(144 days)
No
The summary explicitly states that the device does not perform analysis, visualization, or data transform functions, and there is no mention of AI or ML in the text. The analysis software is a separate, previously cleared component.
No.
Explanation: The device is intended for diagnostic evaluation of patients for apnea and snoring, and records data such as airflow and breathing effort. It is explicitly stated that it "does not have the capacity for alarms or the triggering of actions or therapies," indicating it is not a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring."
No
The device description explicitly states that the SAM Model 9-10000 incorporates built-in piezo electric effort and body position sensors and device electronics into a belt-worn enclosure. It also mentions measuring sound/airflow, respiratory effort, and acceleration/position, indicating the presence of hardware components beyond just software.
Based on the provided text, the SNAP Diagnostics SAM Model 9-10000 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Device Function: The SNAP Diagnostics SAM Model 9-10000 records physiological parameters directly from the patient's body (airflow, breathing effort, body position). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to record physiological data as an aid for diagnostic evaluation of patients for apnea and snoring. This is a direct measurement of physiological function, not an analysis of a biological sample.
Therefore, the device falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring.
The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Snap Diagnostics SAM Model 9-10000 is an upgraded version of the Snap Diagnostics Model 8 (K110064, the predicate device) where the only area of change is the data logger component of the Model 8 sleep apnea home sleep test (HST) and recording system. The SAM Model 9-10000 is meant to be used with previously-cleared components of the predicate device including Snap Model 8 accessories and Snap Model 8 analvsis software.
The Snap Diagnostics SAM Model 9-10000 differs from the K110064 predicate in the implementation of built in piezo electric effort and body position sensors rather than using external sensors, incorporation of the device electronics into the belt-worn effort sensor enclosure, and support for external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350).
The Snap Diagnostics SAM Model 9-10000 interfaces with the K110064 predicate analysis software only by way of exporting files using the USB port, and this occurs at Snap Diagnostics or a lab location. The SAM Model 9-10000 cannot transfer files over the internet. These files are identical in format to the files output by the predicate data logger. The K110064 predicate analysis software is unchanged and is not the subject of this 510(k).
Just like the Snap Diagnostics Model 8 predicate device, the Snap Diagnostics SAM Model 9-10000 is designed to be used in the patient's home. A SAM Model 9-10000 with a fully charged battery is delivered to the patient along with accessories. The patient uses the data logger for one or more overnight recordings, then returns the device and accessories to Snap Diagnostics or the lab. A technician retrieves the data from the SAM Model 9-10000 using the USB port. The previously-cleared analysis software (K110064) is then used by a supervising technician to review the data and generate a home sleep test (HST) report. This HST report is sent by Snap Diagnostics to the patient's clinical team, who interpret the HST in the context of other relevant clinical data. Just like for the predicate device, Snap Diaqnostics or a lab wipes the SAM Model 9-10000 of all data, cleans, inspects, and recharges it, and then provides the SAM Model 9-10000 to the next patient for use.
The Snap Diagnostics SAM Model 9-10000 is capable of logging the heart rate and blood oxygenation data from external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350), but does not itself measure or otherwise manipulate those data.
Just like the predicate, the Snap Diagnostics SAM Model 9-10000 itself measures sound/airflow, respiratory effort, and acceleration/position.
The Snap Diagnostics SAM Model 9-10000 data logger does not perform sleep scoring or any other diagnostic, analysis, visualization, or data transform function, nor does the device have the capacity for alarms or the triggering of actions or therapies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.
The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory.
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)
Comparative performance evaluations between the Snap SAM Model 9-10000 and the predicate device, the Snap Model 8 (K110064), demonstrated that the two devices are substantially equivalent in performance.
In addition, comprehensive performance testing according to the following standards and guidelines were conducted:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (Edition 3.2 2020-08 Consolidated Version)
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Edition 2.1 2020-07 Consolidated Version)
- IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests (Edition 4.1 2020-09 Consolidated Version)
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (Fifth Edition 2018-08)
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems (Edition 1.0 2017-02)
Bench testing confirmed that the device met design requirements and the requirements of applicable standards.
