MODEL 2500A PALMSAT PULSE OXIMETER

K050056 · Nonin Medical, Inc. · DQA · Jun 21, 2005 · Cardiovascular

Device Facts

• Record ID: K050056
• Device Name: MODEL 2500A PALMSAT PULSE OXIMETER
• Applicant: Nonin Medical, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Handheld digital pulse oximeter; measures functional oxygen saturation (SpO2) and pulse rate via red and infrared light absorption through perfused tissue. Features include patient-specific audible/visual high-priority alarms, equipment-specific medium-priority alarms, user-selectable alarm limits, alarm history recall, and variable pitch pulse beep. Operated by clinicians in clinical settings; provides numerical SpO2 and pulse rate data on LED display. Enhanced signal processing enables monitoring during motion and low perfusion. Benefits include continuous patient monitoring and timely alerts for physiological changes.

Clinical Evidence

Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications. Bench testing was also performed. No specific numerical results (e.g., mean bias, ARMS) are provided in the summary document.

Technological Characteristics

Handheld digital pulse oximeter; utilizes red and infrared light absorption sensing principle. Powered by alkaline batteries or optional NiMH rechargeable battery pack. Features LED display for SpO2, pulse rate, and alarm status. Includes enhanced signal processing for motion and low perfusion. No routine calibration required.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring spot-check or continuous monitoring of functional oxygen saturation (SpO2) and pulse rate, including patients in motion or no-motion conditions and those with good or poor perfusion.

Regulatory Classification

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 2500 PalmSAT® Pulse Oximeter (K001930)
• Model 2500 PalmSAT® Pulse Oximeter with 2500C and 2500B (K002690)

Submission Summary (Full Text)

{0}------------------------------------------------

Kosoosb

JUN 2 1 2005

# Attachment 6

### 510(k) Summary

| Submitter: | Nonin Medical, Inc. | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Lori Roth<br>Clinical/Regulatory Specialist<br>Nonin Medical, Inc.<br>13700 1st Ave North<br>Plymouth, MN 55441-5443 | |
| Date Prepared: | January 7, 2005 | |
| Trade Name: | Model 2500A PalmSAT® Pulse Oximeter | |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.2700 | |
| Product Code: | 74 DQA | |
| Predicate Device(s): | The predicate devices are the Model 2500 PalmSAT®<br>Pulse Oximeter, K001930, cleared on July 22, 2000<br>and the Model 2500 PlamSAT® Pulse Oximeter with<br>2500C and 2500B, K002690, cleared on October 11,<br>2000. | |
| Device Description: | The Model 2500A PalmSAT® with Alarms is a digital<br>handheld pulse oximeter that displays numerical<br>values for functional oxygen saturation of arterial<br>hemoglobin (SpO₂) and pulse rate using one of a<br>range of Nonin compatible oxygen sensors. It<br>features an easy-to-read display that presents patient<br>data and status information. The display features<br>light-emitting diodes (LED) that show the SpO2, pulse<br>rate values, tricolor pulse quality indicator, alarm bar,<br>alarm silence indicator, and low battery indicator.<br><br>New Features<br>• Patient-specific audible and visual high priority<br>alarms.<br>• Equipment-specific audible and visual medium<br>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<br>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 [phone]. 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 [phone] 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)<br>Number<br>(if known) | K050056 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Nonin Medical, Inc. Model 2500A |
| Indications<br>for Use | The Nonin® Model 2500A Pulse Oximeter with Alarms is<br>indicated for use in measuring and displaying functional oxygen<br>saturation of arterial hemoglobin (SpO₂) and pulse rate for adult,<br>pediatric, and neonatal patients. It is intended for spot-checking<br>and / or continuous monitoring of patients during motion and no<br>motion conditions, and for patients who are well or poorly<br>perfused. |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use<br>(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

.

: