(81 days)
Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments. The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor. The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.
The Sandman Pocket is a physiological data recorder that is part of a polysomnography system. It consists of two units: the Recorder Unit, which stores the data and sends it to a USB port, and Headbox Unit, which is the connection point for all patient sensors with the exception of the Nellcor Puritan Bennett oximetry probe. The role of the Sandman Pocket is only to capture the data and pass it to the host with the necessary accuracy and reliability according to the product and communication control specifications. A fundamental characteristic of the Sandman Pocket is the ability to be an ambulatory/portable physiological data recorder. Because of its small size and light weight (about 210 grams including the battery), the system is compact and durable. The Headbox Unit is used for connecting patient electrodes and sensors. It includes Bipolar channels, pressure sensors, power supply for a dedicated body position sensor, an abdomen sensor, a chest sensor, a snore sensor and a thermistor. The patient inputs are isolated with a CF type isolation level. The Sandman Pocket device is provided without standard sensors. The system builder should integrate the device with FDA cleared Nellcor Puritan Bennett sensors only and specified for the usage with NELL-1 module. The Headbox Unit captures the biological signals from the human body surface through specialized sensors and electrodes, while the Recorder Unit amplifies the very low electrical signal and filters the signals to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are sent to a host computer for review and analysis. The host can "program" the amplifier behavior by setting the sampling frequency and the dynamic range allowed and so on. The host computer reads the acquired data through a dedicated interchange protocol, and allows a clinician to analyze the data using sleep review analysis software, provided by the end user or system builder. The clinician must use an electrically isolated computer (with a medical grade isolation transformer or medical grade power supply) or batterysupplied laptop when the Sandman Pocket device is connected to the host PC and the patient is connected to the Sandman Pocket Headbox. The Sandman Pocket system is not in any way involved in the data management performed by the host. The host computer must operate using one of the following Operating System: Microsoft Windows 98 / ME / NT / 2K / XP. The device has a built-in impedance meter. This function allows the clinician to check the electrode contact impedance and display the results of the check on the display. The display is located in the Recorder Unit, while the circuitry controlling the impedance meter is located in the Headbox Unit. The Sandman Pocket can be powered through 3 Alkaline 1.5V standard non rechargeable batteries or via the USB cable. The user is recommended to use a medical grade type PC. The Sandman Pocket system consists of two interconnected units: the Headbox Unit and the Recorder Unit.
The Sandman Pocket is a physiological data recorder intended for use in collecting and recording physiological data for polysomnography and sleep disorder studies in pediatric through adult patients, in both home and hospital environments. It is not intended for life support, vital sign monitoring in an ICU, or as an automated apnea monitor. It must be used under the direction or supervision of a physician, technologist, or clinician.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a table of acceptance criteria and performance against those criteria in a typical evaluation study format.
However, the "Technological Characteristics Substantial Equivalence Comparison Table" implicitly serves to show that the performance characteristics of the Sandman Pocket are comparable to the legally marketed predicate devices, thereby meeting the unstated "acceptance criteria" of being as safe and effective as the predicates.
I will construct a table showing key performance characteristics of the Sandman Pocket alongside its predicate devices, as this is the closest equivalent to stated "acceptance criteria" through comparison. The "reported device performance" is implicitly shown to be acceptable by its similarity to the predicates.
