(464 days)
Not Found
Not Found
No
The summary describes a mechanical device (IABs with a peel-away hemostasis device) and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section lists several medical conditions (e.g., refractory left ventricular power failure, cardiogenic shock, septic shock) and procedures (e.g., support for failed angioplasty) for which the device is used, indicating its role in treating or managing health conditions.
No
The device description and intended use indicate it is an Intra-Aortic Balloon (IAB) for cardiac support and power failure, not for diagnosing conditions.
No
The device description clearly states the addition of a "peel-away hemostasis device" to existing "Arrow IABs," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes conditions related to the heart and circulatory system, requiring direct intervention within the body. This is characteristic of a therapeutic or supportive medical device, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "IAB" (Intra-Aortic Balloon), which is a mechanical device inserted into the aorta to assist the heart. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
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
Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral requraitation 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
The addition of a new peel-away hemostasis device to four existing Arrow IABs makes them now "universal" IABs, in that they can be used as is for sheathless insertion techniques, or can be used with current standard sheaths if the sheathless feature is not desired, by peeling it away and discarding it.
The four new "Universal" products are therefore substantially equivalent to eight current Arrow IAB products.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices.
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.
Not Found
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
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
. Il IN 1 1998
SECTION 2 - 510(k) SUMMARY and CERTIFICATION
510(k) SUMMARY
The addition of a new peel-away hemostasis device to four existing Arrow IABs makes them now "universal" IABs, in that they can be used as is for sheathless insertion techniques, or can be used with current standard sheaths if the sheathless feature is not desired, by peeling it away and discarding it.
The four new "Universal" products are therefore substantially equivalent to eight current Arrow IAB products.
The device new "Universal" are 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 requraitation 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 devices have comparable technological characteristics to the predicate devices.
The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices.
CERTIFICATION
Since this is a class III device, the required class III Special Certification is appended as Attachment 1.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Robert A. Szurgot Project Engineer Arrow International Research/Enqineerinq 3000 Bernville Road Readinq, Pennsylvania 19605
Re: K970689 Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device (IAB-04840-U; IAB-04250-U; IAB-04240-U; IAB-04230-U) Regulatory Class: III (Three) Product Code: 74 DSP Dated: June 6, 1997 Received: June 11, 1997
Dear Mr. Szurgot:
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, labeling, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. Robert A. Szurgot
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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K970689 |
|---|---|
| Device Name: | Arrow Intra-Aortic Balloon Catheter wutn |
| Peel-Away Hemostasis Device | |
| Indications For Use: | IAB-04840-U |
| IAB-04240-U | |
| IAB-64230-U |
DSP TI
970,3535
Antia-Aartic Balloon and Cantrol
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 infrfaction, 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)
Bose L. Lemuele
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K970689 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96