K Number

Device Name

Handheld Pulse Oximeter, Model SP-20

Manufacturer

Shenzhen Creative Industry Co., Ltd.

Date Cleared

2018-11-13

(424 days)

Product Code

DQA FLL

Regulation Number

870.2700

Intended Use

The Handheld Pulse Oximeter is intended for measuring the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.

Device Description

This SP-20 Handheld Pulse Oximeter is an integrated product with a modular design. It simultaneously measures physiological parameters by integrated modules and corresponding accessories. The measurement results are displayed, stored and transferred by the central processing unit. The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123711, K052693

Reference Devices

K063641, K111463

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological parameter measurement and data display/transfer.

Therapeutic

No.
The device is strictly for measuring and monitoring physiological parameters (pulse rate, functional oxygen saturation, and temperature) and does not provide therapy or treatment.

Diagnostic

Yes

The device is intended for measuring pulse rate, functional oxygen saturation (SpO2), and temperature, which are physiological parameters used to assess a patient's health status, fitting the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "integrated product with a modular design" that "simultaneously measures physiological parameters by integrated modules and corresponding accessories," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 Handheld Pulse Oximeter measures physiological parameters directly from the patient's body (pulse rate, SpO2, and temperature) using non-invasive methods (likely a sensor on the finger or ear). It does not analyze samples taken from the body.

The device's function aligns with a medical device used for monitoring vital signs, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DQA, FLL

Device Description

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

clinical institutions and homes.

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 twelve (12) subjects in the testing were a group of volunteers consisting of 3 women and 9 men. All subjects had no known illnesses, and no subject was anemic. The group was a mixture of ethnic backgrounds, having skin color ranging from light to dark. The ages of the group were from 22 to 38. A total of 24 samples were obtained per subject. Data was recorded by Bickler-Ye Lab and provided for analysis.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical testing was performed to demonstrate substantial equivalence to the predicate device. The twelve (12) subjects in the testing were a group of volunteers consisting of 3 women and 9 men. All subjects had no known illnesses, and no subject was anemic. The group was a mixture of ethnic backgrounds, having skin color ranging from light to dark. The ages of the group were from 22 to 38. A total of 24 samples were obtained per subject. Data was recorded by Bickler-Ye Lab and provided for analysis. Testing validated the submitted device was effective in determining SPO2 and no adverse effects or complications were noted.

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.

K123711, K052693

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.

K063641, K111463

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

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

Shenzhen Creative Industry Co., Ltd. % Charlie Mack Principal Engineer IRC USA 2095 East Lindrick Drive Chandler, Arizona 85249

Re: K172792

Trade/Device Name: Handheld Pulse Oximeter, SP-20 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: September 20, 2018 Received: October 12, 2018

Dear Charlie Mack:

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 mav, 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 avare 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 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Todd D. Courtney -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

Indications for Use

510(k) Number (if known) K172792

Device Name Handheld Pulse Oximeter, SP-20

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date: September 23, 2018

Company and Correspondent submitting:

Name - Shenzhen Creative Industry Co., Ltd. Address – 2/F, Block 3, Nanyou Tian'an Industry Town Shenzhen, China 518054 Tel: +86-755-26431671 Fax: +86-755-26435433 Contact - Mrs. Jia Wang General Manager

US Agent and Correspondent Mr. Charles Mack Principal Engineer IRC USA 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-6254938 Email: charliemack@irc-us.com

Device:

Trade/proprietary name: Handheld Pulse Oximeter, SP-20

Common Name: Pulse Oximeter

Classification Name: Oximeter

1. Predicate Devices:

| Manufacturer | Device | 510(k)
Number |
|----------------------------------------------------------|--------------------------|------------------|
| Shenzhen Creative
Industry Co., Ltd | PATIENT MONITOR, UP-7000 | K123711 |
| Shenzhen Mindray Bio-
Medical Electronics
Co., Ltd | PM-50 PULSE OXIMETER | K052693 |

1. Classifications Names & Citations:
  DQA, SpO2; FLL, Temperature;

Description:

Device Description:

The SP-20 Handheld Pulse links with the compatible 510(k) cleared IR Ear thermometer Device (option). Since the SP-20 receives data from the 510(k) cleared IR Ear thermometer and no data is transmitted to the thermometer, it does not affect the operations or accuracy of the linked IR Ear thermometer Device.