| Product Characteristic | Predicate Device 1 (Suzanne K990565) | Predicate Device 2 (Alice 5 K040595) | Sandman Pocket (Submission Device) | Implicit Acceptance Criteria / Demonstrated Performance |
|---|---|---|---|---|
| A/D Resolution | 12 bit | 16 bit | 16 bit | The device should have comparable or better Analog-to-Digital conversion resolution. Sandman Pocket meets/exceeds. |
| Max Number of Channels | 35 | 55 | 22 | The device should support a sufficient number of channels for its intended use. Sandman Pocket provides 22, indicating capability for polysomnography. |
| Recording Channels | EEG, EOG, EMG, ECG, Resp. Efforts, | EEG, EOG, EMG, ECG, Resp. Efforts, | EEG, EOG, EMG, ECG, Resp. Efforts, | The device should record essential physiological parameters for polysomnography. Sandman Pocket records comparable parameters. |
| Airflow, Ambient Sounds, Body | Airflow, Ambient Sounds, Body | Airflow, Body position, SpO2, | ||
| Position, Ambient Light, SpO2, | Position (external), SpO2, Pulse | Pulse rate, Plethysmograph, | ||
| Pulse rate, Differential Pressure | rate, Plethysmograph, Differential | Differential pressure | ||
| Passbands (Example: EEG) | 0.625 to 18 Hz | Neurological Channels: 0.32 to 106 Hz | 0.1 to 135 Hz | The device should have appropriate frequency response for accurate signal acquisition. Sandman Pocket's ranges are generally broader or comparable. |
| Sampling Rate (Example: Fast waves) | 120 samples/s | 2000 samples/s | Programmable up to 2048 sample/s | The device should have sufficient sampling rates for various physiological signals. Sandman Pocket offers flexible and high sampling rates. |
| Data Recording Method | PCMCIA card, magnetic/optical disk | Computer hard drive, CD, Ethernet | Internal NAND flash chip | The device should reliably store physiological data. Sandman Pocket uses internal flash for portability. |
| Memory for 8hr Study | 20 MB | 600 MB (without audio/video), 6 GB (with audio/video) | 28 MB | The device should have sufficient memory capacity for typical study durations. Sandman Pocket's memory size is comparable to one predicate and significantly less than another (due to fewer channels and no video/audio). |
| Power | Battery/Medical Grade AC-DC | Medical grade AC Power Supply | Battery/USB powered | The device should have suitable power options for its intended use (ambulatory/portable). Sandman Pocket's battery/USB power aligns with its portable design. |
| Sensors | Commercially available | Commercially available | FDA Cleared sensors only | The device should be compatible with appropriate sensors. Sandman Pocket specifies FDA cleared sensors. |
| Mechanical Safety | Complies with Nov' 93 Draft | IEC 60601-1, CSA C22.2 No. 601.1, EN 60601-1, UL 60601-1, AS 3200.1.0 | IEC 60601-1, CSA C22.2 No 601-1-M90, UL 2601 | The device should meet established safety standards. Sandman Pocket complies with relevant international standards. |
| Electrical Safety | CSA C22.2 No. 601-1-M90, UL 2601 | IEC 60601-1, IEC 60601-2-25, etc. | IEC 60601-1, IEC 60601-1-4, | The device should meet established safety standards for electrical operation. Sandman Pocket complies with relevant international standards. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1, IEC 61000-4-x, | IEC 60601-1-2, CISPR 11, | IEC 60601-1- 2, IEC 61000-3-x, | The device should meet established EMC standards to avoid interference. Sandman Pocket complies with relevant international standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific clinical study with a test set of patient data to evaluate the performance of the Sandman Pocket.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Nellcor Puritan Bennett Inc. SUZANNE K990565 and Respironics, IN Alice S K040595) through direct comparison of technological characteristics, intended use, and conformance to recognized consensus standards (e.g., electrical safety, EMC).
Therefore:
- Sample size for the test set: Not applicable/Not provided, as a clinical performance study on patient data is not described.
- Data provenance: Not applicable/Not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
Since no clinical study with a test set requiring ground truth establishment is described in the provided document:
- Number of experts: Not applicable/Not provided.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
As there is no described clinical study with a test set, there is no adjudication method mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided 510(k) summary. The submission focuses on substantial equivalence based on technical specifications and intended use comparison.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This device is a physiological data recorder, not a diagnostic algorithm. Its primary function is to capture and store physiological signals for subsequent review and analysis by a clinician using sleep review analysis software. It does not perform automated diagnoses or interpretations; therefore, a "standalone algorithm only" performance study, as typically understood for AI/CADe devices, is not relevant or described for this type of device.
The study presented focuses on the device's technical specifications - how accurately and reliably it records data, and its compliance with relevant safety and performance standards.
7. The Type of Ground Truth Used
As no clinical performance study involving diagnostic interpretation is described, the concept of "ground truth" (e.g., pathology, outcomes data, expert consensus) is not directly applicable in the traditional sense for evaluating the device's output. The device itself is recording raw physiological data, not producing interpretations that require a ground truth for validation. Its "truth" lies in its ability to faithfully capture the actual electrical signals.
The "ground truth" for the device's functioning is implicitly its adherence to:
- Its own product and communication control specifications for data capture accuracy and reliability.
