(44 days)
K041281 Datascope's Linear 7.5Fr. IAB, K031636 -. Datascope's CS100 IAB Pump, K031569 Datascope's 8Fr. IAB, K013326 Datascope's Fidelity 8Fr. IAB, K060309 - Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, K040801 Arrow International's Intra-Aortic Balloon Catheter, K021462 - Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System, K981660 Arrow International (C.R. Bard, Inc.) 8Fr 40 cc and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB)
Not Found
No
The summary describes a standard electromechanical intra-aortic balloon pump system that synchronizes with physiological signals (ECG or arterial pressure) using established principles of counterpulsation. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The synchronization mechanism appears to be based on deterministic algorithms rather than learning-based approaches.
Yes
The device is described as an "electromechanical systemused to inflate and deflate intra-aortic balloons" that "provides temporary support to the left ventricle via the principle of counterpulsation." It is indicated for various medical conditions such as "Refractory unstable angina", "Acute MI", and "Cardiogenic shock", directly implying a therapeutic purpose.
No
The device is an intra-aortic balloon pump, which provides temporary support to the left ventricle. While its operation is adjusted based on physiological signals (ECG or arterial pressure waveform), its primary function is therapeutic (counterpulsation therapy) rather than diagnostic. The indications for use also list various medical conditions that the pump supports rather than diagnoses.
No
The device description explicitly states it includes an "electromechanical system" (the CS300 Intra-Aortic Balloon Pump) and a "Fiber optic pressure Sensor IAB assembly," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "electromechanical system used to inflate and deflate intra-aortic balloons" to provide "temporary support to the left ventricle via the principle of counterpulsation." This describes a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The components listed (pump, catheter) are consistent with a device used for direct physiological support within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to mechanically assist the heart.
Therefore, the CS300 Intra-Aortic Balloon Pump and its associated catheter are considered medical devices for therapeutic use, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CS300 Intra-Aortic Balloon Pump has the following indications for use:
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intraaortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.
Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:
- 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 (comma separated list FDA assigned to the subject device)
DSP
Device Description
The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta.
The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following:
- . CS300 Intra-Aortic Balloon Pump
- Fiber optic pressure Sensor IAB assembly .
- . Revised packaging tray with cable retention feature
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
descending aorta, just distal to the left subclavian artery
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
health care facility setting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical tests: There has been no clinical evaluation of the new device in the U.S.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K041281 Datascope's Linear 7.5Fr. IAB, K031636 -. Datascope's CS100 IAB Pump, K031569 Datascope's 8Fr. IAB, K013326 Datascope's Fidelity 8Fr. IAB, K060309 - Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series, K040801 Arrow International's Intra-Aortic Balloon Catheter, K021462 - Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System, K981660 Arrow International (C.R. Bard, Inc.) 8Fr 40 cc and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB)
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.
Not Found
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).
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.
0
063525
Attachment D
JAN -5 2007
510(k) SUMMARY FOR DATASCOPE'S IABP SYSTEM FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON (IAB) CATHETER and CS300 INTRA-AORTIC BALLOON PUMP (IABP) CONTROL SYSTEM
(Prepared in accordance with 21 CFR Part 807.92)
A. GENERAL INFORMATION
| Submitter: | Datascope Corp.
Cardiac Assist Division |
|-----------------|-----------------------------------------------------------------------|
| Address: | 15 Law Drive
Fairfield, NJ 07004 |
| Contact Person: | Nancy Cohen
Manager Regulatory Affairs and Product
Surveillance |
| Phone: | 973/244-6104 |
| Fax: | 973/244-6243 |
| Email: | Nancy_Cohen@datascope.com |
| Date: | November 21, 2006 |
B. DEVICE INFORMATION
| Generic Name: | Intra-Aortic Balloon (IAB) Catheter and
Control System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Datascope's IABP System [Fiber Optic
Pressure Sensor Intra-Aortic Balloon (IAB)
Catheter and CS300 Intra-Aortic Balloon
Pump (IABP) Control System] |
| Classification Name: | Intra-Aortic Balloon (IAB) Catheter and
Control System is classified under 21CFR
870.3535 |
C. PREDICATE DEVICE INFORMATION
Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is substantially equivalent to the following marketed devices:
- K041281 Datascope's Linear 7.5Fr. IAB, Substantially . Equivalent 6/07/04
- Datascope's CS100 IAB Pump, Substantially K031636 -. Equivalent 8/11/03
- K031569 Datascope's 8Fr. IAB. Substantially Equivalent . 6/10/03
1
- K013326 Datascope's Fidelity 8Fr. IAB, Substantially . Equivalent 11/02/01
- Arrow AutoCAT Intra-Aortic Balloon Pump . K060309 -(IABP) Series, Substantially Equivalent 4/06/06
- K040801 Arrow International's Intra-Aortic Balloon . Catheter, Substantially Equivalent 5/06/04
- . K021462 - Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System, Substantially Equivalent 6/06/02
- Arrow International (C.R. Bard, Inc.) 8Fr 40 cc . K981660 and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB)
D. DEVICE DESCRIPTION/INTENDED USE DEVICE DESCRIPTION
The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta.
INTENDED USE
CS300 Intra-Aortic Balloon Pump has the following indications for use:
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intraaortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.
Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:
- 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
2
- 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 .
E. TECHNOLOGICAL CHARACTERISTICS
The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following:
- . CS300 Intra-Aortic Balloon Pump
- Fiber optic pressure Sensor IAB assembly .
- . Revised packaging tray with cable retention feature
These modifications to the Datascope IAB System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] have been demonstrated not to affect safety or effectiveness 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.
G. CLINICAL TESTS
There has been no clinical evaluation of the new device in the U.S.
H. CONCLUSIONS
Based on the information presented in this 510(k) premarket notification, Datascope's IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is considered substantially equivalent to Datascope's currently marketed IAB Catheters and Control Systems.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The eagle is positioned in the center of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN -5 2007
Datascope Corp. c/o Ms. Nancy Cohen Manager Regulatory Affairs and Product Surveillance 15 Law Drive Fairfield, NJ 07004
K063525 Re:
Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: III Product Code: DSP Dated: December 15, 2006 Received: December 18, 2006
Dear Ms. Cohen:
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, 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 (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.
4
Page 2 - Ms. Nancy Cohen
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 (240) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
Blymmuta for
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System)
Indications For Use:
CS300 Intra-Aortic Balloon Pump has the following indications for use:
The balloon pump is an electromechanical system used to inflate and deflate intra-aortic It provides temporary support to the left ventricle via the principle of balloons. counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.
B. Asmmento
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063525
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
6
Attachment B
Indications for Use
Koc 35 25 510(k) Number (if known):
Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System
Indications For Use:
Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:
- 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 .
Blummo
on Sign-Off lon of Cardiovascular Devices
Prescription Use x
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)