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.
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
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
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June 4, 2024
Snap Diagnostics, LLC % Tom Renner Regulatory Consultant Vision28 915 SW Rimrock Way Suite 201-402 Redmond, Oregon 97756
Re: K240100
Trade/Device Name: SAM Model 9-10000 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: April 26, 2024 Received: April 30, 2024
Dear Tom Renner:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of 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
3
Indications for Use
510(k) Number (if known) K240100
Device Name SAM Model 9-10000
Indications for Use (Describe)
The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring.
The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place tory. Both pediatric and adult patients may be tested.
Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.
| 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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4
Contact Details
| Applicant Name: | Snap Diagnostics, LLC |
|---|---|
| Applicant Address: | 616 Atrium Drive Suite 100 |
| Vernon Hills, IL 60061 United States | |
| Applicant Contact: | Dr. Gil Raviv |
| Applicant Contact Telephone: | 847-777-0000 |
| Applicant Contact Email: | gil@snapdiagnostics.com |
| Correspondent Name: | Vision28 |
| Correspondent Address: | 915 SW Rimrock Way Suite 201-402 |
Correspondent Contact: Correspondent Contact Phone: Correspondent Contact Email:
Redmond, OR 97756 United States Tom Renner 541-359-5939 tom@vision28.com
Device Information
| Device Trade Name: | SAM (Model 9-10000) |
|---|---|
| Common Name: | Breathing frequency monitor |
| Classification Name: | Ventilatory Effort Recorder |
| Regulation Number: | 868.2375 |
| Product Code: | MNR |
Legally Marketed Predicate Device
| Predicate #: | K110064 |
|---|---|
| Predicate Trade Name: | Snap Model 8 |
| Product Code: | MNR |
Intended Use/Indications for Use
The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring.
The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
5
Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.
Device Description Summary
The Snap Diagnostics SAM Model 9-10000 is an upgraded version of the Snap Diagnostics Model 8 (K110064, the predicate device) where the only area of change is the data logger component of the Model 8 sleep apnea home sleep test (HST) and recording system. The SAM Model 9-10000 is meant to be used with previously-cleared components of the predicate device including Snap Model 8 accessories and Snap Model 8 analvsis software.
The Snap Diagnostics SAM Model 9-10000 differs from the K110064 predicate in the implementation of built in piezo electric effort and body position sensors rather than using external sensors, incorporation of the device electronics into the belt-worn effort sensor enclosure, and support for external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350).
The Snap Diagnostics SAM Model 9-10000 interfaces with the K110064 predicate analysis software only by way of exporting files using the USB port, and this occurs at Snap Diagnostics or a lab location. The SAM Model 9-10000 cannot transfer files over the internet. These files are identical in format to the files output by the predicate data logger. The K110064 predicate analysis software is unchanged and is not the subject of this 510(k).
Just like the Snap Diagnostics Model 8 predicate device, the Snap Diagnostics SAM Model 9-10000 is designed to be used in the patient's home. A SAM Model 9-10000 with a fully charged battery is delivered to the patient along with accessories. The patient uses the data logger for one or more overnight recordings, then returns the device and accessories to Snap Diagnostics or the lab. A technician retrieves the data from the SAM Model 9-10000 using the USB port. The previously-cleared analysis software (K110064) is then used by a supervising technician to review the data and generate a home sleep test (HST) report. This HST report is sent by Snap Diagnostics to the patient's clinical team, who interpret the HST in the context of other relevant clinical data. Just like for the predicate device, Snap Diaqnostics or a lab wipes the SAM Model 9-10000 of all data, cleans, inspects, and recharges it, and then provides the SAM Model 9-10000 to the next patient for use.
The Snap Diagnostics SAM Model 9-10000 is capable of logging the heart rate and blood oxygenation data from external wrist worn oximeters (Wellue CheckMe Oximeter cleared under K191088 and Nonin 3150 Oximeter cleared under K102350), but does not itself measure or otherwise manipulate those data.
