(222 days)
No
The summary does not mention AI, ML, or any related concepts like training sets, test sets, or complex algorithms beyond standard signal processing for SpO2 and pulse rate.
No.
The device's description explicitly states, "The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment." This indicates it's for measurement and screening, not for therapeutic intervention.
No
The device description explicitly states: "The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment."
No
The device description explicitly states it consists of a "main unit, SpO2 sensor, wristband and charging cable" and describes hardware components like "MCU, power management circuit, SpO2 measurement circuit, display control circuit." This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Oxiband Pulse Oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Oxiband Function: The Oxiband Pulse Oximeter measures physiological parameters directly from the patient's body (SpO2 and pulse rate) using a sensor placed on the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring, displaying, storing, and transmitting SpO2 and pulse rate. This is a direct measurement of physiological function, not an analysis of a biological sample.
- Device Description: The description reinforces that it's a portable health wrist oximeter that measures SpO2 and pulse rate. It doesn't mention any components or processes related to analyzing biological specimens.
Therefore, the Oxiband Pulse Oximeter falls under the category of a non-IVD medical device that measures physiological parameters.
N/A
Intended Use / Indications for Use
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring.
The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment.
The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc.
The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
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
sleep labs, long-term care, hospitals and home use. (Prescription Use)
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)
Non-clinical tests were conducted on the subject pulse oximeter device to verify that the subject device met design specifications was substantially equivalent to the predicates. The test results demonstrated that the subject device complies with electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, battery safety, home used medical devices safety.
The subject device is considered as skin contacting for duration less than 24 hours. The patient contact materials used by the subject device have been tested to compile with the ISO 10993, and is substantially equivalent to the predicates.
The software for this subject device was considered as a "moderate" level of concern, which is the same as the predicates. Software verification and validation testing were conducted and documentation was provided.
The predicate device, our own previously 510(k) cleared Checkme Pro Health Monitor (K150869) is in compliance with clinical testing according to ISO14155: 2011 and ISO 80601-2-61: 2011. In addition, the SpO2 accuracy performance results showed the Checkme Pro Health Monitor with external SpO2 sensor to have an ARMS of 1.88 during steady state conditions over the range of 70%-100%. The results showed that the SpO2 accuracy of Checkme Pro Health Monitor claimed under the range of 70%-100% by the manufacturer is in compliance.
At the same time, the Oxiband Pulse Oximeter and Checkme Pro Health Monitor with external SpO2 sensor shows the equivalence in intended use, sensor design, hardware design, algorithm design and technical specification. The subject and predicate devices are substantially equivalent. The aforementioned information justifies the use of the predicate device Checkme Pro Health Monitor clinical study results for the subject device, Oxiband pulse oximeter. The SpO2 accuracy of the Oxiband pulse oximeter claimed in the range of 70%-100% by the manufacturer is also in compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 measurement accuracy: 70%-100%: ±2% (Arms:1.88)
SpO2 resolution: 1%
Pulse rate measurement range: 30 bpm~250 bpm
Pulse rate accuracy: ±2bpm or ±2% (whichever is greater)
Pulse rate resolution: 1bpm
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.
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
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Shenzhen Viatom Technology Co., Ltd. % Vaibhav Rajal Official Correspondent for Shenzhen Viatom Technology Co., Ltd mdi Consultants, Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021
Re: K191088
Trade/Device Name: Oxiband (Checkme) O2 Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: October 31, 2019 Received: November 1, 2019
Dear Vaibhav Rajal:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191088
Device Name Oxiband (Checkme) O2 Pulse Oximeter
Indications for Use (Describe)
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY
1. Submitter's Identification:
| Applicant: | Establishment Registration Number: 3011200896
Shenzhen Viatom Technology Co., Ltd
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67
Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101
www.viatomtech.com |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Zhou Saixin
General Manager
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67
Xin'an Street, Baoan District, Shenzhen Guangdong, CHINA 518101
Phone: +86 755 86638929
Fax: +86 755 22649904
Email: zhousaixin@viatomtech.com |
| Prepared by: | Mr. Vaibhav Arvind Rajal
Regulatory Consultant
mdi Consultants, Inc.
