(29 days)
The Instylla Microcatheter 1.2 is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Instylla Microcatheter 1.2 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 ≤0.010in (0.25mm) 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 1.2Fr (0.40mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.012in (0.30mm) 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 with side-port 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.
This FDA 510(k) summary describes a device, the Instylla Microcatheter 1.2, which is essentially a modification of a previously cleared predicate device (Instylla Microcatheter K200744). Therefore, the acceptance criteria and performance data mainly focus on demonstrating that the modified device's performance is equivalent to or better than the predicate, especially regarding the changes made.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Instylla Microcatheter 1.2 "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, specific numerical acceptance criteria values and reported performance values are not explicitly provided in this summary for most tests. The summary lists the types of tests performed.
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance (Not Explicitly Stated Numerically) |
|---|---|---|---|
| Bench Testing & Functional Testing | Visual Inspection of Components | Met specifications | Passed |
| Dimensional Verification of Components | Met specifications | Passed | |
| Trackability | Met specifications | Passed | |
| Kink Resistance | Met specifications | Passed | |
| Pushability and Torqueability | Met specifications | Passed | |
| Tip Radiopacity | Met specifications | Passed | |
| Fluid and Infusate Compatibility | Met specifications | Passed | |
| Injection of Fluids (Flowrate) and Tip Stability | Met specifications | Passed | |
| Freedom from Leakage | Met specifications | Passed | |
| Static Burst Pressure | Met specifications | Passed | |
| Catheter Shaft Tensile Strength | Met specifications | Passed | |
| Microcatheter Compatibility with Standard Microcatheters, Guidewires and Syringes | Met specifications | Passed | |
| Accessory Compatibility and Functionality | Met specifications | Passed | |
| Biocompatibility | Cytotoxicity | In accordance with ISO 10993-1 | Successfully completed |
| Sensitization | In accordance with ISO 10993-1 | Successfully completed | |
| Irritation or Intracutaneous Toxicity | In accordance with ISO 10993-1 | Successfully completed | |
| Acute Systemic Toxicity | In accordance with ISO 10993-1 | Successfully completed | |
| Material-Mediated Pyrogenicity | In accordance with ISO 10993-1 | Successfully completed | |
| Hemolysis | In accordance with ISO 10993-1 | Successfully completed | |
| Complement Activation | In accordance with ISO 10993-1 | Successfully completed | |
| Partial Thromboplastin Time | In accordance with ISO 10993-1 | Successfully completed | |
| In Vivo Thromboresistance - Jugular Vein | In accordance with ISO 10993-1 | Successfully completed | |
| Sterility | Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved via validated EO process |
| EO and ECH levels | Acceptable in accordance with ISO 10993-7 | Acceptable | |
| Bacterial Endotoxin Level | <20 endotoxin units (EU)/device | Validated to be within limits | |
| Shelf Life | Maintain performance and sterile barrier | Over 6 months | Successfully demonstrated |
Note: The document explicitly states "The Instylla Microcatheter 1.2 met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." This general statement serves as the reported performance for all the tests, even though specific numerical results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the various bench and functional tests, biocompatibility tests, sterility tests, or shelf-life studies. It only lists the types of tests performed.
Regarding data provenance: All listed tests are laboratory-based (bench testing, functional testing, biocompatibility, sterility, shelf life) and were conducted by the manufacturer, Instylla, Inc., in the United States. There is no indication of retrospective or prospective data from patient use, as clinical studies were deemed unnecessary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there was no "test set" in the context of clinical data requiring expert review to establish ground truth. The acceptance criteria for this device relied on engineering performance specifications, biocompatibility standards, and sterility validations.
4. Adjudication Method for the Test Set
This information is not applicable. Since no clinical test set requiring expert adjudication was conducted, there was no adjudication method used. The evaluation centered on technical specifications and regulatory standards.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, 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." This means there was no study comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical catheter, not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily based on:
- Engineering Specifications and Bench Test Results: Performance against predefined technical thresholds for properties like trackability, kink resistance, pushability, flow rate, tensile strength, etc.
- International Standards and Regulatory Guidance: Compliance with standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135, AAMI TIR28, ISO 10993-7), and endotoxin levels.
- Prior Predicate Device Performance: The underlying assumption is that the predicate device (Instylla Microcatheter K200744) was safe and effective, and the modified device's equivalence to the predicate (or improvement where specified, e.g., smaller OD/ID) served as its "ground truth" for safety and effectiveness.
8. The Sample Size for the Training Set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The development and testing of the device rely on engineering principles, materials science, and physical testing, not data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons mentioned in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
April 15, 2021
Instylla, Inc. Jennifer Greer Regulatory Affairs Manager 201 Burlington Road, North Building Bedford, Massachusetts 01730
Re: K210808
Trade/Device Name: Instylla Microcatheter 1.2 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 16, 2021 Received: March 17, 2021
Dear Jennifer 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.
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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 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.04.15
11:45:22 -04'00'
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) K210808
Device Name Instylla Microcatheter 1.2
Indications for Use (Describe)
The Instylla Microcatheter 1.2 is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
| 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 logo for Instylla. The logo consists of the word "instylla" in a sans-serif font. The "i", "n", and "s" are in black, while the "t", "y", "l", and "a" are in black. A red curved line goes through the middle of the word, starting above the "i" and ending below the second "l".
