(182 days)
Not Found
No
The description details a standard pulse oximetry measurement principle based on light absorption and signal processing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a non-invasive device intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
The device is intended for "spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate," which are measurements used to assess a patient's physiological state. Such measurements, especially when used in a hospital setting for diagnostic purposes or monitoring health conditions, qualify the device as diagnostic, as it provides information relevant to diagnosing or monitoring health conditions. While not always used for primary diagnosis, the data it provides is often crucial for diagnostic processes or for monitoring patients.
No
The device description explicitly states that the device consists of hardware components such as a detector and emitter LED, signal amplify unit, CPU, display unit, and power unit. It also describes the physical mechanism of operation involving light absorption and detection. While the device is "software-driven," it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The description clearly states the device is a "portable, non-invasive device intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital". It works by applying a sensor to the fingertip and measuring light absorption through the skin and tissue. It does not involve collecting and analyzing a sample (like blood, urine, or tissue) outside of the body.
- The mechanism of action is based on light absorption through tissue. The description details how the device uses red and infrared light and a photodetector to measure light absorption in the pulsating arteriolar bed. This is a physical measurement taken directly from the patient's body, not an analysis of a biological sample.
Therefore, while it's a medical device used for diagnosis and monitoring, it falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The proposed devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display SpO2 and pulse rate value.
The proposed devices consist of detector and emitter LED, signal amplify unit, CPU, display unit and power unit.
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.
The proposed devices of MD300CF3 and MD300CF61 have pulse rate tone modulation function. The function of pulse rate tone modulation is that the device can make a sound of Di-Di-Di to reflect pulse rate in real time.
The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.
The Fingertip Pulse Oximeters MD300C series share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Fingertip Pulse Oximeters MD300C series are the same.
The devices are software-driven and the software validation is provided in Section of Software.
Differences between models:
- Display Range SpO2: MD300C1 (0-99%), MD300C2, MD300CF3, MD300CF61, MD300C63 (0-100%), MD300C61 (0-99%)
- Measurement Range SpO2: MD300C1, MD300C61 (70%-99%), MD300C2, MD300CF3, MD300CF61, MD300C63 (70%-100%)
- Accuracy SpO2: MD300C1, MD300C61 (70%-99%: ±2%), MD300C2, MD300CF3, MD300CF61, MD300C63 (70%-100%: ±2%). For 0%-69%: no definition for all models.
- Display Screen: MD300C1, MD300C61 (LED), MD300C2, MD300CF3, MD300CF61, MD300C63 (OLED)
- Pulse rate tone modulation function: MD300CF3, MD300CF61 (Y), MD300C1, MD300C2, MD300C61, MD300C63 (N)
- The shape and size of shell: Although the proposed devices have different appearances, their sizes are similar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units)
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
Description of the test set: 12 healthy adult volunteer subjects (ages 21-31yr, 45-78kg, with light to dark pigmentation). Sample size: 12. Data source: From the lab of the first affiliated hospital, Sun Yat-sen University. Annotation protocol: The study protocol was subjected to ISO 9919:2005 Annex EE. Procedures of testing required in EE2 were adopted. Each system was evaluated during steady state / non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Clinical Test, Non-clinical Test.
Sample size: 12 healthy adult volunteer subjects for clinical test.
Key results:
Non-clinical Test:
- Broad-band Vibration Test
- Pulse rate and SpO2 Accuracy Test for 3000 cycles' cleaning
- System Performance Test
- Shelf life Test
- Test for Pulse Signal Strength Indicator Bar
- Performance Test according to ISO 9919
- Electromagnetic Compatibility Test According to IEC 60601-1-2
- Electrical Safety Test According to IEC 60601-1
- Irritation、Sensitization and Cytotoxicity Test according to ISO 10993
- Animal skin irritation test: No evidence of significant irritation from the test extract to rabbits. Compliance with FDA guidance.
- In Vitro Cytotoxicity: No cytotoxic potential.
- Skin Irritation Test: No evidence of causing sensitization.
The test results indicate that the safety and effectiveness of the proposed devices is identical to that of the predicate device.
Clinical Test:
- The results of the study provide supporting evidence that the MD300C63 Fingertip Pulse Oximeter is compliance to the accuracy specification claimed by the manufacturer.
