(237 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard pulse oximetry functionality and data storage/transfer.
No.
The device is strictly for measuring and monitoring physiological parameters (SpO2 and pulse rate) and does not provide any form of therapy or treatment.
Yes
A Pulse Oximeter measures functional oxygen saturation (SpO2) and pulse rate (PR), which are physiological parameters used to assess a patient's health status. This falls under the definition of a diagnostic device, as it provides information that can aid in diagnosis, even if it's not performing the diagnosis itself.
No
The device description explicitly states it is a "wrist-worn" device and measures physiological parameters, indicating it includes hardware components for sensing and measurement, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Pulse Oximeter Function: A pulse oximeter measures physiological parameters (SpO2 and pulse rate) by shining light through the skin (typically on a finger). This is a non-invasive measurement performed on the living body, not on a sample taken from the body.
The provided information clearly describes a device that measures physiological parameters directly from a patient, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.
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 and Pediatric
Intended User / Care Setting
hospitals, clinics, or home.
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:
- Safety and EMC: Tests performed according to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; IEC 60601-1-2:2007; IEC 60601-1-11 Edition 2.0 2015-01. Results demonstrate compliance with standard's requirements.
- Biocompatibility: Evaluation according to ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation tests. Results demonstrate biocompatibility.
- Performance: Meets performance standards of ISO 80601-2-61 First edition 2011-04-01.
- Software Verification and Validation: Software documentation provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
- Cleaning Validation: Device was cleaned according to User's Manual procedure, and met all performance requirements after cleaning.
- Shelf Life: Not subject to shelf life as the device does not contain any sterile or degradable components.
Clinical:
- Clinical testing was conducted per Annex EE Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 Measurement Accuracy: ±3% (during 70%-100%), Undefined (during 0-70%)
- Pulse Rate Accuracy: ±2bpm or ±2% (whichever is greater)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Shenzhen Creative Industry Co., Ltd. % Charles Mack Principal Engineer International Regulatory Consultants (IRC) 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K201468
Trade/Device Name: Pulse Oximeter, AP-10 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 11, 2020 Received: December 28, 2020
Dear Charles 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 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 Actinclude 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
1
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-devices/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 (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
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Indications for Use
510(k) Number (if known)
Device Name Pulse Oximeter, AP-10
Indications for Use (Describe)
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.
| 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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510(k) Summarv
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
Date: December 11, 2020
-
- Company and Correspondent submitting:
Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, Shenzhen, P.R.China 518110 Tel: +86-755-26433325 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
- Company and Correspondent submitting:
-
- Device:
Trade/proprietary name: Pulse Oximeter, AP-10 Common Name : Pulse Oximeter Classification Name : Oximeter Product Code : DQA Regulation Number: 21CFR870.2700 Device Class : 2
- Device:
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-
- Predicate Devices:
| Manufacturer | Device | 510(k)
Number |
|----------------------------------------|--------------------------------|------------------|
| Shenzhen Creative
Industry Co., Ltd | Handheld Pulse Oximeter, SP-20 | K172792 |
Reason for submission: New device 4.
Device Description: 5.
This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.
The following page exhibits a brief tabular display of the device functions and operation as compared to the predicate device.
Indication for use:
This Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediatric patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.
Comparison with the predicate device:
Shenzhen Creative Industry Co., Ltd. believes that the Pulse Oximeter, AP-10 is substantially equivalent to the Shenzhen Creative Industry Co., Ltd; Handheld Pulse Oximeter, Model SP-20 (K172972).
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Comparison to Predicate Devices
| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
|---|---|---|---|
| Manufacturer | Shenzhen Creative Industry Co., LTD. | Shenzhen Creative Industry Co., LTD. | N/A |
| Name and model | Pulse Oximeter, AP-10 | Handheld Pulse Oximeter, SP-20 | N/A |
| 510(K) Number | Pending | K172792 | N/A |
| Product Code | DQA | DQA | Same |
| Indication for Use | This Pulse Oximeter is intended for measuring and | ||
| recording the functional oxygen saturation (SpO2) | |||
| and pulse rate (PR). It is intended for spot check and | |||
| continuous recording of SpO2, PR of adult or | |||
