(27 days)
No
The document explicitly states "CALYSTO Series IV does not provide interpretive functions" and there are no mentions of AI, ML, or related terms in the provided text.
No
The device is described as a monitoring, data acquisition, and assessment system for physiological and hemodynamic data, without any mention of providing or facilitating treatment.
Yes
The device is intended for "complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment" and facilitates "information gathering" and "analytical assessment" in various clinical laboratories. This aligns with the definition of a diagnostic device, which collects and analyzes data to aid in understanding a patient's condition.
No
The device description and intended use clearly indicate that the CALYSTO Series IV is a system for physiologic/hemodynamic monitoring and data acquisition, which inherently involves hardware components to acquire physiological signals. The mention of "Patient Care Monitors and Central Station System" in the predicate device further supports the presence of hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is for "complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment." This involves monitoring vital signs and physiological data directly from the patient, not analyzing samples taken from the patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples. Its function is focused on acquiring and processing real-time physiological data.
The device is a patient monitoring and data management system used in clinical settings, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility 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 health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.
Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations 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 does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.
Product codes
MWI
Device Description
The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.
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 health care providers.
cardiac catheterization, invasive 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)
Verification, validation and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Pass/Fail criteria were based on the specifications cleared for the predicate device and the test results showed substantial equivalence.
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
§ 870.2300 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
KO63547
Section 6 - 510(K) Summary
| Submitted by: | Witt Biomedical Corporation (a wholly owned subsidiary of Philips Holding
USA, Inc.)
305 North Drive
Phone: (321) 253-5693
Fax: (321) 253-0372 | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | James Luker | |
| Date Prepared: | November 20, 2006 | JEC 21 2006 |
| Proprietary Name: | CALYSTO Series IV, Patient Care Monitor and Central Station System | |
| Common Name: | Physio-monitoring and Information System | |
| Classification Name: | 21 CFR § 870.2300 74 MWI
Monitor, Physiological, Patient (without Arrhythmia detection or alarms)
Class II | |
| Predicate Device: | CALYSTO Series IV, Patient Care Monitor and Central Station System
K033030 | |
| Device Description: | The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. | |
| Substantial Equivalence: | The modified CALYSTO Series IV System is substantially equivalent to the currently cleared CALYSTO Series IV System (K033030). Evidence of substantial equivalence is provided in section 10. | |
| Intended Use: | The CALYSTO Series IV is intended for complete physiologic/hemodynamic
monitoring, clinical data acquisition and analytical assessment for cardiac
catheterization, invasive radiology and electrophysiology laboratories. Its users,
responsible to interpret the data made available, will be professional health care
providers. CALYSTO Series IV provides the ability to transmit patient data
files for storage, analysis and viewing at distributed locations within the clinical
facility 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 health care providers. User
adjustable alarms (both visual and audible), alert the operator to anomalous
occurrences and facilitate timely responses.
Use of CALYSTO Central Station and Patient Care Monitors is not intended
where unattended patient monitoring is desired or in situations where
arrhythmia detection is required.
The CALYSTO Series IV ECG Management system is intended for | |
1
| 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 does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. | |
|---|---|
| Technological | |
| Characteristics: | The modified device has the same technological characteristics as the legally marketed predicate device (K033030). The modifications consist of the implementation of the Respironics Capno 5 End Tidal CO2 mainstream and LoFlo sidestream End Tidal CO2 modules. In addition the Masimo MX-1 pulse oximetry module will be integrated with the current device as an option to the currently cleared Nellcor MP 506 pulse oximetry module. The specifications and accuracy of the proposed modules are equivalent to the currently legally marketed predicate device |
| Summary of | |
| Substantial | |
| Equivalence: | The modified CALYSTO Series IV system is substantially equivalent to the legally marketed predicate device. The modifications do not change the intended use or operating parameters of the system. No contraindications have been added or removed as a result of the modifications |
| Verification, | |
| Validation, and | |
| Testing: | Verification, validation and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Pass/Fail criteria were based on the specifications cleared for the predicate device and the test results showed substantial equivalence. |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2006
Witt Biomedical Corp. c/o James Luker QA/RA Engineer 305 North Drive Melbourne, FL 32934
Re: K063547
Trade Name: Calysto Series IV Physio-Monitoring and Information System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II Product Code: MWI Dated: November 24, 2006 Received: November 17, 2006
Dear Mr. Luker:
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 - Mr. Luker
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 may be obtained 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,
Blzimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 5 -INDICATION FOR USE STATEMENT 510(k) Number:
Device Name: CALYSTO Series IV Physio-monitoring and Information System
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility 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 health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.
Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.
V 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)
Blummenon
Division Sign-Offi Division of Cardiovascular Devices 510(k) Number Kni, 354
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