The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.

Device Description

The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.

AI/ML Overview

The TrapIt Trapping Balloon Catheter is intended to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. It is not intended for use outside of the guide catheter.

The device's substantial equivalence was established through performance and biocompatibility tests.

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Kink resistance/ flexibility	Not specified, but likely refers to maintaining lumen patency and structural integrity during bending.	The device passed.
Radiopacity	Not specified, but generally refers to sufficient visibility under fluoroscopy.	The device passed.
Catheter bond strength	Not specified, but likely refers to the strength of various junctions within the catheter.	The device passed.
Tip bond strength	Not specified, but likely refers to the strength of the bond at the catheter tip.	The device passed.
Crossing profile	Not specified, but generally refers to ease of navigation through vessels.	The device passed.
Balloon preparation, deployment & retraction	Not specified, but likely refers to smooth and consistent inflation/deflation and proper positioning.	The device passed.
Balloon rated burst	Not specified, but refers to the maximum pressure the balloon can withstand without bursting.	The device passed.
Balloon fatigue	Not specified, but refers to the ability of the balloon to withstand repeated inflation/deflation cycles.	The device passed.
Balloon compliance	Not specified, but refers to the balloon's ability to expand to its intended diameter at a given pressure.	The device passed.
Effective length	Not specified, but refers to the usable length of the catheter within the body.	The device passed.
Tip length	Not specified, but refers to the length of the catheter tip.	The device passed.
Balloon inflation time	Not specified, but refers to the time taken for the balloon to fully inflate.	The device passed.
Balloon deflation time	Not specified, but refers to the time taken for the balloon to fully deflate.	The device passed.
Shaft outer diameter	Not specified, but refers to the external diameter of the catheter shaft.	The device passed.
Coating Particulate Evaluation	Not specified, but refers to the absence of unacceptable levels of particulates from the coating.	The device passed.
Packaging integrity	Not specified, but refers to the ability of the packaging to maintain sterility and protect the device.	The device passed.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Hemocompatibility)	Per ISO 10993-1, indicating acceptable biological response.	The device passed all biocompatibility tests.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for individual tests. The tests were likely conducted on a representative sample of devices according to established engineering and quality control protocols. The provenance of this data is internal to the manufacturer (IMDS Operations B.V.). The tests are performed as part of the device verification process to demonstrate safety and performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are engineering performance and biocompatibility evaluations, not clinical studies requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human readers or interpretation of medical images. The acceptance of test results would be based on predefined criteria and successful completion of the tests.

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

Not applicable. This device is a medical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The TrapIt Trapping Balloon Catheter is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests is established by the specifications and acceptance criteria for each test, based on engineering principles, material science, and relevant international standards (e.g., ISO 10993-1 for biocompatibility). For example, the ground truth for "Balloon rated burst" would be the pressure at which the balloon should not burst according to design specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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January 21, 2020

IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150 9301 NZ Roden The Netherlands

Re: K191229

Trade/Device Name: TrapIt Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 16, 2019 Received: December 18, 2019

Dear Edwin Schulting:

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,

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K191229

Device Name TrapIt

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: April 26th, 2019

Submitter's Name / Contact Person Manufacturer IMDS Operations BV Ceintuurbaan Noord 150 9301 NZ Roden. The Netherlands Establishment Registration #3007740583

Contact Person

Florence Wagter Director of Quality Assurance and Regulatory Affairs Tel: 0031651453880 Fax: 0031508200231

General Information Trade Name Common/ Usual Name Classification Name Product Code

Predicate Device

TrapIt Trapping Balloon Catheter Catheter, percutaneous DOY K162253. Trapper Exchange Device, Creganna Medical

Device Description

Intended Use

The Traping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIt Trapping Balloon Catheter is not intended for use outside of the guide catheter.

Technological Characteristics Comparison

The TrapIt is similar in design to the predicate device and both are dedicated trapping, percutaneous balloon catheters intended to facilitate interventional device exchange in a PCI procedure. With the exception of dimensional, material and package configuration differences, the TrapIt is similar in design and technological characteristics to the predicate device. The dimensional, material and package configuration differences were successfully evaluated in performance tests.

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Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through performance and biocompatibility tests and results did not raise new questions of safety or effectiveness. The TrapIt Trapping Balloon Catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:

1. Kink resistance/ flexibility
1. Radiopacity
1. Catheter bond strength
Tip bond strength 4)
ર) Crossing profile
Balloon preparation, deployment & retraction 6)
Balloon rated burst 7)
1. Balloon fatigue
1. Balloon compliance
1. Effective length
1. Tip length
1. Balloon inflation time
1. Balloon deflation time
1. Shaft outer diameter
1. Coating Particulate Evaluation
1. Packaging integrity

Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:

Cytotoxicity
Sensitization
Irritation ●
Systemic toxicity ●
Pyrogenicity
. Hemocompatibility

The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the TrapIt Trapping Balloon Catheter is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).