Just like the predicate, the Snap Diagnostics SAM Model 9-10000 itself measures sound/airflow, respiratory effort, and acceleration/position.
6
The Snap Diagnostics SAM Model 9-10000 data logger does not perform sleep scoring or any other diagnostic, analysis, visualization, or data transform function, nor does the device have the capacity for alarms or the triggering of actions or therapies.
Comparisons with the Predicate
l. Indication for Use
The two systems are the same in their regulatory parameters including indications for use, intended population, regulatory class, classification name and product code.
| Snap SAM Model 9-10000 | Snap Model 8 (K110064) | Differences | |
|---|---|---|---|
| Indications for use | The SNAP Diagnostics SAM | ||
| Model 9-10000 device is | |||
| intended to record airflow, | |||
| breathing effort and body | |||
| position and is indicated for use | |||
| as an aid for diagnostic | |||
| evaluation of patients for apnea | |||
| and snoring. | |||
| The SNAP Diagnostics SAM | |||
| Model 9-10000 is not intended | |||
| as a substitute for full | |||
| polysomnography when | |||
| additional parameters such as | |||
| sleep stages or EEG activity | |||
| are required. | |||
| The target population consists | |||
| of patients who are suspected | |||
| of apnea and/or complain | |||
| about snoring. The majority of | |||
| the test procedures will take | |||
| place at the patient's home, | |||
| although some may take place | |||
| in a sleep laboratory. Both | |||
| pediatric and adult patients | |||
| may be tested. | |||
| Use of this device must be | |||
| under the direct supervision of | |||
| a qualified adult (parent or | |||
| guardian) or health care | |||
| practitioner trained in the use of | |||
| the Snap Diagnostics SAM | The Snap Model 8 device is | ||
| indicated for use in the | |||
| diagnostic evaluation of | |||
| patients for apnea and | |||
| snoring and to provide | |||
| quantitative and qualitative | |||
| analysis of apnea and | |||
| snoring. | |||
| The SNAP Model 8 testing | |||
| system is not intended as a | |||
| substitute for full | |||
| polysomnography when | |||
| additional parameters such as | |||
| sleep stages or EEG activity | |||
| are required. | |||
| The target population consists | |||
| of patients who are suspected | |||
| of apnea and/or complain | |||
| about snoring. The majority of | |||
| the test procedures will take | |||
| place at the patient's home, | |||
| although some may take | |||
| place in a sleep laboratory. | |||
| Both pediatric and adult | |||
| patients may be tested. | |||
| CAUTION: US Federal law | |||
| restricts this device to sale by | |||
| or on the order of a physician. | |||
| Use of this device must be | |||
| under the direct supervision of | |||
| a qualified adult (parent or | Minor | ||
| differences: the | |||
| Model 9 IFU | |||
| clarifies the role | |||
| of the device in | |||
| providing data, | |||
| and moves the | |||
| Rx statement to | |||
| be outside the | |||
| Indications | |||
| statement. |
II. Regulatory Parameters
7
K240100 SAM Model 9-10000
Traditional 510(k) Summary
| | Model 9-10000 device. | guardian) or health care
practitioner trained in the use
of the SNAP Model 8 device. | |
|-----------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------|------|
| Intended population | Pediatric and adult. | Pediatric and adult. | None |
| Common or usual name | Sleep apnea home sleep test
(HST) | Sleep apnea home sleep test
(HST) | None |
| Regulatory Class | Class II | Class II | None |
| Classification name
and product code | 868.2375 Breathing
frequency monitor
MNR | 868.2375
Breathing
frequency monitor
MNR | None |
lll. Technological Characteristics
| Technological
Characteristic | Snap SAM Model 9-
10000 | Snap Model 8 (K110064) | Differences |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Respiratory
Measurement | Effort, Flow (14Hz)
Audio (2240Hz) | Effort, Flow (14Hz)
Audio (2240Hz) | None |
| Oximeter
Measurement | SpO2, Pulse Rate (14Hz) | SpO2, Pulse Rate (14Hz) | None |
| Body Position
Channel | 6 discrete positions:
Upright, Inverted, Prone,
Supine, Left, Right
Sampling Rate: 14 Hz | 5 discrete positions:
Upright, Prone, Supine,
Left, Right
Sampling Rate: 14Hz | Additional position
available in Model 9
-10000.
