LD-Oxi system

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2016 LD Technology LLC Albert Maarek Quality Manager 100 N. Biscayne Blvd. Suite 500 Miami. Florida 33132 Re: K160956 Trade/Device Name: LD-Oxi 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: June 3, 2016 Received: June 6, 2016 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. 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 (reporting of medical devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number K160956 Device Name LD-Oxi- system Indications for Use (Describe) LD-Oxi system is intended 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 analysis 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. 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. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ## 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/0 description: The image shows the logo for LD Technology. The logo consists of a green plant-like design inside of a circle on the left, and the text "LD Technology" on the right. The text is in a light gray color and is slightly italicized. ### L.D Technology LLC. Special 510(k) Premarket Notification Number: Preparation date: March 2, 2016 ### 510(k) Summary LD-Oxi 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 Owner of LD Technology: MAAREK Albert Address: L.D Technology 100 N.Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 Email: albert.ldteck@gmail.com 2. Device Name / Classification LD-Oxi System components: 21 CFR 870.2300 21 CFR 870.2700 Product Codes: MWI and DQA. Classification: Class II Classification Panel: Cardiovascular /Anesthesiology #### 3. Predicate legally marketed device Electro Sensor Oxi (ESO) K102442 Applicant: LD Technology LLC Product codes: MWI and DQA #### 4. Device Description The LD-Oxi System is a programmable electro medical system (PEMS) including: 2 USB plug and play Pulse oximeter device including an electronic circuit and reusable Adult SpO2 probe 2 Software installed on a computer #### Description of the features 网 Displays SpO2%, pulse rate value and vertical bar graph pulse amplitude - (photoplethysmography). ನ Mathematical analysis of the pulse waveform (photoelectrical Plethysmography feature). - Mathematical analysis of the Heart Rate Variability (HRV feature). {4}------------------------------------------------ ### Software specifications The system carries out the following operations: Image /page/4/Figure/2 description: The image is a block diagram showing the flow of information in a system. The system starts with "HARDWARE" at the bottom, followed by "PROTOCOL COMMUNICATION". The "PROTOCOL COMMUNICATION" block feeds into "SpO2 %" and "Pulse wave", which then feed into "Photoelectrical plethysmography analysis". The "Photoelectrical plethysmography analysis" block feeds into "Heart rate", which then feeds into "Heart rate variability analysis". All of these blocks feed into "BACK UP" at the top. #### 5. Intended use and indications for use LD-Oxi system is intended 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 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. 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 not 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 used by practitioner. #### 6. Device specifications and comparison with predicate device | Specifications | ESO | LD-Oxi | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SIMILARITIES | | | | Intended use | To spot check or monitor Oxygen saturation of<br>arterial hemoglobin (SpO2%) and pulse rate.<br>To analyze the pulse waveform (Photoelectrical<br>Plethysmography or PP) provided by the<br>oximeter. It only provides mathematical<br>analyses of the input of the SpO2 measurement.<br>To analyze the basic rhythms of the NN or RR<br>intervals in heart rate, both in the time domain<br>and in the frequency domain (short time 5 | To spot check or monitor Oxygen saturation of<br>arterial hemoglobin (SpO2%) and pulse rate.<br>To analyze the pulse waveform (Photoelectrical<br>Plethysmography or PP) provided by the<br>oximeter. It only provides mathematical<br>analyses of the input of the SpO2 measurement.<br>To analyze the basic rhythms of the NN or RR<br>intervals in heart rate, both in the time domain<br>and in the frequency domain (short time 5 | | | minutes). It only provides mathematical analysis | minutes). It only provides mathematical analysis | | | of the input of the heart rate variability. | of the input of the heart rate variability. | | | The mathematical analysis of Photoelectrical | The mathematical analysis of Photoelectrical | | | Plethysmography and HRV ARE NOT intended | Plethysmography and HRV ARE NOT intended | | | use for diagnosis. | use for diagnosis. | | | The software provides a visual alarm for the | The software provides a visual alarm for the | | | values of the heart rate and/or SpO2 percent out | values of the heart rate and/or SpO2 percent out | | | of the normal range and for the bad quality | of the normal range and for the bad quality | | | signal transmission. The data are stored in PC in | signal transmission. The data are stored in PC in | | | the Backup system of the ESO software. | the Backup system of the ESO software. | | Prescription for use | The device is intended use only for adult | The device is intended use only for adult | | | subjects (> 20 years old) This Oximeter is | subjects (> 20 years old) This Oximeter is | | | intended to be used in spot-checking ( 5 | intended to be used in spot-checking ( 5 | | | minutes) The device is intended use in licensed | minutes) The device is intended use in licensed | | | practitioner's office | practitioner's office | | | This device is no intended to be used at home, in | This device is no intended to be used at home, | | | hospital or out-of-hospital transport | in hospital or out-of-hospital