(58 days)
Not Found
No
The description mentions "computer technology" and "automatically selected and controlled," but does not use terms like AI, ML, or deep learning, nor does it describe characteristics typically associated with AI/ML development (training/test sets, specific algorithms). The focus is on automated control based on physiological data, which is common in many non-AI medical devices.
Yes
The device description explicitly states that the IABP "provides cardiac assist therapy" and "provides temporary support to patients," indicating its role in treating medical conditions. The "Intended Use / Indications for Use" section further lists specific conditions it is clinically indicated for, such as acute coronary syndrome and complications of heart failure.
No
The device is an Intra-Aortic Balloon Pump, which provides cardiac assist therapy by counterpulsation. While it utilizes physiological data, its primary function is therapeutic (providing support and decreasing afterload/preload), not diagnosing a medical condition.
No
The device description explicitly states it is an "Intra-Aortic Balloon Pump (IABP) System" which provides "cardiac assist therapy" and utilizes "computer technology". This indicates a physical device with integrated software, not a standalone software application. The performance studies also reference standards related to "Medical Electrical Equipment" and "Programmable Electrical Medical Systems," further supporting the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications listed (Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, Complications of Heart Failure) describe clinical conditions treated directly within the patient's body.
- Device Description: The description clearly states the device provides "cardiac assist therapy" and works through "counterpulsation" to affect blood flow and pressure within the aorta. This is a direct physiological intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose or provide information about a disease or condition.
The device is an Intra-Aortic Balloon Pump (IABP), which is a therapeutic medical device used to support cardiac function in vivo.
N/A
Intended Use / Indications for Use
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
Product codes (comma separated list FDA assigned to the subject device)
DSP
Device Description
The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
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 AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device including the following:
- FDA Guidance: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Requlations - Preliminary Draft. December 8.1993
- FDA Guidance: "General Principles of Software Validation -Final Guidance' January 11, 2002
- FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005
- IEC 60601-1-4:1997: Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems
- EN 55024:1998: Information Technology Equipment-Immunity Characteristics
- EN 55022:1998: Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement
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.
K983866, K965209, K002256, K021462
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 17, 2022
Arrow Intl., Inc. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth St. Everett, Massachusetts 02149
Re: K060309
Trade/Device Name: Autocat Intra-Aortic Balloon Pump Series Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP
Dear Karen Provencher:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 6, 2005. Specifically, FDA is updating this SE Letter to reflect an administrative correction corresponding to the reclassification of intra-aortic balloon and control system (1ABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), as detailed in the final order published on December 20, 2019 (see here for more information: https://www.federalregister.gov/documents/2013/12/30/2013-31218/cardiovascular-devicesreclassification-of-intra-aortic-balloon-and-control-systems-foracute#:~:text=The%20Food%20Drug%20Administration%20(FDA)%20is%20issuing%20a%20fina 1,(special%20controls)%2C%20and%20to). In addition, IABP devices indicated for septic shock or pulsatile flow generation will remain Class III devices and would not be appropriate for the premarket notification pathway(510(k)), instead requiring a premarket approval (PMA).
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Alejandra Cambonchi, OHT2: Office of Cardiovascular Devices, 301-796-0552, Alejandra.Cambonchi(@fda.hhs.gov.
Sincerely, Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
6 2006
Arrow International, Inc. c/o Ms. Karen Provencher Senior Regulatory Affairs Specialist 9 Plymouth Street Everett, MA 02149
Re: K060309
K000507
Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III Product Code: DSP Dated: March 17, 2006 Reccived: March 23, 2006
Dear Ms. Provencher:
We have reviewed your Section 510(k) premarket notification of intent to market the device . we nave reviewed your bection >10(tr) premation is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreative to regard) the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 7776, the encordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette Herefore, market the device, subject to the general controls provisions of the Act. The r our may, therefore, market the act include requirements for annual registration, listing of general controls provisions of uactice, 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 such additional controls. Existing major regulations affecting your device can may ve subject to back to begulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Karen Provencher
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1 Dri 3 issuation of a vith other requirements of the Act that TDA has made a determination that your in the Federal agencies. You must or any I ederal statutes and regulations and united to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), ademig (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) on the vice as described in your Section 510(k) This letter with anow you to obgin maneting your and equivalence of your device to a legally premarket notification. The PDA miding of Saccanada 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), please If you desire specific acries ion 708 101 - 101 - 120 - 120. Also, please note the regulation entitled, Connact the Office of Compulline and (21) (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Befremdender for
Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K060309
Device Name
AutoCAT Intra-Aortic Balloon Pump Series
Indications for Use (Describe)
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized, sans-serif font. The word is a dark blue color, and the "R" in "Teleflex" has a circle around it, indicating that it is a registered trademark. The font is bold and the letters are close together.
