APK SPO2 PULSE OXIMETER SENSOR
Device Facts
| Record ID | K082846 |
|---|---|
| Device Name | APK SPO2 PULSE OXIMETER SENSOR |
| Applicant | APK Technology Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | Apr 3, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The APK SpO2 Pulse Oximeter Sensor (Resuable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospital-type facilities, and home environments. The APK SpO2 Pulse Oximeter Sensor (Disposable) is intended for Disposable when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.
Device Story
Non-invasive pulse oximeter sensors (reusable and disposable) measure arterial oxygen saturation (SpO2) and pulse rate. Sensors emit red and infrared light through tissue (e.g., finger); a photodiode receives non-absorbed light. Signals are transmitted to a host oximeter device, which amplifies the signal and uses an algorithm to calculate the ratio of oxygenated to total hemoglobin based on light absorption. Used in hospitals and home environments by clinicians or patients. Output is displayed on the host oximeter to assist in monitoring patient oxygenation status.
Clinical Evidence
Clinical testing performed in accordance with ISO 9919:2005. Performance testing conducted to verify electrical safety and electromagnetic compatibility per IEC 60601-1 and IEC 60601-1-2. Performance testing completed with intended oximeter equipment.
Technological Characteristics
Red and infrared LED light sources; photodiode receiver. Configurations include finger clip, soft, and wrapping types. Electrical safety and EMC compliant with IEC 60601-1 and IEC 60601-1-2. Non-sterile. Not software-driven (sensor component only).
Indications for Use
Indicated for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in adult and pediatric patients (>5kg) in hospital and home settings.
Regulatory Classification
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.
Predicate Devices
- Epic SpO2 Sensor-Model#E412-20 (K002223)
Submission Summary (Full Text)
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# Chapter III 510(k) Summary
APR - 3 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
K082846
#### 1. Applicant Device Information
Device Common Name: SpO2 Pulse Oximeter sensor Device Trade/Proprietary Name:
- APK Sp()2 Pulse Oximeter Sensor (Reusable) a.
- APK SpO2 Pulse Oximeter Sensor (Disposable) b.
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Classification Information:
- (1) Classification Name: Oximeter
- (2) Regulation Number:870.2700
- (3) Product Code: DQA
- (4) Class: II
- (5) Review Panel: Anesthesiology
# 2. Submitter Information
# Manufacturer Name and Address
APK Technology Co., Ltd 6C, C2 Building, Industru of HengFeng Hezhou, Xixiang, Baoan District Shenzhen, Guangdong, 518126,China Contact Person of the Submission Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China, 20030
III-1
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Premarket Notification 510(k) Chapter III 510(k) Summary Report No .: TE20080917
Phone: +86-21-64264467 Fax:760-466-5084 Email: Diana.hong(@mid-link.net
3. Predicate Device
Epic SpO2 Sensor-Model#E412-20(K002223) Manufactured by: Epic Medical Equipment Services,Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074
#### 4. Device Description
4.1 The basic technology principle
The applicant sensor APK SpO2 Pulse Oximeter Sensor (Reusable and Disposable) measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.
The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].
SpO2 = [HbO2]/([Hb+[HbO2]]
Those sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.
The device is not software-driven.
The applicant sensors are not for implant. Those sensors are not sterile and do not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological product.
4.2 The description of Reusable series SpO2 sensor
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The Reusable series SpO2 sensor include 65 kinds of models. The mainly difference of each model SpO2 sensor included in Reusable Series SpO2 Sensors is the appearance , intended lay user and matched oximeter equipment.
We can understand that surface difference as the configuration difference, which of the Reusable series SpO2 sensor can separate into three parts as finger clip type, soft type and wrapping type. Althought the sensor have difference in surface and configuration, but all of models in the Reusable series SpO2 sensor have the same technology principle and raw material.
The Reusable series SpO2 sensor have two kinds of intended population, adult and pediatric.
The Reusable series SpO2 sensor have several kinds of matched oximeter equipment, for match those equipment, Reusable series SpO2 sensor have completed the performance test with intended oximeter.
4.3 The description of Disposable series SpO2 sensor
The Disposable series SpO2 sensor include 2 kinds of models. The mainly difference of each model SpO2 sensor included in Disposable Series SpO2 Sensors is the appearance , intended lay user and matched oximeter equipment.
The Disposable series SpO2 sensor have two kinds of intended population, adult and pediatric.
The Disposable series SpO2 sensor have several kinds of matched oximeter equipment, for match those equipment, Disposable series SpO2 sensor have completed the performance test with intended oximeter.
#### 4.4 Test Description
The Reusable and Singe Use series SpO2 sensor are electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2.
All the information about the device performance were provided.
The Clinical Test Report following ISO 9919:2005, Medical electrical equipment-Particular requirements for the basic safety and essential performance of pulse oximeter
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equipment for medical use.
# 5. Intended Use
- 5.1 the Intended Use of APK SpO2 Pulse Oximeter sensor (Reusable)
The APK SpO2 Pulse Oximeter Sensor (Resuable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.
- 5.2 the Intended Use of APK SpO2 Pulse Oximeter Sensor (Disposable)
The APK SpO2 Pulse Oximeter Sensor (Disposable) is intended for Disposable when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.
#### 6. Substantially Equivalence Determination
#### Comparison Analysis
The Reusable and Disposable SpO2 sensor have same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The only difference is Operating temperature, PR Measuring range, Atmosphere pressure.
#### Conclusion
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
APR - 3 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APK Technology Company, Limited C/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion Number 19, Lane 999, Zhong Shan Nan Er Road Shanghai, CHINA 20030
Re: K082846
Trade/Device Name: APK Sp02 Pulse Oximeter Sensor (Reusable) APK Sp02 Pulse Oximeter Sensor (Disposable) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 19, 2009 Received: March 23, 2009
Dear Ms. Hong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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# Page 2 - Ms. Hong
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sybilte Y. Michaud md.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indication for Use
510(k) Number (if known): __
Device Name: APK SpO2 Pulse Oximeter sensor (Reusable)
Indications for Use:
The APK SpO2 Pulse Oximeter sensor (Reusable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.
Prescription Use _ √ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _1_ of _2
Susan Ruape
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC180846
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# Indication For Use
510(k) Number (if known):
Device Name: APK SpO2 Pulse Oximeter sensor (Disposable)
Indications for Use:
The APK SpO2 Pulse Oximeter sensor (Disposable) is intended for single use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.
Prescription Use J (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Carey
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082846
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