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.

Device Description

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

The Instylla Microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016 in (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 allow for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The Instylla Microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short catheter extension and a long catheter extension adapter are also included. The Instylla Microcatheter is available in 122, 142 and 162 cm usable lengths.

AI/ML Overview

The provided text describes Instylla, Inc.'s K191731 510(k) submission for their Instylla Microcatheter. The document outlines the device's characteristics, its comparison to predicate devices, and the performance and safety studies conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting limitations in the information for certain requested points:

Acceptance Criteria and Device Performance for Instylla Microcatheter (K191731)

The acceptance criteria for the Instylla Microcatheter revolved around demonstrating substantial equivalence to a predicate device (CrossCath Support Catheter, K093052) through various performance benchmarks and safety assessments. Since this is a 510(k) submission, the "acceptance criteria" are implied by the comprehensive pre-clinical testing conducted to show that the device performs as safely and effectively as the predicate, and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly list numerical "acceptance criteria" values for each test, but it clearly states that the Instylla Microcatheter "met the predetermined acceptance criteria" for all tests and that "No new safety or performance issues were raised during testing."

Given the context of a 510(k), the implied acceptance criterion for each test is that the Instylla Microcatheter performs comparably to the predicate device or within recognized safety and effectiveness standards for such devices.

Acceptance Criteria (Implied)	Reported Device Performance
Visual Inspection of Components: Pass visual inspection.	Met specifications.
Dimensional Verification of Components: Meet specified dimensions.	Met specifications.
Trackability: Demonstrate effective navigation.	Met specifications.
Kink Resistance: Maintain lumen integrity under kinking stress.	Met specifications.
Pushability and Torqueability: Allow for controlled manipulation.	Met specifications.
Tip Radiopacity: Be visible under fluoroscopy.	Met specifications.
Fluid, Infusate, and Chemical Compatibility: Maintain integrity with various substances.	Met specifications.
Injection of Fluids (Flowrate) and Tip Stability: Deliver fluids effectively and stably.	Met specifications.
Freedom from Leakage: No leaks under specified pressure.	Met specifications.
Static Burst Pressure: Resist bursting at specified pressures.	Met specifications.
Catheter Shaft Tensile Strength: Withstand pulling forces.	Met specifications.
Microcatheter Compatibility with High Flow Microcatheters, Guidewires and Syringes: Ensure proper interface with accessories.	Met specifications.
Tuohy-Borst with Side-Port and Extension Accessory Compatibility and Functionality: Ensure proper interface with accessories.	Met specifications.
Biocompatibility: Pass ISO 10993-1 tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Toxicity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis, Complement Activation Assay, Partial Thromboplastin Time, In Vivo Thromboresistance Jugular Vein).	Successfully completed all listed tests.
Sterility: Achieve SAL of 10^-6 via EO sterilization.	Achieved SAL of 10^-6. Endotoxin level <20 EU/device.
Shelf Life (6-months): Maintain performance and sterile barrier for 6 months.	Demonstrated.
No new safety or performance issues compared to predicate.	"No new safety or performance issues were raised during testing."

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

The document does not explicitly state the specific sample sizes for each individual bench test (e.g., how many catheters were tested for kink resistance). It broadly mentions "bench testing and functional testing to verify specifications" and "testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device."

Test Set Sample Size: Not explicitly stated for specific tests. It implies a sufficient number of devices were tested to meet statistical significance for product verification and validation.
Data Provenance: The studies were pre-clinical bench and lab-based testing performed by the manufacturer, Instylla, Inc. The country of origin for the data is not specified beyond being generated by a US-based company (Waltham, MA). The data is prospective in the sense that it was generated specifically for this 510(k) submission, not retrospectively analyzed from existing patient data.

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

This question is not applicable to this type of submission. The "ground truth" for device performance in a 510(k) pre-clinical bench testing context is established by engineering specifications, recognized industry standards, and comparison to the predicate device's known performance characteristics, not by expert consensus on clinical data. The tests themselves are designed to objectively measure physical and chemical properties and performance.

4. Adjudication Method for the Test Set

This question is not applicable as there were no subjective clinical interpretations requiring adjudication. Performance against predetermined specifications and predicate device equivalence are evaluated based on objective test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, marker material, manufacturing and sterilization processes are the same as the predicate devices and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device."

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

This question is not applicable as the Instylla Microcatheter is a physical medical device, not an artificial intelligence (AI) algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance does not apply.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" was based on:
- Engineering Specifications: Predetermined design and performance requirements for the microcatheter.
- Industry Standards: Adherence to relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization).
- Predicate Device Equivalence: The performance of the Instylla Microcatheter was evaluated against the known characteristics and performance of the legally marketed predicate device (CrossCath Support Catheter).

8. The Sample Size for the Training Set

This question is not applicable as the Instylla Microcatheter is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

This question is not applicable for the same reason as point 8.

Summary

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August 13, 2019

Instylla, Inc. Ms. Amita Shah Vice President, Regulatory and Quality Affairs 204 Second Avenue Waltham, MA 02451

Re: K191731

Trade/Device Name: Instylla Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: June 27, 2019 Received: June 28, 2019

Dear Ms. Shah:

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,

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) K191731

Device Name Instylla Microcatheter

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the word "instylla" in black font. An orange line starts above the "i" and curves over the "s", "t", and "y" before ending below the second "l". The orange line gives the impression of a wave over the word.

