(149 days)
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No
The summary describes software that analyzes data but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development like training or test sets.
No
The device is described as an "aid in the diagnosis" of sleep disorders and a "decision support system," indicating it helps detect or identify a condition, rather than treat or manage it.
Yes
The intended use statement explicitly states, "It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders." The device description also reiterates that it is a "sleep diagnosis software application" used "as an aid in the diagnosis of sleep and sleep related breathing disorders."
Yes
The device description explicitly states "HypnoCore's HC1000P is a sleep diagnosis software application" and describes its function as analyzing data, without mentioning any accompanying hardware developed or included by the submitter. While it relies on data acquired from a patient, the device itself is presented as the software component performing the analysis.
Based on the provided information, the HC1000P software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The HC1000P software analyzes data acquired from a sleeping patient (ECG and pulse oxygen saturation). This data is collected from the patient, not a sample taken from the patient (like blood, urine, or tissue).
- The description focuses on analyzing physiological signals. ECG and pulse oxygen saturation are physiological measurements, not laboratory tests performed on biological samples.
- The intended use is aid in diagnosis based on these physiological signals. This aligns with devices that monitor and analyze physiological data for diagnostic purposes, rather than devices that test biological samples.
Therefore, the HC1000P software falls outside the typical definition and scope of an In Vitro Diagnostic device. It is more accurately described as a physiological monitoring and analysis software used as a diagnostic aid.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
HypnoCore's HC1000P is a sleep diagnosis software application. This software is 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 by HypnoCore is a novel propriety ECG based diagnostic system for sleep disorders.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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510(k) Summary
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
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- (b) Manufacturer HypnoCore, Ltd. 3 Hazoran Street, Sappir Industrial Park Address: Netanya Israel, 42506
Mfg. Phone: 972-9-8858075
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.
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- 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 (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,
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): |