(424 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the Shenzhen Creative Industry Co., Ltd. Handheld Pulse Oximeter, SP-20 based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices and adherence to various safety and performance standards rather than explicitly stating numerical acceptance criteria for SpO2 and Pulse Rate accuracy with corresponding numerical performance results. However, it does state compliance with the general requirements of the standards.
Based on the information, the primary performance standard for the pulse oximeter function is:
| Acceptance Criteria (Standard & Description) | Reported Device Performance |
|---|---|
| IEC 60601-1:1990+A1+A2+A13: Medical devices Part1: General requirements for safety | Complied with standard's 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 | Complied with standard's 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 | Complied with standard's requirements (Home Healthcare Electrical Safety) |
| ISO80601-2-61_SpO2: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Complied with standard's requirements (General requirements: Alarm system and SpO2/PR performance) |
| IEC/TR60878:2003: Graphical symbols for electrical equipment in medical practice | Complied with standard's requirements (Graphical symbols) |
| ISO 10993-1:2009: Biological evaluation of medical devices--Part 1: Evaluation and testing | Complied with standard's requirements (Biological evaluation) |
| ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5 Tests for In Vitro Cytotoxicity | Complied with standard's requirements (Biological Estimation) |
| ISO 10993-10:2010: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity | Complied with standard's requirements (Biological Estimation) |
| Cleaning and Disinfection Validation | Complied with standards (details not given on specific criteria) |
| Performance of SpO2 and TEMP through 510(k) cleared modules (normal operating states, appearance, structure, basic performance, system performance) | Test results demonstrate compliance with the standards. |
Important Note for SpO2 and Pulse Rate: While ISO 80601-2-61 covers the particular requirements for pulse oximeter equipment, the document does not explicitly state the specific accuracy (e.g., Arms value) or bias results for SpO2 or Pulse Rate as acceptance criteria or reported performance results. It only states general compliance with the standard. Typically, pulse oximeter standards define specific accuracy requirements (e.g., Arms ≤ 3% for SpO2 between 70-100%). It's implied that the device meets these within the standard, but the specific numbers are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Twelve (12) subjects.
- Data Provenance: The subjects consisted of volunteers (3 women and 9 men) with no known illnesses and no anemia. They represented a mixture of ethnic backgrounds with skin colors ranging from light to dark, and ages from 22 to 38. A total of 24 samples were obtained per subject.
- Study Type: This appears to be a prospective clinical testing for performance validation. The location of the test is not explicitly stated as a country, but it says "Data was recorded by Bickler-Ye Lab and provided for analysis," which might hint at a US-based lab given Dr. Jeffrey Bickler's affiliation with UCSF.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the clinical testing in the traditional sense of consensus reading for diagnostic imaging. Instead, for pulse oximetry, the "ground truth" for oxygen saturation is typically established through direct arterial blood gas analysis, a recognized clinical standard. However, this document does not explicitly state how ground truth for SpO2 was established in the clinical test. It states "Testing validated the submitted device was effective in determining SPO2."
4. Adjudication Method for the Test Set
Not applicable in the context of this pulse oximeter performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers are interpreting images or data and their disagreements need to be resolved. For pulse oximetry, the comparison is usually against a physiological standard (e.g., co-oximetry).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not done. The study described is a clinical validation of the device's accuracy in measuring SpO2 and pulse rate, not a comparative effectiveness study involving human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described "Clinical testing" focuses on the device's performance in measuring SpO2. This is a standalone performance test of the device (algorithm/sensor system) without human interpretation in the loop. The device directly provides numerical readings (SpO2, Pulse Rate).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the method for establishing ground truth for SpO2 in the clinical trial. For pulse oximeters, the accepted gold standard for SpO2 is typically fractional arterial oxygen saturation (SaO2) measured by a co-oximeter from an arterial blood sample. While the document mentions "Testing validated the submitted device was effective in determining SPO2," it doesn't detail the comparison method.
8. The Sample Size for the Training Set
No information about a training set is provided. This device is a pulse oximeter, not an AI/ML-driven diagnostic algorithm that typically requires a separate training set. Its principle of operation is based on optoelectronics and signal processing, which doesn't usually involve a "training phase" in the same way an AI model does.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/ML algorithm is not relevant to this type of device based on the provided information.
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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
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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
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Indications for Use
510(k) Number (if known) K172792
Device Name Handheld Pulse Oximeter, SP-20
Indications for Use (Describe)
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.
| 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
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-
- Predicate Devices:
| Manufacturer | Device | 510(k)Number |
|---|---|---|
| Shenzhen CreativeIndustry Co., Ltd | PATIENT MONITOR, UP-7000 | K123711 |
| Shenzhen Mindray Bio-Medical ElectronicsCo., Ltd | PM-50 PULSE OXIMETER | K052693 |
-
- Classifications Names & Citations:
DQA, SpO2; FLL, Temperature;
- Classifications Names & Citations:
- Description:
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.
Below is a brief tabular display of the monitor functions and operations.
| Function | ProductCode | Module 510K Status | |
|---|---|---|---|
| Built-in Function: | |||
| Built-in | SpO2Pulse Rate | DQA | Creative SpO2 sensor only (K063641) |
| External Linked Function (Optional): | |||
| Built-in | TEMP | FLL | Valeo VT-601E IR Ear thermometer (K111463) |
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-
- 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.
