(9 days)
Not Found
No
The summary describes a standard electrocardiograph for acquiring, displaying, and recording ECG signals. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing and storage.
No
The device is described as an electrocardiograph for acquiring, recording, and displaying ECG leads, which are diagnostic functions. Its intended use states "These measurements are not intended for a specific clinical diagnosis," and that the "clinical significance of the ECG tracings must be determined by the physician," indicating it provides information for diagnosis rather than direct treatment.
Yes
The device is described as an "electrocardiograph" which is used for "evaluation of the cardiovascular system" and will "acquire, record 12 ECG leads simultaneously." While the text states "These measurements are not intended for a specific clinical diagnosis," it also says, "The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings," implying that the device provides data that contributes to a diagnosis, even if it doesn't provide the final diagnosis itself. Therefore, it serves a diagnostic purpose.
No
The device description explicitly states it consists of two basic components: the processing unit and the patient acquisition module, indicating hardware components beyond just software.
Based on the provided information, the Portable ECScope 12i is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Portable ECScope 12i acquires and records electrical signals from the surface of the body (ECG leads) to evaluate the cardiovascular system. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for evaluating the cardiovascular system by acquiring and recording ECG leads. It explicitly mentions that the measurements are not intended for a specific clinical diagnosis and the clinical significance must be determined by a physician in conjunction with other clinical findings. This further reinforces that it's a diagnostic tool that provides data, not an analysis of biological samples.
Therefore, the Portable ECScope 12i falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously, and display 3 leads at a time in its display unit.
Portable ECScope 12i is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
Product codes
DPS
Device Description
Portable ECScope 12i is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module.
Portable ECScope 12i is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVL, Avf, V1, V2, V3, V4, V5 & V6, featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer.
Portable ECScope 12i can record and store in its Database up to 34 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed and printed on the external printer using a PC.
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
licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Portable ECScope 12i was subjected to safety and performance tests against regulatory standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
K080036
p1/3
DyAnsys
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of Safe Medical Devices Act (SMDA) 1990 and 21 CFR 807.92.
510(k) Number:
Applicant Information:
Date Prepared: 17th Nov 2007
Name: DyAnsys, Inc., Address: c/o Emery & Howard. 577, Airport Boulevard, Suite 610, Burlingame, CA 95032 Phone: 650.579.7100 Fax: 650.579.7313
| Contact Person: | Srini Nageshwar |
|---|---|
| Phone Number: | 650.579.7100 |
| Fax: | 650.579.7313 |
| Mobile: | 408.480.4700 |
Device Information:
Classification: Class II Trade Name: Portable ECScope 12i Common Name: ECG Monitor Classification Name: Electrocardiograph
Predicate Devices:
- a. K Number: K072353. Model Name: Portable ECScope Manufacturer - DyAnsys, Inc
- b. K. Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO
- c. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A
Dyansys, Inc
JAN 1 6 2008
1
Image /page/1/Picture/0 description: The image contains the text "K080036" and "p2/3" at the top. Below that is the word "DyAnsys" with a symbol to the left of it. The symbol looks like a greater than sign with a line and a dot below it.
Device Description:
Portable ECScope 12i is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module.
Portable ECScope 12i is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVL, Avf, V1, V2, V3, V4, V5 & V6, featuring 3-lead Display Unit, alphanumeric keyboard and an option to print the ECG data using the Print Tool on A4 Sheet Paper or Direct Printing through connected printer.
Portable ECScope 12i can record and store in its Database up to 34 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed and printed on the external printer using a PC.
Intended Use:
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously, and display 3 leads at a time in its display unit.
Portable ECScope 12i is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
Comparison to Predicate Device(s):
The Portable ECScope 12i is substantially equivalent to the following predicate devices:
- a. K Number: K072353. Model Name: Portable ECScope Manufacturer - DyAnsys, Inc
- b. K Number: K954980. Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO
- c. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer -- REMCO ITALIA S.P.A
Dyansys, Inc
2
K080036 7313
Image /page/2/Picture/1 description: The image contains a logo or symbol followed by the text "DyAnsys". The symbol appears to be a stylized representation of an arrow or a similar design. The text "DyAnsys" is written in a clear, sans-serif font and is positioned to the right of the symbol. The overall impression is that of a company logo or brand identifier.
Portable ECScope 12i handheld battery operated Multi channel electrocardiograph is intended 1. to be used for the evaluation of the cardiovascular system. Portable ECScope 12, will acquire, display and record Multi channel ECG signal. Portable ECScope 12i can store in its database up to 34 ECG signal records. The device features a 10 lead ECG.
The Portable ECScope 12i has the same intended use as the legally marketed predicate devices. 2. The intended use of the Portable ECScope 12i is the same as the predicates.
The Portable ECScope 12i was subjected to safety and performance tests against regulatory 3. standards. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DyAnsys, Inc. c/o Mr. Srini Nageshwar CEO Emery & Howard 577, Airport Boulevard, Suite 610 Burlingame, CA 95032
Re: K080036
Portable ECScope 12i Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: January 02, 2008 Received: January 07, 2008
Dear Mr. Nageshwar:
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.
4
Page 2 - Mr. Srini Nageshwar
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
K
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously and display 3 leads in its display unit.
Portable ECScope 12i is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) number 16807836
Page 1 of 1
(Posted November 13, 2003)