Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that the device's role is "only to record the data" and that it is "not in any way involved in the data management performed by the host." There is no mention of AI or ML in the document.

Therapeutic

No
The device is a physiological data recorder used to collect and store physiological signals for analysis; it does not provide any treatment or therapy.

Diagnostic

Yes

Explanation: The device is described as a "physiological data recorder intended to collect and record data from multiple physiological channels." It's used by or on the order of a physician and records various physiological signals (EEG, EOG, ECG, airflow, etc.). While it only records the data and a separate software performs analysis, the act of collecting and recording physiological data for eventual analysis by a physician for medical purposes falls under the umbrella of diagnostic activity. The Intended Use/Indications for Use states it's for recording data from "multiple physiological channels," which aligns with the initial stage of diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "wearable data recorder" that "collects and stores physiological signals," indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Galaxy device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The Galaxy device collects physiological data directly from the patient's body (EEG, EOG, ECG, airflow, etc.). It does not analyze blood, urine, tissue, or other biological samples.
The device's function is solely data recording. The description explicitly states, "The role of the Galaxy is only to record the data." The analysis and reporting are performed by a separate, cleared host software application. IVDs typically perform the analysis themselves or are integral to the analytical process.
The intended use is to collect and record physiological data. This is distinct from the purpose of an IVD, which is to provide information about a physiological state, disease, or condition based on the examination of a specimen.

In summary, the Galaxy is a physiological data recorder, not a device that analyzes biological specimens to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

Product codes

MNR

Device Description

The Galaxy is a wearable data recorder that collects and stores physiological signals. The role of the Galaxy is only to record the data. The following physiological signals may be collected and stored by the Galaxy device:
-EEG, EOG, EMG, ECG
-Nasal/oral Airflow
-Snore
-Thoracic and Abdominal Effort
-Body Position
-Pulse Oximetry, including: Oxygen Saturation (SpO2), Pulse Rate, Plethysmograph
The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by a cleared host software application. The Galaxy data recorder is not in any way involved in the data management performed by the host.

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

Not Found

Intended User / Care Setting

It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

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)

The functionality of the design of the device was verified through verification testing. All tests met the required acceptance criteria. The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing. The Risk Traceability Matrix provided in the Risk Assessment assured that all hazards identified by the risk assessment are successfully mitigated.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K061996

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

TAB 5

K083874
page 1 of 4

JAN 2 6 2009

510(K) SUMMARY

Date of Submission

Official Contact

Image /page/0/Picture/5 description: The image shows the word "RESPIRONICS" in bold, black letters. Above the word, there are three curved lines that are also in black. The lines appear to be a stylized design element, possibly representing airflow or breathing.

19 November 2008 Manufacturing Facility Address Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 Phone: 724-387-7442 Fax: 724-387-7490 Andrew.Zeltwanger@Respironics.com

Proprietary Name Galaxy
Common/Usual Name Ventilatory Effort Recorder

Device Classification Name Ventilatory Effort Recorder

Classification Reference 21 CFR 868.2375

Classification

Product Code

Predicate Devices

Appropriate Classification Panel

MNR

EB Neuro, S.p.A. Sandman Pocket (K061996)

Class II

Anesthesiology

Reason for submission New device

1

page 2 of 4

Galaxy

Substantial Equivalence

This premarket notification submission demonstrates that the Respironics, Inc. Galaxy data recorder is substantially equivalent to the EB Neuro, S.p.A. Sandman Pocket (K061996).

The functionality of the design of the device was verified through verification testing. All tests met the required acceptance criteria. The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing. The Risk Traceability Matrix provided in the Risk Assessment assured that all hazards identified by the risk assessment are successfully mitigated.

Intended Use

The Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

Device Description

The Galaxy is a wearable data recorder that collects and stores physiological signals. The role of the Galaxy is only to record the data. The following physiological signals may be collected and stored by the Galaxy device:

트 EEG, EOG, EMG, ECG
트 Nasal/oral Airflow
l Snore
I Thoracic and Abdominal Effort
회 Body Position
B Pulse Oximetry, including:
- Oxygen Saturation (SpO2) o
- Pulse Rate o
- Plethysmograph o

The recorded data is stored on a secure digital (SD) card and may be passed on to a PC for analysis and reporting of the data by a cleared host software application. The Galaxy data recorder is not in any way involved in the data management performed by the host.

2

Galaxy
page 3 of 4

Technological Characteristics / Predicate Device Comparison

Like the Sandman Pocket predicate device, the Galaxy is intended to collect physiological signals from various points on the patient's body and to record those signals. Refer to Table 5-1 for a comparison of the Galaxy to the identified predicate device.

| Characteristic | EB Neuro, S.p.A.
Sandman Pocket
(K061996) | Respironics
Galaxy Data Recorder |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in collecting and
recording physiological data to be
used in polysomnography and
sleep disorder studies. The device
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.

Table 5-1: Galaxy Data Recorder Comparison to Predicate Device

3

Traditional 510(k) Tab 5 – 510(k) summary

(End of Tab.)

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:

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Galax

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated C/O Mr Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinors 60062

JAN 2 6 2009

Re K083874 Trade/Device Name Galaxy Regulation Number 21 CFR 868 2375 Regulation Name Breathing Frequency Monitor Regulatory Class II Product Code MNR Dated January 13, 2009 Received January 15, 2009

Dear Mr Devine

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

If your device is classified (see above) into either 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

5

Page 2 - Mr Devine

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 you to begin marketing 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISIOn of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely vours.

Anthony Oration for
Ginette Y Michaud, M D

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

6

Indications for Use

510(k) Number (if known):

Device Name: Galaxy

Indications for Use:

The Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy is intended for use in a supervised (hospital) or unsupervised (home) environment.

Prescription Use Over-The-Counter Use 1 resemption OSE
(Part 21 CFR 801 Subpart D) AND/OR (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)

Signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K083874

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