HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM

K073269 · Hypnocore, Ltd. · MNR · Apr 18, 2008 · Anesthesiology

Device Facts

• Record ID: K073269
• Device Name: HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
• Applicant: Hypnocore, Ltd.
• Product Code: MNR · Anesthesiology
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.

Device Story

HC1000P is a sleep diagnosis software application; analyzes continuous ECG and pulse oxygen saturation data from sleeping patients. Software acts as a decision support system for trained medical professionals; output used in conjunction with clinical information and patient examination. Not intended as sole basis for clinical diagnosis or management. Benefits include assisting clinicians in identifying sleep-related breathing disorders.

Clinical Evidence

Retrospective analysis against a clinical study was performed to validate the software's diagnostic results against the gold standard. No specific sensitivity, specificity, or AUC metrics were provided in the summary.

Technological Characteristics

Software-based diagnostic system; processes ECG and pulse oxygen saturation data. Operates as a decision support tool for clinical use. No specific hardware materials or connectivity standards are detailed.

Indications for Use

Indicated for patients undergoing sleep monitoring to aid in the diagnosis of sleep and sleep-related breathing disorders.

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

• Compass F10 System (K041904)
• Noga Automated Sleep Study Scoring and Data Management System (K070326)

Submission Summary (Full Text)

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# 510(k) Summary

K073269

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

APR 1 8 2008

- George J. Hattub Submitter's 1. (a) MedicSense, USA Address: 291 Hillside Avenue Somerset, MA 02726
- 1. (b) Manufacturer HypnoCore, Ltd. 3 Hazoran Street, Sappir Industrial Park Address: Netanya Israel, 42506

Mfg. Phone: [phone]

Shuli Eyal, Ph.D. Contact Person:

Date: March 20, 2008

- Device & 2. Breathing Frequency Monitor (Class 2), Product Code MNR, Classification Name: 21 CFR 868.2375 - Tradename of device: HC1000P Sleep Diagnosis Software System.
#### Compass F10 System (K041904) Predicate Device: 3. Noga Automated Sleep Study Scoring and Data Management System (K070326)

- HypnoCore's HC1000P is a sleep diagnosis software application. This software is 4. Description: used as an aid in the diagnosis of sleep and sleep related breathing disorders. The HC1000P is able to acomplish this by analyzing continuous ECG and pulse oxygen saturation data acquired from a sleeping patient. The interpretation of the results provided by the HC1000P software package is performed in conjunction with clinical information and examination of the patient obtained by a trained professional familiar with sleep medicine.
- HC1000P software analysis's ECG and pulse oxygen saturation data acquired from 5. Intended Use: a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.
- 6. Comparison of Technological With respect to technology, the HC1000P Sleep Diagnosis Software System Characteristics: is substantially equivalent in that the results it produces, are valid when compared against the gold standard and its predicate devices. This was statistically confirmed through a retrospective analysis against a clinical study.

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#### INTRODUCTION 1.

#### 1.1. WHAT IS HC1000P?

HC1000P by HypnoCore is a novel propriety ECG based diagnostic system for sleep disorders.

#### 1.2. INTENDED USE

HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.

#### 1.3. DISCLAIMER

This software is intended as a decision support system for persons who have received appropriate medical training, and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or management. Any deviation of the application of medical information from the program, other than the original design or intended use there of, is not advised and considered a misuse of the software product. For additional guidance see published studies.

### 1.4. DOCUMENT CONVENTIONS

Pay particular attention at specific points in a procedure when one of the following messages appears:

### CAUTION:

Image /page/1/Picture/11 description: The image shows a black warning sign. The sign is in the shape of a triangle, and it has a thick black border. Inside the triangle is a large black exclamation point.

Cautions indicate instructions that if not followed may result in damage to the software or sub optimal results.

Image /page/1/Picture/13 description: The image shows the word "NOTE:" in bold, uppercase letters. To the right of the word "NOTE:" is a blurry image of what appears to be a person's head. Below the word "NOTE:" is a blurry black shape.

Notes provide pertinent information to help obtain optimum performance from the software.

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Image /page/2/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 stripes representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2008

HypnoCore, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K073269

Trade/Device Name: HC1000P Sleep Diagnosis Software System Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: April 3, 2008 Received: April 7, 2008

Dear Mr. Hattub:

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.

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Page 2 - Mr. Hattub

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

Sincerely yours,

Syrita Y. Michael Davis

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

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## Indications for Use

510(k) Number (if known): |< ഗ 7 3 2 6 9

Device Name: HC1000P Sleep Diagnosis Software System

Indications For Use: HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.

Prescription Use X (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)

Mi Vunt

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

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510(k) Number: K073269