(151 days)
Not Found
Not Found
No
The provided text focuses on data acquisition, storage, transmission, and basic analytical assessment, but explicitly states it does not provide interpretive functions and is not intended for arrhythmia detection, which are common applications for AI/ML in this domain. There are no mentions of AI, ML, deep learning, or related concepts.
No
The device is described as being for "monitoring, data acquisition and analytical assessment" and "receiving and storing...data" for "review and report generation purposes." There is no indication that it provides any form of therapy or treatment.
Yes
The device is intended for "complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment" and "complete physiologic monitoring, clinical data acquisition and analytical assessment," which are core functions of diagnostic devices. It helps healthcare providers interpret data to understand a patient's condition.
No
The intended use and device descriptions (though the latter is "Not Found" in the provided text, the intended use strongly implies hardware components) describe a system for "complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment," which typically involves hardware sensors and monitoring equipment in addition to software. The description of "CALYSTO Central Station and Patient Care Monitors" further suggests hardware components.
Based on the provided text, the CALYSTO Series IV, CALYSTO Central Station and Patient Care Monitors, and CALYSTO Series IV ECG Management system are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The descriptions provided focus on monitoring physiological parameters (hemodynamic, ECG), data acquisition and analysis, and data management.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
The devices described are clearly intended for in vivo monitoring and data management within a clinical setting, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, and invasive clinical data acquisition and analytical assessment in cardiac catheterization, radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional healthcare providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, or may function as a stand-alone device.
Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional healthcare providers. The monitors allow the operator to set and disable alarms (both visual and audible), and facilitate timely responses.
Use of CALYSTO Central Station and Patient Care Monitors is not intended where arrhythmia detection is required.
The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV has no interpretive functions, but integrates ECG data generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional healthcare providers. CALYSTO Series IV provides the ability to transmit ECG data remotely for storage, analysis, and viewing at distributed locations within an intranet, or may function as a stand-alone device.
Product codes
74 MWI
Device Description
Not Found
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
Professional healthcare providers / cardiac catheterization, radiology and electrophysiology laboratories, any healthcare 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2004
Witt Biomedical Corporation c/o Mr. Elfriede Pagan RA Specialist 305 North Drive Melbourne, FL 32934
K033030 Re:
KUS 5030
Trade Name: Calysto Series IV, Patient Care Monitors and Central Station, and ECG Management System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 MWI Dated: December 18, 2003 Received: December 22, 2003
Dear Mr. Pagan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(tr) premained is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the encrosure) to regars nement date of the Medical Device American on to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recatismed in above approval of a premarket approval application (PMA). and Cosment Act (Act) that to not requence subject to the general controls provisions of the Act. The You may, merciole, manel the device, of the Act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affective your device can may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Cours concerning your device in the Federal Register.
1
Page 2 -- Mr. Elfriede Pagan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be auvised that FDA s issuance of a buice complies with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations asminities. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CFR Part 807), fabening (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions our device as described in your section 510(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to begin manceing your antial equivalence of your device to a legally premarket notification. The PDF miding of backed the sour 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 do need and Also, please note the regulation entitled, coniact the Office of Comphanes at (5 x notification" (21CFR Part 807.97). You may obtain " Misbrailding by Icrerches to premainst notifical virus (1) == == == = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = other geleral information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, International and Solless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Duma R. Vachner
( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K033030
Device Name: CALYSTO Series IV, Patient Care Monitor and Central Station, and ECG Management System
Indications For Use:
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, The CALTSTO Senes IN is intendou for cardiac catheterization, invasive clifical data acquisition and analytical accocomisms. Its users, responsible to interpret the data
radiology and electrophysiology laboratories. Its users, responsible to int radiology and electrophysiology laborater care providers. CALYSTO Series IV made available, will be professional noakn over for storage, analysis and viewing at provides the ablity to transmit patient active via intraget or internet, or may function as a stand-alone device.
Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
The CALYSTO Central Station and Patient Care Monitors are intended for complete The CALYSTO Central Olation and Pation Callerity on and analytical assessment within any priyslologic monitoring, cimical actures are acquires the data made available, will healthcare environment. Its users, roopeneralist to lable alarms (both visual and audible), be professional neath ouro providerer over over and facilitate timely responses.
alch the operater to antial Station and Patient Care Monitors is not intended where Use of CALYSTO Central Station and Patient State Montonere arrhythmia detection is required.
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)
Dona R. Vochrel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K035030
Page 1 of 2 _
3
Indications for Use
510(k) Number (if known): K033030
Device Name:__CALYSTO Series IV, Patient Care Monitor and Central Station, and ECG Management System
Indications For Use:
The CALYSTO Series IV ECG Management system is intended for receiving and The CALTSTO Selles IV EOO Management of Stories. ECG data is stored,
storing resting, stress and holter ECG data from source devices. ECG data is stored, storing resting, stress and noiler 200 ed.w.a.it in review and procedural report unateled, in its onginal formal, and made available interpretive functions, but generation purposes. OAL FOTO Generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will expandable uatabase. Its accro, responsible of the series IV provides the ability to be prolessional neath care providere. Or storage, and viewing at distributed locations within transmit ECG uata mes for storage, and fromet, or may function as a stand-alone device.
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)
Daina R. Adams
iori Sign-Off) on of Cardiovascular Devices
. K) Number K033030
Page 2 of 2