Arrow International, Inc
9 Plymouth Street Everett, MA 02149 USA Phone: 617-389-6400 617-387-2157 Fax:
510(k) Summary K060309
AutoCAT Series IABP Series Date Prepared: February 3, 2006 Date Summary Updated: July 28, 2015
A. Submitter's Name:
Arrow International, Inc. 9 Plymouth Street, Everett, MA 02149
Updated Correspondent Address:
Fusun Tufan Senior Requlatory Affairs Manager Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
B. Company Contact
Michael Malis Director RA/QA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
C. Device Name
Trade Name: AutoCAT Intra-Aortic Balloon Pump Series Common Name: Intra-Aortic Balloon Pump (IABP) Classification Name: Intra-Aortic Balloon and Control System
Predicate Devices D.
Arrow International AutoCAT Series IABP System represents the integration of four Arrow IABP technologies which is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:
- · AutoCAT, cleared in K983866, (1/6/00)
- · ACAT 1, cleared in K965209, (1/23/98)
- · ACAT 2, cleared in K002256, (5/3/01)
- · FOS / FOMS IAB Black Box, cleared in K021462, (6/6/02)
Description of Device ய்
The Intra-Aortic Balloon Pump (IABP) provides cardiac assist therapy. The IABP provides temporary support to patients with impaired left ventricular function through the therapeutic method referred to as counterpulsation increases coronary and systemic profusion, decreasing after load (myocardial work) and decreasing preload.
The AutoCAT Series IABP System utilizes computer technology to select and maintain precise
5
Image /page/5/Picture/0 description: The image shows the word "Teleflex" in a stylized, sans-serif font. The word is in a dark blue color, and there is a registered trademark symbol to the right of the "x". The logo appears to be for a company called Teleflex.
IAB inflation and deflation timing and triggering based on current physiological data from the patient. The system offers two modes of operation, the Autopilot mode, where functions are automatically selected and controlled by the IABP and the Operator mode where the user has control over settings and selections.
F. Indications for Use
The AutoCAT Intra-Aortic Balloon Pump Series is clinically indicated for the following conditions:
- a. Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgerv ﻘ
- Complications of Heart Failure C.
G. Comparison of Technological Characteristics
Software V2.22 features the modifications to the following- Clarification I The modified Modification to Pre-set Start-up Settings, General Improvements in AutoPilot Timing, Modifications to AP Zero and Calibration Function, Improvements in AutoPilot Signal Switching & Selection, General Improvements in Triggering, Improved Purge Cycle & Helium Refill Function, Recognition of IAB Connector Volumes, Improved Noise Recognition and Handling, Modifications to Arrhythmia Timing Function, Alarm Handling Improvements, Additions to Help Text. Activation of Modem Function. Reqular Output of RS232
Summary Performance Data H.
The AutoCAT IABP Series with modified software meets all the same performance standards of the unmodified device including the following:
-
- FDA Guidance: "Guidance for the Preparation and Content of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Requlations - Preliminary Draft. December 8.1993
- FDA Guidance: "General Principles of Software Validation -Final Guidance' January 11, 2002 2.
-
- FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Final Guidance' May 11, 2005
-
- IEC 60601-1-4:1997: Medical Electrical Equipment- General Requirements for Safety-Collateral Standard: Programmable Electrical Medical Systems
-
- EN 55024:1998: Information Technology Equipment-Immunity Characteristics
-
- EN 55022:1998: Information Technology Equipment- Radio Disturbance Characteristics Limits and Methods of Measurement