(138 days)
There are no reference devices mentioned in the provided text.
No
The description focuses on standard pulse oximetry technology using light absorption and does not mention any AI/ML components or algorithms for data processing or interpretation.
No
The device is described as a pulse oximeter intended for "measuring the pulse rate and functional oxygen saturation (SpO2)", indicating a diagnostic or monitoring function rather than a therapeutic one. It does not exert any direct treatment or amelioration of a condition.
Yes
The device is described as measuring pulse rate and functional oxygen saturation (SpO2), which are diagnostic measurements used to assess a patient's physiological state. It provides numerical values (SpO2 and pulse rate) that can be used for spot-checking a patient's condition, indicating its role in providing objective information for diagnosis or monitoring.
No
The device description explicitly details hardware components, including a sensor device placed on the patient's body, light wavelengths, a photodetector, and battery power. It also mentions a wireless data transmission function, implying hardware for communication. This is not a software-only device.
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 description clearly states that the device measures pulse rate and oxygen saturation (SpO2) through the patient's finger. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use is for "measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger," and for "spot-checking a patient's SpO2 and pulse rate." This aligns with a physiological monitoring device, not an in vitro diagnostic test.
Therefore, this pulse oximeter falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.
These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are used by adult and pediatric patients. These devices are recommended for use on the index fingers of 1.0 - 2.2 cm thick.
Product codes
DQA
Device Description
A blood-oxygen saturation reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. The reading may be referred to as SaO2. Readings vary from 0 to 100%. Normal readings in a healthy adult, however, range from 94% to 100%. The term SpO2 means the SaO2 measurement determined by pulse oximetry. In its most common (transmissive) application mode, a sensor device is placed on a thin part of the patient's body. The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle and fat. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure SpO2 and body pulse simultaneously.
The PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in a home and clinical environment. The index finger is the recommended site. It is intended for spot-checking adult and pediatric patients on fingers between 1.0 -2.2 cm thick.
This oximeter has a wireless data transmission function. The user can transmit the SPO2 and pulse rate data to a computer through the wireless communication module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's finger
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Home or clinical environment. Used by adult and pediatric patients.
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: Verification Tests (Electrical Safety, EMC, Biocompatibility, Safety and Performance, Performance Parameter Test)
Sample Size: Not explicitly stated, but testing was performed for multiple devices and parameters.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
- Electrical Safety: Tests performed include: Legibility of marking, Durability of marking test, Leakage current, Dielectric strength test, Ball pressure test of thermoplastic parts, Excessive temperatures test, Single fault condition test, Mechanical strength tests.
- EMC: Tests performed include: Radiated emission, Electrostatic discharge, RF field strength susceptibility, Power frequency magnetic field susceptibility test.
- Biocompatibility: In Vitro Cytotoxicity (MTT Method), Skin Sensitization (GPMT Method), Skin Irritation (Animal skin irritation test).
- Safety and Performance: Protection against excessive temperatures, Ingress of water (IPX1), Shock test, Vibration test.
- Performance Parameter Test: SpO2 measuring range: 0%-99%; SpO2 measuring accuracy: 70%-100% +/- 3%; 69% no defined 0%; PR measuring range: 30bpm-240bpm; PR measuring accuracy: +/- 2bpm or +/- 2% (whichever is greater).
- All new devices are exactly same as predicate devices in measuring electro-circuit module (cushion rubber, emitter and receiver).
- The submitted devices comply with the acceptance criteria in the SP02 standards and FDA guidance documents.
Key Metrics
SpO2 measuring accuracy: 70%-100% +/- 3%; 69% no defined 0%
PR measuring accuracy: +/- 2bpm or +/- 2% (whichever is greater)
Predicate Device(s)
Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641, and PC 60 NW Fingertip Oximeter K120502.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping faces creating a sense of depth and dimension. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Shenzhen Creative Industry Co., Ltd. c/o Mr. Charles Mack IRC 12226 Washington Lane Parker, Arizona 85344
Re: K150093
Trade/Device Name: Pulse Oximeter PC-66A: PC-66C: PC-60B1; PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; POD-1W; PC-60NW-1; PC-68A; PC-68B; and PC-68C. Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 12, 2015 Received: May 4, 2015
Dear Mr. 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. 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150093
Device Name
Pulse Oximeter PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N;POD-1; POD-2; POD-3;POD-1W;PC-60NW-1; PC-68A; PC-68B; PC-68C.
