(140 days)
No
The summary describes a mechanical device with a computerized control system and a fiber optic pressure sensor, but there is no mention of AI or ML capabilities.
Yes
Explanation: The device is indicated for use in conditions like Acute Coronary Syndrome and Complications of Heart Failure, and its description states it is placed in the aorta to improve cardiovascular functioning, all of which aim to treat or alleviate a disease or condition.
No
The device, FIBEROPTIX IAB, is an intra-aortic balloon pump catheter designed to improve cardiovascular functioning by regulating the inflation and deflation of a balloon in the aorta. While it has a fiber optic pressure sensor, its primary function is therapeutic (improving function) rather than diagnostic (detecting or identifying a condition). The "Intended Use / Indications for Use" section focuses on conditions for which the device is used for treatment, not diagnosis.
No
The device description clearly outlines physical components including an inflatable balloon, catheter, lumens, and a fiber optic pressure sensor, indicating it is a hardware device with a computerized control system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in vivo (within the body) to improve cardiovascular functioning by being placed in the aorta. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The description details a physical device (a balloon catheter) that is inserted into the aorta. This is consistent with an in vivo therapeutic or diagnostic device, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVDs.
The device is an Intra-Aortic Balloon (IAB) catheter, which is a medical device used to assist the heart's pumping function.
N/A
Intended Use / Indications for Use
FIBEROPTIX® IAB with the 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 FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.
The FIBEROPTIX IAB 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.
The FIBEROPTIX IAB has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
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 FIBEROPTIX IAB is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- Balloon Volume Test
- Aneurysm Test
- Durability Test
- Catheter Insertion Test
- Catheter Tip to Balloon Bond Tensile per ISO 10555-1
- Outer Lumen to Balloon Bond Tensile per ISO 10555-1
- Catheter Rate Limit Test
- Sheath and Dilator Surface Visual Inspection per ISO 11070
- Sheath and Dilator Tensile Testing per ISO 11070
- 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.
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.
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 contains the logo of the U.S. Food & 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 13, 2019
Arrow International, Inc. Niyati Boghani Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K190117
Trade/Device Name: Fiberoptix IAB Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: April 16, 2019 Received: April 17, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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
2
Indications for Use
510(k) Number (if known)
K190117
Device Name FIBEROPTIX® IAB
Indications for Use (Describe)
FIBEROPTIX® IAB with the 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 11, 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
Fax: (763) 656-4253 | |
| Trade Name | Proprietary Name:
Common Name:
Product Code:
Classification Name:
Regulation No.:
Regulatory Class: | FIBEROPTIX® IAB
Intra-Aortic Balloon Catheter (IAB)
DSP
Intra-aortic balloon and control system
21 CFR 870.3535
Class II |
| Legally
Marketed
Predicate
Device | K021462 Arrow Intra-Aortic Balloon Fiber Optic Sensor/ Fiber Optic Measurement System (Arrow International, Inc.- Cleared June 6, 2002) | |
| Reference
Device | K010330 Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared March 2, 2001) | |
4
- Device The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the Description aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon.
The FIBEROPTIX IAB 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.
The FIBEROPTIX IAB has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
Indications for The FIBEROPTIX IAB with the Intra-Aortic Balloon Pump as a control system Use is indicated for use in any of the following conditions:
-
- Acute Coronary Syndrome
-
- Cardiac and Non-Cardiac Surgery
-
- Complications of Heart Failure
Technological The subject FIBEROPTIX IAB is similar in design and identical in indications Characteristics for use to the predicate, Arrow Intra-Aortic Balloon Fiber Optic Sensor / Fiber Comparison Optic Measurement System Catheter. Compared to the predicate device, the FIBEROPTIX IAB has an 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 FIBEROPTIX IAB is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- · Balloon Volume Test
- Aneurysm Test
- · Durability Test
- · Catheter Insertion Test
- · Catheter Tip to Balloon Bond Tensile per ISO 10555-1
- · Outer Lumen to Balloon Bond Tensile per ISO 10555-1
- · Catheter Rate Limit Test
- · Sheath and Dilator Surface Visual Inspection per ISO 11070
- · Sheath and Dilator Tensile Testing per ISO 11070
- 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.
5
Substantial Equivalence Conclusion
The subject FIBEROPTIX IAB Catheter is substantially equivalent to the specified predicate device based on comparison of the device functionality, 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.