CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Applicant
Witt Biomedical Corp
Product Code
MWI · Cardiovascular
Decision Date
Feb 24, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2300
Device Class
Class 2
Indications for Use
The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, cardiac catheterization, invasive clinical data acquisition and analytical assessment within cardiac catheterization, 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 for storage, analysis and viewing at distributed locations 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. The CALYSTO Central Station and Patient Care Monitors provide the ability to alert the operator to alarms (both visual and audible), 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 stores the data 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 for storage, analysis and viewing at distributed locations via intranet or internet, or may function as a stand-alone device.
Device Story
CALYSTO Series IV functions as patient care monitor, central station, and ECG management system. Inputs include physiologic/hemodynamic signals and ECG data from source devices. System stores, transmits, and displays data for clinical review and report generation; operates as stand-alone or networked via intranet/internet. Used by professional healthcare providers in clinical settings (cath labs, radiology, electrophysiology). Device provides visual/audible alarms and data management; does not perform automated arrhythmia detection or interpretive analysis. Healthcare providers interpret raw data to facilitate clinical decision-making and patient monitoring. Benefits include centralized data access and timely response to patient status changes.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Physiologic/hemodynamic monitoring and ECG management system. Connectivity via intranet/internet or standalone. Software-based data storage and display. Does not include automated interpretive functions or arrhythmia detection algorithms.
Indications for Use
Indicated for professional healthcare provider use in physiologic/hemodynamic monitoring, cardiac catheterization, invasive clinical data acquisition, and ECG data management (resting, stress, Holter) in healthcare environments including cath labs, radiology, and electrophysiology labs. Contraindicated for unattended patient monitoring or situations requiring arrhythmia detection.
Regulatory Classification
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.
Submission Summary (Full Text)
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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.
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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
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**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 _
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## 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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
