(16 days)
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System")
This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.
SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
This device SONOPLUS 3000 is a combination product that includes Electrocardiograph and manual Stethoscope.
It displays ECG and heart rate data with automatic pacemaker detection, auto scaling of ECG amplitudes and filtering.
A Windows-based software installed on an external computer allows for:
- creating patient database
- downloading, storing, graphically displaying as well as printing required data from device
- setting date on device
- communicating with PULSONIC website for software updates
The provided text "K051126" does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the SONOPLUS 3000 device, an electrocardiograph and manual stethoscope combination.
It focuses on establishing substantial equivalence to a predicate device (CADITEC's CADISCOPE, 510k #K990809) based on technological characteristics like indications for use, target population, design, materials, and performance.
Therefore, I cannot provide the requested information in the table or the subsequent points as the input does not contain a description of acceptance criteria or a study.
The document only states "13-Safety and Effectiveness of the device: This device is safe and effective as the other predicate devices cited above." and "14-Summary comparing technological characteristics with other predicate device: ...Performance | Similar". This indicates a comparison to a predicate device, but no specific performance study or acceptance criteria are detailed.
{0}------------------------------------------------
K051126
b. 1/2
510(k) Summary As Required by 21 section 807.92 ( c )
MAY 1 9 2005
PULSONIC AG MEDICAL TECHNOLOGY 1-Submitter Name:
2-Address: Forrlibuckstrasse 110 Zurich. SWITZERLAND CH 8005
- 3-Phone: +41 (0)-272 75 03
4-Fax: +41 (0)-272 75 01
5-Contact Person: Artemio Granzotto, General Manager
6-Date summary prepared: March 7th, 2005
7-Device Trade or Proprietary Name: Cardioscope SONOPLUS 3000
8-Device Common or usual name: Electrocardiograph
9-Device Classification Name: Electrocardiograph
10-Substantial Equivalency is claimed against the following device:
CADITEC's CADISCOPE, 510k #K990809
11-Description of the Device:
This device SONOPLUS 3000 is a combination product that includes Electrocardiograph and manual Stethoscope.
It displays ECG and heart rate data with automatic pacemaker detection, auto scaling of ECG amplitudes and filtering.
A Windows-based software installed on an external computer allows for:
- creating patient database ।
- downloading, storing, graphically displaying as well as printing required data from device
- setting date on device -
- communicating with PULSONIC website for software updates -
12-Intended use of the device:
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System")
This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.
SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate devices cited above.
PAGE E 1
{1}------------------------------------------------
This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.
REFER TO MAIN SUBMISSION FOR COMPLETE DETAILS
| FDA file reference number | 510K # K980105 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Similar |
| Target population | Similar |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not applicable |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Pulsonic AG Medical Technology c/o Mr. Mark Job Regulatory Technology Services, Inc. 1394 25th Street NW Buffalo, MN 55313
Re: K051126
Trade Name: SONOPLUS 3000 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: May 2, 2005 Received: May 3, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 310(x) premained 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 regally mancted provice Americal Device Ameradments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food True commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food. Drug, devices that have been recuired in acceracy will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosmetic Act (Act) that do not require approvince the general controls provisions of the Act. The You may, ulerelove, market the devices, basyer in the more of registration, listing of general controls provisions of the rict mendo roquiations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is Classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroling and on 898. In addition, FDA may be found in the Code of Peachar Registerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Mark Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualled of a backers on alle other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a delemination that your concerned by other Federal agencies. You must or any Federal statures and regulations daministered of out not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to comply with an the Act s requirements, more manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if any 1000 1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declems be revice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your dev i his letter will anow you to begin maketing of substantial equivalence of your device to a legally premarket notheadon. The PDA miding of backand to 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 If you desire specific advice for your ac now of our of one of the regulation entitled, contact the Office of Comphanes as (216) => 5 => = = = = 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) viously who "Misoranding by reference to premails.com the Act may be obtained from the from the Other general information on your responsional 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,
Bzimmernan for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): Ko51126
Device Name: SONOPLUS 3000
Indications For Use:
This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System")
This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and
environmental conditions and it is in no way meant to be diagnostic.
SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
S Prescription Use (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)
immismen
fori Sign-Off) (Diggion Sign-On)
Division of Cardlovascular Devices 251166 510(k) Number_
Page 1 of 1 __
§ 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).