(182 days)
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Not Found
No
The provided text does not mention AI, ML, or any related concepts in the intended use, device description, or other sections.
Yes
The device is indicated for conditions such as "Refractory Ischemia," "Myocardial Infarction," and "Cardiogenic Shock," which are medical conditions that the device helps to treat or manage, qualifying it as a therapeutic device.
No
The description of the System 96 Intra Aortic Balloon Pump (IABP) and its indications for use show that it is a therapeutic device used to support cardiac function in patients with various cardiac conditions, not a device used to diagnose medical conditions.
No
The device description explicitly states "Intra-Aortic Balloon Pump (IABP)", which is a hardware device. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Datascope System 96 Intra-Aortic Balloon Pump (IABP) 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 Description and Intended Use: The description and intended uses clearly indicate that the System 96 is a mechanical pump used to assist the heart's function within the body (intra-aortic). It's a therapeutic device, not a diagnostic test performed on samples outside the body.
The listed indications for use are all clinical conditions that the IABP is used to treat or support, not to diagnose.
N/A
Intended Use / Indications for Use
The following are the indications for use for the System 96 Intra Aortic Balloon Pump:
- 0 Refractory Ischemia
- Myocardial Infarction 0
- Preoperative Hemodynamic Stability 0
- Weaning from Cardio Pulmonary Bypass 0
- Refractory Ventricular Failure 0
- Cardiogenic Shock 0
- 0 Unstable Refractory Angina
- Septic Shock 0
- Angioplasty Support 0
- Intraoperative Pulsatile Flow Generation 0
Any other uses are not recognized by Datascope Corporation as bonafide.
Product codes
DSP
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan E. Mandy Manager Regulatory and Clinical Affairs Datascope Corporation JUL == 1 1097 580 Winters Avenue Paramus, New Jersey 07652 ----------
кае 5236 Re: Datascope System 96 Intra-Aortic Balloon Pump (IABP) Requlatory Class: III (Three) Product Code: DSP Dated: April 18, 1997 Received: April 21, 1997
Dear Ms. Mandy:
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 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 controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Susan E. Mandy
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 yourdesire specific advice for your device on our-labeling hand 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 (301) 594-4639. Also, please note the regulation entitled, "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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Hic Balloon and 870, 3535 1112222 DSP TI K 4652363 510(k) Number (if known): Device Name: Datascope System 96 Intra Ac
Indications For Use:
The following are the indications for use for the System 96 Intra Aortic Balloon Pump:
- 0 Refractory Ischemia
- Myocardial Infarction 0
- Preoperative Hemodynamic Stability 0
- Weaning from Cardio Pulmonary Bypass 0
- Refractory Ventricular Failure 0
- Cardiogenic Shock 0
- 0 Unstable Refractory Angina
- Septic Shock 0
- Angioplasty Support 0
- Intraoperative Pulsatile Flow Generation 0
Any other uses are not recognized by Datascope Corporation as bonafide.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera Campbele
ivision Sign-Off sion Sign Our, Respiratory, d Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96