Accelerometer is
integral to the
device in the Model
9-10000 and is an
external accessory
in the Model 8. Both
are mounted on the
strap in the center
of the patient's
chest. |
| Controls | On/Off button
(After on button press,
Record starts after fixed
delay) | On/Off
Record | Record button not
needed in Model 9-
10000 as recording
automatically starts
after a fixed delay. |
| Control type: | Pushbutton | Pushbutton | None |
| Indicators | LED | LED and LCD | Model 9-10000
uses LED indicators
only. |
| Effort Sensor | Integral to device
Sample Rate: 14 Hz
Gain 0.3 +/- 0.1 at 1Hz
Output Amplitude: 0-2.4V
(1.2V +50mV/-30mV
baseline)
Frequency Response: | External accessory
Sample Rate: 14 Hz
Gain 0.3 +/- 0.1 at 1Hz
Output Amplitude: 0-2.4V
(1.2V +50mV/-30mV
baseline)
Frequency Response: DC | The Model 9-10000
electronics are in
the same enclosure
as the effort sensor.
Both devices, use
the same effort
sensor |
| | DC to 7-16Hz (14Hz nominal) | to > 7 Hz (14Hz nominal) | components, are worn on the chest, and attach to the same strap |
| Oximeter | External wireless connection to wrist worn Nonin 3150 or Wellue Checkme O2 Max | Internal Nonin OEMIII module, wired connection to finger probe. | Predicate device used internal Nonin OEMIII module. Model 9-10000 connects via BLE to external wrist-worn Nonin 3150 (cleared under K102350) or Wellue Checkme O2 Max (cleared under K191088) oximeters. |
| Oximeter
Specifications | Nonin 3150:
SpO2: 0-100%, +/- 2 digits 70-100%
PR: 18-321 BPM, +/- 3 digits
(Meets 80601-2-61:2011)
Wellue:
SpO2: 0-100%, +-2 digits 80-100%, +/- 3 digits 70-
80%
PR: 30-250 BPM +/- 2% or 2 digits (whichever is greater)
(Meets 80601-2-61:2011) | Nonin OEMIII: SpO2 0-
100%, +/- 3 digits 70-
100%
PR: 18-300 BPM, +/- 3 digits
(Meets 80601-2-61:2011) | SpO2 and Pulse rate accuracy of the oximeters used with the Model 9-10000 are the same or better than the oximeter used with the Model 8. |
| Microphone | External accessory | External Accessory | Microphones are identical except for the connector. |
| Audio
Specifications | Bandwidth: 20Hz - 760Hz
Sampling Rate: 2240Hz
Bit Resolution: 12-bit
Dynamic Range: 2V | Bandwidth: 20Hz - 760Hz
Sampling Rate: 2240Hz
Bit Resolution: 12-bit
Dynamic Range: 2V | None |
| System
Dimensions | 0.57 inches (H)
2.17" (W)
1.65" (D) | 1.375 inches (H)
5.5 inches (W)
4 inches (D) | Model 9-10000 is smaller. |
| Operating
Ambient
Temperature | 5 to 40 deg C | 5 to 32 deg C | Model 9-10000 has a wider tested temperature range per IEC 60601-1-11. |
| Operating
Ambient
Humidity | 15 to 85% non-
condensing | 20 to 60% non-
condensing | Model 9-10000 has a wider tested humidity range per IEC 60601-1-11. |
| Power | 3.6V Rechargeable | AC 100-240V 50-60Hz | Model 9-10000 |
| Lithium Battery | 3.6V Lithium backup | uses battery power
only | |
| Data Storage | Internal Flash Memory | Removable Flash
Memory card | Data is stored on
internal Flash
memory on the
Model 9-10000 and
extracted through
the USB port rather
than through a
removable Flash
memory card. |
| File Format | Snap Diagnostics
proprietary | Snap Diagnostics
proprietary | None. |
| External
Interfaces | USB - Charging and
Factory interface
BLE - SpO2 Connection
and Factory Interface to
authorized external
device. | USB - Factory Interface | Model 9-10000 has
an additional BLE
interface for
connecting to the
Oximeters and to
the authorized
external device. |
8
K240100 SAM Model 9-10000
Traditional 510(k) Summary
9
K240100 SAM Model 9-10000 Traditional 510(k) Summary
IV. Discussion of Similarities and Differences
The two systems are substantially equivalent in their regulatory parameters including indications for use, intended population, regulatory class, classification name and product code. The two systems are substantially equivalent with respect to the implementation of most features, including:
- . Respiratory effort, flow, and audio measurement. Circuits, gain, frequency response, resolution, accuracy, and sampling rate are identical.