Below is a brief tabular display of the monitor functions and operations.

| | Function | Product
Code | Module 510K Status |
|--------------------------------------|--------------------|-----------------|--------------------------------------------|
| Built-in Function: | | | |
| Built-in | SpO2
Pulse Rate | DQA | Creative SpO2 sensor only (K063641) |
| External Linked Function (Optional): | | | |
| Built-in | TEMP | FLL | Valeo VT-601E IR Ear thermometer (K111463) |

1. Indication for use:
  The Handheld Pulse Oximeter is intended for measuring and recording the pulse rate, functional oxygen saturation (SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active continuous monitoring.
1. Comparison with the predicate device:
  Shenzhen Creative Industry Co., Ltd. believes that the Handheld Pulse Oximeter, SP-20 is substantially equivalent to the Shenzhen Creative Industry Co., Ltd; Patient Monitor, UP-7000 (K123711) and the Shenzhen Mindray Bio-Medical Electronics Co., Ltd; Pm-50 Pulse Oximeter (K052693) Performance Testing:

| Serial

Number/Version	Standard and Description	Scope
IEC 60601-1:
1990+A1+A2+A13	Medical devices Part1: General requirements for safety
and Amendment 1, Amendment 2 and Amendment 13	General
requirements:
Electrical Safety
IEC 60601-1-2:
2014	Medical electrical equipment-
part 1-2: General requirements for basic safety and
essential performance - Collateral standards:
Electromagnetic compatibility -Requirements and tests	General
requirements:
EMC
IEC 60601-1-11:
Ed. 2.0, 2015	Medical electrical equipment-part 1-11: general
requirements for basic safety and essential
performance -collateral standard: Requirement for
medical electrical equipment and medical electrical
systems used in home healthcare environment	General
requirements:
Electrical Safety
ISO80601-2-
61_SpO2	Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential
performance of pulse oximeter equipment	General
requirements:
Alarm system
IEC/TR60878:
2003	Graphical symbols for electrical equipment in medical
practice	General
requirements:
Graphical symbols
ISO 10993-1:2009	Biological evaluation of medical devices--Part 1:
Evaluation and testing	Biological
evaluation
ISO 10993-5:2009	Biological Evaluation of Medical Devices - Part 5 Tests
for In Vitro Cytotoxicity.	General
requirements:
Biological
Estimation
ISO 10993-
10:2010	Biological Evaluation of Medical Devices - Part 10:
Tests for Irritation and Delayed-Type Hypersensitivity	General
requirements:
Biological
Estimation

All of the test results noted in the table above complied with the standard's requirements.

Comparison of technological characteristics:

Characteristics	Submitted Device	Predicate Device	Discussion for the difference
Name and model	Handheld Pulse Oximeter
SP-20	Patient Monitor
UP-7000
Manufacturer	Shenzhen Creative Industry
Co., LTD.	Shenzhen Creative Industry
Co., LTD.
FDA Classification	SpO2: CFR870.2700, DQA
TEMP: CFR880.2910, FLL
(Optional function-
K111463)	SpO2: CFR870.2700, DQA
TEMP: CFR880.2910, FLL
ECG: CFR870.2300, MWI
NIBP: CFR870.1130, DXN
CO2: CFR868.1400, CCK
Physical
dimension(mm)
/weight(kg)	158 mm (L) × 73 mm (W) ×
25 mm (H)
/ 230g (including battery)	300 (L) x150 (W) x290 (H)
/ 5.2kg (including battery)	The SP-20 is handheld
device, and is smaller
compared to the Predicate
Device (UP-7000). The SP-20
device meets the mechanical
test requirements defined in
IEC60601-1, IEC60601-1-11
and ISO80601-2-61.
Display	3.5" color TFT LCD	12.1" Color TFT	N/A
Type, Degree of
protection against
electric shock	Class II with an internal
electric power supply;
Type BF applied parts.	Class I with an internal
electric power supply.
Where the integrity of the
external protective
earth(ground) in the
installation or its conductors
is in doubt, the equipment
shall be operated from its
internal electric power
supply(batteries)
CO2: BF (defibrillation proof)
SpO2/ NIBP/ TEMP/ ECG/
RESP: CF (defibrillation
proof)	The SP-20 device is powered
by an external adapter and
battery, which is Class II with
internal electric power supply
device according to
IEC60601-1, and applied
parts of the SP-20 device are
type BF according to
IEC60601-1.
Power supply	Battery or AC	Battery or AC	Identical
Power source	Power adapter: input: 100-
240VAC, 50/60Hz; output:
5VDC/1A
Internal power supply:
2000mAh lithium battery	(100-240) VAC 50/60Hz
100VA;
Rechargeable sealed lead-
acid battery, 12V 2.3AH	According to product design
request, the SP-20 device is
powered by an external
adapter and lithium battery,
which meet IEC60601-1 and
IEC60601-1-2 requirements.
Low battery
indicator	Yes	Yes	Identical
Characteristics	Submitted Device	Predicate Device	Discussion for the
difference
Storage data	Yes	Yes	Identical
Flammable
anesthetics	No	No	Identical
Operating
environment	Operating Temperature:
5°C~40°C
Operating Humidity:
15%~93%, non-condensing
Atmospheric pressure:
70kPa~106kPa	Operating Temperature:
5°C~40°C
Humidity: 30%~80%, non-
condensing
Atmospheric pressure:
70kPa~106kPa	The environmental operating
conditions of the SP-20 device
meets IEC60601-1 and
IEC60601-1-11 requirements.
Storage condition	Ambient temperature : -
20°C~60°C
Relative humidity: 10%~95%,
non-condensing
Atmospheric pressure:
50kPa~107.4kPa	Temperature: -20°C~60°C
Humidity: 10% ~95%, non-
condensing
Atmosphere: 53k ~106kPa	The environmental storage
conditions of the SP-20 device
meets IEC60601-1 and
IEC60601-1-11 requirements.
Optional printer	N/A	Available	N/A
Oximetry
technique	Creative SpO2 module with
the same principle as PC-
60(K063641) Creative SpO2
sensor only
KM-SPO-01 SpO2 module
with KS-C01
KM-SPO-01 SpO2 module
with KS-YW02	Creative SpO2 module with
the same principle as PC-
60(K063641) Creative SpO2
sensor only
KM-SPO-01 SpO2 module
with KS-C01	Identical
Measuring mode	Spot-check and Continuous
recording.	Continuous monitoring	The SP-20 device is intended
for spot checking and
continuous recording of SpO2
measurement data, but is not
intended for continuous
monitoring, and meets
ISO80601-2-61 requirements.
Applied part	Detachable SpO2 probe/
Dual-wavelength LED sensor	Detachable SpO2 probe/
Dual-wavelength LED sensor	Identical

