(119 days)
Not Found
No
The summary describes a standard pulse oximeter with basic functions like displaying values, setting alarms, and using a bargraph. There is no mention of AI, ML, or any advanced data processing that would suggest the use of such technologies.
No.
The device is a diagnostic and monitoring tool, not a therapeutic one. It measures physiological parameters (SpO2 and pulse rate) and alerts users to out-of-range values, which assists in patient assessment but does not provide treatment.
Yes
The device is intended for noninvasive continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate, displaying oxygen saturation, heart rate, and pulse strength, and indicating alarms if measurements are outside user-set limits. These functions are used to assess a patient's physiological state, which is a key characteristic of a diagnostic device.
No
The device description explicitly details hardware components such as a handheld unit, battery, keypad, LED displays, and a charger unit. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Smartsigns MP1 and MP1R are described as pulse oximeters. They measure functional arterial oxygen saturation (SpO2) and pulse rate noninvasively by placing a sensor on the patient's body (typically a finger). This is a direct measurement of physiological parameters, not an analysis of a sample taken from the body.
- Intended Use: The intended use clearly states "noninvasive continuous or spot check monitoring".
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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 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
- 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 heart rate are outside user-set alarm limits.
Product codes (comma separated list FDA assigned to the subject device)
DOA
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.
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 and pediatric patients
Intended User / Care Setting
healthcare professionals for monitoring adult and pediatric patients in hospitals and hospital-type facilities.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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.
1
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.
2
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.
3
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
4
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