(157 days)
No
The description mentions a "computerized control system" but provides no details suggesting AI/ML capabilities. The performance studies focus on physical device characteristics and equivalence to a predicate device, not on algorithmic performance. There are no mentions of AI, ML, DNN, training/test sets, or key performance metrics typically associated with AI/ML devices.
Yes
The device is used to improve cardiovascular functioning in conditions such as Acute Coronary Syndrome and Heart Failure complications, which are therapeutic applications.
No
The device description and intended use indicate that the Intra-Aortic Balloon Pump is a therapeutic or supportive device designed to improve cardiovascular functioning, not to diagnose a condition.
No
The device description explicitly details physical components like an inflatable balloon, catheter, inner lumen, and outer lumen, and the performance studies involve bench tests on these physical components. While it mentions a "computerized control system," the primary focus and description are on the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The UltraFlex IAB is a physical device (a balloon catheter and control system) that is inserted into the aorta to directly assist cardiovascular function. It does not analyze samples taken from the body.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties and functionality of the device itself, not the accuracy of a diagnostic test.
Therefore, the UltraFlex IAB falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
UltraFlex(TM) IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:
- Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgery
- Complications of Heart Failure
Product codes (comma separated list FDA assigned to the subject device)
DSP
Device Description
The UltraFlex IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) regulates the inflation and deflation of the balloon.
The UltraFlex IAB catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta
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 technological differences between the subject and the predicate devices have been evaluated through bench tests to provide evidence that the UltraFlex IAB is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- Catheter Insertion Test
- Aneurysm Test
- Durability Test
- Catheter Tip to Balloon Bond Tensile per ISO 10555-1
- Outer Lumen to Balloon Bond Tensile per ISO 10555-1
- Sheath and Dilator Surface Visual Inspection per ISO 11070
- Sheath and Dilator Tensile Testing per ISO 11070
- Balloon Volume Test
- Catheter Rate Limit Test
- Kink Resistance
- Sheath and Dilator Dimensional Analysis
The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the catheter is substantially equivalent to the predicate device.
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.
K993966 Arrow 8Fr. NarrowFlex® Universal Intra-Aortic Balloon Catheter
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.
K010330 Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter, K000729 Arrow Ultra 8® 8 Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter
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.
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Image /page/0/Picture/0 description: The image shows 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 28, 2019
Arrow International, Inc. Niyati Boghani Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K190101
Trade/Device Name: UltraFlex IAB Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: April 30, 2019 Received: May 2, 2019
Dear Niyati Boghani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel 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
Enclosure
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Indications for Use
510(k) Number (if known)
K190101
Device Name UltraFlex™ IAB
Indications for Use (Describe)
UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:
-
Acute Coronary Syndrome
-
Cardiac and Non-Cardiac Surgery
-
Complications of Heart Failure
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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2. 510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: June 18, 2019
| Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
16 Elizabeth Drive
Chelmsford, MA 01824
Establishment Registration: 3010532612
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Reading, PA 19605:
Owner/ Operator: 2518433 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company
Contact | Deb Fleetham
Manager, Regulatory Affairs
Arrow International, Inc.
16 Elizabeth Drive
Chelmsford, MA 01824
deb.fleetham@teleflex.com
Phone: (612) 403-3806 |
| Trade Name | Proprietary Name: UltraFlex™ IAB
Common Name: Intra-Aortic Balloon Catheter (IAB)
Product Code: DSP
Classification Name: Intra-aortic balloon and control system (21 CFR 870.3535). Regulatory Class II |
| Legally
Marketed
Predicate
Devices | K993966 Arrow 8Fr. NarrowFlex® Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared February 18, 2000) |
| Reference
Devices | K010330 Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared March 2, 2001) K000729 Arrow Ultra 8® 8 Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared May 19, 2000) |
| Device
Description | The UltraFlex IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) regulates the inflation and deflation of the balloon.
The UltraFlex IAB catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip |
4
outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.
Indications of The UltraFlex IAB with the intra-aortic balloon pump as a control system is Use indicated for use in any of the following conditions:
-
- Acute Coronary Syndrome.
-
- Cardiac and Non-Cardiac Surgery
-
- Complications of Heart Failure
Technological The subject UltraFlex IAB is similar in design and identical in indications Characteristics for use to the predicate device, Arrow 8Fr. NarrowFlex® Universal Intra-Comparison Aortic Balloon Catheter. Compared to the predicate device, UltraFlex IAB has a modified central lumen, increased balloon size/volume, and the size of the supplied insertion sheath and dilator was increased to accommodate the larger balloon.
The technological differences between the subject and the predicate devices have been evaluated through bench tests to provide evidence that the UltraFlex IAB is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- Catheter Insertion Test
- Aneurysm Test ●
- Durability Test
- Catheter Tip to Balloon Bond Tensile per ISO 10555-1 ●
- Outer Lumen to Balloon Bond Tensile per ISO 10555-1 ●
- Sheath and Dilator Surface Visual Inspection per ISO 11070 ●
- Sheath and Dilator Tensile Testing per ISO 11070 ●
- Balloon Volume Test
- Catheter Rate Limit Test ●
- Kink Resistance ●
- Sheath and Dilator Dimensional Analysis ●
The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the catheter is substantially equivalent to the predicate device.
The subject UltraFlex IAB Catheter is substantially equivalent to the Substantial Equivalence specified predicate device based on comparison of the device functionality, Conclusion technological characteristics, and indications for use. The device modifications and results of design verification tests do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device.