- The Fingertip Pulse Oximeter can be used under steady state / non-motion conditions for the range 70-100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
SpO₂:
- 70%-99%: ±2% (for MD300C1, MD300C61)
- 70%-100%: ±2% (for MD300C2, MD300CF3, MD300CF61, MD300C63)
- 0%-69%: no definition
PR: - 30~99BPM: ±2BPM
- 100~235BPM: ±2%
Resolution:
SpO₂: 1%
PR: 1BPM
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
Section 3 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the devices.
The assigned 510(K) number is K130947.
3.1 Submitter Information
Manufacturer Name and Address:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 320, West Building 4, No.83 Fuxing Road, Beijing 100039, P.R.China
Contact Person:
Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No.9 Shuangyuan Road, Badachu Hi -tech Zone, Shijingshan District, Beijing, P.R. China, 100041 Phone: +86-10-88798300 Ext 6020 Fax: 215-4052545 Email: cc@choicemmed.com Date Prepared: April 27, 2013
3.2 Proposed Device Information
Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C1/MD300C2/MD300CF3/MD300CF61/MD300C61/MD300C63 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: II Panel: Anesthesiology
3.3 Predicate Device
Model 9550 Onyx® II Finger Pulse Oximeter K-number: K051107 Product Code: DQA
Indications for Use: The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is
OCT 03 2013
1
intended for spotchecking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site. Manufactured by:
Nonin Medical, Inc. 13700 Ist Ave. N. Plymouth, MN 55441-5443
3.4 Device Description
The proposed devices of Fingertip Pulse Oximeters MD300C series are fingertip devices, which can display SpO2 and pulse rate value.
The proposed devices consist of detector and emitter LED, signal amplify unit, CPU, display unit and power unit.
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 940 nm, which is infrared light.
Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.
The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.
The proposed devices of MD300CF3 and MD300CF61 have pulse rate tone modulation function. The function of pulse rate tone modulation is that the device can make a sound of Di-Di-Di to reflect pulse rate in real time.
The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products.
The Fingertip Pulse Oximeters MD300C series share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Fingertip Pulse Oximeters MD300C series are the same.
The devices are software-driven and the software validation is provided in Section of Software
2
et Notification 510(k) Submission - Section 3 510(K) Summary
Premarket Notification 510(k) Submission – Section 3 10(K) Summary
The differences between each model of the proposed devices are shown the table 3-
| MD300C1 | MD300C2 | MD300CF3 | MD300CF61 | MD300C61 | MD300C63 | ||
|---|---|---|---|---|---|---|---|
| Display Range | SpO₂ | 0-99% | 0-100% | 0-100% | 0-100% | 0-99% | 0-100% |
| PR | 0~254BPM | 0~254BPM | 0~254BPM | 0~254BPM | 0~254BPM | 0~254BPM | |
| Measurement | |||||||
| Range | SpO₂ | 70%-99% | 70%-100% | 70%-100% | 70%-100% | 70%-99% | 70%-100% |
| PR | 30~235BPM | 30~235BPM | 30~235BPM | 30~235BPM | 30~235BPM | 30~235BPM | |
| Accuracy | SpO₂ | 70%-99%: ±2% | 70%-100%: ±2% | 70%-100%: ±2% | 70%-100%: ±2% | 70%-99%: ±2% | 70%-100%: ±2% |
| SpO₂ | 0%-69%: | ||||||
| no definition | 0%-69%: | ||||||
| no definition | 0%-69%: | ||||||
| no definition | 0%-69%: | ||||||
| no definition | 0%-69%: | ||||||
| no definition | 0%-69%: | ||||||
| no definition | |||||||
| PR | 30~99BPM: | ||||||
| ±2BPM | 30~99BPM: | ||||||
| ±2BPM | 30~99BPM: | ||||||
| ±2BPM | 30~99BPM: | ||||||
| ±2BPM | 30~99BPM: | ||||||
| ±2BPM | 30~99BPM: | ||||||
| ±2BPM | |||||||
| PR | 100~235BPM: | ||||||
| ±2% | 100~235BPM: | ||||||
| ±2% | 100~235BPM: | ||||||
| ±2% | 100~235BPM: | ||||||
| ±2% | 100~235BPM: | ||||||
| ±2% | 100~235BPM: | ||||||
| ±2% | |||||||
