(149 days)
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.
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.
Here's an analysis of the provided 510(k) summary for the HC1000P Sleep Diagnosis Software System, outlining the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of target performance metrics (e.g., minimum sensitivity, specificity, or accuracy values). Instead, it states that the device's results are "valid when compared against the gold standard and its predicate devices" and that this was "statistically confirmed through a retrospective analysis against a clinical study."
Therefore, I cannot populate a table with specific acceptance criteria and reported numerical performance. The "acceptance criterion" in this context appears to be demonstrating statistical equivalence or validity against a gold standard in a retrospective clinical study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set used in the retrospective analysis. It refers generally to "a clinical study."
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: The study was a "retrospective analysis."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. It mentions that "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," but this refers to the intended use context, not the ground truth establishment for the validation study. The summary also refers to validation against a "gold standard" but does not specify how this gold standard was established or by whom.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for establishing the ground truth of the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- MRMC Study: The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The study described is a retrospective analysis comparing the device's output to a "gold standard."
- Effect Size: Consequently, no effect size for human reader improvement with AI assistance is provided.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted. The description states: "This was statistically confirmed through a retrospective analysis against a clinical study" to show the device's results are "valid when compared against the gold standard." This implies the algorithm's performance was evaluated independently against an established gold standard. The device is intended as an "aid in the diagnosis" and a "decision support system," with final interpretation by a "trained professional," but the validation described is of the software's output itself.
7. The Type of Ground Truth Used
The ground truth used was referred to as the "gold standard" from a "clinical study." While the specific nature of this "gold standard" is not explicitly detailed (e.g., expert consensus based on polysomnography, pathology), the context of "sleep and sleep related breathing disorders" strongly suggests that the gold standard would likely involve conventional polysomnography (PSG) studies interpreted by board-certified sleep specialists.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set. The study described is a retrospective analysis for validation, not a description of the model development process.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for a training set (if one was used) was established.
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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): |< 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
§ 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).