- Indication for use:
-
- 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:
- Comparison with the predicate device:
| SerialNumber/Version | Standard and Description | Scope |
|---|---|---|
| IEC 60601-1:1990+A1+A2+A13 | Medical devices Part1: General requirements for safetyand Amendment 1, Amendment 2 and Amendment 13 | Generalrequirements:Electrical Safety |
| IEC 60601-1-2:2014 | Medical electrical equipment-part 1-2: General requirements for basic safety andessential performance - Collateral standards:Electromagnetic compatibility -Requirements and tests | Generalrequirements:EMC |
| IEC 60601-1-11:Ed. 2.0, 2015 | Medical electrical equipment-part 1-11: generalrequirements for basic safety and essentialperformance -collateral standard: Requirement formedical electrical equipment and medical electricalsystems used in home healthcare environment | Generalrequirements:Electrical Safety |
| ISO80601-2-61_SpO2 | Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essentialperformance of pulse oximeter equipment | Generalrequirements:Alarm system |
| IEC/TR60878:2003 | Graphical symbols for electrical equipment in medicalpractice | Generalrequirements:Graphical symbols |
| ISO 10993-1:2009 | Biological evaluation of medical devices--Part 1:Evaluation and testing | Biologicalevaluation |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5 Testsfor In Vitro Cytotoxicity. | Generalrequirements:BiologicalEstimation |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10:Tests for Irritation and Delayed-Type Hypersensitivity | Generalrequirements:BiologicalEstimation |
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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 OximeterSP-20 | Patient MonitorUP-7000 | |
| Manufacturer | Shenzhen Creative IndustryCo., LTD. | Shenzhen Creative IndustryCo., LTD. | |
| FDA Classification | SpO2: CFR870.2700, DQATEMP: CFR880.2910, FLL(Optional function-K111463) | SpO2: CFR870.2700, DQATEMP: CFR880.2910, FLLECG: CFR870.2300, MWINIBP: CFR870.1130, DXNCO2: CFR868.1400, CCK | |
| Physicaldimension(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 handhelddevice, and is smallercompared to the PredicateDevice (UP-7000). The SP-20device meets the mechanicaltest requirements defined inIEC60601-1, IEC60601-1-11and ISO80601-2-61. |
| Display | 3.5" color TFT LCD | 12.1" Color TFT | N/A |
| Type, Degree ofprotection againstelectric shock | Class II with an internalelectric power supply;Type BF applied parts. | Class I with an internalelectric power supply.Where the integrity of theexternal protectiveearth(ground) in theinstallation or its conductorsis in doubt, the equipmentshall be operated from itsinternal electric powersupply(batteries)CO2: BF (defibrillation proof)SpO2/ NIBP/ TEMP/ ECG/RESP: CF (defibrillationproof) | The SP-20 device is poweredby an external adapter andbattery, which is Class II withinternal electric power supplydevice according toIEC60601-1, and appliedparts of the SP-20 device aretype BF according toIEC60601-1. |
| Power supply | Battery or AC | Battery or AC | Identical |
| Power source | Power adapter: input: 100-240VAC, 50/60Hz; output:5VDC/1AInternal power supply:2000mAh lithium battery | (100-240) VAC 50/60Hz100VA;Rechargeable sealed lead-acid battery, 12V 2.3AH | According to product designrequest, the SP-20 device ispowered by an externaladapter and lithium battery,which meet IEC60601-1 andIEC60601-1-2 requirements. |
| Low batteryindicator | Yes | Yes | Identical |
| Characteristics | Submitted Device | Predicate Device | Discussion for thedifference |
| Storage data | Yes | Yes | Identical |
| Flammableanesthetics | No | No | Identical |
| Operatingenvironment | Operating Temperature:5°C~40°COperating Humidity:15% | Operating Temperature:5°C~40°CHumidity: 30% | The environmental operatingconditions of the SP-20 devicemeets IEC60601-1 andIEC60601-1-11 requirements. |
| Storage condition | Ambient temperature : -20°C~60°CRelative humidity: 10% | Temperature: -20°C~60°CHumidity: 10% ~95%, non-condensingAtmosphere: 53k ~106kPa | The environmental storageconditions of the SP-20 devicemeets IEC60601-1 andIEC60601-1-11 requirements. |
| Optional printer | N/A | Available | N/A |
| Oximetrytechnique | Creative SpO2 module withthe same principle as PC-60(K063641) Creative SpO2sensor onlyKM-SPO-01 SpO2 modulewith KS-C01KM-SPO-01 SpO2 modulewith KS-YW02 | Creative SpO2 module withthe same principle as PC-60(K063641) Creative SpO2sensor onlyKM-SPO-01 SpO2 modulewith KS-C01 | Identical |
| Measuring mode | Spot-check and Continuousrecording. | Continuous monitoring | The SP-20 device is intendedfor spot checking andcontinuous recording of SpO2measurement data, but is notintended for continuousmonitoring, and meetsISO80601-2-61 requirements. |
| Applied part | Detachable SpO2 probe/Dual-wavelength LED sensor | Detachable SpO2 probe/Dual-wavelength LED sensor | Identical |
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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.
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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
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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
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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:
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.
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.
§ 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).