(90 days)
Not Found
No
The document describes a standard intra-aortic balloon catheter system and does not mention any AI or ML components.
Yes
The device is described with indications for use that include treating various medical conditions such as unstable angina, myocardial infarction, and cardiogenic shock, and supporting cardiac function, which are all therapeutic purposes.
No
The intended use and device description state that the device provides "Support for diagnostic, percutaneous revascularization, and interventional procedures," indicating it aids in procedures that may be diagnostic but is not itself a diagnostic device.
No
The device description explicitly states it is an "Intra-Aortic Balloon Catheter System" and describes the placement of a physical balloon in the aorta, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this is an "Intra-Aortic Balloon Catheter System" placed in the descending aorta. Its purpose is to provide mechanical support to the cardiovascular system in various clinical situations. It does not involve testing samples from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, or diagnostic testing of biological specimens.
Therefore, this device is a therapeutic 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 (comma separated list FDA assigned to the subject device)
74DSP, DSP
Device Description
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K013326 - Datascope 8Fr. 25, 34 & 40cc Alt B IAB, K003598 - Datascope Profile 8Fr. 34 & 40cc Alt B IAB, K980780 - Datascope Percor STAT-DL 9.5Fr. 25, 34 & 40cc Alt B IAB, K964987 - Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion, K965236 - Datascope System 96 Intra-Aortic Balloon Pump, K002256 - Arrow ACAT 2 Intra-Aortic Balloon Pump
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
APR 2 4 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
DATASCOPE Intra-Aortic Balloon Catheter Systems
(Prepared in accordance with 21 CFR Part 807.92)
Pursuant to Section 513(I)(3)(A) of the Food, Drug, and Cosmetic act, Datascope Corp. is required to submit this Premarket Notification either an "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Datascope Corp. chooses to submit a summary of information respecting safety and effectiveness.
GENERAL INFORMATION A.
| Submitter: | Datascope Corp. |
|---|---|
| Cardiac Assist Division | |
| Address: | 15 Law Drive |
| Fairfield, NJ 07004 | |
| Contact Person: | JoAnn Wolf |
| Regulatory Affairs Associate |
B. DEVICE INFORMATION
| Generic Name: | Intra-Aortic Balloon (IAB) Catheter |
|---|---|
| Trade Name: | Datascope Intra-Aortic Balloon (IAB) Catheter |
| Classification Name: | Intra-Aortic Balloon (IAB) Catheters are classified under 21 CFR |
| 870.3535 |
Product Code: 74DSP
ﺰ PREDICATE DEVICE INFORMATION
Datascope's Intra-Aortic Balloon Catheters Indications for Use are substantially equivalent to the following marketed devices:
| K013326 - | Datascope 8Fr. 25, 34 & 40cc Alt B IAB |
|---|---|
| K003598 - | Datascope Profile 8Fr. 34 & 40cc Alt B IAB |
| K980780 - | Datascope Percor STAT-DL 9.5Fr. 25, 34 & 40cc Alt B IAB |
| K964987 - | Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion |
| and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Insertion | |
| K965236 - | Datascope System 96 Intra-Aortic Balloon Pump |
| K002256 - | Arrow ACAT 2 Intra-Aortic Balloon Pump |
All of the above referenced premarket notifications were found substantially equivalent by FDA.
1
D. DEVICE DESCRIPTION/INTENDED 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
E. TECHNOLOGICAL CHARACTERISTICS
Datascope's enhanced Indications for Use for IAB Systems are substantially equivalent to the predicate devices.
Supporting published data establish that the expanded Indications for Use is substantially equivalent to the predicate devices and does not affect the safety and effectiveness of the device.
F. NON-CLINICAL TESTS
N/A
G. CLINICAL TESTS
N/A
H. CONCLUSIONS
Based on the information presented in this 510(k) premarket notification, Datascope's expanded Indications for Use for the IAB Catheter System are considered substantially equivalent to the predicate devices' Indications for Use for their currently marketed IAB Catheter System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2002
Ms. JoAnn Wolf Regulatory Affairs Associate Datascope Corporation Cardiac Assist Division 15 Law Drive Fairfield, NJ 07004
Re: K020257
Trade Name: Datascope's 8Fr. 25, 34 & 40cc IAB; True Sheathless DL 9.5Fr. 25, 34 & 40cc IAB; Percor STAT-DL 9.5Fr. 34 & 40cc IAB for Optional Sheathless Insertion; Percor STAT-DL 10.5Fr. 50cc IAB Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon Catheter Regulatory Class: Class III (three) Product Code: DSP Dated: January 23, 2002 Received: January 24, 2002
Dear Ms. Wolf:
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.
3
Page 2 - Ms. JoAnn Wolf
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of actived and I Dr unation that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I other battler and states and station of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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 premaince nodicate 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Rödl & Partner
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): Known): Known)
Datascope's 8Fr. 25, 34 & 40cc IAB; True Sheathless DL 9.5Fr., 25, 34 & 40cc IAB; Device Name: Percor STAT-DL 9.5Fr. 34 & 40cc IAB for Optional Sheathless Insertion; Percor STAT-DL 10.5Fr. 50cc IAB
Indications for Use:
Intra-Aortic Balloon Catheter System to be used for the following:
- 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 .
This information can be found in Section 3 - Attachment I of our Premarket Notification under the section titled "II. Indications".
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use OR
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K000257