Indications for Use (Describe)
The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.
These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are used by adult and pediatric patients. These devices are recommended for use on the index fingers of 1.0 - 2.2 cm thick.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: April 10, 2015
1. Company:
Name - Shenzhen Creative Industry Co., Ltd. Address 2/F, Block 3, Nanyou Tian'an Industry Town, Shenzhen, GD 518054, P.R. China Telephone – +86-755-26431671 Fax – +86-755-26435433 Contact – Mrs. Jia Wang Email charliemack@irc-us.com
Correspondent:
Name- IRC Address- 12226 Washington Lane, Parker, Arizona 85344 Telephone- 931-625-4938 Contact- Charlie Mack Email- charliemack@irc-us.com
2. Device :
| Trade/proprietary name | Pulse Oximeter: PC-66A; PC-66B;
PC-66C;PC-60B1; PC-60B5; PC- 60D; PC-60D2;
PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A;
PC-68B; PC-68C; POD-1W; POD- 60NW-1 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Oximeter |
| Classification Name | Oximeter |
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3. Predicate Devices :
Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641and PC 60 NW Fingertip Oximeter K120502.
This submission is a Special 510(k) submission, based upon standards and the predicate is simply the original basis of the submitted device.
-
- Classifications Names & Citations :
21CFR 870.2700 Oximeter, DQA, Class2
- Classifications Names & Citations :
5. Description :
5.1 General
A blood-oxygen saturation reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. The reading may be referred to as SaO2. Readings vary from 0 to 100%. Normal readings in a healthy adult, however, range from 94% to 100%. The term SpO2 means the SaO2 measurement determined by pulse oximetry. In its most common (transmissive) application mode, a sensor device is placed on a thin part of the patient's body. The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle and fat. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure SpO2 and body pulse simultaneously.
The PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in a home and clinical environment. The index finger is the recommended site. It is intended for spot-checking adult and pediatric patients on fingers between 1.0 -2.2 cm thick.
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This oximeter has a wireless data transmission function. The user can transmit the SPO2 and pulse rate data to a computer through the wireless communication module.
-
- Indication for use :
The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.
- Indication for use :
These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are intended to be used by adult and pediatric patients. These devices are recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.
-
- Comparison with predicate device :
Please refer to the table on the following page for a comparison between the predicates and the submitted devices.
- Comparison with predicate device :
The submitted devices are compared to the Shenzhen Creative Industry Co., Ltd, PC-60 Fingertip Oximeter K063641 and PC 60 NW Fingertip Oximeter, K120502.
This submission is a Special 510(k) submission, based upon standards and the predicate is simply the original basis of the submitted device.
