(28 days)
The Datascope 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheter has the following indications for use:
- Refractory ventricular failure.
- Cardiogenic shock.
- Unstable refractory angina.
- Impending infarction.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias.
- Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients.
- Septic shock.
- Weaning from cardiopulmonary bypass.
- Intraoperative pulsatile flow generation.
- Support for failed angioplasty and valvuloplasty.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery. The intra-aortic balloon is placed in the descending aorta just below the subclavian artery to provide temporary support during the following situations: Refractory ventricular failure, Cardiogenic shock, Unstable refractory angina, Impending infarction, Impending infarctions due to acute myocardial infarction, Ischemic related intractable ventricular arrhythmias, Ischemic related intractable voluncial and coronary angiography or angioplasty patients, Septic shock, Weaning from cardiopulmonary bypass, Interoperative pulsatile flow generation, Support for failed angioplasty and valvuloplasty.
The provided document describes the safety and effectiveness of Datascope's 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheters. However, it does not contain a study that presents specific acceptance criteria and detailed device performance results.
Here's a breakdown of the information available based on your request, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The document states that the "results of in-vitro tests conducted demonstrate that the functionality and performance characteristics are comparable to the currently marketed devices" (Section F, NON-CLINICAL TESTS). This implies a comparison to predicate devices, but no specific criteria or performance metrics are listed for the new device or the predicates.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document explicitly states: "There have been no clinical evaluations of the new device" (Section G, CLINICAL TESTS). This indicates that no clinical test set was used for the new device. The in-vitro tests are mentioned but no details regarding sample size or provenance are given.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided. Since there were no clinical evaluations for the new device, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As no clinical test set was used, no adjudication method would have been required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable and not provided. The document describes a medical device (intra-aortic balloon catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable and not provided. The device is a physical medical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used:
This information is not applicable and not provided for the new device directly. Given the statement "There have been no clinical evaluations of the new device," any ground truth would pertain to the predicate devices or general medical understanding, not a specific test set for this submission.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. As this is a medical device and not an AI or machine learning model, the concept of a "training set" in this context is not relevant.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. See point 8.
In summary:
The provided document describes a 510(k) premarket notification for a medical device seeking substantial equivalence to existing predicate devices. The submission relies on non-clinical (in-vitro) tests to demonstrate comparability in functionality and performance characteristics. No clinical studies were performed on the new device, meaning there is no information regarding clinical acceptance criteria, device performance in a clinical setting, test set size, expert ground truth, or adjudication methods for this specific submission.
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NOV 02 2001
KD13326
Attachment D
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
DATASCOPE'S 8Fr. Polyimide Alt B 25, 34 & 40cc Intr-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 Wolf |
| Regulatory Affairs Associate |
DEVICE INFORMATION B.
| Generic Name: | Intra-Aortic Balloon Catheter (IAB) |
|---|---|
| Trade Name: | Datascope's Intra-Aortic Balloon Catheter (IAB) |
| Classification Name: | Intra-Aortic Balloon Catheters (IAB) are classified under 21 CFR870.3535 |
PREDICATE DEVICE INFORMATION C.
Datascope's 8Fr. Polyimide Alt B 25, 34 & 40cc Intra-Aortic Balloon Catheters (IAB) are substantially equivalent to the following marketed devices:
- · K003598, Datascope Profile 8 Fr. Alt B Intra-Aortic Balloon Catheters w/Gas Lumen Insert (S/E 12/21/00).
- · K994157, Datascope 8Fr. Polyimide Intra-Aortic Balloon Catheters (S/E 3/13/00)
- · K943896, Datascope Staged Guide Wire (S/E 12/22/95)
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DEVICE DESCRIPTION/INTENDED USE D.
The intra-aortic balloon is placed in the descending aorta just below the subclavian The intra-aortic banoon is placed in the costoming during the following the following situations:
- Refractory ventricular failure ●
- Cardiogenic shock ●
- Unstable refractory angina .
- Impending infarction .
- Impending infarctions due to acute myocardial infarction .
- Ischemic related intractable ventricular arrhythmias .
- Ischemic related intractable voluncial and coronary angiography or . angioplasty patients
- . Septic shock
- Weaning from cardiopulmonary bypass ●
- Interoperative pulsatile flow generation ●
- Support for failed angioplasty and valvuloplasty .
TECHNOLOGICAL CHARACTERISTICS E.
Datascope's 8Fr. Polyimide Alt B 25, 34 & 40cc Catheters are substantially qquivalent to the predicate devices with regard to intended use. Material modifications to Datascope's 8Fr. catheters include adding a previously cleared alternate membrane material (Alt B), adding a full length polyimide co-lumen with blue colorant to the material (All B), adding a full lenging the catheter tip to a composite of previously cleared catheter tip materials. A dimensional change to the cather's imem previously cleared caneter thange from .023" to .030". In addition, a modified .025 stainless steel guide wire has replaced the nitinol guide wire the insertion kit. These .025 stamiess stech guide who has replaced and B IAB 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 The results of in-viro tests conceeted are comparable to the currently marketed devices.
CLINICAL TESTS G.
There have been no clinical evaluations of the new device.
CONCLUSIONS H.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with a bird-like shape above them. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 02 2001
Ms. JoAnn Wolf Regulatory Affairs Associate Datascope Corporation Cardiac Assist Division 15 Law Drive Fairfield, NJ 07004
K013326 Re:
Datascope 8 Fr. Polyimide Alt B Intra-Aortic Balloon Catheter Regulation Number: 870.3535 Regulation Name: Intra-Aortic balloon and control system Regulatory Class: Class III Product Code: 74 DSP Dated: October 4, 2001 Received: October 5, 2001
Dear Ms. Wolf:
We have reviewed your Section 510(k) promarket notification of intent to market the device w & no reviews 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 ass butted in the enactment date of the Medical Device Amendments, or to devices that provision in the provisions 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 therefore, mainer the act include requirements for annual registration, listing of devices, good econufacturing 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 n your de rio is orasthild 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 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
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Page 2 - Ms. JoAnn Wolf
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.
control provisions (because begin marketing your device as described in your Section 510(k) This icter will anow you to oegin mains of substantial equivalence of your device to a legally premitset notification: "The I DA miding of babbanian or 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 If you desire specific acrison. 10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF Far 80%. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1500. First of Compliance at (301) 594-4639. Also, please note the your device, prease comable by reference to premarket notification" (21CFR Part 807.97). Ice users information on your responsibilities under the Act may be obtained from the Division Offici general information on Jour 1957 100 Proper Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html
Sincerely yours,
James E. Dillard III
Director
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KD13326
Attachment B
Indications for Use Statement
| 510(k) Number | K013326 |
|---|---|
| Device Name | Datascope 8Fr. Polyimide Alt B 25, 34 & 40cc Intra-Aortic Balloon Catheter |
| Indications for Use | The Datascope 8Fr. Polyimide Alt B Intra-Aortic Balloon Catheter has the following indications for use: |
- Refractory ventricular failure.
- Cardiogenic shock.
- Unstable refractory angina.
- Impending infarction.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias.
- Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients.
- Septic shock.
- Weaning from cardiopulmonary bypass.
- Intraoperative pulsatile flow generation.
- Support for failed angioplasty and valvuloplasty.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CCRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number R013326
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.