| Resolution | SpO₂ | 1% | 1% | 1% | 1% | 1% | 1% |
| PR | 1BPM | 1BPM | 1BPM | 1BPM | 1BPM | 1BPM | |
| Display Screen | LED | OLED | OLED | OLED | LED | OLED | |
| Pulse rate tone | |||||||
| modulation function | N | N | Y | Y | N | N | |
| The shape and size of | |||||||
| shell | Although the proposed devices have different appearances, their sizes are similar. Please see the pictures of each model of the proposed device for the differences in appearance. |
3
remarket Notification 510(k) Submission - Section 3 510(K) Summar
3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device |
|---|---|---|
| Device Name | Fingertip Pulse Oximeter MD300C series | Finger Pulse Oximeter (K051107) |
| Model | MD300C series: MD300C1/MD300C2/MD300CF3 | |
| /MD300CF61MD300C61/MD300C63 | Onyx® II Model 9550 | |
| Regulation No. | 21 CFR 870.2700 | 21 CFR 870.2700 |
| Classification | II | II |
| Classification Name | Oximeter | Oximeter |
| Product Code | DQA | DQA |
| Indications for Use | The Fingertip Pulse Oximeters, MD300C series, are | |
| portable, non-invasive devices intended for spot | ||
| checking of arterial hemoglobin oxygen saturation | ||
| (SpO2) and pulse rate of adult and pediatric patient at | ||
| hospital (including clinical use in internist/surgery, | ||
| Anesthesia, and intensive care units)." | The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a | |
| small, lightweight portable device indicated for use in | ||
| measuring and displaying functional oxygen saturation of | ||
| arterial hemoglobin (SpO2) and pulse rate. It is intended for | ||
| spotchecking of adult and pediatric patients on fingers (other | ||
| than the thumb) between 0.3 - 1.0 inch (0.8-2.5 cm) thick. The | ||
| index finger is the recommended site. | ||
| Comparison Statement | The proposed devices have the same indications for use and classification. | |
| Components | The applicant device consists of detector and emitter | |
| LED, signal amplify unit, CPU, data display unit and | ||
| power unit | photo detector, LED, signal amplify unit, CPU, display unit | |
| and power unit |
able 3-2 Comparison Table
4
. . . .
3-5
.
5
| emarket Notification 510(k) Submission - Section 3 510(K) Summary | |||
|---|---|---|---|
| SpO2 resolution | 1% | 1% | |
| PR Display Range | 0-254bpm | 18-321bpm | |
| PR Accuracy | ±2bpm (30-99bpm) and 2% (100-235bpm) | ±3% (20-250 BPM) | |
| PR resolution | 1bpm | 1 bpm | |
| Operating | |||
| temperature | 5℃~40℃ | 0°C~40 °C | |
| Relative humidity | ≤80% (operating) | ||
| ≤93% (storage) | 10%~90% (operating) | ||
| 10%~95% (storage) | |||
| Atmosphere | |||
| pressure | 86kPa~106kPa | Up to 40,000 feet | |
| pulse rate tone | |||
| modulation function | Available: MD300CF3、MD300CF61 | ||
| Not Available: MD300C1、MD300C2、MD300C61、MD300C63 | Not Available | ||
| Comparison Statement | The applicant device has similar device specifications as the predicate device. | ||
| Battery | |||
| cover | ABS | ABS | |
| Contacting | |||
| Material | Fingertip | ||
| Cushion | Medical Silicon gel | Medical Silicon gel | |
| Enclosure | ABS | ABS | |
| Comparison Statement | The contacting materials of applicant device are as same as that of the predicate device. | ||
| Performance | |||
| Testing | The bench tests include Test for Pulse signal strength | ||
| Indicator Bar、Pulse rate and SpO2 accuracy test for 3000 | |||
| cycles Cleaning. Test for Random vibration, wide band and | |||
| Test according to ISO9919. All the bench test results are | |||
| provided in Performance Testing-Bench | |||
| Bench Test | Meet the requirements of FDA Guidance | ||
| Clinical Test | Conformed to ISO 9919 | ||
| Conformed to ISO 9919 |
ket Notification 510(k) Submission - Section 3 510(K) Summary
.
6
is and the same of the second of the states of the states of the country of the country of the country of the country of the country of the country of the country of the coun
.
.