- SpO2 and pulse rate measurement using cleared third party oximeters. ●
- The presence of a body position channel. ●
- On/Off controls. ●
- Status indicators (LED or LCD). ●
- Storage of recordings to flash memory
- The presence of communication interfaces. ●
The two systems also utilize the same cannula, cannula strap, microphone, and belt. They produce identical recording file structures.
The two systems differ in the following respects:
- The Model 9-10000 oximeter source has changed from that of the predicate. ● Data resolution and sampling rate are the same.
- An additional discrete position is available in the Model 9-10000 compared to . the predicate, and the accelerometer has been made integral to the device.
- The Record button is not needed in the Model 9-10000 as recording ● automatically starts after a fixed delay.
- The Model 9-10000 uses LED indicators only.
- The Model 9-10000 electronics are in the same enclosure as the effort sensor. ●
10
Both the Model 9-10000 and the predicate use the same effort sensor components, are worn on the chest, and attach to the same strap.
- . While the predicate device used an internal Nonin OEM module, the Model 9-10000 connects via BLE to external wrist-worn Nonin 3150 (cleared under K102350) or Wellue Checkme O2 Max (cleared under K191088) oximeters.
- . SpO2 and Pulse rate accuracy of the oximeters used with the Model 9-10000 are the same or better than the oximeter of the predicate.
- The Model 9-10000 is smaller than the predicate.
- . The Model 9-10000 has a wider tested temperature range than the predicate per IEC 60601-1-11.
- . The Model 9-10000 has a wider tested humidity range than the predicate per IEC 60601-1-11.
- The Model 9-10000 uses battery power only. ●
- . Data is stored on internal Flash memory on the Model 9-10000 and extracted through the USB port rather than through the removable Flash memory card of the predicate.
- . The Model 9-10000 has an additional BLE interface for connecting to the oximeters and to the authorized external device.
- . These differences do not materially affect product safety, efficacy, technological basis, or use.
Non-Clinical and/or Clinical Tests Summary
Comparative performance evaluations between the Snap SAM Model 9-10000 and the predicate device, the Snap Model 8 (K110064), demonstrated that the two devices are substantially equivalent in performance.
In addition, comprehensive performance testing according to the following standards and guidelines were conducted:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety ● - Collateral standard: Safety requirements for medical electrical systems (Edition 3.2 2020-08 Consolidated Version)
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements for . basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Edition 2.1 2020-07 Consolidated Version)
- IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - requirements and tests (Edition 4.1 2020-09 Consolidated Version)
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (Fifth Edition 2018-08)
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid ● electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems (Edition 1.0 2017-02)
11
Bench testing confirmed that the device met design requirements and the requirements of applicable standards.
Conclusions
The two devices have substantially equivalent intended uses and the same main classification. They have many of the same features. They are used on the same populations. The two products are different in minor ways that do not materially affect their technological basis or use.
Based upon comparisons of requlatory parameters, software features, amplifier features, and comparative performance evaluations, the Snap SAM Model 9-10000 is substantially equivalent to the predicate device, the Snap Model 8 (K110064).