- International standards for electrical safety (IEC 60601-1, UL 2601, CSA C22.2 No 601-1-M90), and electromagnetic compatibility (IEC 60601-1-2, etc.).
8. The Sample Size for the Training Set
The provided 510(k) summary does not describe any training sets as part of a machine learning or algorithmic development process. The Sandman Pocket is a hardware data acquisition device, and its design and verification are based on engineering principles and regulatory standards, not on model training with large datasets.
9. How the Ground Truth for the Training Set was Established
Since no training set is described, the method for establishing its "ground truth" is not applicable.
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510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham Official Correspondent The Anson Group 11460 N. Meridian St. Suite 150 Carmel, IN 46032 Phone: (317) 569-9500 x 103 Facsimile: (317) 569-9520 Contact Person: Carri Graham Date: June 12, 2006 807.92(a)(2) Trade Name: Sandman Pocket Common Name: Ventilatory Effort Recorder Classification Name(s): Ventilatory Effort Recorder Classification Number: MNR 807.92(a)(3) Predicate Device(s) Nellcor Puritan Bennett Inc. SUZANNE K990565 Respironics, IN Alice S K040595
Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.
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807.92 (a)(4)
Device Description
The Sandman Pocket is a physiological data recorder that is part of a polysomnography system. It consists of two units: the Recorder Unit, which stores the data and sends it to a USB port, and Headbox Unit, which is the connection point for all patient sensors with the exception of the Nellcor Puritan Bennett oximetry probe.
The role of the Sandman Pocket is only to capture the data and pass it to the host with the necessary accuracy and reliability according to the product and communication control specifications.
A fundamental characteristic of the Sandman Pocket is the ability to be an ambulatory/portable physiological data recorder. Because of its small size and light weight (about 210 grams including the battery), the system is compact and durable.
The Headbox Unit is used for connecting patient electrodes and sensors. It includes Bipolar channels, pressure sensors, power supply for a dedicated body position sensor, an abdomen sensor, a chest sensor, a snore sensor and a thermistor. The patient inputs are isolated with a CF type isolation level. The Sandman Pocket device is provided without standard sensors. The system builder should integrate the device with FDA cleared Nellcor Puritan Bennett sensors only and specified for the usage with NELL-1 module.
The Headbox Unit captures the biological signals from the human body surface through specialized sensors and electrodes, while the Recorder Unit amplifies the very low electrical signal and filters the signals to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are sent to a host computer for review and analysis. The host can "program" the amplifier behavior by setting the sampling frequency and the dynamic range allowed and so on.
The host computer reads the acquired data through a dedicated interchange protocol, and allows a clinician to analyze the data using sleep review analysis software, provided by the end user or system builder. The clinician must use an electrically isolated computer (with a medical grade isolation transformer or medical grade power supply) or batterysupplied laptop when the Sandman Pocket device is connected to the host PC and the patient is connected to the Sandman Pocket Headbox.
The Sandman Pocket system is not in any way involved in the data management performed by the host. The host computer must operate using one of the following Operating System:
Microsoft Windows 98 / ME / NT / 2K / XP.
The device has a built-in impedance meter. This function allows the clinician to check the electrode contact impedance and display the results of the check on the display. The
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display is located in the Recorder Unit, while the circuitry controlling the impedance meter is located in the Headbox Unit.
The Sandman Pocket can be powered through 3 Alkaline 1.5V standard non rechargeable batteries or via the USB cable. The user is recommended to use a medical grade type PC.
The Sandman Pocket system consists of two interconnected units: the Headbox Unit and the Recorder Unit.
Image /page/2/Figure/4 description: The image shows a diagram of a recorder unit and a headbox unit. The recorder unit has a USB port and a serial port for CPAP. The headbox unit has inputs for abdomen, chest, body position, snore, thermistor, and cannula. An oximeter cable is also shown.
SANDMAN POCKET System Connection Diagram
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The Headbox Unit has the following functions:
- Physically connects the source of signals (the patient) to the amplifier. ●
- Provide impedance testing capabilities ●
- Provide Analog to Digital (A/D) conversion .
The Recorder Unit has the following functions:
- Amplify and isolate signals coming from the electrodes .
- Reference input channels ●
- Generate calibration pulse .
- Provide dynamic range (gain), sampling rate and active channels selection .
- Performs antialiasing filtering for optimal Analog to Digital conversion .
