APNEICARE CONNECTION CENTER/INTERNET ANALYSIS

K082968 · Apneicare, LLC · MNR · Jan 2, 2009 · Anesthesiology

Device Facts

• Record ID: K082968
• Device Name: APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
• Applicant: Apneicare, LLC
• Product Code: MNR · Anesthesiology
• Decision Date: Jan 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, summarize, to generate user defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders. ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician. The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Device Story

Client-server software system for sleep study data management; Connection Center (PC-based) binds patient info to study data from external sleep devices; transmits data via encrypted HTTPS to Internet Analysis server. Server performs mathematical data processing; identifies waveform patterns (SpO2, pulse); scores desaturation and respiratory events using DPAR objects; provides manual rescoring and visualization tools. Used in home care, clinics, and hospitals by clinicians/technicians. Output reports aid physicians in diagnosing sleep disorders; facilitates data management, viewing, and reporting.

Clinical Evidence

Bench testing only. Comparative testing demonstrated equivalence to predicate devices.

Technological Characteristics

Client-server architecture; Connection Center runs on Windows XP/Vista (.NET 2.0); Internet Analysis server runs on Windows Server 2008, SQL Server 2005, and .NET 3.5. Data transmission via 128-bit HTTPS. No patient-contact materials.

Indications for Use

Indicated for all individuals undergoing evaluation for sleep and respiratory-related sleep disorders. Used under supervision of physician, sleep technologist, or clinician. No contraindications.

Regulatory Classification

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.

Predicate Devices

• Vitascore BV - Vitascore (K072014)
• Respironics - ProFox Software (K001708)

Submission Summary (Full Text)

{0}------------------------------------------------

K082968

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 30-Dec-2008

# JAN - 2 2009

### Company

ApneiCare, LLC PO Box 418 Worthington, OH 43085

#### Official Contact:

ApneiCare, LLC Craig Pickerill, Vice President [e-mail] P 614-774-6003

# Proprietary or Trade Name:

ApneiCare Connection Center / Internet Analysis

#### Common/Usual Name:

Polysomnography Scoring Software

# Classification Information:

Regulation Number: 21 CFR 868.2375 Regulation Name: Ventilatory Effort Recorder Regulatory Class: Class II Product Code: MNR

Device: ApneiCare Connection Center / Internet Analysis

Predicate Devices: Vitascore BV - Vitascore - 510(k) K072014 Respironics - ProFox Software - 510(k) K001708

# Device Description:

ApneiCare Connection Center / Internet Analysis is composed of two components: The Connection Center and the Internet Analysis Application. The ApneiCare Connection Center and the ApneiCare Internet Analysis Application function in a client server relationship.

The purpose of ApneiCare Connection Center is to download stored data from supported devices that are typically used to evaluate sleep and sleep related respiratory disorders. It allows users to

{1}------------------------------------------------

# Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 30-Dec-2008

export sleep data, and interact with the ApneiCare Internet Analysis to run analysis reports on sleep studies.

ApneiCare Connection Center will operate under Windows XP and Windows Vista; but more importantly is built on Microsoft .NET Framework. The ApneiCare applications have been designed on Microsoft .NET Framework to take advantage of the latest laver of abstraction to allow for Operating System changes in the future while lowering the probability of the application being negatively impacted by operating system changes. "ApneiCare Connection Center is responsible for binding patient information to the study and downloading the data off of the source device. The ApneiCare Connection Center is a small program on the PC with functionality limited to that of general purpose data entry, storage and communication, it performs no data manipulation functions. The data is then communicated to ApneiCare Internet Analysis via an Internet connection, where the sleep analysis and reporting is performed. The ApneiCare Connection Center has built in features to insure that required patient information is entered and that internet connectivity is available. All Internet activity is encrypted and secure. Each transaction between ApneiCare Connection Center and ApneiCare Internet Analysis is conducted over at least 128-bit HTTPS using private and public encryption.

Saved tests can be converted into ASCII format for importing to spreadsheets or databases. The patient information consists of the patient name and address, an ID number, patient insurance and other relevant information. The ApneiCare Internet Analysis Application provides information pertaining to the waveform patterns, such as those of the SpO2 and pulse recording, to aid physicians with the diagnosis of sleep and breathing disorders. Individual desaturation and respiratory events in series (cycles) are scored by algorithm. These patterns are identified using DPAR objects. In addition, to the Internet Analysis the ApneiCare Internet Analysis DPAR Case Viewer application module may also be used to manually score events and visually compare and analyze across multiple channels of data.

The ApneiCare Internet Analysis Application is primarily a mathematical data processing function that reports cycling respiratory events across multiple channels of data. The functionality of the ApneiCare Internet Analysis Application is not time critical or real time. Therefore delays in internet transfer do not impact functionality. The ApneiCare Internet Analysis Application also performs a data management functions which allows the various authorized users of the system to access, view, report and analyze individual cases. The ApneiCare Connection Center is compiled for .NET 2.0, and dependent upon the .NET Framework as the OTS. .NET 2.0 is provided by Microsoft and contains the CLR (Common Language Runtime) which has abstracted ApneiCare Connection Center away from specific Microsoft Windows Operating System Versions. The ApneiCare Internet Analysis application is a server application, runs on Windows Server 2008 and SQL Server 2005, and .NET 3.5, it is managed in a centralized location by ApneiCare.

{2}------------------------------------------------

# Non-Confidential Summary of Safety and Effectiveness Page 3 of 4 30-Dec-2008

# Indications for Use:

ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, summarize, to generate user defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders.

ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders.

ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician.

The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

| Attributes | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use<br>General | ApneiCare Connection Center/Internet Analysis is intended to<br>be used as an aid in the diagnosis of sleep and respiratory<br>related sleep disorders. The ApneiCare Connection Center<br>and ApneiCare Internet Analysis Application is intended to be<br>used as an information and decision management tool to<br>import/record and transmit/transfer data typically captured to<br>evaluate sleep and respiratory related sleep disorders. |
| Intended use<br>Specific | ApneiCare Connection Center/Internet Analysis is intended to<br>be used as an aid in the diagnosis of sleep and respiratory<br>related sleep disorders. The ApneiCare Connection Center<br>and ApneiCare Internet Analysis Application is intended to be<br>used as an information and decision management tool to<br>import/record and transmit/transfer data typically captured to<br>evaluate sleep and respiratory related sleep disorders. |
| Environments of use | home care, nursing home, sub-acute institutions, sleep clinics<br>or hospitals |
| Patient Population | All individuals |
| Contraindications | None |
| Prescription | Prescription |
| Materials | None in patient contact |
| Performance | Comparative testing demonstrate equivalence to the predciate |

#### Device Attributes:

{3}------------------------------------------------

# Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 30-Dec-2008

# Differences Between Other Legally Marketed Predicate Devices

The is viewed as substantially equivalent to the following predicate devices - Vitascore K072014 ProFox Software K001708.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

{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 consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ApneiCare, LLC C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

. .

Re: K082968

Trade/Device Name: ApneiCare Connection Center/Internet Analysis Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: October 2, 2008 Received: October 6, 2008

IAN - 2 2009

Dear Mr. 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. 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. Dryden

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clas

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

# Enclosure

{6}------------------------------------------------

Page 1 of 1

# 510(k) Number:

# K082968

Device Name:

ApneiCare Connection Center / Internet Analysis

# Indications for Use:

ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, summarize, to generate user defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders.

ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders.

ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an . information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician. The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

signature

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

510(k) Number: K082968