(8 days)
The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope 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 specific clinical diagnosis. The clinical significance must be determined by a physician.
Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), 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 can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.
The provided text is a 510(k) summary for the Portable ECScope device. It details the device's description, intended use, and comparison to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in detailed performance studies for AI/algorithm-based devices.
The document states:
"The Portable ECScope 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."
This indicates that the device underwent testing according to a recognized standard for electrocardiographs, but the specific acceptance criteria, test results, and details of how those results were obtained are not included in this summary.
Therefore, I cannot provide the requested information in the table or the detailed breakdown of study parameters because the provided text does not contain this information.
If this were an AI or algorithmic device submission, the 510(k) summary would typically include a dedicated section detailing performance data, acceptance criteria, ground truth establishment, and details of the study design. This document is a more traditional medical device submission for an ECG monitor, which relies on demonstrating adherence to established performance standards for hardware and basic functionality, rather than complex algorithmic performance metrics against a clinical ground truth.
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AUG 3 0 2007
21 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.
K022323 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
3rd July 2007 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: | Portable ECScope |
| Common Name: | ECG Monitor |
| Classification Name: | Electrocardiograph |
Predicate Devices:
- a. K Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO
- b. K. Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A
Device Description:
Portable ECScope is a multi channel electrocardiograph for the simultaneous acquisition of the 7 ECG leads i.e L1, L2, L3, aVR, aVL, aVF and one of the chest leads (V1-6), 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.
Dyansys, Inc
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Portable ECScope can record and store in its Database up to 200 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be reviewed, printed on the external printer using a PC.
Intended Use:
Portable ECScope handheld battery operated Multi channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope will acquire, display and record Multi channel ECG signal.
Portable ECScope 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 any specific clinical diagnosis. The clinical significance must be determined by the physician.
Comparison to Predicate Device(s):
The Portable ECScope is substantially equivalent to the following predicate devices:
- a. K Number: K954980. Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO
- b. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A
- Portable ECScope handheld battery operated Multi channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope will acquire, display and record Multi channel ECG signal. Portable ECScope can store in its database up to 200 ECG signal records. The device features a 5 lead ECG.
The Portable ECScope has the same intended use as the legally marketed predicate devices. The 2. intended use of the Portable ECScope is the same as the predicates.
- The Portable ECScope 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.
Page 2 of 2
Dyansys, Inc
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2007
DyAnsys Inc. c/o Mr. Ned Devine, Underwriters Laboratories, Inc. Senior Staff Engineer 333 Pfingsten Road Northbrook, IL 60062
Re: K072353
Trade/Device Name: Portable ECScope Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: August 21, 2007 Received: August 22, 2007
Dear Mr. Devine:
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. 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 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,
B. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072353
Device Name: Portable ECScope_________________________________________________________________________________________________________________________________________________
Indications for Use:
The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals.
The Portable ECScope 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 specific clinical diagnosis. The clinical significance must be determined by a physician.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blammina
(Division Sign-Off Division of Cardiovascular Devi 510(k) Number
Page ( of )
(Posted November 13, 2003)
§ 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).