The Instylla Microcatheter is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

Device Description

The Instylla Microcatheter includes a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤0.014in (0.36mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

The microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allows for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short extension adaptor, a long extension adapter and a duckbill check-valve are also included. The Instylla Microcatheter is available in 122cm, 142cm and 162cm usable lengths.

AI/ML Overview

This document describes the Instylla Microcatheter with check-valve connector and asserts its substantial equivalence to a previously cleared predicate device (Instylla Microcatheter, K191731). As such, the study focuses on verifying that the modified device meets the same performance criteria as the predicate, rather than establishing entirely new acceptance criteria or conducting a clinical effectiveness study.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Attribute	Reported Device Performance
Functional Performance	Accessory Compatibility and Functionality	Met predetermined acceptance criteria. No new safety or performance issues raised.
Biocompatibility	Cytotoxicity	Successfully completed.
	Sensitization	Successfully completed.
	Irritation or Intracutaneous Toxicity	Successfully completed.
	Acute Systemic Toxicity	Successfully completed.
	Material-Mediated Pyrogenicity	Successfully completed.
	Hemolysis	Successfully completed.
Sterility	Sterility Assurance Level (SAL)	10⁻⁶ (validated per ISO 11135)
	Bacterial Endotoxin Level	<20 endotoxin units (EU)/device
Shelf Life	Performance and Sterile Barrier Maintenance	Maintains performance and sterile barrier over 2-year shelf life.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific bench and functional test. It refers to these as "testing" and "evaluation." Given the nature of a 510(k) submission focusing on substantial equivalence for a minor modification (addition of a duckbill check-valve connector), these tests are typically conducted on a representative sample of devices.

Provenance: This is a retrospective comparison to the predicate device. The tests are performed "in-house" by the manufacturer (Instylla, Inc.) to demonstrate that the modified device performs comparably to the previously-cleared device. The data provenance is effectively manufacturer-generated test data. No specific country of origin for test data is mentioned beyond the company's US location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable to this type of submission. This is a bench and functional testing report for a device modification, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO for sterility, defined limits for endotoxins/biocompatibility observations).

4. Adjudication Method for the Test Set

Not applicable. As described above, this is laboratory-based testing against predefined specifications, not judgmental classification requiring adjudication.

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 is not an AI/Software as a Medical Device (SaMD) submission. It concerns a physical medical device (microcatheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described (functional, biocompatibility, sterility, shelf life) is based on:

Engineering Specifications: For functional tests like accessory compatibility, the ground truth is whether the device meets its design specifications and operates as intended.
International Standards: For biocompatibility (ISO 10993-1) and sterility (ISO 11135), the ground truth is adherence to the validated methods and acceptable limits defined by these standards.
Predetermined Acceptance Criteria: The document mentions "predetermined acceptance criteria" for functional testing, implying a comparison to established benchmarks, likely derived from the predicate device's performance or industry best practices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning/AI device.

Summary

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April 21, 2020

Instylla, Inc. Jennifer Greer Regulatory Affairs Manager 204 2nd Avenue Waltham, Massachusetts 02451

Re: K200744

Trade/Device Name: Instylla Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 20, 2020 Received: March 23, 2020

Dear Ms. Greer:

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

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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 medical devices and radiation-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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention 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) K200744

Device Name Instylla Microcatheter

Indications for Use (Describe)

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Instylla. The logo is composed of the word "instylla" in black letters, with a red dot above the "i" and a red curved line running through the middle of the word. The curved line starts above the "i" and ends below the second "l" in "instylla."

K200744 - 510(k) Summary

Submitter Information:

Instylla, Inc. 204 2nd Avenue Waltham, MA 02451

Contact Person:

Jennifer Greer Regulatory Affairs Manager Phone: 585-260-2882 E-mail: jennyg@instylla.com

Date Prepared:

April 20, 2020

Subject Device:

Proprietary Name:	Instylla Microcatheter
Common Name:	Catheter, Continuous Flush
Classification Name:	Continuous flush catheter(21 CFR 870.1210, Product Code KRA)
Device Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

Proprietary Name:	Instylla Microcatheter
Manufacturer:	Instylla, Inc.
510(k) Number:	K191731

Device Description:

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≤0.014in (0.36mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

Indications for Use:

The Instylla Microcatheter is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The indications for use statement for the modified Instylla Microcatheter with check-valve connector remain unchanged from the cleared device.