510(k) Summary - K210808
Submitter Information:
Instylla, Inc. 201 Burlington Road North Building Bedford, MA 01730
Contact Person:
Jennifer Greer Regulatory Affairs Manager Phone: 781-622-9293 E-mail: jennyg@instylla.com
Date Prepared:
March 16, 2021
Subject Device:
| Proprietary Name: | Instylla Microcatheter 1.2 |
|---|---|
| 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: | K200744 |
Device Description:
The Instylla Microcatheter 1.2 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 ≤0.010in (0.25mm) 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 1.2Fr (0.40mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.012in (0.30mm) along its length. The proximal end of the microcatheter incorporates
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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 with side-port 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.
Indications for Use:
The Instylla Microcatheter 1.2 is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
The indications for use statement for the modified Instylla Microcatheter 1.2 remains unchanged from the cleared predicate device.
Comparison of Technological Characteristics to the Predicate Devices:
The Instylla Microcatheter 1.2 is substantially equivalent in intended use and fundamental technological characteristics to the legally marketed predicate device. The below table summarizes in design and configuration of the Instylla Microcatheter 1.2 compared with the predicate device.
| Attribute | Subject Device:Instylla Microcatheter 1.2 | Predicate Device:Instylla Microcatheter(K200744) | SubstantialEquivalence |
|---|---|---|---|
| Indications for Use | The Instylla Microcatheter isintended for use in smallvessel or super selectiveanatomy for peripheraldiagnostic and interventionalprocedures. The InstyllaMicrocatheter can be used forthe infusion of diagnostic,embolic, or therapeuticmaterials into vessels. | The Instylla Microcatheter isintended for use in smallvessel or super selectiveanatomy for peripheraldiagnostic and interventionalprocedures. The InstyllaMicrocatheter can be used forthe infusion of diagnostic,embolic, or therapeuticmaterials into vessels. | Same |
| Basic Design/Components | Microcatheter, 4Fr Tuohy-Borst with Side Port Adaptor,Short Extension Adapter, LongCatheter Adapter and DuckbillCheck-Valve Connector | Microcatheter, 4Fr Tuohy-Borst with Side Port Adaptor,Short Extension Adapter, LongCatheter Adapter and DuckbillCheck-Valve Connector | Same |
| Catheter Material | Thermoplastic elastomers(PEBAX), PTFE (inner layer),platinum/iridium marker,polycarbonate (hub) | Thermoplastic elastomers(PEBAX), PTFE (inner layer),platinum/iridium marker,polycarbonate (hub) | Same |
| Principle ofOperation | Manually tracked over asteerable guidewire to accessvasculature. | Manually tracked over asteerable guidewire to accessvasculature. | Same |
| Inner Diameter | 0.012 in (0.30mm) | 0.016in (0.41mm) | The subjectdevice has a |
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| Attribute | Subject Device:Instylla Microcatheter 1.2 | Predicate Device:Instylla Microcatheter(K200744) | SubstantialEquivalence |
|---|---|---|---|
| Outer Diameter | 1.2Fr (0.40mm) | 1.7Fr (0.56mm) | smaller innerdiameter.The subjectdevice has asmaller outerdiameter. |
| Usable Lengths | 122cm, 142cm, 162cm | 122cm, 142cm, 162cm | Same |
| GuidewireCompatibility(Size) | 0.010in (0.25mm) | 0.014in (0.36mm) | The change inouter diameterresults incompatibilitywith a smallerguidewire. |
| RadiopaqueMarker | Yes | Yes | Same |
| Method ofSterilization | Ethylene Oxide (EO) to a SALof 10-6 | Ethylene Oxide (EO) to a SALof 10-6 | Same |
| Shelf Life | 6 Months | 6 Months | Same |
The modified Instylla Microcatheter 1.2 only differs from the legally marketed predicate device in that it has a 1.2Fr OD compared to the 1.7Fr OD of the predicate device. The intended use, indications, principle of operation, packaging, sterilization and technological characteristics remain identical between the subject and predicate device.
Performance Data
Performance testing of the final, sterilized Instylla Microcatheter 1.2 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:
- Visual Inspection of Components =
- -Dimensional Verification of Components
- -Trackability
- -Kink Resistance
- -Pushability and Torqueability
- Tip Radiopacity -
- -Fluid and Infusate Compatibility
- = Injection of Fluids (Flowrate) and Tip Stability
- e Freedom from Leakage
- -Static Burst Pressure
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- -Catheter Shaft Tensile Strength
- -Microcatheter Compatibility with Standard Microcatheters, Guidewires and Syringes
- Accessory Compatibility and Functionality -
The Instylla Microcatheter 1.2 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 1.2 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 1.2:
- . Cytotoxicity
- . Sensitization
- . Irritation or Intracutaneous Toxicity
- . Acute Systemic Toxicity
- . Material-Mediated Pyrogenicity
- . Hemolysis
- . Complement Activation
- 9 Partial Thromboplastin Time
- . In Vivo Thromboresistance - Jugular Vein
Sterility
The Instylla Microcatheter 1.2 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. The Instylla Microcatheter 1.2 was evaluated and adopted into the validated process per AAMI TIR28 Product adoption and process equivalence for ethylene oxide sterilization. The EO and ECH levels were determined to be acceptable in accordance with ISO 10993-7 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.
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 1.2 has a 6-month 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, 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.
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Conclusion
Instylla has demonstrated that the Instylla Microcatheter 1.2 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 K200744 on April 21, 2020.
§ 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).