(31 days)
Not Found
No
The summary describes a physical medical device (intra-aortic balloon catheter) with a dimensional modification. There is no mention of software, algorithms, or any technology related to AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for "intra-aortic balloon counterpulsation therapy" and is indicated for conditions such as "Refractory unstable angina", "Acute MI", and "Cardiogenic shock" to "increase blood supply to the heart muscle and decrease the work of the left ventricle." This directly describes a therapeutic intent and action on the body.
No
The device is described as being used for "intra-aortic balloon counterpulsation therapy," which is a therapeutic intervention, not a diagnostic one. While it can be used to "support for diagnostic, percutaneous revascularization, and interventional procedures," its primary function is therapeutic.
No
The device description clearly states it is an "Intra-aortic Balloon Catheter and Accessories," which are physical medical devices used for intra-aortic balloon counterpulsation therapy. The modification described is dimensional, relating to the physical balloon membrane and inner lumen. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a therapeutic intervention performed within the patient's body (intra-aortic balloon counterpulsation therapy). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical catheter and balloon designed to be inserted into the aorta. This is a medical device used for treatment, not for analyzing biological samples.
- No mention of analyzing biological samples: The text does not mention collecting or analyzing any samples from the patient.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Datascope's 8Fr. 50cc 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 - system, balloon, intra-aortic and control
Device Description
Datascope's 8Fr. 50cc 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 modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.
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 were conducted. The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices. No clinical evaluation was performed 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, K031569, K013326, K903930
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
K091449 pg 10f 3
Attachment D
JUN 1 8 2009
510(k) SUMMARY
FOR
DATASCOPE's 8Fr. 50cc IAB and ACCESSORIES
(Prepared in accordance with 21 CFR Part 807.92)
GENERAL INFORMATION A.
Submitter: Address: Contact Person: Phone: Fax: Date:
Datascope Corp. 15 Law Drive Fairfield, NJ 07004 Dolly Mistry Global Regulatory Affairs Specialist 973/244-6162 973/244-6243 May 15, 2009
B. DEVICE INFORMATION
Generic Name: Trade Name:
Intra-Aortic Balloon Catheter (IAB) Datascope's 8Fr. 50cc IAB and Accessories Classification Name: Intra-Aortic Balloon Catheters (IABs) are classified under 21CFR 870.3535
C. PREDICATE DEVICE INFORMATION
Datascope's 8Fr. 50cc IAB and Accessories are substantially equivalent to the following marketed devices:
K041281 - Datascope's Linear 7.5Fr. IABs, S/E 6/7/04
K031569 - Datascope's CA40 8Fr. IABs, S/E 6/10/03
K013326 - Datascope's Fidelity 8Fr. IABs, S/E 11/02/01
K903930 - Datascope's Percor Stat DL 10.5Fr. 50cc IABs, S/E 3/17/97
1
D. DEVICE DESCRIPTION/INTENDED USE
Datascope's 8Fr. 50cc 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
E.
- 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
Datascope's 8Fr. 50cc IABs and Accessories are substantially equivalent to the predicate devices with regard to intended use.
The modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.
2
KO91449 3043
D-3
These modifications to the 8Fr. IABs and Accessories 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.
G. CLINICAL TESTS
There has been no clinical evaluation of the new device in the U.S.
CONCLUSIONS H
Based on the information presented in this 510(k) premarket notification, Datascope's 8Fr. 50cc IAB and Accessories are considered substantially equivalent to Datascope's currently marketed IABs and accessories.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The seal is simple and professional, reflecting the department's important role in public health.
Public Health Service
JUN 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Datascope. Corp. c/o Ms. Dolly Mistry Global Regulatory Affairs 15 Law Drive Fairfield, New Jersey 07004
Re: K091449
Trade/Device Name: Datascope Mega 50cc 8 Fr. Intra-Aortic Balloon (IAB) Catheter & Accessories Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class III (three) Product Code: DSP - system, balloon, intra-aortic and control Dated: May 15, 2009 Received: May 18, 2009
Dear Ms. Mistry:
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 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. Dolly Mistry
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
una R. Vocher
Image /page/4/Picture/6 description: The image contains a handwritten symbol or character on the left side. To the right of the symbol are three lines of text, but the text is not clear enough to be read. The symbol appears to be a stylized or cursive letter, possibly a 'W' or a similar shape.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment B
100 1000 ,在
Indications for Use Statement
| 510(k) Number (If known) | K091449 |
|---|---|
| Device Name | Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories |
| Indications for Use | Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories 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 | |
| Prescription Use (Part 21 CFR 801 Subpart D) | X 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) | |
| (Division Sign-Off) Division of Cardiovascular Devices |
510(k) Number Kool449
B-I