3-7
7
| rket Notification 510(k) Submission - Section 3 510(K) Summary | Label and Labeling | |
|---|---|---|
| Animal skin irritation test | No evidence of significant | |
| irritation from the test extract | ||
| to rabbits | Compliance with FDA guidance | |
| In Vitro Cytotoxicity | No cytotoxic potential | |
| Skin Irritation Test | No evidence of causing | |
| sensitization | ||
| Animal skin irritation test | No evidence of significant | |
| irritation from the test extract | ||
| to rabbits | Compliance with FDA guidance | |
| ABS plastic |
. .
・
8
3.6 Intended Use
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).
3.7 Test
Non-clinical Test
The Fingertip Pulse Oximeters MD300C series are designed and tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC 60601 1 Medical Electrical Equipment Partl : General requirements for safety. ●
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1: General requirements 0 for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
- � ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
The Software Validation is in compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices".
| No. | Test Name |
|---|---|
| 1 | Broad-band Vibration Test |
| 2 | Pulse rate and SpO2 Accuracy Test for 3000 cycles' cleaning |
| 3 | System Performance Test |
| 4 | Shelf life Test |
| 5 | Test for Pulse Signal Strength Indicator Bar |
| 6 | Performance Test according to ISO 9919 |
| 7 | Electromagnetic Compatibility Test According to IEC 60601-1-2 |
| 8 | Electrical Safety Test According to IEC 60601-1 |
| 9 | Irritation、Sensitization and Cytotoxicity Test according to ISO 10993 |
The list of non-clinical test performed on the proposed device.
The test results indicate that the safety and effectiveness of the proposed devices is identical to that of the predicate device.
9
Clinical Test
The Fingertip Pulse Oximeters MD300C1 / MD300CF3/ MD300CF3/ MD300CF61 / MD300C61 / MD300C63 share the same pulse oximeter sensor and oxygen saturation module. So we considered a clinical test of one of the proposed devices could cover that of other devices. The clinical test of other proposed devices can be exempted. And we conducted clinical test for one of the proposed devices, and the model is MD300C63.
The Clinical Test was conducted according to ISO 9919:2005, Annex EE.2 in the lab of the first affiliated hospital, Sun Yat-sen University. The study protocol was subjected to ISO 9919:2005 Annex EE. Procedures of testing required in EE2 were adopted.
Subjects:
After Institutional Review Board (IRB) approval, 12 healthy adult volunteer subjects (ages 21-31yr, 45-78kg, with light to dark pigmentation) were included in the study conducted to evaluate the SpO2 accuracy performance.
Methods:
Each system was evaluated during steady state / non-motion conditions with various levels of induced hypoxia resulting in stable oxygen saturation levels between 100% and 70% SaO2. Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison.
Adverse events and complications:
There are no adverse events during the clinical test.
Conclusion:
The results of the study provide supporting evidence that the MD300C63 Fingertip Pulse Oximeter is compliance to the accuracy specification claimed by the manufacturer. The Fingertip Pulse Oximeter can be used under steady state / non-motion conditions for the range 70-100%.
3.8 Determination of substantial equivalence
The proposed devices of Finger Pulse Oximeters MD300C series have the 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 differences only exist in display screen、 SpO2 and PR display range、appearance and audible/visual indicator and pulse rate tone modulation functions. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.
10
Image /page/10/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 curved lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the eagle. The text is in all capital letters and is arranged in a circular fashion to match the border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
Beijing Choice Electric Technology Company, Limited Mr. Lei Chen Quality Director North Building 3F. No. 9 Shuangyuan Road, Badachu Hi-tech Zone. Shijingshan District Beijing China 100041
Re: K130947
Trade/Device Name: Fingertip Pulse Oximeter MD300C1, MD300CF3. MD300CF61, MD300C61, and MD300C63 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 30, 2013 Received: September 3, 2013
Dear Mr. Chen:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.
If your device is classified (see above) into cither 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.
11
Page 2 - Mr. Chen
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 (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.
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.goy/MedicalDevices/ResourcesforYou/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/McdicalDevices/Safety/ReportaProhlem/gletault.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/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Tejashri R
Clinical D
DAGRID
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
12
Section 2 Indications for Use Statement
Indications for Use
510(k) Number (if known): Fingertip Pulse Oximeter MD300C1、MD300C2、MD300CF3、 Device Name: ___ MD300CF61、MD300C61、MD300C63
Indications for Use:
The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units).
Prescription Use __ イ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nayan J. Patel -S
2013.10.02 16:54:45
-04'00'
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