(97 days)
No
The description explicitly states that the system only provides "mathematical analysis" of the input values and does not mention any AI or ML techniques.
No.
The "Intended Use / Indications for Use" section explicitly states that the system "only provides mathematical analysis of input PTG values" and that "It is practitioner to make proper judgement based on these values." It also mentions, "The system only provides mathematical analysis of input PTG values" and "The device is not intended for use in support life and not for continuously monitoring." This indicates that the device is for analysis and monitoring, not for direct treatment or therapy.
Yes
The device is described as an "Oxi-W system" that performs "mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition" and "mathematical analysis of the heart rate to the autonomic nervous system function." It also "provides a visual alarm for the heart rate and/or SpO2 percent out of the normal range." These functions indicate the device takes measurements and analyzes them to provide information about a patient's physiological state, which is characteristic of a diagnostic device. While it states it only provides "mathematical analysis" and the "practitioner to make proper judgement," the analysis itself aims to provide insights into health conditions.
No
The device description explicitly states that the Oxi-W System is a programmable electro medical system (PEMS) including both a pulse oximeter (hardware) and software installed on a computer. The hardware component collects data and transmits it to the software.
Based on the provided information, the Oxi-W system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically involves blood, urine, tissue, or other biological specimens.
- The Oxi-W system analyzes data obtained from the human body without taking a sample. It uses a pulse oximeter to measure SpO2 and pulse rate non-invasively through the skin (specifically, the index finger). The software then performs mathematical analysis on the photoplethysmography (PTG) waveform.
The device is a non-invasive physiological monitoring device that provides information about oxygen saturation, pulse rate, microvascular condition, and autonomic nervous system function based on the analysis of the pulse waveform. It does not involve the analysis of biological samples in a laboratory setting, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
Oxi-W system is intended for use:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.
To analyze the basic rhythms of the NN or RR intert rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate to the autonomic nervous system function.
The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).
The device is intended for use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended for use in support life and not for continuously monitoring
The system will be used by practitioner.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA
Device Description
The Oxi-W System is a programmable electro medical system (PEMS) including:
- Pulse oximeter with data transmission via Bluetooth. -
- -Software installed on a computer
Hardware :
- collects SpO2%, pulse rate value and vertical bar graph pulse amplitude -
(photoplethysmography) and sends the encrypted numbers to the Software.
Software:
- Display SP02%, and photoplethysmography. -
- Mathematical analysis of the pulse waveform (Photoplethysmography) using the first and second derivative of the wave to provide values related to the microvascular condition.
- Mathematical analysis of the pulse waveform (Photoplethysmography) to detect the heart rate and provides values of the heart rate variability related to the autonomic nervous system function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmography (PTG)
Anatomical Site
Index finger
Indicated Patient Age Range
adult subjects (> 20 years old)
Intended User / Care Setting
licensed practitioner's office, used by practitioner. Not intended for home, hospital, or out-of-hospital transport.
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)
Clinical Test:
Since the Oxi W algorithms and hardware have the same intended use and results as the predicate device, the Oxi-W does not require clinical tests since the predicate device does not provide any clinical Test.
Oxi_W testing:
- Laboratory tests
IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) + AM1 (2012), Medical -Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance.
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.
ISO 80601-2-61:2011 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. - CRC (Cyclic redundancy check) Coding was performing to demonstrate the software performance to accurately capture, store, and analyze the data measured by the hardware
- Calibration tests (simulator oximeter)
- Software verification and validation(SRS/SDS/STD/STR)
- Bluetooth testing and cybersecurity risk analysis according to the FDA Wireless Guidance (2014), Cybersecurity Guidance (2013) and Design of Bluetooth version 4.0 white paper and FDA released a Safety Communication on March 3,2020.
Key results: Based on the tests, the differences in technological characteristics of the proposed device compared to the predicate device do not affect its performance, safety, and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PR Accuracy: +3
SpO2% accuracy: 70%100%:±2% , 069%, unspecified
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.
LD-Oxi system cleared under K160956
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.
PC-60 NW Fingertip Oximeter cleared under K120502
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LD Technology LLC Albert MAAREK Quality Manager 100 N. Biscayne Blvd Suite 502 Miami, Florida 33132
Re: K200141
Trade/Device Name: Oxi-W System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA Dated: March 31, 2020 Received: April 1, 2020
Dear Albert MAAREK:
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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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
2
Indications for Use
510(k) Number
Device Name
Oxi-W system
Indications for Use (Describe)
Oxi-W system is intended for use:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate.
To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.
To analyze the basic rhythms of the NN or RR intert rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate to the autonomic nervous system function.
The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes).