Direct Tel. 201-887-3180
Phone- 516-482-9001
Fax- 516-482-0186
Email: vaibhav@mdiconsultants.com |
| Date Prepared: | November 25, 2019 |
2. Name of the Device:
Device Common Name: Pulse Oximeter Device Trade Name: Oxiband (Checkme) O2 Pulse Oximeter Model: Oxiband Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA
3. Predicate Device information:
3.1 Primary Predicate Device
510(k) Number: K172366 Trade/ Device Name: Wrist Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter
4
Regulatory Class: II Product Code: DOA Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
3.2 Reference Predicate Device
510(k) Number: K150869 Trade/ Device Name: Checkme Pro Health Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: II Product Code: MWI Manufacturer: Shenzhen Viatom Technology Co., Ltd.
4. Device Description:
The Oxiband (Checkme) O2 Pulse Oximter is a lightweight, portable health wrist oximeter for use in sleep labs, long-term care, hospitals and home use. The device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/ or continuous data collection, and not continuous monitoring.
The data and results provided by this device are for pre-check screening purpose only and cannot be directly used for diagnostic or treatment.
The device consists of main unit, SpO2 sensor, wristband and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc.
The device is powered by an internal battery. The device is not for life supporting or life sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
5. Indications for Use/ Intended Use:
The Oxiband Pulse Oximeter is a wrist pulse oximeter indicated for use in measuring, displaying, storing, and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot-check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.
5
| Characteristics | Subject Device | Primary
Predicate Device | Reference
Predicate
Device | Substantial
Equivalence
or Difference |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of the
device | Oxiband
(Checkme) O2
Pulse Oximeter | Wrist Pulse
Oximeter
MD300W314B4 | Health Monitor
Checkme Pro | Substantially
Equivalent. |
| Manufacturer | Shenzhen
Viatom
Technology
Co., Ltd | Beijing Choice
Electronic
Technology Co.,
Ltd. | Shenzhen
Viatom
Technology
Co., Ltd | Substantially
Equivalent. |
| 510(K) Number | K191088 | K172366 | K150869 | Substantially
Equivalent. |
| Product code | 21 CFR
870.2700, DQA | 21 CFR
870.2700, DQA | 21 CFR
870.2300, MWI
Secondary
product codes:
21 CFR
870.2700, DQA
21 CFR
870.2340, DPS
21 CFR
880.2910, FLL
21 CFR
870.2300, DRT | Substantially
Equivalent. |
| Classification | II | II | II | Substantially
Equivalent. |
| Indication for
Use | The Oxiband
Pulse Oximeter
is a wrist pulse
oximeter
indicated for
use in
measuring,
displaying,
storing and
transmitting
functional
oxygen
saturation of
arterial
hemoglobin
(SpO2) and
pulse rate for
adult patients. It | The Wrist Pulse
Oximeter is a
wrist pulse
oximeter
indicated for use
in measuring,
displaying,
storing and
transmitting
functional
oxygen saturation
of arterial
hemoglobin
(SpO2) and pulse
rate for adult,
adolescent, child
and infant
patients. It is | The Checkme
Pro Health
Monitor is
intended to be
used for
measuring,
displaying,
reviewing and
storing of ECG
(adults only),
oxygen
saturation and
pulse rate
(adults only for
continuous data
collection and
recording,
adults and | Compared
with Primary
Predicate
Device:
Both the
subject device
and the
primary
predicate
device have
same IFU
including
measuring,
displaying,
storing and
transmitting of
pulse oxygen
saturation |
| is intended for | intended for spot- | pediatrics for | (SpO2) and Pulse Rate. | |
| spot-check and/
or continuous
data collection,
and not
continuous
monitoring. It
can be used in
sleep labs, long-
term care,
hospitals and
home use. | check and/ or
data collection,
recording and
transmitting. It
can be used in
sleep labs, long-
term care,
hospitals and
home use. | spot-checking)
and temperature
in the home or
in healthcare
facilities.