- Provide, when requested, the Pulse Transition Time (PTT) calculation. .
- Send the digital data through the USB interface to the host ●
- Provide the Oximeter option .
- . Manage the display
- Manage the Time .
- Manage the batteries power supply .
807.92(a)(5)
Intended Use(s)
The Sandman Pocket is intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments.
The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor.
The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.
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.
Technological Characteristics Substantial Equivalence Comparison Table
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
|---|---|---|---|
| Regulatory | |||
| Device class | Class II | Class II | Class II |
| Product code | MNR | GWQ | MNR |
| Device type | Ventilator EffortRecorder | Electroencephalograph | Ventilator EffortRecorder |
| Regulation Number | 868.2375 | 882.1400 | 868.2375 |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Labelling | |||
| Intended use | Intended for use incollecting and recordingphysiological data to beused in diagnosing sleepdisorders | Intended to record,display and printphysiologicalinformation toclinicians/physicians.These parameters arepresented graphicallyon a computer screenfor diagnostic review,similar in applicationto the use of atraditional paper basedpolygraph recorder.The device will beused in hospitals,institutions, sleepcenters or clinics, orother testenvironments whereadult or infant patientsrequire thedocumentation ofvarious sleep or otherphysiologicaldisorders.This device does notprovide alarms and isnot intended for use asan automated apneamonitor. | Intended for use incollecting andrecordingphysiological data tobe used inpolysomnography andsleep disorder studies.For use in either homeor hospitalenvironments with apediatric through adultpatient population.This device does notprovide alarms and isnot intended for use asan automated apneamonitor |
| Target population | Pediatric through adult(excluding neonates andinfants) | Pediatric through adult(including all pediatricsubpopulations) | Pediatric through adult(including all pediatricsubpopulations) |
| Environment of use | Hospital and home | Hospitals, institutions,sleep centers, or othertest environments. | Hospital and home |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan Bennet | Alice 5(Predicate Device)Respironics | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Warnings | Items related to sensorirritation, strangulationavoidance and off-labeluse. | Items related to sensorirritation, strangulationavoidance, and off-label use. | Items related to sensorirritation,strangulationavoidance and off-label use. |
| Contraindications | Items related to designand indicated uselimitations, such as notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment. | Items related to designand indicated uselimitations, such as notfor use in thepresence offlammable substancesor anesthetic mixtureswith air oxygen ornitrous oxide,defibrillation, andMRI equipment, andnot for use asautomated apneamonitor or acontinuous monitor. | Items related to designand indicated uselimitations, such asnot for use in thepresence of flammableanesthetics or inconjunction withdefibrillationequipment.The Sandman Pocket isnot intended for use aslife support equipmentsuch as a vital signmonitoring in intensivecare unit. The devicedoes not producealarms and is notintended as anautomated apneamonitor.The Sandman Pocketis only to be usedunder the direction orsupervision of aphysician,technologist orclinician. It will notprevent or restore theinterruption or loss ofany physiologicalsystem. |
| Prescription status | Available only on theorder of a physician. | Available only on theorder of a physician. | Available only on theorder of a physician. |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Service instructions | No field serviceallowed. | No field serviceallowed. | No field serviceallowed. |
| Design | |||
| CommunicationInterfaces | Physiological signalsare sent to the SlowWave and Fast Waveheadbox through thesensor cables.The Slow Wave andFast Wave headboxessends the data to theRecorder Plus modulewhere the data is storedeither to a flash memorycard or to a PC via afiber optic interface. | Physiological signalsare sent from thepatient sensors to theheadbox through thesensor cables.The data is sampledand sent to the basestation where it isstored on a disk until itis sent through anEthernet connection toa Host PC. | Physiological signalsare sent from thepatient sensors to theamplifier box throughthe sensor cables.The amplifier boxsends the data to therecorder where thedata is stored in flashmemory in bothattended andunattended studies.During attendedstudies, the data isalso transmitted to acomputer in real-timevia a USB cable. Afterunattended studies,data can bedownloaded from therecorder using a USBcable. |
