OxSAT 100

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION". S.L.P. Ltd. % Paul Dryden Consultant S.L.P. Ltd. c/o ProMedic, LLC 131 Bay Point Dr. NE. St Petersburg, Florida 67060 Re: K191574 Trade/Device Name: OxSAT 100 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 6, 2019 Received: December 9, 2019 # Dear Paul Dryden: 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. 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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 (if known) # K191574 Device Name OxSAT 100 Indications for Use (Describe) The SLP OxSAT 100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible PSG and/or HST device. It is not intended for use with low perfused patients. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-size: 16px;"> <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |----------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 16px;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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" FORM FDA 3881 (7/17) Page 1 of 1 SC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ | Date Prepared: | 1-Apr-20 | |----------------------------|--------------------------------------------------------------------------------------------------------| | Sponsor: | Doron D. Patt<br>S.L.P. Ltd<br>62 Anilewicz Street<br>Tel-Aviv, Israel 67060<br>Tel: +972 (9) 834 6731 | | Proprietary or Trade Name: | OxSAT 100 | | Common/Usual Name: | Oximeter | | Classification Name: | Oximeter<br>DQA, Class II, CFR 870.2700 | | Predicate Device: | Nonin Model 4100, 510(k) K043359 | # Device Description: The SLP OxSAT 100 is a pulse oximeter module that photoelectrically determines the oxygenation of blood in a part of the body, based upon the sensor placement. The OxSAT 100 contains the electronics to interface to an attached sensor. The red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The OxSAT 100 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), Pulse rate and plethysmographic data to compatible polysomnogram ("PSG") and/or home sleep testing ("HST") devices. Pulse amplitude is not displayed. The OxSAT 100 is powered by the host monitor. The wavelength of red LED is 660nm and Infrared LED is 910 nm with maximum optical output power of less than 1 mW. TThe OxSAT 100 Module is not intended for use with skin contact and, therefore, has not been tested for biocompatibility. The OxSAT 100 is either attached to the outside of a belt on the patient or is set off to the side of the bed. An extension cable might be used with the sensors to avoid skin contact. ### Indications for Use: The SLP OxSAT 100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible PSG and/or HST device. It is not intended for use with low perfused patients. # Contraindications: None ### Substantial Equivalence Discussion Table 1 compares the SLP OxSAT 100 to the predicate device for equivalence of: {4}------------------------------------------------ ## Indications - The SLP OxSAT 100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible PSG and/or HST device. It is not intended for low perfused patients. Discussion - The indications are similar to the predicate Nonin Model 4100 Patient Oximeter Module. The host PSG and/or HST device will dictate the monitoring use. ## Patient Population - Both are intended for pediatrics (3 years and older) and adult populations. # Environment of Use - The environment of use is the same. # Prescriptive - Both are prescriptive. # Design and Technology - The OxSAT 100 contains the electronics to interface to an attached sensor. The red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The OxSAT 100 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. Pulse amplitude is not displayed. The OxSAT 100 is powered by a host monitor. The wavelength of red LED is 660nm and Infrared LED is 910 nm with maximum optical output power of less than 1 mW. Discussion - The proposed device is powered by connection to a compatible device whereas the predicate device is selfpowered and uses Bluetooth to transmit data to a compatible device. In either case no data is displayed by the proposed or predicate device itself. # Performance Specifications - Both have equivalent specifications. ### Compliance with standards - The OxSAT 100 complies with AAMI ANSI ES60601-1, IEC 60601-1-2, and ISO-80601-2-61. The predicate complies with the same standards. ### Performance Testing ### Non-clinical - We have performed bench tests and found that the OxSAT 100 met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following: - Verification Testing - Testing for compliance to AAMI ES 60601-1 - Testing for compliance to IEC 60601-1-2, - Testing for compliance to IEC 80601-2-61 ● {5}------------------------------------------------ The results demonstrate that the device