(386 days)
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No
The summary does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The "automated detection of capture" is described as a function of the control program, not explicitly linked to AI/ML.
No
The device is indicated for diagnosis and planning of treatment, not for actual treatment or therapy. It assists in electrophysiology studies for diagnostic purposes.
Yes
The device is indicated for "diagnosis" of supraventricular and other miscellaneous arrhythmias, which directly aligns with the definition of a diagnostic device.
No
The device description explicitly mentions both "EPStim Software" and "Bloom DTU Electrophysiology Program Stimulator," indicating a hardware component (the stimulator) is part of the system. The software controls this hardware.
Based on the provided information, 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 an "Electrophysiology Stimulator" used for "electrophysiology studies for the diagnosis, and the planning of treatment of supraventricular and other miscellaneous arrhythmias." This involves stimulating the heart's electrical activity directly in a living patient, not analyzing samples taken from the body.
- Intended Use: The intended use describes a procedure performed in vivo (within the living body) in an electrophysiology laboratory setting.
Therefore, the DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DTU-215 Programmable Electrophysiology Stimulator with the EPStim Electrophysiology Stimulator Control Program is indicated for patients that are candidates for electrophysiology studies for the diagnosis, and the planning of treatment of complex and other miscellaneous arrhythmias.
The EPStim is intended for assisting a physician in performing an electrophysiology study by providing automated control of the DTU-215 Programmable Stimulator. The System provides for compilation, storage and rapid execution of a customized series of stimulator outputs. The system allows for rapid measurement of capture during cardiac electrophysiological testing.
The DTU-215 Programmable Stimulator is intended for use in the electrophysiology setting under the direction of qualified personnel trained to administer electrophysiological procedures.
Product codes
JOQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Electrophysiology setting under the direction of qualified personnel trained to administer electrophysiological procedures.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Y - 5 2000
Mr. Michael Parmenter Fischer Imaging Corporation 12300 North Grant Street Denver, CO 80241-3120
K991293 Re: Epstim Software and Bloom DTU Electrophysiology Program Stimulator Requlatory Class: II (two) Product Code: JOQ Dated: March 27, 2000 Received: March 28, 2000
Dear Mr. Parmenter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
1
Page 2 - Mr. Michael Parmenter
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Mark McMullen
James E. Dillard III Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER (IF KNOWN): K991293
DEVICE NAME: EPStim and DTU-215
INDICATIONS FOR USE:
The DTU-215 Programmable Electrophysiology Stimulator with the EPStima The DI U-215 Programmable Electrophysions is indicated for patients that are
Electrophysiology Stimulator Control Program is indicated for patients of the Electrophysiology Stimulator Contor i rogan is massis, and the planning of treatment
candidates for electrophysiology studies for the diagnosis, and the planny and candidates for electrophysiology studies for the diagnologics, and in provide of the proopy and other miscellaneous arrhythmias.
The EPstim is intended for assisting a physician in performing an electrophysiology study
of the system of the more of the DE Pressurements Stimulator . The system The EPstim is intended for assisting a prysician in presemmator. The System
by providing automated control of the DTU-215 Programmalle Stimulator by providing automated collici of the DTC-21-110g. canstonized series of stimulator provides for compilation, storage and rapid exceded of a valience of capture during cardiac electrophysiological testing.
The DTU-215 Programmable Stimulator is intended for use in the electrophysiology The DI U-213 Programmabic Stimulator is meeting under the direction of qualified personnel trained to administer electrophysiological procedures.
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| (Per 21 CFR 801.109) | X | OR | Over-The-Counter-Use |
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| | K991293 |