This device is
not intended to
substitute for a
hospital
diagnostic ECG
device and not
to be used on
patients with
implanted
cardiac devices,
such as
pacemakers
and/or
implanted
cardio-
defibrillators
(ICDs). | Both the
devices are
wrist pulse
oximeter.
The subject
device is used
for adult
patients
whereas the
predicate
device is used
in a wider
range of
patient
population like
adult,
adolescent,
child and
infant patients
The subject
device is used
for spot-check
or continuous
data collection,
and not
continuous
monitoring
whereas the
primary
predicate
device is
intended for
spot-check
and/ or data
collection. The
primary
predicate
device is also
not used for
continuous
monitoring, so
they are
substantially | |
6.Comparison to the 510(k) Cleared Devices (Predicate Devices):
6
7
| | | different
expression. |
|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Compared
with
Reference
Predicate
Device:
Both the
subject device
and the
reference
predicate
device have
similar
function
including
measuring,
displaying,
storing and
transmitting of
pulse oxygen
saturation
(SpO2) and
Pulse Rate.
The reference
predicate
device is a
Cardiac
Monitor and
has more
function (such
as ECG and
Temperature).
The ECG,
Temperature
and SpO2 are
separate
function in
reference
predicate
device, so the
ECG and
Temperature
functions do
not affect the
SpO2 and |
8
| | | | | Pulse Rate
accuracy, the
differences
will not raise
new questions
of safety and
effectiveness.
The subject
device is used
for spot-check
or continuous
data collection,
and not
continuous
monitoring in
adults whereas
the reference
predicate
device is used
in adults only
for continuous
data collection
and recording,
adults and
pediatrics for
spot-checking .
The reference
predicate
device is also
not used for
continuous
monitoring, the
subject device
is based ob the
reference
predicate
device, so they
are
substantially
equivalent, just
different
expression. | | | Predicate
Device: |
|--------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rx or OTC | Rx | Rx | Rx | Substantially
Equivalent. | | | The subject
device is used
for adult
patients
whereas the
predicate
device is used
in a wider
range of
patient
population like
adult,
adolescent,
child and
infant patients.
The
differences
does not affect
the safety and
effectiveness
of the subject
device. |
| Patient type | Adult | Adult,
Adolescent, Child
and Infant | Adult and
pediatric | Compared
with Primary | | | Compared
with
Reference
Predicate
Device: |
| | | The subject
device is used
for adult
patients
whereas the
reference
predicate
device is used
in a wider
range of
patient types
like adults and
pediatric
patients. tTe
differences
does not affect
the safety and
effectiveness | | | | | |
9
10
| | | | | of the subject
device. | SpO2 display
range | 0%-100% | 70%-100% | 0%-100% | Compared
with Primary
Predicate
Device:
The subject
device has a
wider SpO2
display range
of 0% to 100%
whereas the
predicate
device SpO2
range is 70%
to 100%. The
SpO2 display
range of
subject device
meets the
requirements
of the ISO
80601-2-61
and the FDA
Guidance of
pulse
oximeter-
premarket
notification
issued on
March 4, 2013,
so the
difference does
not affect the
safety and
effectiveness
of the Subject
device. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------------------|----------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design principle | The subject
device design is
based on the
reference
predicate device
(Checkme Pro
Health
Monitor), so
they use the
same design
principle. | The device uses
pulse oximetry
technology to
measure
functional
oxygen saturation
in the blood.
Pulse oximetry
works by
applying a sensor
to a pulsating
arteriolar vascular
bed, such as a
finger. The 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). | The device uses
pulse oximetry
technology to
measure
functional
oxygen
saturation in the
blood. Pulse
oximetry works
by applying a
sensor to a
pulsating
arteriolar
vascular bed,
such as a finger.
The 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). | Substantially
Equivalent. | SpO2
measurement
accuracy | 70%-100%:
±2%
(Arms:1.88)
70%-80%: ±3% | 70%-100%: ±2%;