performs as intended and is substantially equivalent to the performance of the predicate and in accordance with applicable standards. #### Biocompatibility and Materials - The only patient contacting materials of the OxSAT 100 are the sensors which have been previously cleared. The OxSAT 100 module is not intended for use with skin contact and, therefore, has not been tested for biocompatibility. The OxSAT 100 is either attached to the outside of a belt on the patient or is set off to the side of the bed. An extension cable might be used with the OxSAT 100 to avoid skin contact. #### Host System Compatibility - Testing demonstrated that the following host PSG and HST systems are compatible with the OxSAT 100. All host systems are considered as capable of continuous measurements. | Host System | K# | Environment | |----------------|---------|-------------------------------| | Embletta PDS | K041904 | Hospital, Sleep Center | | Alice 6 | K040595 | Hospital, Sleep Center, Other | | Alice NightOne | K083874 | Hospital, Sleep Center, Home | | Embla S4500 | K024322 | Hospital, Sleep Center, Other | | Embla N7000 | K024322 | Hospital, Sleep Center, Other | | ApneaLink Air | K143272 | Hospital, Sleep Center, Home | | Compumedics | K000068 | Hospital | | Embletta MPR | K122516 | Hospital, Sleep Center, Home | | Embleeta Gold | K073682 | Hospital, Sleep Center, Home | ### Clinical Testing - Testing to ensure clinical accuracy of the device in accordance with ISO 80601-2-61. This testing and results showed compliance to the standard. ### Differences – The identified difference: - . Data transmission via cable vs. Bluetooth The OxSAT 100 has been evaluated and tested and confirmed that the difference does not raise different questions of safety or effectiveness when compared to the predicate device for the proposed indications for use. #### Substantial Equivalence Conclusion The OxSAT 100 is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. {6}------------------------------------------------ | CHARACTERISTICS | OxSAT 100 | Nonin Model 4100 Patient Oximeter<br>Module (K043359) | Comments | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Indications for use | The SLP OxSAT 100 Patient Oximeter<br>Module is indicated for use in<br>measuring and transmitting functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate, and<br>plethysmographic data to a compatible<br>PSG and/or HST device. It is not<br>intended for low perfusion patients. | The Nonin® Bluetooth® -enabled Model<br>4100 Patient Oximeter Module is indicated<br>for use in measuring and transmitting<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate, and<br>plethysmographic data to a compatible<br>Bluetooth-enabled device. | Similar indications<br>Both require connection to a<br>compatible device to display<br>collected data | | Type of use | Continuous based on the host device | Spot checking<br>Continuous | Similar | | Motion | Non-motion | Non-motion | Similar | | Patient Population | Pediatrics and Adults | Pediatrics and Adults | Similar | | Perfusion | Well | Well<br>Poorly | Similar | | Environment of Use | Sleep Study setting and home use | Sleep study settings and home use | Similar | | Technology | Transmissive | Transmissive | Similar | | System components / Configurations | | | | | Batteries | Powered by compatible device | 2 x 1.5 AAA batteries | Similar | | SpO2 Display Range | 0% to 100% SpO2 | 0% to 100% SpO2 | Similar | | Pulse rate declared<br>accuracy range | 20-300 BPM | 18-300 BPM | Similar | | Sensors | APK - K082846<br>Solaris - K100077 | Nonin sensors | Similar | # Table 1 Device Comnarison {7}------------------------------------------------ # 510(k) Summary Page 5 of 5 | CHARACTERISTICS | OxSAT 100 | Nonin Model 4100 Patient Oximeter<br>Module (K043359) | Comments | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------| | Accuracy | | | | | SpO2 | 70-100% ± 2 digits | 70-100% ± 2 digits | | | Pulse rate | ± 3 digits | ± 3 digits | Similar | | Display | On the compatible device | On the compatible device | | | Data transmission | Direct connection to compatible device | Bluetooth to compatible device | | | Application site | Digits | Digits | Similar | | Operation mode | Depends upon the host device | Spot checking or continuous monitoring | Similar | | LED wavelengths<br>(multiple) | 660 and 910 nm | 660 and 910 nm | Similar | | Functional and safety<br>testing | ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61 | ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>ISO 80601-2-61 | Similar | | Biocompatibility | The OxSAT 100 Module has not been<br>tested for biocompatibility.<br>Accessory sensors have been tested and<br>are considered<br>Surface Contact Skin<br>Limited duration (<24 hours) | Surface contact<br>Skin<br>Limited duration (<24 hours) | Similar |