(75 days)
No
The document explicitly states that the device uses an "ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow," which is a traditional algorithmic approach, not AI/ML. There are no mentions of AI, ML, DNN, training sets, or test sets, which are typical indicators of AI/ML technology in a 510(k) summary.
No
The device is a software application for viewing, editing, printing, and archiving electrocardiograph records and providing analysis. It does not directly treat or manage a disease or condition.
Yes
The device "provides analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician," indicating it contributes to the diagnostic process by analyzing medical data.
Yes
The device description explicitly states that INFINITY MegaCare is a "computer software program" and a "software application" installed on a user-provided server. It processes digitized ECG records from various hardware devices but is itself described solely as software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that INFINITY MegaCare processes digitized electrocardiograph records. These records are electrical signals measured on the body, not samples taken from the body (like blood, urine, or tissue).
- The analysis is of electrical signals, not biological or chemical properties of a sample. The device analyzes ECG waveforms, which represent the electrical activity of the heart. This is distinct from analyzing the composition or properties of a biological sample.
Therefore, INFINITY MegaCare falls under the category of a medical device that processes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.
INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.
INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.
The device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended for use with all patient populations.
Product codes
LOS, DQK
Device Description
INFINITY MegaCare is a computer software program that allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, ambulance ECG devices, Holter ECG devices and the INFINITY Monitoring System.
INFINITY MegaCare uses the Microsoft Windows 2000 server operating system, Microsoft IIS Web server, and Microsoft SOL Server 2000 relational database. The system consists of a software application, which is installed on a user provided IBM compatible server running the Microsoft Windows 2000 Server operation system. MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281).
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
all patient populations
Intended User / Care Setting
Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
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)
Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)
Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K980625, K992637, K974420, K946281
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Solutuions Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Ouality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: June 20, 2003
Trade Name, Common Name and Classification Name:
A. Trade Name: INFINITY MegaCare
- B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| System, ECG Analysis | LOS | ||
| Computer, diagnostic, programmable | DQK | II | 21CFR 870.1425 |
Predicate Device Identification:
| K980625 | Infinity MultiView WorkStation Enhanced with
Diagnostic Statements (Rest ECG) |
|---------|----------------------------------------------------------------------------------|
| K992637 | Muse Cardiovascular Information System |
| K974420 | TraceMaster ECG Management System |
| K946281 | Burdick Eclipse 4 Electrocardiograph |
Device Description:
INFINITY MegaCare is a computer software program that allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, ambulance ECG devices, Holter ECG devices and the INFINITY Monitoring System.
Page 1 of 2
COMPANY CONFIDENTIAL
Siemens Medical Solutuions Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
INFINITY MegaCare uses the Microsoft Windows 2000 server operating system, Microsoft IIS Web server, and Microsoft SOL Server 2000 relational database. The system consists of a software application, which is installed on a user provided IBM compatible server running the Microsoft Windows 2000 Server operation system. MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281).
Intended Use:
INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.
INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. Infinity MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.
INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.
Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)
Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidance: Section R
COMPANY CONFIDENTIAL
Siemens Medical Solutions Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping human profiles or figures. The symbol is abstract and appears to be in motion or flowing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923
Re: K031970
Trade Name: Siemens INFINITY MegaCare Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: June 20, 2003 Received: June 26, 2003
Dear Ms. Greco:
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.
3
Page 2 - Ms. Penelope H. Greco
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. E. Zeller, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K031970
Page 1 of 1
510(k) Number (if known):
Siemens INFINITY MegaCare Device Name:
Indications for Use:
INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.
INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.
INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.
The device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended for use with all patient populations.
MRI Compatibility Statement:
The INFINITY MegaCare is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
rdiovascular Devices
510(k) Number K031170