(334 days)
Not Found
No
The summary describes a standard pulse oximeter with basic user interface features and alarms, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No
The device is a pulse oximeter, which is a diagnostic device used for monitoring. It does not provide any therapeutic intervention.
Yes
A pulse oximeter measures physiological parameters (SpO2 and pulse rate) to assess a patient's health status, which falls under the definition of a diagnostic device. The "Intended Use" explicitly states "monitoring of functional arterial oxygen saturation (SpO2) and pulse rate," which are diagnostic measurements.
No
The device description explicitly states it is a "handheld, battery powered pulse oximeter" and mentions hardware components like a user interface board, keys, and a display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring functional arterial oxygen saturation (SpO2) and pulse rate. This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device description confirms it's a handheld pulse oximeter used for monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or performing tests on these samples to diagnose a condition or provide information about a physiological state. The device measures light absorption through the finger to determine oxygen saturation.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This pulse oximeter is a non-invasive monitoring device.
N/A
Intended Use / Indications for Use
The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
Product codes (comma separated list FDA assigned to the subject device)
DOA
Device Description
The HS10A is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and functional arterial oxygen saturation in arterial blood. The HS10A include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings. The device also has menu features to allow the user to set the time, date and measurement alarm limits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospitals and clinics.
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
The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult male and female volunteers (with a total of 300 blood samples) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data: The pulse oximeter was subjected to clinical testing. The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult male and female volunteers (with a total of 300 blood samples) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The SpO2 accuracy results include: 1.391% which meets the accuracy requirement of less than or equal to 2% under no motion condition. The accuracy specification is reported as accuracy root mean square (Arms).
Non-clinical Performance Data: The following practices were followed and monitored for development of the Digital blood pressure monitor: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1, ISO 10993-5, ISO 10993-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy results include: 1.391% which meets the accuracy requirement of less than or equal to 2% under no motion condition. The accuracy specification is reported as accuracy root mean square (Arms).
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
March 27, 2018
Image /page/0/Picture/1 description: The image shows the contact information for Hunan Accurate Bio-Medical Technology Co., Ltd. The contact person is Zhou Le, who is the RA Manager. The address is M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development, Changsha, 410208 CN.
Re: K171241
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: February 2, 2018 Received: February 23, 2018
Dear Zhou Le:
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 May 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Pulse Oximeter
Indications for Use (Describe)
The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the logo for Accurate. The logo consists of an orange symbol on the left and the word "accurate" in orange on the right. The symbol on the left is made up of three overlapping triangles, with each triangle having a slightly different shade of orange. The word "accurate" is written in a sans-serif font.
Section 5 510(K) Summary
Prepared Date: 2018/1/31
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
Submitter Information
Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China, Phone number: +86- 731-89745029 Fax number: +86- 731-89745029 Contact person: Zhou Le E-mail: regulation@accbiomed.com
Name of device
Trade name: Pulse Oximeter Models: HS10A Classification name: Oximeter Production requlation: 21CFR 870.2700 Product code: DQA Classification Panel: Cardiovascular Device Classification: Class2
Predicate Device
OxiMaX™ NPB-40 Pulse Oxirneter (K051352, Nelicor Pui-itan Bennett)
Description
The HS10A is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and functional arterial oxygen saturation in arterial blood. The HS10A include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings. The device also has menu features to allow the user to set the time, date and measurement alarm limits.
l ntended use
The pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
Page 1 of 4
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Image /page/4/Picture/1 description: The image features the word "accurate" in a bold, sans-serif font, rendered in a vibrant orange color. To the left of the word, there is a stylized logo consisting of three overlapping triangles, also in varying shades of orange, creating a sense of depth and dimension. The logo and the word "accurate" are positioned horizontally, forming a cohesive brand representation.
Substantially Equivalent
A comparison of key similarities and differences between the subject device (Model HS10A) and the predicate devices (K051352) is provided below.
| Item | HS10A
Subject device | OxiMaXTM NPB-40
Predicate device | Comment |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended use
&indications for
use | The handheld pulse oximeter is
indicated for continuous or spot
check monitoring of functional
arterial oxygen
saturation
(SpO2) and pulse rate of adult
patients in hospitals and clinics. | The OxiMaxTM NPB-40 handheld
pulse oximeter is indicated for
continuous or spot
check monitoring of functional
arterial oxygen
saturation
(SpO2) and pulse rate of adult,
pediatric and neonatal patients in
hospital, hospital type facilities,
transport and mobile
environments as well as in the
home care environment. | Similar |
| Prescriptive | Prescription Use | Prescription Use | Same |
| Measurement
place | Finger | Finger or toes | Similar |
| Operation
Principle | The Pulse Oximeter works by
applying a sensor to a pulsating
arteriolar vascular bed. The
sensor contains a dual light
source and photo detector.
Skin,bone, tissue, and venous
normally absorb a constant
amount of light during systole
and diastole, as blood volume
increases and decreases. The
ratio of light absorbed at systole
and diastole is translated into an
oxygen saturation measurement.