Comparison of Technological Characteristics to the Predicate Devices:

The Instylla Microcatheter with check-valve connector is substantially equivalent in intended use and fundamental technological characteristics to the legally marketed predicate device. The below table summarizes the similarities in design and configuration of the Instylla Microcatheter with check-valve connector compared with the predicate devices.

Attribute	Subject Device:Instylla Microcatheter with Check-Valve Connector	Predicate Device:Instylla Microcatheter(K191731)
Indications for Use	The Instylla Microcatheter is intendedfor use in small vessel or superselective anatomy for peripheraldiagnostic and interventionalprocedures. The Instylla Microcathetercan be used for the infusion ofdiagnostic, embolic, or therapeuticmaterials into vessels.	Same
Basic Design/Components	Microcatheter, 4Fr Tuohy-Borst withSide Port Adaptor, Short ExtensionAdapter, Long Catheter Adapter andDuckbill Check-Valve Connector	Microcatheter, 4Fr TuohyBorst with Side Port Adaptor,Short Extension Adapter, andLong Extension Adapter

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Attribute	Subject Device:Instylla Microcatheter with Check-Valve Connector	Predicate Device:Instylla Microcatheter(K191731)
Catheter Material	Thermoplastic elastomers (PEBAX),PTFE (inner layer), platinum/iridiummarker, polycarbonate (hub)	Same
Principle ofOperation	Manually tracked over a steerableguidewire to access vasculature.	Same
Inner Diameter	0.016in (0.41mm)	Same
Outer Diameter	1.7Fr (0.56mm)	Same
Usable Lengths	122cm, 142cm, 162cm	Same
GuidewireCompatibility (Size)	0.014in (0.36mm)	Same
RadiopaqueMarker	Yes	Same

The modified Instylla Microcatheter with check-valve connector only differs from the legally marketed predicate device in that it is packaged with one (1) duckbill check-valve connector. The intended use, indications, principle of operation, and technological characteristics remain identical between the subject and predicate device.

Performance Data

Performance testing of the final, sterilized Instylla Microcatheter with check-valve connector included bench testing and functional testing to verify specifications related to the modification of the device. The following testing was repeated for the modified device:

Accessory Compatibility and Functionality
The Instylla Microcatheter with check-valve connector met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.

Biocompatibility Testing

A biocompatibility evaluation was conducted on the Instylla Microcatheter with check-valve connector in accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process." The following biocompatibility tests were successfully completed to demonstrate substantial equivalence of the modified Instylla Microcatheter with check-valve connector:

. Cytotoxicity

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Sensitization ●
Irritation or Intracutaneous Toxicity ●
Acute Systemic Toxicity
Material-Mediated Pyrogenicity
Hemolysis

Sterility

The Instylla Microcatheter with check-valve connector is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10 °. The sterilization process was validated per ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. A bacterial endotoxin test (BET), also known as the Limulus amebocyte lysate (LAL) test, was also validated to establish that the microcatheter endotoxin level will be <20 endotoxin units (EU)/device.

Shelf Life

The Instylla Microcatheter with check-valve connector has a 2-year shelf life. Shelf life studies have been conducted to demonstrate that the device maintains its performance and the packaging will maintain its sterile barrier over the entirety of the intended shelf life.

Clinical Performance Data

The fundamental technological characteristics, indications for use, marker material, manufacturing and sterilization processes are the predicate devices and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.

Conclusion

Instylla has demonstrated that the Instylla Microcatheter with check-valve connector is substantially equivalent in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use/indication for use and fundamental technology as the legally marketed predicate device, Instylla Microcatheter, which was cleared under 510(k) Premarket Notification K191731 on August 13, 2019.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).