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| Submitted Device | Predicate | Differences |
|---|---|---|
| PC-66A | PC-60- K063641 | The specific differences between the submitted PC 66A and predicate is the size of the |
| LCD screen, the physical dimensions, and a variation in the body style. None of the | ||
| electronics or sensors have been altered with this new device. The changes are made | ||
| for marketing purposes and do not affect the performance, as none of the components | ||
| which affect operation have been altered. | ||
| The altered case still maintains the same thickness for to protect the circuitry. The | ||
| body color of the submitted device is a different color and the new material has | ||
| undergone biocompatibility testing to validate for patient use. | ||
| PC-66B | PC-60- K063641 | The specific differences between the submitted PC 66B and predicate is the size of the |
| LCD screen, changes from a LCD to an OLED (organic LED display), body color and | ||
| a variation in the body style. The only variation in the body style is the submitted | ||
| device has a dimpled surface at one end, while the predicate has two ripples. None of | ||
| the electronics or sensors have been altered with this new device. The changes are | ||
| made for marketing purposes and do not affect the performance, as none of the | ||
| components which affect operation have been altered. | ||
| The altered case still maintains the same thickness to protect the circuitty. The | ||
| material for the outer shell has undergone biocompatibility testing. | ||
| PC-66C | PC-60- K063641 | The specific differences between the submitted PC 66B and predicate is the size of the |
| LCD screen, changes from a LCD to an OLED (organic LED display), body color and | ||
| a variation in the body style. The only variation in the body style is the submitted | ||
| device has a dimpled surface at one end, while the predicate has two ripples. None of | ||
| the electronics or sensors have been altered with this new device. The changes are | ||
| made for marketing purposes and do not affect the performance, as none of the | ||
| components which affect operation have been altered. | ||
| The altered case still maintains the same thickness to protect the circuitty. The | ||
| material for the outer shell has undergone biocompatibility testing. | ||
| Submitted Device | Predicate | Differences |
| PC-60B1 | PC-60- K063641 | The specific differences between the submitted PC 66B and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED display), body color and a variation in the body style. The only variation in the body style is the submitted device has a smooth surface at one end, while the predicate has two ripples. The LCD screen on the submitted device has been shifted to display from the side rather than the top down version of the predicate. The readings are still easy to see. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| PC-60B5 | PC-60- K063641 | The specific differences between the submitted PC 60B5 and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED display), body color and a variation in the body style. The only variation in the body style is the submitted device has a dimpled surface at one end, while the predicate has two ripples. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| PC-60D | PC-60- K063641 | The specific differences between the submitted PC 60D and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED color display), body color and a variation in the body style. The only variation in the body style is the submitted device has a dimpled surface at one end, while the predicate has two ripples. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| Submitted Device | Predicate | Differences |
| PC-60D2 | PC-60- K063641 | The specific differences between the submitted PC 60D2 and predicate is the size of the LCD screen, color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm longer and wider and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. | ||
| PC-60E | PC-60- K063641 | The specific differences between the submitted PC 60E and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED color display), body color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. | ||
| PC-60N | PC-60- K063641 | The specific differences between the submitted PC 60N and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED color display), body color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing | ||
| Submitted Device | Predicate | Differences |
| POD-1 | PC-60- K063641 | The specific differences between the submitted POD-1 and predicate is the size of the LCD screen, color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| POD-2 | PC-60- K063641 | The specific differences between the submitted POD-2 and predicate is the size of the LCD screen, color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| POD-3 | PC-60- K063641 | The specific differences between the submitted POD-3 and predicate is the size of the LCD screen, color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. |
| Submitted Device | Predicate | Differences |
| PC-68A | PC-60NW K120502 | The specific differences between the submitted PC-68A and predicate is the changes from a LCD to an OLED (organic LED color display), body color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. | ||
