(25 days)
Not Found
No
The description focuses on dimensional changes and material modifications to a mechanical device (intra-aortic balloon catheter and introducer set). There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is used for "intra-aortic balloon counterpulsation therapy" to improve cardiovascular functioning in various medical conditions, directly treating physiological issues.
No
The device is used for therapy (intra-aortic balloon counterpulsation therapy) and to improve cardiovascular functioning, not for diagnosing conditions.
No
The device description clearly details physical components like catheters, introducers, and dilators, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for intra-aortic balloon counterpulsation therapy within the body (in the aorta). This is a therapeutic procedure performed directly on a patient.
- Device Description: The device description details a catheter and balloon designed for placement and manipulation within the aorta.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.
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)
DSP
Device Description
Datascope's 7.5Fr. Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
The modification to the Datascope predicate 8Fr. IAB is dimensional only. The dimension of the co-extruded polyurethane blend catheter will be changed from 8Fr. to 7.5Fr. and the polyimide inner lumen dimension will be changed from .030" to .027".
To accommodate the smaller 7.5Fr. IAB catheter, Datascope's predicate 8Fr. Reinforced Catheter Introducer has been modified from 8Fr. to 7.5Fr., and the Stepped Dilator from 5-8Fr. to 4-7.5Fr.
Modifications to the 8Fr. Reinforced Catheter Introducer Set also include a change in the material of the sheath hub and internal tubing, color code the introducer hub and dilator to industry standard (orange for 7Fr.), change the hub cap design from round to square, change dilator/sheath interface from a snap-fit to a lock-fit design, and add an alternate source contract manufacturer. The material changes are all previously FDA cleared materials.
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)
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.
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
Image /page/0/Picture/0 description: The image shows the word "Datascope" in a bold, serif font. Above the word is a curved line that starts thick on the left and thins out as it curves to the right. The word is the main focus of the image and is centered.
innovation is the best medicine
JUN - 7 2004
Attachment D
Datascope Corp. Cardiac Assist Division 15 Law Drive Fairfield. NJ 07004 Tel: 973.244.6100 Fax: 973.244.6279
510(k) SUMMARY
FOR
DATASCOPE'S 7.5Fr. IAB and ACCESSORIES
(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 | |
| Phone: | 973/244-6123 |
| Fax: | 973/244-6243 |
| Date: | May 12, 2004 |
DEVICE INFORMATION B.
| Generic Name: | Intra-Aortic Balloon Catheter (IAB) |
|---|---|
| Trade Name: | Datascope's 7.5Fr. IAB and Accessories |
| Classification Name: | Intra-Aortic Balloon Catheters (IABs) are classified |
| under 21CFR 870.3535 |
PREDICATE DEVICE INFORMATION C.
Datascope's 7.5Fr. IAB and Accessories are substantially equivalent to the following marketed devices:
| K031569 - Datascope's Blow-Molded 8Fr. IAB, S/E 6/10/03 |
|---|
| K013326 - Datascope's Fidelity 8Fr. IAB, S/E 11/02/01 |
| K002365 - Datascope's Reinforced Catheter Introducer Set, S/E 8/25/00 |
1
DEVICE DESCRIPTION/INTENDED USE D.
Datascope's 7.5Fr. Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.
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 7.5Fr. IABs and Accessories are substantially equivalent to the predicate devices with regard to intended use.
The modification to the Datascope predicate 8Fr. IAB is dimensional only. The dimension of the co-extruded polyurethane blend catheter will be changed from 8Fr. to 7.5Fr. and the polyimide inner lumen dimension will be changed from .030" to .027".
To accommodate the smaller 7.5Fr. IAB catheter, Datascope's predicate 8Fr. Reinforced Catheter Introducer has been modified from 8Fr. to 7.5Fr., and the Stepped Dilator from 5-8Fr. to 4-7.5Fr.
2
Modifications to the 8Fr. Reinforced Catheter Introducer Set also include a change in the material of the sheath hub and internal tubing, color code the introducer hub and dilator to industry standard (orange for 7Fr.), change the hub cap design from round to square, change dilator/sheath interface from a snap-fit to a lock-fit design, and add an alternate source contract manufacturer. The material changes are all previously FDA cleared materials.
These modifications to the 8Fr. IABs and Accessories have been demonstrated not to affect safety or efficacy of the device.
NON-CLINICAL TESTS F.
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 G.
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 7.5Fr. IAB and Accessories are considered substantially equivalent to Datascope's currently marketed IABs and accessories.
3
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that represent the staff of Asclepius, the Greek god of healing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Datascope Corp. c/o Ms. JoAnn Taylor Global Regulatory Affairs Specialist 15 Law Drive Fairfield, NJ 07004
Re: K041281
Datascope's 7.5Fr. IAB and Accessories Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class III (three) Product Code: DSP Dated: May 12, 2004 Received: May 13, 2004
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becement of the device is substantially equivalent (for the indications forched a o re and in sure) to legally marketed predicate devices marketed in interstate for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, in excordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, manner in to 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 may 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. JoAnn Taylor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DT has intates and regulations administered by other Federal agencies. You must or any I cactar stutures and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quart) Bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction control provisions (seting your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally prematice notification. The President 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 If you desire 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 (2017) 594-1057. Thiss, production as about 97) you may obtain. Other general information on your presponsibilities under the Act may be obtained from the Division of Small Manufacturers, Itsponsional 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,
Dina R. Vachner
GA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories
Indications For Use:
Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories have 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 .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
Duna R. Lochner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_k04128