| Microprocessor | Siemens 80C53712 MHz | Unknown | Texas InstrumentsTMS320UC5402 onrecorderTexas InstrumentsMSP430F169 onheadbox |
| A/D Resolution | 12 bit | 16 bit | 16 bit |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan Bennet | Alice 5(Predicate Device)Respironics | Sandman Pocket(submission device)EB Neuro |
| K990565 | K040595 | Via this Submission | |
| Data recording | On PCMCIA card,magnetic disk or opticaldisk (via a personalcomputer). | Computer hard drive,compact disc, ortransferred viaEthernet connection toa Host PC. | On internal NANDflash chip |
| Configuration | Desktop and wearable | Desktop only | Wearable |
| Amount of memoryrequired for a typical8 hour study. | 20 MB | 600 MB withoutaudio/ video6 GB with audio/video | 28 MB |
| NOTE: Alice 5 cancollect up to 21neurological channels.These channels arerecorded at very highsampling rates. Inaddition, Alice 5records video at veryhigh frame rates withno compression. Thesetwo factors contributeto the large study size.All data are stored tocomputer hard disk. | |||
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Sampling rate | Slow waves :12 samples/sFast waves :120 samples/s | Neurological channels2000 samples/s | Fast waves:For example, ECGprogrammable up to2048 sample/sMedium waves:For example, EMG,EOG, Snoreprogrammable up to1024 sample/sSlow waves: Forexample, airflow,respiratory effort,body positionprogrammable up to256 sample/s |
| Power | Battery powered(internal) or MedicalGrade AC-DC PowerSupply | Medical grade ACPower Supply | Battery powered orUSB powered |
| Sensors | Commercially availablesensors only | Commerciallyavailable sensors only | FDA Cleared sensorsonly |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Performances | |||
| Maximum number ofchannels | 35 | 55 | 22 |
| Recording channelsEEGEOGEMGECGRespiratory effortsAirflowAmbient soundsBody positionAmbient lightSpO2Pulse ratePlethysmographDifferential pressureActimeterDerived channel | YesYesYesYesYesYesYesYes - internalYes - internalYes - internalYes - internalNoYes - internalNoN/A | YesYesYesYesYesYesYesYes - externalNoYes - internalYes - internalYesYes - externalYesPulse Transit Time(PTT) - A calculationof the time betweenthe occurrence of theR wave on the EKGand the peak flow onthe plethysmogram.RR Interval -Measurement of theperiod of timebetween twoconsecutive R waveson the EKG. Displaysas a real-time beat-to-beat heart rate | YesYesYesYesYesYesNoYes - externalNoYes - internalYes - internalYesYes - internalNoPulse Transit Time(PTT) - A calculationof the time betweenthe occurrence of theR-wave on the EKGand 50% ascendingslope on theplethysmogram.Heart rate - Derivedfrom the ECG channel |
| calculation. | |||
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan BennetK990565 | Alice 5(Predicate Device)RespironicsK040595 | Sandman Pocket(submission device)EB NeuroVia this Submission |
| Passbands | |||
| EEG | 0.625 to 18 Hz | Neurological Channels | 0.1 to 135 Hz |
| EOG | 0.625 to 18 Hz | 0.32 to 106 Hz | 0.1 to 135 Hz |
| EMG | 0.625 to 18 Hz | 0.1 to 135 Hz | |
| ECG | 0.625 to 18 Hz | 0.1 to 135 Hz | |
| Respiratory efforts | 0.055 to 1.25 Hz | 0.1 to 45 Hz | |
| Airflow | 0.1 to 1.3 Hz | 0.015 to 10 Hz | |
| Ambient sounds | None | None | |
| Pressure sensor | 0 to 175 Hz | DC to 15 Hz | |
| SpO2 | NPB proprietary | NPB proprietary | |
| Pulse rate | NPB proprietary | NPB proprietary | |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan Bennet | Alice 5(Predicate Device)Respironics | Sandman Pocket(submission device)EB Neuro |
