(20 days)
Not Found
No
The summary describes a standard electrocardiograph for acquiring and recording ECG signals, with no mention of AI or ML capabilities for analysis or interpretation.
No
The device is used for diagnosis and recording of ECG signals, not for treating or rehabilitating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the ECScope 100 is "intended to be used for the diagnosis of cardiovascular system complications."
No
The device description explicitly states it consists of two basic components: the processing unit and the patient acquisition module, and mentions hardware components like a display unit, keyboard, and USB connectivity for printing.
Based on the provided information, the ECScope 100 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.
- ECScope 100 Function: The ECScope 100 acquires and records electrical signals from the surface of the patient's body (ECG leads) to assess the cardiovascular system. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for acquiring and recording ECG leads for the diagnosis of cardiovascular system complications. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, the ECScope 100 falls under the category of a medical device that measures physiological signals, not an IVD.
N/A
Intended Use / Indications for Use
ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously.
ECScope 100 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
74 DPS
Device Description
ECScone 100 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.
ECScope 100 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 Display Unit, alphanumeric keyboard and an option to print the ECG data by transferring the image file to computer through USB key or USB Cable on A4 Sheet Paper or Direct Printing through connected printer.
ECScope 100 can record and store in its Database up to 30 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be printed on the external printer by directly connecting the printer or by transferring data through USB cable/Key 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
ECScope 100 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.
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 ECScope 100 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
MAY 28 2009
\ 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:
1st October 2008 Date Prepared:
| 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: | 408.354.8447 |
| Facsimile Number: | 650.579.7313 |
Device Information:
Classification: Class II Trade Name: ECScope 100 ECG Monitor Common Name: Classification Name: Electrocardiograph, CFR 870.2340 Product Code: 74 DPS
Predicate Devices:
- a. K Number: K072353. Model Name: Portable ECScope Manufacturer - DyAnsys, Inc
- b. K Number: K080036. Model Name: Portable ECSCOPE 12i Manufacturer - DyAnsys, Inc
- c. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A
Dyansys, Inc
1
ീ DyAnsys
Device Description:
ECScone 100 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.
ECScope 100 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 Display Unit, alphanumeric keyboard and an option to print the ECG data by transferring the image file to computer through USB key or USB Cable on A4 Sheet Paper or Direct Printing through connected printer.
ECScope 100 can record and store in its Database up to 30 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be printed on the external printer by directly connecting the printer or by transferring data through USB cable/Key using a PC.
Intended Use:
ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously.
ECScope 100 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 ECScope 100 is substantially equivalent to the following predicate devices:
- a. K Number: K072353. Model Name: Portable ECScope Manufacturer - DyAnsys, Inc
- b. K Number: K080036. Model Name: Portable ECScope 12i Manufacturer - DyAnsys, Inc
- c. K. Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A
Dyansys, Inc
2
Image /page/2/Picture/1 description: The image contains the word "DyAnsys" next to a symbol. The symbol is a stylized image of a hook. The text is in a simple, sans-serif font and is black in color.
ECScope 100 handheld battery operated Multi channel electrocardiograph is intended to be 1. used for the evaluation of the cardiovascular system. ECScope 100 will acquire and record Multi channel ECG signal. ECScope 100 can store in its database up to 30 ECG signal records. The device features a 10 lead ECG.
The ECScope 100 has the same intended use as the legally marketed predicate devices. 2.
The ECScope 100 was subjected to safety and performance tests against regulatory standards. 3. Final testing for the product included various performance tests as per ANSI/AAMI EC11: 1991 Guidance Document.
Dyansys, Inc
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized representation of an eagle.
MAY 28 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DyAnsys, Inc. c/o Mr. Ned Devine Sr. Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K091358
Trade/Device Name: ECScope 100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Codes: DPS Dated: May 6, 2009 Received: May 8, 2009
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally broke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard) in the Medical Device Amendments, or to commerce prior to May 20, 1976, the eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110.) that to nevies, subject to the general controls provisions of the Act. The I ou may, merelore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (cost controls. Existing major regulations affecting your device it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oouo orcerning your device in the Federal Register.
4
Page 2 - Mr. Ned Devine
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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:
ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously.
ECScope 100 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) (ODE)
Concurrence of CDRH, Office of Device Evaluation
of (Posted November 13, 2003) Page Page
K6-91358
(Division Sign-Off) Division of Cardiovascular Devices KO91350 510(k) Number_