transport | | | The device is not intended use in support life | The device is not intended use in support life | | | and not for continuously monitoring | and not for continuously monitoring | | | The system will be used by practitioner. | The system will be used by practitioner. | | Material in contact with<br>the patient | Reusable SPo2 probe PTU latex free | Reusable SPo2 probe PTU latex free | | Scientific Background | Based on the red and infrared light absorption | Based on the red and infrared light absorption | | | characteristics of oxygenated and deoxygenated | characteristics of oxygenated and deoxygenated | | | hemoglobins. | hemoglobins. | | Placement of the prove | Index finger | Index finger | | Power<br>supply | 5V (power supply by USB port) | 5V (power supply by USB port) | | Classification | Class II | Class II | | Degree of protection<br>against electric shocks | BF | BF | | Operating mode | Continuous use | Continuous use | | IR light features | | | | Wavelength: | 905 +10 nm | 880nm +10 nm | | Radiant Flux: | 2.0mW | 6.75mW | | Spectral Bandwidth: | 50nm | 50nm | | Forward Voltage: | 1.7V | 1.7V | | Reverse Voltage: | 5V | 5V | | RED light features | | | | Wavelength: | 660nm+2nm | 660nm +2nm | | Radiant Flux: | 1.8mW | 6.65mW | | Spectral Bandwidth: | 25nm | 25nm | | Forward Voltage: | 2.4V | 2.4V | | Reverse Voltage: | 5V | 5V | | Pulse wave | | | | Resolution | 1% | 1% | | Signal Strength | 0-15 | 0-15 | | Bargraph | 0-15 | 0-15 | | Plethysmogram | 0 - 100, auto-gained for highest resolution | 0 - 100, auto-gained for highest resolution | | Pulse rate | | | | Measuring NO Alarm<br>Range | 30~235 bpm | 30~235 bpm | | Resolution | 1bpm | 1bpm | | Serial Communication<br>Logic Levels | 3.3V CMOS voltage levels | 3.3V CMOS voltage levels | | Voltage | $+3.3 \pm 0.17$ V DC | $+3.3 \pm 0.17$ V DC | | Average Current | 15mA | 15mA | | <b>DEVICE MODIFICATIONS</b> | | | | Standard met | 60601-1 2nd Ed<br>60601-1-2 2nd Ed<br>ISO 9919 | 60601-1 3th Ed<br>60601-1-2 3th Ed<br>ISO 80601-2-61 | | Module oximeter<br>Circuit board | OEM from Beijing Choice Electronic Technology<br>Co. Ltd.( MD300I k072825) | OEM from Contec medical Ltd (CMS50 E<br>K090671) | | Circuit board size | 128 (L) x 143 (W) x 33 (H) mm | 57(L) × 32(W) × 30 (H) mm | | Circuit board weight | 1.2 Kg | 50 g | | Data transmission<br>Speed | 4800 Bauds | 19200 Bauds | | Probe connection | LEMO | NELLCOR | | Mathematical analysis<br>of the heart rate | At rest | At rest and during Ewing tests | {5}------------------------------------------------ {6}------------------------------------------------ ## 7. Contra-indications ## Σ Patients undergoing external defibrillation - A Patients connected to electronic life support devices, or any implanted electronic device. - 2 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. - 2 When using the finger probe, utilize the arm not in use for blood pressures, arterial lines, or having an AV fistula or pressure dressing. - 2 Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein - Sigmificant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methhemoglobin, will affect the accuracy of the SpO2 measurement. - 2 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 - 2 Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as electro surgery equipment. - 2 Operation of this device may be adversely affected in the presence of computed tomography (CT) equipment. - 2 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. {7}------------------------------------------------ ## 8. Undesirable side effects: Side effects or adverse reactions are none known to date. ## 9. Substantial equivalence Predicate legally marketed device Electro Sensor Oxi K102442 Applicant: LD Technology LLC. Product code MWI ### Similarities: - V Same intended use - V Same technological characteristics as the predicate device - √ Same safety and effectiveness ### New characteristic: - > Size and weight of the circuit board - > Data transmission speed (Baud) - > Probe connection - > Additional mathematical analysis of the heart rate variability during tests. - > Updated standards ### 10. Performances and Effectiveness - 1. Calibration tests (simulator oximeter) 2., Software verification (SRS/SDS/STD/STR/ Software algorithms tests with input data from the MIT-BIH database) - 4. Peer reviews for the photoelectrical plethysmography mathematical analysis. - 5. Peer review reference for the heart rate variability mathematical analysis. The new characteristics: - > Size and weight of the circuit board - Data transmission speed (Baud) - > Probe connection - > Addition mathematical analysis of the heart rate variability during tests. - V Updated standards Do not affect the performances and effectiveness of the modified device # 11. General Safety Concerns I.e.-LD-Oxi Risk management The new characteristics: - √ Size and weight of the circuit board - Data transmission speed (Baud) - V Probe connection - > Addition mathematical analysis of the heart rate variability during tests. - V Updated standards Do not affect the general safety of the modified device as shown by the laboratory testing using the updated standards {8}------------------------------------------------ # 12. Standards - V IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Third Edition December 2006 - > IEC60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Third Edition 05/17/2007 - V IEC 80601-2-61: Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of oximeters. 04/11/2011 - V Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005 - √ ISO 14971: Medical devices Application of risk management to medical devices. March 01 2007 ## Conclusions LD-Oxi is equivalent in performances, technology, safety and efficacy to the legally marketed predicate device. ### Signature: ## Albert MAAREK Premarket notification [510K] Number: k160956