| CPAP (ContinuousPositive AirwayPressure) | K990565Suzanne supports allmodels of CPAPdevices because theCPAP deviceconnections were air-based rather thanelectrically based.Using apneumotachograph kit,users could connecthoses and adapters tothe CPAP device andthe flow and pressurenipples on the Suzanneslow wave headbox tomeasure CPAP airflowand/or air pressure at themask out-take duringnasal CPAP/Bi-leveltitration. | K040595Alice 5 supports theuse of all Respironicslab therapy devices:Aria LXBiPAP ProDuet LXHarmonyHeartPAPREMStar AutoREMStar ProREMStar Pro with C-FlexSynchronyVirtuoso LX | Via this SubmissionSandman Pocket storesdata from NellcorPuritan BennettGK420E, GK425, andGK425ST CPAPdevices. When therecorder is alsoconnected to the hostcomputer, the SandmanPocket not only storesdata in the on-boardmemory, but also acts asa passive bridge betweenthe aforementioned GKCPAP and the hostcomputer by receivingdata streams from theCPAP and transmittingthe data streams to thehost computer and viceversa.When the SandmanPocket is connected to athird party CPAP deviceand a host computer,Sandman Pocket acts asa passive bridge betweenthe third party CPAPdevice and the computerby receiving datastreams from the CPAPand transmitting the datastreams to the hostcomputer and vice versa.Alternatively, SandmanPocket may also handleCPAP deviceconnections in the same |
| ProductCharacteristic | Suzanne(Predicate Device)Nellcor Puritan Bennet | Alice 5(Predicate Device)Respironics | Sandman Pocket(submission device)EB Neuro |
| K990565 | K040595 | Via this Submission | |
| Mechanical safety | Device complies withthe requirements ofNov' 93 DraftReviewer's Guidance | Device complies withthe InternationalStandardIEC 60601-1CSA C22.2 No. 601.1EN 60601-1UL 60601-1AS 3200.1.0** Australian Deviationto IEC 60601-1 | Device complies withthe InternationalStandardIEC 60601-1CSA C22.2 No 601-1-M90UL 2601 |
| Electrical safety | Device complies withthe InternationalStandardCSA C22.2 No. 601-1-M90UL 2601Device complies withthe requirements ofNov' 93 DraftReviewer's Guidance | Device complies withthe InternationalStandardIEC 60601-1Guidance, whenapplicable, has beenadopted from thefollowing standards:IEC 60601-2-25IEC 60601-1-26IEC 60601-2-40IEC 60601-2-49 | Device complies withthe InternationalStandardIEC 60601-1IEC 60601-1-4IEC 60601-1-26CSA C22.2 No 601-1-M90UL 2601 |
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510(k) Summary
EB Neuro, S.p.A.
Sandman Pocket
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| ProductCharacteristic | Suzanne(Predicate Device) | Alice 5(Predicate Device) | Sandman Pocket(submission device) |
|---|---|---|---|
| Nellcor Puritan Bennet | Respironics | EB Neuro | |
| K990565 | K040595 | Via this Submission | |
| ElectromagneticCompatibility (EMC) | Device complies withthe following EMCstandardsIEC 60601-1IEC 61000-4-2IEC 61000-4-3IEC 61000-4-6Mil Std 462DIEC 61000-4-4IEC 61000-4-5EN55011 Class BDevice complies withthe requirements ofNov' 93 DraftReviewer's Guidance | Device complies withthe InternationalStandardIEC 60601-1-2,including thefollowing standards:CISPR 11IEC 61000-3-2IEC 61000-3-3IEC 61000-4-2,IEC 61000-4-3IEC 61000-4-4,IEC 61000-4-5,IEC 61000-4-6,IEC 61000-4-8IEC 61000-4-11 | Device complies withthe InternationalStandardIEC 60601-1- 2,including thefollowing standards:IEC 61000-3-2IEC 61000-3-3IEC 61000-4-2IEC 61000-4-3,IEC 61000-4-4,IEC 61000-4-5,IEC 61000-4-6,IEC 61000-4-8IEC 61000-4-11EN55011 class BEN55014-1 |
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Image /page/15/Picture/0 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 forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Regulatory Technology Services LLC C/O Mr. Mark Job Responsible Third Party Official EB NEURO, S.P.A. 1394 25th Street NW Buffalo, Minnesota 55313
Re: K061996
Trade/Device Name: Sandman Pocket Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: September 22, 2006 Received: September 25, 2006
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.
OCT - 3 2006
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.
" This letter will allow your o begin maketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{17}------------------------------------------------
Indications for Use
510(k) Number (if known):
Sandman Pocket Device Name:
Indications For Use:
Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is indended for pediatric through adult patient populations, and can be used in either home or hospital environments.
The Sandman Pocket is not intended for use as life supporting equipment, such as a vital sign monitoring in on intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor.
The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
busiom
(Sign-Off)
en of Anesthesiology, General Hospital,
Con Control, Dental Devices
Number: K061996
§ 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).