| PC-68B | PC-60NW K120502 | The specific differences between the submitted PC-68B and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED display), body color and a variation in the body style. The only variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing. | ||
| PC-68C | PC-60NW K120502 | The specific differences between the submitted PC-68B and predicate is the size of the LCD screen, changes from a LCD to an OLED (organic LED color display), body color and a variation in the body style. The variation in the body style is the submitted device is 3 mm larger in all length and thickness and 3 mm thinner. The submitted device also has a depression at one end of the upper body. None of the electronics or sensors have been altered with this new device. The changes are made for marketing purposes and do not affect the performance, as none of the components which affect operation have been altered. |
| The altered case still maintains the same thickness to protect the circuitry. The material for the outer shell has undergone biocompatibility testing | ||
| Submitted Device | Predicate | Differences |
| POD-1W | PC-60NW K120502 | The specific difference between the submitted POD-1W and predicate is the color. |
| None of the electronics or sensors have been altered with this new device. The | ||
| changes are made for marketing purposes and do not affect the performance, as none | ||
| of the components which affect operation have been altered. | ||
| The altered case still maintains the same thickness to protect the circuitry. The | ||
| material for the outer shell has undergone biocompatibility testing. | ||
| POD-60NW-1 | PC-60NW K120502 | The only attribute that is different in these is that the changes from a LCD to an |
| OLED (organic LED display). One device reads top down and the other reads from | ||
| the bottom up. |
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8. Performance Data :
| No. | Category | Directives/Standards | Title & Comments |
|---|---|---|---|
| 1 | General | 93/42/EEC | Medical Device Directive |
| 21CFR820 | Code of Federal Regulations | ||
| IEC60601-1:2005 | General requirements for Safety and Essential | ||
| Performance | |||
| ISO14971 Second | |||
| edition 2007-03-01 | Medical devices-Application of risk | ||
| management to medical devices | |||
| 2 | EMC | IEC60601-1-2:2007 | Medical Electrical Equipment-Part 1- |
| 2:General Requirements for Safety - | |||
| 2.Collateral Standard-Electromagnetic | |||
| compatibility - Requirements and tests | |||
| 3 | Biocompatibility | ISO 10993-1:2009 | Biological evaluation of medical devices -- |
| Part 1: Evaluation and testing within a risk | |||
| management process | |||
| ISO10993-5: 2009 | Biological evaluation of medical devices -- Part | ||
| 5: Tests for In Vitro cytotoxicity | |||
| ISO10993-10: 2010 | Biological evaluation of medical devices - Part | ||
| 10: Tests for irritation and skin sensitization | |||
| 4 | Labeling | FDA Guidance | Labelling Regulatory Requirements for |
| Medical Devices | |||
| 5 | SpO2 | ISO 80601-2-61 First | |
| edition 2011-04-01 | Medical electrical equipment - Part 2-61: | ||
| Particular requirements for basic safety and | |||
| essential performance of pulse oximeter | |||
| equipment | |||
| IEEE/ISO 11073-10404 | |||
| First edition 2010-05-01 | Health informatics - Personal health device | ||
| communication - Part 10404: Device | |||
| specialization - Pulse oximeter | |||
| FDA Guidance | Pulse Oximeters - Premarket Notification | ||
| Submissions [510(k)s] issued on Mar.4,2013 | |||
| FDA Guidance | General Guidance Document: Non-Invasive | ||
| Pulse Oximeter |
13
9. Design Control Activities
Shenzhen Creative Industry Co., Ltd.'s manufacturing facility is in compliance with the design control procedure requirements as specified in 21 CFR 820.30 of FDA GMP CFR820 Ouality System Regulation and the records are available for review.
All the design changes have been evaluated and the related verification and validation activities were performed by qualified designated individuals and the results demonstrated that the predetermined acceptance criteria for the submitted devices was met.
The difference between the new devices and predicate devices are display screen, physical dimension, appearance and color.
The new devices comply with applicable electric safety and EMC standards. These standards are the same as used to test the predict devices.
The design changes between the new models and predicate device did not alter the light emitter or the receive sensor. The electronics in all of the submitted devices is exactly the same as our predicate devices. Critical dimensions, alignment and case thickness did not change. The case maintains the same integrity to protect the electronics and the LCD is the same segment digital display with the same visibility as the predicate. Testing was performed for Electrical Safety and EMC. The new devices comply with the same standards as the predict devices, which are noted below:
- IEC 60601-1
- IEC 60601-1-2
- ISO 80601-2-61:2011 Clauses 201.17 and 202
The table below is a synopsis of the testing performed.
