(30 days)
The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions:
- Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgery
- Complications of Heart Failure
The FiberOptix® Intra-Aortic Balloon (IAB) Catheter 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) is utilized to regulate the inflation and deflation of the balloon.
The FiberOptix® 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.
The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
The provided text is a 510(k) summary for the FiberOptix® Intra-Aortic Balloon Catheter Kit. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information necessary to answer all parts of your request, especially regarding a clinical study proving the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.
Here's an analysis of what information is available and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Specified acceptance criteria (not detailed) | Met the specified acceptance criteria and performed similar to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified. The study described is "bench tests", implying laboratory testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable. The study was bench testing of the device's physical performance, not an evaluation of diagnostic or clinical interpretation requiring expert consensus.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This was bench testing, not a study involving human adjudication of clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, an MRMC study was not done. The document describes a medical device (an intra-aortic balloon catheter) and its physical performance, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is for a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated as "ground truth" in the context of clinical data. For the bench tests, the "ground truth" would be the engineering specifications and performance standards for the device and its predicate, verified through physical measurements and observations during the tests.
8. The sample size for the training set
- Sample size for training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on verifying the modified design's performance against the predicate.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there is no training set for this type of device and study.
Summary of the Study:
The study described is a series of bench tests (laboratory testing) to provide evidence that the modified FiberOptix® IAB Catheter is substantially equivalent to predicate devices. The technological differences relate to a modified fiber optic sensor configuration for improved robustness.
The specific tests performed were:
- Insertion, Durability Test & (FOS) Static Pressure Test
- Simulated Misuse Test & (FOS) Static Pressure Test
The reported conclusion is that "The results of the verification test met the specified acceptance criteria and performed similar to the predicate device." This demonstrates that the subject device is substantially equivalent based on its physical and functional performance characteristics.
The document does not provide information on clinical trials, human subject data, or AI algorithm performance, as it pertains to a mechanical medical device that is being cleared based on substantial equivalence to a predicate through bench testing.
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April 9, 2020
Arrow International Inc. Apurva Gokhale Senior Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K200634
Trade/Device Name: FiberOptix Intra-Aortic Balloon Catheter Kit Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: March 6, 2020 Received: March 10, 2020
Dear Apurva Gokhale:
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
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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,
for 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) K200634
Device Name
FiberOptix® Intra-Aortic Balloon Catheter Kit
Indications for Use (Describe)
The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically 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)| | 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: 6 March 2020
| Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)16 Elizabeth DriveChelmsford, MA 01824Establishment Registration: 3010532612 |
|---|---|
| Arrow International, Inc. (Subsidiary of Teleflex, Inc.)Reading, PA 19605Owner/ Operator: 2518433 | |
| Company Contact | Apurva N. GokhaleSr. Regulatory Affairs SpecialistArrow International, Inc.16 Elizabeth DriveChelmsford, MA 01824 |
| Regulatory Information | |
|---|---|
| Proprietary Name: | FiberOptix® Intra-Aortic Balloon Catheter Kit |
| Common Name: | System, Balloon, Intra-Aortic and Control System |
| Product Code: | DSP |
| Regulation #: | 870.3535 |
| Description: | Intra-aortic balloon & control system |
| Regulatory Class: | Class II |
Phone: 978-250-5100 extension 722202
- Leqally Marketed ● K190117 Arrow FiberOptix IAB (Arrow International, Inc. - Cleared June 13, Predicate Device 2019)- Primary Predicate
The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, Device Description which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.
The FiberOptix® 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.
The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
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The FiberOptix® IAB Catheter is utilized for intra-aortic balloon counterpulsation Intended Use therapy in the aorta, whereby balloon inflation, during diastole and deflation during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
The FiberOptix® IAB Catheter with the Intra-Aortic Balloon Pump as a control Indications for Use system is clinically indicated for use in any of the following conditions:
-
- Acute Coronary Syndrome
-
- Cardiac and Non-Cardiac Surgery
-
- Complications of Heart Failure
The subject FiberOptix® IAB catheter is similar in design and identical in Technological indications for use to the predicate devices. Arrow Intra-Aortic Balloon Fiber Optic Characteristics Comparison Sensor/ Fiber Optic Measurement System and Arrow FiberOptix IAB Catheter. Compared to the predicate devices, the subject FiberOptix® IAB has a modified configuration of the fiber optic sensor along the distal length of the IAB catheter to improve its robustness.
The technological differences between the subject and the predicate devices have been evaluated through bench tests to provide evidence that the FiberOptix® IAB Catheter is substantially equivalent to the predicate devices. The modified design of the FiberOptix® IAB Catheter has been verified through the following tests:
- Insertion, Durability Test & (FOS) Static Pressure Test ●
- . Simulated Misuse Test & (FOS) Static Pressure Test
The results of the verification test met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the subject FiberOptix® IAB catheter is substantially equivalent to the predicate device.
The subject FiberOptix® IAB Catheter is substantially equivalent to the Substantial specified predicate device, FiberOptix® IAB Catheter (K021462 and K190117) Equivalence Conclusion based on a comparison of the device functionality, materials, 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; therefore, the subject device is substantially equivalent to the predicate device.
§ 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.