The device is intended for use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport
The device is not intended for use in support life and not for continuously monitoring
The system will be used by practitioner.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for LD Technology. The logo consists of a green plant inside of a circle on the left, and the words "LD Technology" in a light green color on the right. The text is in a serif font and is slightly italicized.
510(k) Premarket Notification Number: date: April,17,2019
510(k) Summary K200141
Oxi-W system
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
1. Submitter's Identification:
| Manufacturer | : L.D TECHNOLOGY |
|---|---|
| Address | : 100 N. Biscayne Blvd, Suite 502 Miami, FL, 33132, USA |
| Tel | : 305-379-9900 |
| : albert.ldteck@gmail.com |
2. Device Name / Classification
| Trade name | : Oxi_W system |
|---|---|
| Device Common Name | : Cardiac Monitor |
| Regulation Number | : 21 CFR 870.2300 |
| Product Codes | : MWI, DQA |
| Classification | : Class II |
| Classification Panel | : Anesthesiology |
3. Predicate legally marketed devices
| Primary Predicate Device | : LD-Oxi system cleared under K160956 |
|---|---|
| Applicant | : LD Technology LLC . |
| Product code s | : MWI and DQA |
| Reference Device | :PC-60 NW Fingertip Oximeter cleared under K120502 |
| Applicant | : Shenzhen creative industry Co .Ltd |
| Product code | : DQA |
4. Device Description
The Oxi-W System is a programmable electro medical system (PEMS) including:
- Pulse oximeter with data transmission via Bluetooth. -
- -Software installed on a computer
4
Description of the features
Hardware :
- collects SpO2%, pulse rate value and vertical bar graph pulse amplitude -
(photoplethysmography) and sends the encrypted numbers to the Software.
Software:
- Display SP02%, and photoplethysmography. -
- Mathematical analysis of the pulse waveform (Photoplethysmography) using the first and second derivative of the wave to provide values related to the microvascular condition.
- Mathematical analysis of the pulse waveform (Photoplethysmography) to detect the heart rate and provides values of the heart rate variability related to the autonomic nervous system function.
Software specifications
The system carries out the following operations:
Image /page/4/Figure/12 description: The image shows a block diagram of a system. The diagram includes blocks labeled "BACK UP", "Derivatives", "Photoelectrical plethysmography analysis", "Heart rate", "SpO2 %", "Pulse wave", "Heart rate variability analysis", "PROTOCOL COMMUNICATION", and "HARDWARE". Arrows connect the blocks, indicating the flow of information or processes within the system.
5. Intended use and indications for use
Oxi-W system is intended for use:
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition.
To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function. The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values.
5
The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission.
The data are stored in PC in the Backup system of the Oxi-W software.
The device is intended for use only for adult subjects (> 20 years old)
This Oximeter is intended to be used in spot-checking (5 minutes).
The device is intended for use in licensed practitioner's office
This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended for use in support life and not for continuously monitoring The system will be used by practitioner.
6. Device specifications and comparison with predicate device.
| Specifications | LD-OXI system K K160956 | Oxi-W system | Comparison |
|---|---|---|---|
| Intended use | To spot check or monitor Oxygen | ||
| saturation of arterial hemoglobin | |||
| (SpO2%) and pulse rate. | |||
| To analyze the pulse waveform | |||
| (Photoelectrical Plethysmography or | |||
| PP) provided by the oximeter. It only | |||
| provides mathematical analyses of | |||
| the input of the SpO2 measurement. |
To analyze the basic rhythms of the
NN or RR intervals in heart rate, both
in the time domain and in the
frequency domain (short time 5
minutes). It only provides
mathematical analysis of the input of
the heart rate variability.
The mathematical analysis of
Photoelectrical Plethysmography and
HRV ARE NOT intended use for
diagnosis.
The software provides a visual alarm
for the values of the heart rate and/or
SpO2 percent out of the normal range
and for the bad quality signal
transmission.
The data are stored in PC in the
Backup system of the LD-Oxi
software. | To spot check or monitor Oxygen
saturation of arterial hemoglobin
(SpO2%) and pulse rate.
To analyze the pulse waveform
(Photoplethysmography or PPG)
provided by the oximeter. It only
provides mathematical analysis of the
input of the PTG using the first and
second derivatives of the PTG values
related to the microvascular
condition.
To analyze the basic rhythms of the
NN or RR intervals in heart rate from
the PTG, both in the time domain and
in the frequency domain (short time 5
minutes). It only provides
mathematical analysis of the heart
rate variability values related to the
autonomic nervous system function.
The system only provides
mathematical analysis of the input
PTG values. It is the practitioner's
responsibility to make proper
judgement based on these values.
