(94 days)
No
The summary describes a mechanical intra-aortic balloon and does not mention any AI or ML components or capabilities.
Yes
The device is intended to improve cardiovascular functioning and is used to treat various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device, an intra-aortic balloon, is intended to improve cardiovascular functioning by providing support during various medical conditions, rather than identifying or analyzing a disease or condition.
No
The device description clearly states it is an "intra-aortic balloon," which is a physical medical device inserted into the body. This is not a software-only device.
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 intra-aortic balloon placed in the descending aorta to improve cardiovascular functioning in various clinical situations. This is a therapeutic and supportive device used in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description reinforces the device's function as an implanted balloon for cardiovascular support.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a therapeutic or supportive medical device, not an In Vitro Diagnostic.
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 ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
Product codes
74DSP
Device Description
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 ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
Datascope's Percor STAT-DL® 9.5Fr. & 10.5Fr. IAB are identical to the predicate devices with regard to its indications for use and dimensional specifications. They differ technologically respecting material grade and chemical composition of the components. The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device.
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
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
Not Found
Predicate Device(s)
K940231 & K940178, K905663, K790775, K952221, K943919, K961358
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 7 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR
DATASCOPE PERCOR STAT-DL® 9.5Fr. & 10.5 Fr.INTRA-AORTIC BALLOON (IAB)
(Prepared in accordance with 21 CFR Part 807.92)
Pursuant to Section 513(1)(3)(A) of the Food, Drug, and Cosmetic act, datascope corporation 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 Corporation chooses to submit a summary of information respecting safety and effectiveness.
GENERAL INFORMATION
| Submitter: | Datascope Corp. |
|---|---|
| Cardiac Assist Division | |
| Address: | 15 Law Drive |
| Fairfield, NJ 07004 | |
| Contact Person: | Kevin Crossen |
| Director, Regulatory Affairs and Quality Assurance |
DEVICE INFORMATION B.
A.
| Generic Name: | Intra-Aortic Balloon (IAB) |
|---|---|
| Trade Name: | Datascope Percor STAT-DL® Intra-Aortic Balloon |
| (IAB) | |
| Classification Name: | Intra-Aortic Balloons (IABs) are classified under |
| 21 CFR 870.3535 | |
| Product Code: | 74DSP |
C. PREDICATE DEVICE INFORMATION
Datascope's Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices:
- Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, -K940231 & K940178.
- K905663 Pediatric IAB -
- K790775 Datascope Type "S" IAB -
- K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB's (Boston -Scientific Corp.)
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Image /page/1/Picture/0 description: The image shows a large, bold letter D. The letter is black and has a slightly rough, textured appearance. The background is a grid of small dots, which gives the image a halftone effect. The letter D is the primary focus of the image.
Summary of Safety & Effectiveness/Datascope Percor STAT-DL 9.5 & 10.5Fr. IAB Page 2
- K943919 9.5 Fr. Sensation™IAB (Boston Scientific Corp.)
- K961358 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB -(Arrow International)
DEVICE DESCRIPTION/INTENDED USE D.
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 ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
E. TECHNOLOGICAL CHARACTERISTICS
Datascope's Percor STAT-DL® 9.5Fr. & 10.5Fr. IAB are identical to the predicate devices with regard to its indications for use and dimensional specifications. They differ technologically respecting material grade and chemical composition of the components. The difference in material grade and chemical composition has 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.
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Image /page/2/Picture/0 description: The image shows a large, bold letter D. The letter is black and stands out against a background of small dots arranged in a grid pattern. There are also some faint lines crossing through the letter, possibly indicating guidelines or construction lines used in its design.
Summary of Safety & Effectiveness/Datascope Percor STAT-DL ® 9.5 & 10.5Fr. IAB Page 3
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 Percor STAT-DL® 9.5Fr. & 10.5Fr. IABs are considered substantially equivalent to Datascope's currently marketed IABs.
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