(300 days)
Not Found
No
The description focuses on standard pulse oximetry technology and does not mention any AI or ML components for data processing or analysis.
No
The device is a diagnostic tool designed to measure and transmit physiological data (SpO2, pulse rate, plethysmographic data) to other compatible devices for monitoring purposes, rather than providing therapy or treatment.
Yes
The device is a diagnostic device because it measures and transmits functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data, which are used to assess a patient's physiological state, particularly for sleep studies.
No
The device description explicitly states it is a "pulse oximeter module" that "contains the electronics to interface to an attached sensor." It also mentions "red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell," indicating physical hardware components for light emission and detection. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SLP OxSAT 100 Patient Oximeter Module measures physiological parameters (oxygen saturation and pulse rate) directly from the patient's body using light transmission through the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it measures and transmits data to compatible PSG and/or HST devices for sleep studies. This is a monitoring function, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the SLP OxSAT 100 is a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
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 sensors to avoid skin contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Digits
Indicated Patient Age Range
Pediatrics and Adults
Intended User / Care Setting
Sleep Study setting and home use
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)
Non-clinical: Bench tests were performed 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 Verification Testing, Testing for compliance to AAMI ES 60601-1, Testing for compliance to IEC 60601-1-2, and Testing for compliance to IEC 80601-2-61. 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2: 70-100% ± 2 digits
Pulse rate: ± 3 digits
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
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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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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 (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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (7/17)
Page 1 of 1
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| Date Prepared: | 1-Apr-20 |
|---|---|
| Sponsor: | Doron D. Patt |
| S.L.P. Ltd | |
| 62 Anilewicz Street | |
| Tel-Aviv, Israel 67060 | |
| Tel: +972 (9) 834 6731 | |
| Proprietary or Trade Name: | OxSAT 100 |
| Common/Usual Name: | Oximeter |
| Classification Name: | Oximeter |
| 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
Module (K043359) | Comments |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 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 low perfusion patients. | The Nonin® Bluetooth® -enabled Model
4100 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
Bluetooth-enabled device. | Similar indications
Both require connection to a
compatible device to display
collected data |
| Type of use | Continuous based on the host device | Spot checking
Continuous | Similar |
| Motion | Non-motion | Non-motion | Similar |
| Patient Population | Pediatrics and Adults | Pediatrics and Adults | Similar |
| Perfusion | Well | Well
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
accuracy range | 20-300 BPM | 18-300 BPM | Similar |
| Sensors | APK - K082846
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
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
(multiple) | 660 and 910 nm | 660 and 910 nm | Similar |
| Functional and safety
testing | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-61 | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-61 | Similar |
| Biocompatibility | The OxSAT 100 Module has not been
tested for biocompatibility.
Accessory sensors have been tested and
are considered
Surface Contact Skin
Limited duration (