| Verification Test | Standards/Method | Tests Performed |
|---|---|---|
| Electric Safety | IEC 60601-1: 2005 | 7.1.2 Legibility of marking |
| 7.1.3 Durability of marking test | ||
| 8.7 Leakage current | ||
| 8.8.3 Dielectric strength test | ||
| 8.8.4.1 Ball pressure test of | ||
| thermoplastic parts | ||
| 11.1.1 Excessive temperatures | ||
| test | ||
| 13.2 Single fault condition test | ||
| 15.3 Mechanical strength tests |
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| Verification Test | Standards/Method | Tests Performed | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| IEC 60601-1-2: 2014 | |||||||||||
| CISPR 11: 2010 | |||||||||||
| ISO 80601-2-61:2011 Clauses | |||||||||||
| 201.17 and 202 | Radiated emission (Class B): | ||||||||||
| Frequency | |||||||||||
| (MHz) Distance | |||||||||||
| (Meters) Limits | |||||||||||
| (dBuV/m) 30-230 3 40 230-1000 3 47 | |||||||||||
| EMC | IEC 60601-1-2: 2014 | ||||||||||
| IEC 61000-4-2: 2008 | |||||||||||
| ISO 80601-2-61: 2011 Clauses | |||||||||||
| 201.17 and 202 | Electrostatic discharge: Contact | ||||||||||
| discharge: 6kV, 10 | |||||||||||
| times |
Air discharge: 8kV, 25 times | | | | | | | | | |
| | IEC 60601-1-2: 2014
IEC 61000-4-3: 2010
ISO 80601-2-61: 2011 Clauses
201.17 and 202 | RF field strength susceptibility:
Frequency range: 80MHz to 2.7
GHz
Field strength: 10V/m | | | | | | | | | |
| | IEC 60601-1-2: 2014
IEC 61000-4-8:
2010
ISO 80601-2-61:
2011 Clauses
201.17 and 202 | Power frequency magnetic
field susceptibility test:
Test frequency: 50Hz,
60Hz
Continuous field: 30 A/m
Test duration: 5min
Antenna factor: 0.917A/m | | | | | | | | | |
15
The new devices comply with the biocompatibility requirement defined in ISO10993-1. These are the tests performed on the predicate devices.
The table below is a synopsis of the biocompatibility testing performed on the submitted devices. This is the same battery of biocompatibility tests performed on the predicate devices.
| Verification Test | Standards/Method | Tests Performed |
|---|---|---|
| In Vitro Cytotoxicity | ISO10993-5: 2009 | |
| MTT Method | 8.5 Determination of cytotoxicity | |
| Skin Sensitization | ISO10993-10: 2010 | |
| GPMT Method: Guinea | ||
| Pig | ||
| Maximization Test | ||
| (0.9% Sodium Chloride Extract) | 7.5.6 Evaluation of results | |
| Skin Irritation | ISO10993-10: 2010 | |
| 6.3 Animal skin irritation | ||
| test | 6.3.6 Evaluation of results | |
| Verification | ||
| Test | Standards/Method | Tests Performed |
| Safety and | ||
| Performance | ISO 80601-2-61: | |
| 2011 | 201.11 Protection against excessive | |
| temperatures | ||
| 201.11.6.5.101 | ||
| Ingress of water | ||
| IPX1, test by 14.2.1 of IEC60529: 2001 | ||
| 201.15.3.5.101.1a) | ||
| Shock test | ||
| (IEC 60068-2-27: | ||
| 2008 Test Type1) | ||
| 201.15.3.5.101.1b) | ||
| Vibration test | ||
| (IEC 60068-2-64: | ||
| 2008 Broad-band random vibration | ||
| test) | ||
| Performance Parameter | ||
| Test | Sp02 simulator method | |
| (simulator model: Index 2 | ||
| series) | SpO2 measuring range: 0%-99% | |
| SpO2 measuring accuracy: | ||
| 70%-100% +3%; 69% no defined | ||
| 0% | ||
| PR measuring range: 30bpm-240bpm | ||
| PR measuring accuracy: ±2bpm or | ||
| ±2% (whichever is greater) |
Cleaning and disinfection instructions:
The cleaning and disinfection instruction is same as predicate device. With no change, no verification need was deemed necessary.
Clinical validation of SpO2 :
For all of the submitted devices, the only change is enclosure color, but no change was done for the color of the cushion rubber (material contacting the patient's finger during measuring).
In that the measuring device in the electro-circuit module, cushion rubber, emitter and receiver are the same as predicate devices, we concluded that this will not affect the device performance. No new clinical validation needed.
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Bench Test of SpO2 and Pulse Rate
All new devices are exactly same as predicate devices in measuring electro-circuit module (cushion rubber, emitter and receiver). Generally, new tests are not needed. Taking a conservative approach to performance, we conducted additional verification to show it complies with the requirement, refer to below summary:
17
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 Fingertip Oximeter, models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 is substantially equivalent to the predicate devices and complies with the acceptance criteria in the SP02 standards and FDA guidance documents as described herein.
END