pulse Oximeter with Alarms isindicated for use in measuring and displaying functional oxygensaturation of arterial hemoglobin (SpO₂) and pulse rate for adult,pediatric, and neonatal patients. It is intended for spot-checkingand / or continuous monitoring of patients during motion and nomotion conditions, and for patients who are well or poorlyperfused. |
| 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
.
:
§ 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).