This measurement is referred to
as SpO2. | The NPB-40 uses pulse oximetry
to measure functional oxygen
saturation in the blood. Pulse
oximetry works by applying an
OXIMAX sensor to a pulsating
arteriolar vascular bed, such as a
finger or toe. The OXIMAX sensor
contains a dual light source and a
photo detector. Bone, tissue,
pigmentation, and venous
vessels normally absorb a
constant amount of light over
time. The arteriolar bed normally
pulsates and absorbs variable
mounts of light during the
pulsations. The ratio of light
absorbed is translated into a
measurement of functional
oxygen saturation (SpO2). | Same |
| Display | LCD | LCD | Same |
| Power supply | 31.5 V, AA | 41.5 V, AA | ----- |
| Display range | SPO2:1-100% PR:25-300bpm | SPO2: 1-100%
PR: 20-300bpm | Similar |
| Sp02
measurement
range&
accuracy | 70-100% no less than ±2%(No
motion) | 70-100% no less than ±2%(No
motion)
70-100% no less than
±3%(motion)
70-100% no less than ±2%( Low
Perfusion) | Similar |
| PR
measurement
range&
accuracy | 25-250 bpm no less than ±3
bpm (No motion) | 20-250bpm no less than
+3
bpm(No motion)
on
55-125
bpm
less
than±5bpm(motion)
20-250bpm no less than ±3
bpm(Low perfusion) | Similar |
| Perfusion range | No | 0.03%-20% | Similar |
| Display
Resolution | SP02:1%,PR:1bpm | SP02:1%,PR:1bpm | Same |
| Alarm type | visual alarm and information | visual alarm and information | Same |
| Alarm
limit
range | SPO2 high limit:low limit +1 to
100%
SpO2 low limit:20% to (high
limit-1)
PR high limit: (low limit + 1) to 250
PR low limit: 30 to (high limit-1) | SPO2 high limit:low limit +1 to
100%
SpO2 low limit:20% to (high
limit-1)
PR high limit: (low limit + 1) to 170
PR low limit: 30 to (high limit-1) | Similar |
| Default limit | SPO2: High 100%,Low
90%
PR: High 90 bpm,Low 40bpm | SPO2: High 100%,Low
85%
PR: High 170bpm, Low 40bpm | Similar |
| Memory | No | Yes | Similar |
| Buzzer | Yes | Yes | Same |
| Auto power-off | Yes | Yes | Same |
| Operating
Environment | Temperature: 5℃+40℃+40℃
Humidity : 15% ~ 95% non-
condensing | Temperature: 5℃
15% ~
Humidity :
95% non-
condensing | Same |
| Storage
Environment | Temperature: -20℃+60℃;+60℃;
Humidity :
15% ~ 95%
non-
condensing | Temperature: -20℃
15% ~ 95%
Humidity :
non-
condensing | Same |
| Weight | 300g | 280g | --- |
| Size | 56×124×30 mm | 73X159X35mm | --- |
| Conformance
standard | IEC60601-1
IEC60601-1-2 | IEC60601-1
IEC60601-1-2 | Same |
| ISO10993-5/-10 | ISO10993-5/-10 | | |
| ISO80601-2-61 | ISO80601-2-61 | | |
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Image /page/5/Picture/1 description: The image shows the logo for Accurate. The logo consists of a stylized letter "A" made up of three overlapping triangles in shades of orange, followed by the word "accurate" in orange lowercase letters. The logo is simple and modern, with a focus on the company name.
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Image /page/6/Picture/1 description: The image shows the word "accurate" in orange font. To the left of the word is an orange logo that consists of three overlapping triangles. The triangles are arranged in a way that they appear to be stacked on top of each other. The logo and the word "accurate" are the only elements in the image.
From the comparison form above, the subject device and predicate device have similar intended use, are both prescription use, and have the same Operation Principle, Display screen, Conformance to standard. The subject device claims slightly different patient population & use environment, measurement site and technology parameter. But the subject device met the requirements of IEC60601-1, IEC60601-1-2, ISO80601-2-61and IFU, so these differences between subject device and predicate device do not raise different questions of safety or effectiveness issues since the intended use is a subset of the predicate's intended use.
Non-clinical Performance Data
The following practices were followed and monitored for development of the Digital blood pressure monitor:
- . IEC 60601-1 Electrical Equipment-Part 1: General Requirements for Safety, 2005
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General . Requirements for for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007
- ISO 80601-2-61:2011 Medical electrical equipment -- Part 2-61: . Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-1, Biological evaluation of medical devices-Part 1: . Evaluation and testing, 2009
- . ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: . Tests for irritation and delayed-type hypersensitivity, 2010
Clinical Performance Data
The pulse oximeter was subjected to clinical testing. The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on a total of 12 healthy adult male and female volunteers (with a total of 300 blood samples) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The SpO2 accuracy results include:
- . 1.391% which meets the accuracy requirement of less than or equal to 2% under no motion condition.
The accuracy specification is reported as accuracy root mean square (Arms).
Conclusion
The non-clinical and clinical testing provided in this 510(k) submission demonstrates that the subject device, the Pulse Oximeter, is as safe and as effective, and substantially equivalent to the predicate device.