The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities. The specific medical indications for the use of this device is : - This device is a prescription device - . This device is re-useable and is intended for spot or continuous measurement - 트 This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal. - This device is intended to indicate an alarm if the measured saturation or 트 heart rate are outside user-set alarm limits.

Device Description

The Smartsigns Minipulse MP1 is a hand held, battery powered pulse oximeter used for monitoring pulse rate and saturated oxygen in arterial blood. It is also available as a rechargeable unit (MP1R). The MP1R is supplied with four rechargeable batteries, a Deskstand charger unit and power supply. The MP1R is recharged by docking it on the Deskstand charger unit. The Smartsigns MP1 and MP1R provide audible alarms, a membrane keypad and LED displays to display digital values of heart rate and saturation. Pulse amplitude is displayed by means of a bargraph LED array. The keypad allows the unit to be switched ON and OFF, it also allows the user to set alarm limits for saturation and heart rate.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Huntleigh Healthcare Ltd Smartsigns Minipulse MP1-MP1R, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Safety & Environmental	Compliance with standards	Compliant with IEC 60601-1: 1988, UL 60601-1: 2006, EN 60601-1-2: 2001
SpO2 Accuracy	Within specification	Results obtained within specification following a desaturation trial.
Pulse Rate Accuracy	Within specification	Verified with in-house testing and comparison to predicate device.
Electromagnetic Compatibility (EMC)	Compliant with standards	Completed; results demonstrate compliance.
Electrical Safety	Compliant with standards	Completed; results demonstrate compliance.
Mechanical Durability	Compliant with standards	Completed; results demonstrate compliance.
Temperature/Humidity	Compliant with standards	Completed; results demonstrate compliance.

Note: The document doesn't explicitly state quantitative acceptance criteria for SpO2 and pulse rate accuracy (e.g., "within +/- 2% for SpO2"). It broadly states "within specification" and "verified".

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the desaturation trial. "In-house testing" is mentioned, likely referring to further tests, but no sample size is given.
Data Provenance: The desaturation trial was "conducted by the oximeter OEM." No specific country of origin is mentioned, but the manufacturer is based in the United Kingdom. It is implied to be a prospective study, as it was conducted for the purpose of testing this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The desaturation trial is mentioned, which typically involves comparing the device's readings to laboratory co-oximeter reference values, but no details about human experts or their qualifications for establishing ground truth are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The study focused on the device's technical performance and equivalence to a predicate device, not on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done. The entire study described assesses the performance of the Smartsigns Minipulse MP1 and MP1R device itself (which includes its internal algorithms and hardware) without direct human intervention in the measurement process for the SpO2 and pulse rate. The device is a diagnostic tool, and its accuracy is evaluated on its own.

7. The Type of Ground Truth Used

For SpO2 accuracy, the ground truth for the desaturation trial would typically be laboratory co-oximetry measurements, which are considered the gold standard for arterial oxygen saturation. While not explicitly stated, this is the standard method for such trials.
For pulse rate accuracy, the ground truth would likely be an ECG reference or a precise heart rate monitor.
The document also mentions "comparison to the legally marketed predicate device BCI 3303," implying the predicate device's readings served as a comparative reference.

8. The Sample Size for the Training Set

This information is not applicable as the document describes a hardware medical device with embedded algorithms, not a machine learning model that requires a discrete training set. The "oximeter OEM" would have developed and validated the underlying oximetry technology, but details of their internal development or validation datasets are not provided.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Huntleigh Healthcare Ltd

K08

Smartsigns Minipulse MP1-MP1R

510(k) Summary

OCT 01 2008

1. Applicant Information Submitter:

Address:

Huntleigh Healthcare Limited Diagnostic Products Division Unit 35, Portmanmoor Road Cardiff United Kingdom CF24 5HN

(44) 29 20485885 (44) 29 20492520 Robert McCarthy

May 30th, 2008

Prepared:

Contact:

Telephone:

Fax:

2. Device Information

Propriety Name:

Smartsigns Minipulse MP1 and MP1R

Common/Classification Name:

Pulse Oximeter

3. Identification of legally marketed device to which submitter claims equivalence

Predicate Device:

BCI Smiths Medical 3303 Hand Held pulse Oximeter (510(k) No' K945754)

4. New Device Description

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5. Statement of Intended Use

The Smartsigns Minipulse MP1 and MP1R handheld pulse oximeter is intended for non-invasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. It is intended for use on adult and pediatric patients in hospitals and hospital-type facilities. This device is for prescription use only.

The Smartsigns Minipulse MP1 and MP1R share the same intended use and indications for use as the above referenced predicate device.

6. Summary of Technological Characteristics

The pulse oximetry function is determined by passing two wavelengths of light, one red and one infrared through body tissue to a photodetector. Oxygen saturation calculation is performed on the basis that oxygen rich blood absorbs less red light than oxygen depleted blood. The oximeter function is provided through an OEM oximeter board which uses the same technology found in the legally marketed BCI 3303 pulse oximeter.

7. Brief discussion of the clinical and non-clinical tests

Safety and environmental testing was conducted in accordance with IEC 60601-1: 1988, UL 60601-1: 2006 and EN 60601-1-2: 2001. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient) and temperature/humidity testing have been completed. The results demonstrate that the Smartsigns MP1 and MP1R pulse oximeter is in compliance with the guidelines and standards referenced and that it performs within its specifications and functional requirements.

For oximetry testing a desaturation trial was conducted by the oximeter OEM. The results obtained were within specification. The accuracy of SpO2 and pulse rate have also been verified with in-house testing and comparison to the legally marketed predicate device BCI 3303.

8. Conclusions

Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed device.

This summary on 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, with three lines representing the eagle's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 01 2008

Mr. Robert McCarthy Design Manager Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff, South Glamorgan UNITED KINGDOM CF24 5HN

Re: K081572

Trade/Device Name: Smartsigns Minipulse MP1 and MP1R Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: September 19, 2008 Received: September 22, 2008

Dear Mr. McCarthy:

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 Mav 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.

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Page 2 - Mr. McCarthy

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

H. Rommels Lend mg fory

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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Smartsigns Minipulse MP1-MP1R

Indications for Use

510(k) Number (if known):

Device Name: Smartsigns Minipulse MP1 and MP1R

Indications for Use:

The Smartsigns MP1 and MP1R handheld pulse oximeter is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

It is intended for use by healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities.

The specific medical indications for the use of this device is :

This device is a prescription device
. This device is re-useable and is intended for spot or continuous measurement
트 This device is intended to display oxygen saturation, heart rate and pulse strength or pulsatile signal.
This device is intended to indicate an alarm if the measured saturation or 트 heart rate are outside user-set alarm limits.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

LmaA im,D

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

Premarket Notification (510(k))

May 2008

Regulation Number and Section

§ 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).