(21 days)
No
The summary describes a material and dimensional modification to an existing intra-aortic balloon catheter. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is used to treat various medical conditions, including angina, myocardial infarction, heart failure, and cardiogenic shock, which are all therapeutic indications.
No
The device is described as an intra-aortic balloon catheter intended to improve cardiovascular functioning for various conditions. While it can provide "Support for diagnostic, percutaneous revascularization, and interventional procedures," its primary function is therapeutic support rather than diagnosis itself.
No
The device description clearly states it is an intra-aortic balloon catheter, which is a physical medical device inserted into the body. It also mentions material modifications and physical dimensions, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Datascope CA 40 8Fr. Intra-Aortic Balloon Catheter is a device that is inserted directly into the patient's body (specifically, the descending aorta). Its purpose is to provide mechanical support to the cardiovascular system by inflating and deflating within the aorta.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient.
Therefore, this device falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: Refractory unstable angina . Impending infarction . Acute MI . Refractory ventricular failure ● Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) . Cardiogenic shock ● Support for diagnostic, percutaneous revascularization, and interventional . procedures. Ischemia related intractable ventricular arrhythmias ● Septic shock . Intraoperative pulsatile flow generation ● Weaning from bypass ● Cardiac support for non-cardiac surgery ● Prophylactic support in preparation for cardiac surgery . Post surgical myocardial dysfunction/low cardiac output syndrome ● Myocardial contusion ● Mechanical bridge to other assist devices ● Cardiac support following correction of anatomical defects .
Product codes
DSP
Device Description
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations: Refractory unstable angina . Impending infarction . Acute MI . Refractory ventricular failure ● Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) . Cardiogenic shock ● Support for diagnostic, percutaneous revascularization, and interventional . procedures. Ischemia related intractable ventricular arrhythmias ● Septic shock . Intraoperative pulsatile flow generation ● Weaning from bypass ● Cardiac support for non-cardiac surgery ● Prophylactic support in preparation for cardiac surgery . Post surgical myocardial dysfunction/low cardiac output syndrome ● Myocardial contusion ● Mechanical bridge to other assist devices ● Cardiac support following correction of anatomical defects .
Modifications to Datascope's predicate 8 Fr. IAB catheters include a material modification of Datascope's currently marketed balloon membrane to enable the balloon to be manufactured using different molding process. The catheter tip material is that of a previously FDA cleared IAB tip material and the catheter's tip dimension has been tapered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending aorta just below the subclavian artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices. There have been no clinical evaluations of the new device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Attachment D
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
DATASCOPE'S CA 40 8Fr. Intra-Aortic Balloon Catheters Prepared in accordance with 21 CFR Part 807.92)
GENERAL INFORMATION A.
| Submitter: | Datascope Corp.
Cardiac Assist Division |
|-----------------|------------------------------------------------------|
| Address | 15 Law Drive
Fairfield, NJ 07004 |
| Contact Person: | JoAnn Taylor
Global Regulatory Affairs Specialist |
B. DEVICE INFORMATION
| Generic Name: | Intra-Aortic Balloon Catheter (IAB) |
|---|---|
| Trade Name: | Datascope's 8 Fr. Intra-Aortic Balloon Catheter (IAB) |
| Classification Name: | Intra-Aortic Balloon Catheters (IAB) are classified under 21 CFR |
| 870.3535 |
C. PREDICATE DEVICE INFORMATION
Datascope's CA 40 Intra-Aortic Balloon Catheters (IAB) are substantially equivalent to the following marketed devices:
- K013326, Datascope Fidelity 8Fr. Alt B Intra-Aortic Balloon Catheters (S/E . 11/02/01).
- K003598, Datascope Profile 8Fr. Intra-Aortic Balloon Catheters w/Alt B and Gas . Lumen Insert (S/E 12/21/00)
1
DEVICE DESCRIPTION/INTENDED USE D.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
- Refractory unstable angina .
- Impending infarction .
- Acute MI .
- Refractory ventricular failure ●
- Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) .
- Cardiogenic shock ●
- Support for diagnostic, percutaneous revascularization, and interventional . procedures.
- Ischemia related intractable ventricular arrhythmias ●
- Septic shock .
- Intraoperative pulsatile flow generation ●
- Weaning from bypass ●
- Cardiac support for non-cardiac surgery ●
- Prophylactic support in preparation for cardiac surgery .
- Post surgical myocardial dysfunction/low cardiac output syndrome ●
- Myocardial contusion ●
- Mechanical bridge to other assist devices ●
- Cardiac support following correction of anatomical defects .
TECHNOLOGICAL CHARACTERISTICS E.
Datascope's CA 40 8Fr. IAB Catheters are substantially equivalent to the predicate devices with regard to intended use.
Modifications to Datascope's predicate 8 Fr. IAB catheters include a material modification of Datascope's currently marketed balloon membrane to enable the balloon to be manufactured using different molding process. The catheter tip material is that of a previously FDA cleared IAB tip material and the catheter's tip dimension has been tapered.
These modifications to the 8Fr. IAB catheters have been demonstrated not to affect safety or efficacy of the device.
F. NON-CLINICAL TESTS
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
2
G. CLINICAL TESTS
There have been no clinical evaluations of the new device.
H. CONCLUSIONS
Based on the information presented in this 510(k) premarket notification, Datascope's CA 40 8 Fr. IAB Catheters are considered substantially equivalent to Datascope's currently marketed IABs.
3
Public Health Service
JUN 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Datascope Corporation Cardiac Assist Division c/o Ms. JoAnn Taylor Global Regulatory Affairs Specialist 15 Law Drive Fairfield. NJ 07004
Re: K031569
8Fr. Intra-Aortic Balloon Catheter Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon Catheter Regulatory Class: Class III (three) Product Code: DSP Dated: May 19, 2003 Received: May 20, 2003
Dear Ms. Taylor:
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. Iisting 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.
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Page 2 - Ms. JoAnn Taylor
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 (301) 594-4646. 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 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/dsmaldsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment B
Indications for Use Statement
| 510(k) Number | K031569 |
|---|---|
| Device Name | Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters |
| Indications | |
| for Use | Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters have the following |
| indications for use: | |
| Refractory unstable anginaImpending infarctionAcute MIRefractory ventricular failureComplications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)Cardiogenic shockSupport for diagnostic, percutaneous revascularization, and interventional procedures.Ischemia related intractable ventricular arrhythmiasSeptic shockIntraoperative pulsatile flow generationWeaning from bypassCardiac support for non-cardiac surgeryProphylactic support in preparation for cardiac surgeryPost surgical myocardial dysfunction/low cardiac output syndromeMyocardial contusionMechanical bridge to other assist devicesCardiac support following correction of anatomical defects |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CCRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| Over-The-Counter Use | _________________ |
| 510(k) Number | K031569 |