(357 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
K961358
No
The document describes a mechanical device (intra-aortic balloon) and its comparison to predicate devices based on physical characteristics and performance tests, with no mention of AI or ML.
Yes
The device is intended to treat several medical conditions such as refractory left ventricular power failure, cardiogenic shock, and support for failed angioplasty, which are medical indications for therapeutic use.
No
The provided text describes an intra-aortic balloon pump (IABP) device used for cardiac support in various critical conditions. Its "Intended Use / Indications for Use" section lists therapeutic applications like supporting left ventricular power failure, cardiogenic shock, and mechanical complications due to myocardial infarction. It does not mention any function for detecting, assessing, or monitoring diseases or conditions. The "Summary of Performance Studies" focuses on physical characteristics and performance test results, not diagnostic accuracy.
No
The device description explicitly states it is a physical device ("identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S") with a balloon and specific dimensions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to supporting the heart and circulatory system in patients experiencing various forms of cardiac failure and shock. These are clinical interventions performed directly on the patient's body.
- Device Description: The device is described as an intra-aortic balloon (IAB), which is a mechanical device inserted into the aorta to assist the heart. This is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.
Product codes
74 DSP
Device Description
This device is identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc Sheathless IAB-04230S predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The nonclinical test results included in the submission showing comparable performance to the predicate devices are as follows:
Insertion characteristics
- Distal tip flexibility .
- Deflection .
- Column strength . Performance Test
- . Total cycle time
- Displaced volume .
- First response .
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY - K963865
SEP | 6 1997
The device is substantially equivalent to the following legally marketed Arrow intra-aortic balloon devices:
-
- 8 Fr-40cc Sheathless NarrowFlex™, with Nitinol inner lumen and kink resistant outer lumen, product no. IAB-04840S, premarket notification K961358.
-
- 8 Fr-30cc, Sheathless, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230S, premarket notification K961358.
This device is identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc Sheathless IAB-04230S predicate.
The device is indicated for the following conditions:
Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.
The device has comparable technological characteristics to the predicate devices.
The nonclinical test results included in the submission showing comparable performance to the predicate devices are as follows:
Insertion characteristics
- Distal tip flexibility .
- Deflection .
- Column strength . Performance Test
- . Total cycle time
- Displaced volume .
- First response .
96124
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International SEP 1 6 1997 2400 Bernville Road Reading, Pennsylvania 19605
Re: K963865 Arrow 8Fr - 30cc Narrowflex™ Sheathless Intra-Aortic Balloon Catheter Regulatory Class: III (Three) Product Code: 74 DSP Dated: July 18, 1997 Received: July 21, 1997
Dear Mr. Nickel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Thomas D. Nickel
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callshan
Thomas J. Callarian, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
870.3535- DSP III- Intra-aortic Balloons Control
System
510(k) Number (if known): K 963865-
Arrow 8 Fr. 30cc Narrow Flex Sheathless Introl. Device Name: Balloon Casheter
Indications For Use:
Refractory left ventricular power failure. Cardiogenic shock/unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular septal defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Setta L. Lemperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K 96 3865
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)