(386 days)
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 supraventricular 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 and provides for automated detection of capture during cardiac electrophysiological testing.
The DTU-215 Programmable Stimulator is intended for use in the electrophysiology laboratory setting under the direction of qualified personnel trained to administer electrophysiological procedures.
EPStim Software and Bloom DTU Electrophysiology Program Stimulator
I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EPStim Software and Bloom DTU Electrophysiology Program Stimulator.
While it states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications for Use," it does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes.
- Details about standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on the regulatory clearance process and the intended use of the device, rather than the specifics of its performance validation testing.
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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
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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
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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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| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter-Use(Optional Format 1-2-9) |
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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).