The software provides a visual alarm
for the values of the heart rate and/or
SpO2 percent out of the normal range
and for the bad quality signal
transmission. The data are stored in
PC in the Backup system of the Oxi-W
software. | Difference (1) |
6.1 Intended use and indication for use comparison
6
| Indication and
Prescription for
use | The device is intended for use only for
adult subjects (> 20 years old) This
Oximeter is intended to be used in
spot-checking (5 minutes) The
device is intended for use in licensed
practitioner's office
This device is no intended to be used
at home, in hospital or out-of-
hospital transport
The device is not intended for use in
support life and not for continuously
monitoring
The system will be use by practitioner. | The device is intended for use only for
adult subjects (> 20 years old)
This Oximeter is intended to be used
in spot-checking (5 minutes).
The device is intended for use in
licensed practitioner's office
This device is no intended to be used
at home, in hospital or out-of-hospital
transport
The device is not intended for use in
support life and not for continuously
monitoring
The system will be used by
practitioner. | Only grammatical corrections |
| ------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------ |
|---|
6.2 Software specification and comparison with predicate device
| Specifications | LD-OXI software K K160956 | Oxi-W software | Comparison |
|---|---|---|---|
| Software | |||
| measurements | |||
| and Results | SpO2%, Pulse rate, | ||
| Photoplethysmography, Heart rate | |||
| variability analysis at rest and using | |||
| Ewing tests, Photoplethysmography | |||
| Second derivative analysis. | SpO2%, Pulse rate, | ||
| Photoplethysmography, Heart rate | |||
| variability analysis at rest and using | |||
| Ewing tests, Photoplethysmography | |||
| Second derivative analysis | Same | ||
| Data transmitted | |||
| by the hardware | SpO2%, Pulse rate, | ||
| Photoplethysmography, | SpO2%, Pulse rate, | ||
| Photoplethysmography, | Same | ||
| Mode of data | |||
| reception | USB port of the PC | Hardware Bluetooth microcontroller | |
| to PC | Difference (2). |
6.3 Hardware specifications and comparison with reference predicate device.
| Specifications | LD-OXI hardware K160956 | PC-60NW K120502 | Comparison |
|---|---|---|---|
| Scientific | |||
| Background | Based on the red and infrared light | ||
| absorption characteristics of | |||
| oxygenated and deoxygenated | |||
| hemoglobin. | Based on the red and infrared light | ||
| absorption characteristics of | |||
| oxygenated and deoxygenated | |||
| hemoglobin. | Same | ||
| Material in | |||
| contact with the | |||
| patient | Reusable SPo2 probe Thermoplastic | ||
| polyurethane (TPU) material and latex | |||
| free | Reusable SPo2 probe Thermoplastic | ||
| polyurethane (TPU) material and latex | |||
| free | Same | ||
| Placement of the | |||
| probe | Index finger | Index finger | Same |
| Classification | Class II | Class II | Same |
| Degree of | |||
| protection | |||
| against electric | |||
| shocks | BF | BF | Same |
| Operating mode | Continuous use | Continuous use | Same |
7
| Features | To spot check or monitor Oxygen
saturation of arterial hemoglobin,
pulse rate and photoplethysmography
for 5 minutes and transmission of the
data to a software for mathematical
analysis. | To spot check or monitor Oxygen
saturation of arterial hemoglobin,
pulse rate and photoplethysmography
for 5 minutes and transmission of the
data to a software for mathematical
analysis. | Same |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Power supply | Lithium battery 3.7 V rechargeable by
USB port | 2 x LR03 (AAA) alkaline batteries 3V | Difference (3) |
| IR light
Wavelength | 880nm +/- 10 | 890 nm +/- 10 | Same , the small different does not
change the reading according to the
tolerance +/- 10 |
| RED light
Wavelength | 660nm +/- 10 | 663 nm +/- 10 | Same , the small different does not
change the reading according to the
tolerance +/- 10 |
| Pulse rate (PR)
Range | 30235 bpm | 30235 bpm | Same |
| PR Accuracy | +3 | +3 | Same |
| SpO2%
accuracy | 70%100%:±2% , 069%, unspecified | 70%100%:±2% , 069%, unspecified | Same |
| Data
transmission | USB | Bluetooth | Difference(4) |
| Standard met | 60601-1 3rd Ed
60601-1-2 3rd Ed
ISO 80601-2-61 | 60601-1 3rd Ed
60601-1-2 3rd Ed
ISO 80601-2-61 | Same |
| Module oximeter
Circuit board and
components | OEM (K090671)
USB microcontroller
Circuit board integrated to the probe | OEM (K120502)
Bluetooth microcontroller (Soc)
Circuit board integrated to the probe | Difference (5) for the
microcontroller. |
| Data
transmission
Speed | 19200 Bauds | 19200 Bauds | Same |
7. Substantial equivalence
Predicate legally marketed device
LD-Oxi system K K160956 Applicant: LD Technology LLC. Product code MWI, DQA
Similarities:
- Has the same intended and indication for use ( I.e. details analysis of the intended use > writing),
-
Same technological characteristics as the predicate device
-
Same safety and effectiveness
-
Has the same material in contact with the patient
-
Do not affect the Fundamental Scientific Technology
-
Do not change the prescription use
Differences:
Difference (1) The new writing of the intended use is NOT a change or a new intended use, it is only to clarify the reading of the intended use and the utility of the device.
