(15 days)
Not Found
No
The description explicitly states that the analysis is "mathematical analyses" and does not mention any AI or ML techniques. The performance studies focus on standard software verification and comparative testing against a predicate device, not on training or evaluating an AI/ML model.
No.
The device is used for monitoring and analysis of physiological parameters, not for treating a condition.
No
The "Intended Use / Indications for Use" section explicitly states: "The mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis."
No
The device description explicitly states it includes a "USB plug and play hardware device including an electronic box and reusable Adult SpO2 probe," indicating it is not software-only.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using a probe. It then performs mathematical analysis on the resulting waveforms.
- Intended Use: The intended use is for spot checking/monitoring SpO2 and pulse rate, and analyzing the pulse waveform and heart rate variability. Crucially, the document explicitly states that the mathematical analysis of Photoelectrical Plethysmography and HRV are not intended use for diagnosis.
- Sample Type: The device does not analyze samples taken from the body (like blood or urine). It analyzes signals from the body.
Therefore, because the device does not perform tests on samples taken from the body and its analytical features are explicitly stated as not for diagnosis, it does not fit the definition of an In Vitro Diagnostic device. It is a physiological monitoring and analysis device.
N/A
Intended Use / Indications for 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 analyses 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 ESO software.
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 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 use in support life and not for continuously monitoring The system will be use by practitioner.
Product codes (comma separated list FDA assigned to the subject device)
DQA, MWI
Device Description
- USB plug and play hardware device including an electronic box and reusable Adult SpO2 probe
- Software installed on a computer.
Description of the features - Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude.
- Mathematical analysis of the pulse waveform (photoelectrical Plethysmograph' feature).
- Mathematical analysis of the Heart Rate Variability (HRV 'feature).
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 subjects (> 20 years old)
Intended User / Care Setting
licensed practitioner's office
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)
- Calibration tests (simulator oximeter)
- The OEM subcontractor provided the oximeter, sensor, cable connections and software code source and they were cleared for use together.
- Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database)
- Peer reviews for the photoelectrical plethysmography mathematical analysis.
- Peer review reference for the heart rate variability mathematical analysis.
Discussion of Clinical Test performed for the E.S.O:
Since the ES Teck do not required clinical tests.
The HRV and photoelectrical plethysmography analysis are only mathematical analysis and have not been approved by FDA for a specific clinical diagnosis in any device, so that is for reference only, therefore, no clinical validation is required for E.S.O.
Use of the published clinical investigations of the photoelectrical plethysmography and HRV mathematical analysis:
For interpretation of the results we use some published clinical investigations. These clinical investigations had been made with materials using the same technology (Pulse oximeter) and the same anatomical site (fingertip).
The fact to detect the heart rate from the oximeter wave form analysis and not from the EKG module does not affect the performances and the effectiveness of the E.S.O as shown by the peer review and comparative testing between EKG RR intervals (from predicate device) and SP02 RR intervals (from E.S.O) in one hand, and in second hand, comparative HRV analysis results from the predicate device and E.S.O.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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SEP 1 0 2010
L.D Technology LLC.
510(k) Premarket Notification Number: Preparation date: July, 02 2010
510(k) Summary Electro Sensor Oxi / E.S.O
Name of the device: Electro Sensor Oxi Common name: E.S.O Pulse oximeter/Photoelectrical Plethysmograph/Heart Rate variability Regulation number: 21 CFR 870 2700 Product Codc: DQA Classification: Class II Classification Advisory: Cardiovascular/Anesthesiology
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 Owner of LD Technology: MAAREK Albert Address: L.D Technology 100 N.Biscayne Blvd, Suite 500 . Miami, FL, 33132, USA Tel: 305-379-9900 E mail: albert.ldteck@gmail.com
2. Device Name / Classification
Electro Sensor Oxi System components : 21 CFR 870 2700 Product Code: DQA Classification: Class II Classification Panel: Cardiovascular /Anesthesiology
3. Predicate legally marketed device
-
Fredicate regally marketed avile
Electro Sensor Teck (Model PEMS) K083229 Applicant: LD Technology LLC Product code MW. 4. Device Description -
Device Description
- USB plug and play hardware device including an electronic box and reusable Adult SpO2 probe ●
- Software installed on a computer.
1
Description of the features
- Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude. .
- Mathematical analysis of the pulse waveform (photoelectrical Plethysmograph' feature). .
- Mathematical analysis of the Heart Rate Variability (HRV 'feature). .
5. Intended use and indications for 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 analyses 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 ES Teck software.
The device is intended use only for adult subjects (> 20 years old)
This Oximeter is intended to be used in spot-checking (2 minutes)
The device is intended 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 use in support life and not for continuously monitoring The system will be use by practitioner.
The system will be use by practitioner.
6. Performances, specifications and materials
Technical specifications I.e. Device description
Software specifications
The system carries out the following operations:
Image /page/1/Figure/20 description: The image shows a block diagram of a system. The diagram includes blocks labeled "HARDWARE", "PROTOCOL COMMUNICATION", "SpO2 %", "Pulse wave", "Photoelectrical plethysmography analysis", "Heart rate", "Heart rate variability analysis", and "BACK UP". Arrows connect the blocks to show the flow of information.