K191731 - 510(k) Summary

Submitter Information:

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

Contact Person:

Amita Shah VP Regulatory and Quality Affairs Phone: 781-790-4857 Email: amitas@instylla.com

Date Prepared:

August 8, 2019

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:	CrossCath Support Catheter
Manufacturer:	Cook Incorporated
510(k) Number:	K093052

The Renegade™ HI-FLO™ Microcatheter cleared under 510(k) Premarket Notification K140329 was used as a reference device in this submission.

Device Description:

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accommodate steerable guidewires that are ≤ 0.014 in (0.36 mm) 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 indications for use statement is similar to the predicate device, CrossCath Support Catheter.

Comparison of Technological Characteristics to the Predicate Devices:

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

Attribute	Subject Device:Instylla Microcatheter	Predicate Device:CrossCath SupportCatheter (K093052)	Reference Device:Renegade HI-FLOMicrocatheter (K140329)
Indicationsfor Use	The InstyllaMicrocatheter isintended for use insmall vessel or superselective anatomy forperipheral diagnosticand interventionalprocedures. TheInstylla Microcathetercan be used for theinfusion of diagnostic,embolic, ortherapeutic materials	The CrossCath SupportCatheter is intendedfor use in small vesselor super selectiveanatomy for diagnosticand interventionalprocedures, includingperipheral use.	The Renegade HI-FLOMicrocatheter is intendedfor peripheral vascularuse. The microcathetercan be coaxially trackedover a steerableguidewire in order toaccess distal, tortuousvasculature. Once thesubselective region hasbeen accessed, themicrocatheter can beused for the controlled
Attribute	Subject Device:Instylla Microcatheter	Predicate Device:CrossCath SupportCatheter (K093052)	Reference Device:Renegade HI-FLOMicrocatheter (K140329)
			diagnostic, embolic, ortherapeutic materials intovessels. Diagnostic,embolic, or therapeuticagents to be used inaccordance withspecifications outlined bythe manufacturer.
Basic Design/Components	Instylla Microcatheter4Fr Tuohy Borst withSide Port Adaptor,Short ExtensionAdapter, and LongExtension Adapter	Microcatheter	Renegade HI-FLOMicrocatheter, Rotatinghemostatic valve, Shapingmandrel
Material	Thermoplasticelastomers (PEBAX),PTFE (inner layer),platinum/iridiummarker, polycarbonate(hub)	Catheter material notknown,platinum/iridiummarker	Fiber Palladium BraidOuter surface coated withHydro Pass™ HydrophilicCoating, platinum-tungsten tip
Principle ofOperation	Manually tracked overa steerable guidewireto access vasculature.	Manually tracked overa steerable guidewireto access vasculature.	Manually tracked over asteerable guidewire toaccess vasculature.
InnerDiameter	0.016 in (0.41mm)	Not known, 0.014-0.035 in guidewirecompatibilitydependent on catheterconfiguration	0.027 in (0.69 mm)
OuterDiameter	1.7 Fr (0.56mm)	1.9-3.7 Fr, dependenton catheterconfiguration	2.8 Fr (0.93 mm) to 3.0 Fr(1.00 mm) (tapereddesign)
UsableLengths	122 cm, 142 cm, 162cm	65cm, 90 cm, 135 cm,150 cm	80 cm, 105 cm, 115 cm,135 cm, 150 cm
GuidewireCompatibility(size)	0.014 in (0.36 mm)	0.014 in (0.36 mm) -0.035 in (0.89 mm)	0.018 in (0.47 mm)
RadiopaqueMarker	Yes	Yes	Yes

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The subject and primary predicate devices have the same intended use, similar indications, and similar technological characteristics including a similar principle of operation.

The subject and primary predicate devices differ from one another in the components that are packaged with the microcatheter, dimensions and materials. These differences do not raise any new questions about the safety and effectiveness as demonstrated by performance and biocompatibility testing and since the intended use and principal of operation are the similar between the subject and primary predicate device. Both devices are continuous flush catheters that are manually tracked over a steerable guidewire to access vasculature. Additionally, a Tuohy-Borst adapter is contained within the reference device.

Performance Data

Performance testing of the final, sterilized Instylla Microcatheter included bench testing and functional testing to verify specifications fundamental to the design of the device. Testing included the following:

-Visual Inspection of Components
Dimensional Verification of Components -
-Trackability
-Kink Resistance
-Pushability and Torqueability
-Tip Radiopacity
Fluid, Infusate, and Chemical Compatibility -
-Injection of Fluids (Flowrate) and Tip Stability
-Freedom from Leakage
-Static Burst Pressure
Catheter Shaft Tensile Strength -
Microcatheter Compatibility with High Flow Microcatheters, Guidewires and -Syringes
-Tuohy-Borst with Side-Port and Extension Accessory Compatibility and Functionality

Testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device. The Instylla Microcatheter 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 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," consistent

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with a device in direct contact with circulating blood for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final, sterilized Instylla Microcatheter:

Cytotoxicity
Sensitization
Irritation or Intracutaneous Toxicity
Acute Systemic Toxicity
Material-Mediated Pyrogenicity
Hemolysis
Complement Activation Assay
Partial Thromboplastin Time
In Vivo Thromboresistance Jugular Vein ●

Sterility

The Instylla Microcatheter is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10th. 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 has a shelf life of 6-months. 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 same as 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 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, CrossCath Support Catheter, which was cleared under 510(k) Premarket Notification K093052 on December 8, 2009.

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).