Indications for Use differences:

Basic Function:

Both devices have the same functions, which includes Pulse Rate, SpO2, TEMP. Both devices also record data. The predicate has more functions, such as ECG, heart rate, CO2 concentration, and respiration rate. Both the submitted device and predicate comply with the same performance testing standards for the common functions.

Both are Prescription Use.

TEMP:

For the submitted TEMP is optional, but the predicate device's TEMP is a । built-in function
Both devices are for same target population (adult and pediatric) -
-The subject device uses an IR thermometer cleared under K111463 (VT-60E IR thermometer), while the predicate Device uses the electronic thermometer cleared under K982140. Both use FDA cleared temperature measuring devices.
The subject' device has a minor modification for the VT-60E IR thermometer(K111463). The modified VT-601E IR thermometer together with the SP-20 host device passed the applicable performance standards test including IEC60601-1, IEC60601-1-2 and performance test. The modification does not raise different questions of safety and/or effectiveness of VT-601E IR thermometer.

Where Used:

The predict device is applicable for use in hospitals and clinical institutions, while the subject device can also be used at home. Both devices comply with IEC60601-1-11, verifying device performance.

The above differences in the IFU don't result in a new intended use. The subject device complies with the same applicable standards requirement as the predicate device, and it is substantially equivalent to the predicate device.

8. Testing Summary:

Safety and EMC

To verify performance of the SP-20, the following tests were performed:

IEC 60601-1: 2005+A1: 2012 Medical electrical equipment - Part 1: General । requirements for basic safety and essential performance

IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic i

safety and essential performance - Collateral standards: electromagnetic compatibility – Test and requirements

IEC 60601-1-11 Edition 2.0 2015-01, medical electrical equipment - part 1-11: । General requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

The test results from these tests demonstrate the device complies with the requirements.

Performance Data:

For the subject device, SP-20, the following verification tests were performed:

ISO 80601-2-61: 2011 First edition 2011-04-01 Medical electrical equipment i Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Cleaning and Disinfection Validation ।

The device uses 510(k) cleared SpO2 modules with minor modifications and optional TEMP modules. Performance of the SpO2 and TEMP in the performance test report includes normal operating states, appearance, structure, basic performance (SpO2, PR, TEMP) and System Performance. The test results demonstrate compliance with the standards.

Biocompatibility

The subject devices. Handheld Pulse Oximeter, SP-20 is using the similar material as the previously cleared predicate device.

According to the ISO 10993-1: 2009 Annex 1 Biological evaluation tests, the subject device is classified: Surface Device - Contact Skin - Contact Duration≤24H

Tests were conducted for cytotoxicity, skin irritation and sensitization test according to the standards noted below:

ISO 10993-5: 2009 Biological evaluation of medical devices – Part 5 Tests for । In Vitro Cytotoxicity

। ISO 10993-10: 2010 Biological evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity

The test results demonstrate compliance with the requirements of the standards.

Shelf Life:

The Handheld Pulse Oximeter, SP-20 is not subject to the shelf life, as the device doesn't contain any sterile or degradable components.

9. Clinical:

Testing validated the submitted device was effective in determining SPO2 and no adverse effects or complications were noted.

10. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shenzhen Creative Industry Co., Ltd. concludes that the Handheld Pulse Oximeter, SP-20 is substantially equivalent to predicate devices as described herein.