| pediatric patients in hospitals, clinics, or home. This | |||
| device is not intended for continuous monitoring. | This Handheld Pulse Oximeter is intended for | ||
| measuring and recording the pulse rate, | |||
| functional oxygen saturation (SpO2), and | |||
| temperature (optional). It is intended for spot | |||
| check 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. | Similar. | ||
| Type of SpO2 | |||
| Sensor | Transmittance Optical Sensor | Transmittance Optical Sensor | The difference of SpO2 Sensor |
| does not raise any new questions | |||
| SpO2 Module | KM-SPO-04 SpO2 Module with KS-AR01 Probe | KM-SPO-01 SpO2 Module with KS-C01, KS- | |
| YW02 probe | of safety and effectiveness and | ||
| still complies with the ISO80601- | |||
| 2-61 | |||
| Application Site | Finger | Finger | |
| Output | Red (660 nm) @ 2 mW maximum | Red (660 nm) @ 2 mW maximum | |
| Wavelength and | |||
| Radiant Power of | |||
| SpO2 Sensor | Infrared (905 nm) @ 2 mW maximum | Infrared (905 nm) @ 2 mW maximum | |
| Display | 1.44" color TFT LCD | 3.5" color TFT LCD | The display size difference does |
| not raise any new questions of | |||
| safety and effectiveness. | |||
| Measuring Mode | Spot-check and Continuous recording | Spot-check and Continuous recording | Spot-check and Continuous |
| recording | |||
| Display Range | SpO2: 0-100 % | ||
| Pulse Rate: 30-250 bpm | SpO2: 0-100 % | ||
| Pulse Rate: 30-240 bpm | The Pulse Rate display range of | ||
| AP-10 is wider than SP-20, but | |||
| still complies with ISO80601-2-61 | |||
| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
| Display | SpO2: 1% | SpO2: 1% | SpO2: 1% |
| Resolution | Pulse Rate: 1 bpm | Pulse Rate: 1 bpm | Pulse Rate: 1 bpm |
| SpO2 | SpO2: | SpO2: | SpO2: |
| Measurement | Adult and Pediatric: | Adult and Pediatric: | Adult and Pediatric: |
| Accuracy | ±3% (during 70%-100%) | ±3% (during 70%-100%) | ±3% (during 70%-100%) |
| Undefined (during 0-70%) | Undefined (during 0-70%) | Undefined (during 0-70%) | |
| Pulse Rate | Pulse Rate: ±2bpm or ±2% (whichever is greater) | Pulse Rate: ±2bpm or ±2% (whichever is | Pulse Rate: ±2bpm or ±2% |
| Accuracy | greater) | (whichever is greater) | |
| Data Memory | Up to 24 hours data storage (500 pieces of record at | Up to 500 hours of data storage for SpO2 and | The little difference does not raise |
| most) | PR and can be recalled | any new questions of safety and | |
| effectiveness. | |||
| Power Supply | Rechargeable Lithium-lon Polymer Battery | Rechargeable Lithium-Ion Polymer Battery | Both devices are powered by a |
| (3.7V,500mAh) | (3.7V d.c.,1000mAh) | lithium battery, which matches the | |
| design requirement and complies | |||
| with the applicable standards, | |||
| including IEC60601-1, IEC60601- | |||
| 1-2, and IEC62133, etc. | |||
| AC Power for | 100-240VAC, 50-60Hz,15VA max | 100-240VAC, 50-60Hz,0.5A | Both devices are powered by a |
| Battery Charger | lithium battery that full match the | ||
| design requirement and comply | |||
| with the applicable standards, | |||
| including IEC60601-1 and | |||
| IEC60601-1-2. | |||
| Type of | Internal Powered | Internal Powered | Internal Powered |
| Protection | |||
| Degree of | Type BF - applied part | Type BF - applied part | Type BF - applied part |
| Protection - | |||
| sensor | |||
| Enclosure | IP22 | IP22 | The enclosure Degree of Ingress |
| Degree of | Protection complies with the | ||
| Ingress | applicable standards, including | ||
| Protection | IEC60601-1 and ISO80601-2-61. | ||
| Characteristics | Submitted Device | Predicate Device | Differences Discussion |
| Dimension | |||
| (LxWxH) | Watch Case: D 56mmx W 44mmxH 16mm | 158 mm (L) x 73 mm (W) x 25 mm (H) | The physical dimension difference |
| does not raise any new questions | |||
| of safety and effectiveness. | |||
| Weight | Net Weight: about 45g | 230g (including battery) | The weight difference does not |
| raise any new questions of safety | |||
| and effectiveness. | |||
| Patient Contact | |||
| Materials | Complies with ISO10993-1 | Complies with ISO10993-1 | Complies with ISO10993-1 |
| Data update | USB, Bluetooth | N/A | The AP-10 can upload data to the |
| PC through USB or to a | |||
| smartphone through Bluetooth. It | |||
| complies with the applicable | |||
| standard FCC part 15B. | |||
| Operating | Operating temperature: 5~40°C | ||
| Operating humidity: 15%~93% (non-condensing) | |||
| Atmospheric pressure: 70kPa~106kPa | Operating Temperature: 5°C ~40°C | ||
| Operating Humidity: 15%~93%, non- | |||
| condensing | |||
| Atmospheric pressure: 70kPa~106kPa | Operating Temperature: 5°C | ||
| ~40°C | |||
| Operating Humidity: 15%~93%, | |||
| non-condensing | |||
| Atmospheric pressure: | |||
| 70kPa~106kPa | |||
| Storage | Ambient temperature: -20°C ~60°C, | ||
| Relative humidity 10%~95%, | |||
| Atmospheric pressure: 50kPa~107.4kPa. | Ambient temperature: -20°C~60°C | ||
| Relative humidity: 10%~95% | |||
| Atmospheric pressure: 50kPa~107.4kPa | Ambient temperature: -20°C | ||
| ~60°C | |||
| Relative humidity: 10%~95% | |||
| Atmospheric pressure: | |||
| 50kPa~107.4kPa |
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Testing Summary:
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical:
Safety and EMC
To verify the basic safety and essential performance of the AP-10, we performed the tests as noted below:
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-11 Edition 2.0 2015-01Medical 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 demonstrate the subject device complies with the standard's requirements.
Biocompatibility
Patient contact classification is surface contact