8
The sentence "To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement".
Was replaced by :
To analyze the pulse waveform (Photoplethysmography or PPG) provided by the oximeter. It only provides mathematical analysis of the input of the PPG using the first and second derivatives of the PTG values related to the vascular microcirculation condition.
Reason of replacement:
- a) The word Photoplethysmography or PPG is used in peer reviews regarding the technology and therefore, it is commonly understood by the user.
- b) The sentence "mathematical analyses of the input of the SpO2 measurement" is not clear. In fact, the software performs a mathematical analysis of the pulse waveform (PPG) and not of the SPo2 measurement. The mathematical analysis provides the second derivative PPG and the software results come from the detected points ( a,b,c,d and e) of the second derivative PPG.
Therefore, the mathematical analysis will be better understood by the users.
- c) Adding "related to the microvascular condition" is NOT a new intended use, it only clarifies the utility of the performed mathematical analysis of the second derivative PPG.
The sentence "It only provides mathematical analysis of the input of the heart rate variability".
Was replaced by:
It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function.
Reason of replacement:
- Adding "related to the autonomic nervous system function" is NOT a new intended use: it only clarifies the utility of the performed mathematical analysis of the heart rate variability
The sentence "The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis."
Was replaced by:
The system only provides values. It is the practitioner's responsibility to make proper judgements based on these values.
Reason of replacement:
The device provides values related to the autonomic nervous system function and microvascular condition. These values are not intended to provide diagnosis, but only allow the practitioner to judge how those values will be used in the practice.
Difference (2) Mode of Data reception ( Bluetooth vs USB)
Difference (3) Power supply 2 x LR03 (AAA) alkaline batteries 3V vs USB port
Difference (4) and (5) Data transmission Bluetooth versus USB using different microcontrollers.
9
8. Performances and Effectiveness General safety concerns.
Clinical Test:
Since the Oxi W algorithms and hardware have the same intended use and results as the predicate device, the Oxi-W does not require clinical tests since the predicate device does not provide any clinical Test.
Oxi_W testing:
- Laboratory tests
IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) + AM1 (2012), Medical -Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance.
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.
ISO 80601-2-61:2011 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. 2. CRC (Cyclic redundancy check) Coding was performing to demonstrate the software performance to accurately capture, store, and analyze the data measured by the hardware 3. Calibration tests (simulator oximeter)
-
Software verification and validation(SRS/SDS/STD/STR)
-
Bluetooth testing and cybersecurity risk analysis according to the FDA Wireless Guidance (2014), Cybersecurity Guidance (2013) and Design of Bluetooth version 4.0 white paper and FDA released a Safety Communication on March 3,2020.
Difference discussion:
Difference (1) is only to clarify the reading of the intended use and the utility of the device and does not affect the performances and effectiveness and General safety concerns of the proposed device.
Difference (2) requires Software New protocol communication.
The new protocol communication has been verified and validated by the software verification and validation(SRS/SDS/STD/STR) and CRC coding and therefore, does not affect the performances and effectiveness and General safety concerns of the proposed device
Difference (3) regarding the Power supply 2 x LR03 (AAA) alkaline batteries 3V vs USB port Will reduce the risk during the shipping and therefore, does not affect the performances and effectiveness and General safety concerns of the proposed device
Difference (4) and (5) Data transmission Bluetooth versus USB using different microcontrollers. may increase the risk of interference and cybersecurity. The risk of interference and cybersecurity has been tested and evaluated according to according to the FDA Wireless Guidance (2014), Cybersecurity Guidance (2013) and Design of Bluetooth version 4.0 white paper and FDA released a Safety Communication on March 3,2020 and the difference 4 and 5 do not affect the performances and effectiveness and General safety concerns of the proposed device
Therefore, the proposed device using a different cleared hardware than the predicate device does not affect its performance, safety, and effectiveness.
10
Conclusions
In conclusion, the proposed device, Oxi-W system, has the same intended use, and similar technological characteristics compared to the predicate device. The difference in technological characteristics are addressed by performance testing, and do not raise different questions of safety and effectiveness.
Signature:
No text is visible in this image.
Albert MAAREK
Premarket notification [510K] Number: K200141