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7. Contra-indications
- Patients undergoing external defibrillation .
- Patients connected to electronic life support devices, or any implanted electronic device. .
- Do not use this device in the presence of magnetic resonance imaging (MR or MRI) . equipment. MRI equipment may cause induced current to the SpO2 sensor resulting in patient injury.
- This device should not be used on pregnant women. The effects on the fetus, as well as . accuracy of readings are unknown.
- . When using the finger probe, utilize the arm not in use for blood pressures, arterial lines, or having an AV fistula or pressure dressing.
- Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo . carmine, and fluorescein
- Significant levels of dysfunctional hemoglobins, such as carboxyhemoglogin or . methhemoglobin, will affect the accuracy of the SpO2 measurement.
- Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes . in systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings
- Operation of this device may be adversely affected in the presence of strong . electromagnetic sources, such as electro surgery equipment.
- Operation of this device may be adversely affected in the presence of computed . tomography (CT) equipment.
- Do not use this device in the presence of flammable anaesthetics; a spark hazard exists . which may result in explosion.
- Fingernail polish or false fingernails: Fingernail polish or false fingernails may cause . inaccurate SpO2 readings.
8. Undesirable side effects:
Side effects or adverse reactions are none known to date.
9. Substantial equivalence
Predicate legally marketed device
Freureate regaily mai Reted device
Electro Sensor Teck (Model PEMS) K083229 Applicant: LD Technology LLC. Product code MWI
Similarities:
- Substantial equivalence
- Same intended use
- Same technological characteristics as the predicate device
- √ Same safety and effectiveness
New characteristic:
- V The Heart rate detection comes from the oximeter wave form analysis (a/a from SDPTG) and not from the EKG device.
I . . .
3
11. Performances and Effectiveness
-
Calibration tests (simulator oximeter)
-
The OEM subcontractor provided the oximeter, sensor, cable connections and software code source and they were cleared for use together.
16102442 Pa 4 of 5
-
Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database)
-
Peer reviews for the photoelectrical plethysmography mathematical analysis.
-
Peer review reference for the heart rate variability mathematical analysis.
Discussion of Clinical Test performed for the E.S.O:
Since the ES Teck do not required clinical tests.
The HRV and photoelectrical plethysmography analysis are only mathematical analysis and have not been approved by FDA for a specific clinical diagnosis in any device, so that is for reference only, therefore, no clinical validation is required for E.S.O.
Use of the published clinical investigations of the photoelectrical plethysmography and HRV mathematical analysis:
For interpretation of the results we use some published clinical investigations. These clinical investigations had been made with materials using the same technology (Pulse oximeter) and the same anatomical site (fingertip).
The fact to detect the heart rate from the oximeter wave form analysis and not from the EKG module does not affect the performances and the effectiveness of the E.S.O as shown by the peer review and comparative testing between EKG RR intervals (from predicate device) and SP02 RR intervals (from E.S.O) in one hand, and in second hand, comparative HRV analysis results from the predicate device and E.S.O.
- General Safety Concerns
The fact to remove the EKG PCB does not change the general safety to the legally marketed predicate device as shown in the laboratory tests reports of the E.S.O. system (IEC 60601-1-2 and IEC 60601-1-1).
13. Standards
AAMI EC57-1998(R) 2003 Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms
IEC60601-1-1 Issued: 2000/12/14 Ed: 2 Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems
Conateral standard. Daret Todaller. 2 Medical Electrical Equipment Part 1-2: General IDC 00001 P D Issued. Doollateral Standard: Electromagnetic Compatibility - Req. and Tests - Including Section 6 manual review
ISO9919 (From OEM subcontractor) Issued: 2005/03/15 Ed: 2 Medical electrical 1309717 (1 rom OBM sabellings for the basic safety and essential performance of pulse oximeter equipment for medical use
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Conclusions
E.S.O is equivalent in performances, technology, safety and efficacy to the legally marketed predicate device.
Signature:
Image /page/4/Picture/4 description: The image shows a black and white photograph of what appears to be a field or landscape. There are several rows of what could be crops or plants, and they are arranged in a linear fashion. The image quality is not very clear, and the details are difficult to discern.
Albert MAAREK
Premarket notification [510K] Number: K102442
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 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 representing the department's mission. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
L.D. Technology, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC Responsible Third Party Official 1394 25th Street, NW Buffalo, Minnesota 55313
SEP 1 0 2010
K102442 Re:
Trade/Device Name: E.S.O. (Electro Sensor Oxi) Regulatory Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA, MWI Dated: August 25, 2010 Received: August 26, 2010
Dear Mr. Job:
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 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 - Mr. Mark Job
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
WMad
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number: Klo 2442
Device Name: E.S.O (Electro Sensor Oxi)
Indications for Use:
-
To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. ...
SEP 1 0 2010 -
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 analyses 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 ESO software.
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 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 use in support life and not for continuously monitoring The system will be use by practitioner.
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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K102442 |