(91 days)
Not Found Yet
Not Found
No
The summary mentions "proprietary software algorithms" for interpretation but does not explicitly mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC).
No.
Explanation: The device is described as software that interprets, receives, displays, and stores ECG recordings. It does not exert any direct therapeutic effect on a patient. Its function is diagnostic and informational.
Yes
The "Intended Use / Indications for Use" section states that the software is "intended to interpret electrocardiograms," which is a diagnostic function.
No
The device description explicitly states it is a modification to existing software that allows a "12 Lead Simultaneous Cable" to be linked to a PDA. This cable is a hardware component necessary for acquiring the ECG signal, making the overall system not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "interpret electrocardiograms." This involves analyzing electrical signals from the body, not analyzing samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The device receives and processes ECG signals, which are physiological measurements, not in vitro samples.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting analytes, or being used in a laboratory setting for diagnostic testing of samples.
IVDs are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device deals with electrical signals generated by the heart within the body.
N/A
Intended Use / Indications for Use
PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms. PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the ECG signal. PocketView ECG Software allows the ECG information to be displayed on a commercially available personal digital assistant (PDA) running the Windows CE operating software.
Product codes
MHX
Device Description
The proposed device is modification to the Cardioview™ 3000 software that allows the 12 Lead Simultaneous Cable to be linked to commercially available personal digital assistants (PDA) running the Windows CE operating system.
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
Not Found
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
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Summary of Performance Studies
Nonclinical testing was performed to evaluate the modification to the predicate device. Testing verified that the modified device displayed acceptable performance.
Key Metrics
Not Found
Predicate Device(s)
Cardioview™ 3000 software
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
KO13311
510(k) SUMMARY
Submitted by:
JAN 0 3 2002
Micromedical Industries Ltd
Date Prepared:
October 1, 2000
Proposed Device:
PocketView version of Cardioview™ 3000 software
Predicate Device:
Cardioview™ 3000 software
Device Description:
The proposed device is modification to the Cardioview™ 3000 software that allows the 12 Lead Simultaneous Cable to be linked to commercially available personal digital assistants (PDA) running the Windows CE operating system.
Statement of Intended Use:
PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based program intended to interpret electrocardiograms. PocketView ECG software receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the ECG signal. PocketView ECG Software allows the ECG information to be displayed on a commercially available personal digital assistant (PDA) running the Windows CE operating software.
Summary of Technological Characteristics or New Device to Predicate Devices
The technological features of PocketView ECG do not differ significantly from Cardioview™™ 3000 software. The predicate device and the modified device are identical with the exception that the modified device has the connectivity feature allowing the ECG information to be displayed on a commercially available personal digital assistant (PDA) running Windows CE operating system.
CONFIDENTIAL
1
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Nonclinical testing was performed to evaluate the modification to the predicate device. Testing verified that the modified device displayed acceptable performance.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person with outstretched arms, symbolizing care and protection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 3 2002
Mr. Stephen Cresswell MicroMedical Industries, Ltd. 11 Technology Drive Labrador, Queensland AUSTRALIA
Re: K013311
Trade Name: PocketView ECG Software Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class III (three) Product Code: MHX Dated: November 12, 2001 Received: December 4, 2001
Dear Mr. Cresswell:
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. Stephen Cresswell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Odile Tel
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number: K013311
PocketView ECG Software Device Name:
Indication for Use:
PocketView ECG software is a version of Cardioview™ 3000 software, a Windows-based Pocket VIEW DOO soltware is a version di Station and personal digital assistant (PDA). program micindod to merprovers displays and stores a single or standard 12 Lead Focker FCG sontware roost to, is transmitted either locally or transtelephonically using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use __ OR