(29 days)
Not Found
No
The 510(k) summary describes a physical microcatheter and its accessories. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies focus on bench and functional testing of the physical device.
No.
The device is a delivery system for therapeutic materials, rather than a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in super selective anatomy for peripheral diagnostic and interventional procedures." It also mentions that it "can be used for the infusion of diagnostic ... materials into vessels." This indicates that the device has a diagnostic function.
No
The device description clearly details physical components like a catheter, lumen, hub, strain relief, radiopaque marker, and various adapters, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed outside of the body on samples like blood, urine, or tissue.
- Device Function: The Instylla Microcatheter is a medical device used within the body (in vivo) for delivering materials into blood vessels during diagnostic and interventional procedures. It is a tool for accessing and treating anatomical sites, not for analyzing biological specimens.
- Intended Use: The intended use clearly states it's for "peripheral diagnostic and interventional procedures" and for "infusion of diagnostic, embolic, or therapeutic materials into vessels." This describes a procedural tool, not a diagnostic test performed on a sample.
- Device Description: The description details the physical characteristics and function of a catheter used for navigation and delivery within the vasculature. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, the Instylla Microcatheter falls under the category of an interventional or diagnostic medical device used in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K200744
Device Name Instylla Microcatheter
Indications for Use (Describe)
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.
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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:
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
4
≤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.
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 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. | Same |
| Basic Design/
Components | Microcatheter, 4Fr Tuohy-Borst with
Side Port Adaptor, Short Extension
Adapter, Long Catheter Adapter and
Duckbill Check-Valve Connector | Microcatheter, 4Fr Tuohy
Borst with Side Port Adaptor,
Short Extension Adapter, and
Long Extension Adapter |
5
| Attribute | Subject Device:
Instylla Microcatheter with Check-
Valve Connector | Predicate Device:
Instylla Microcatheter
(K191731) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Catheter Material | Thermoplastic elastomers (PEBAX),
PTFE (inner layer), platinum/iridium
marker, polycarbonate (hub) | Same |
| Principle of
Operation | Manually tracked over a steerable
guidewire to access vasculature. | Same |
| Inner Diameter | 0.016in (0.41mm) | Same |
| Outer Diameter | 1.7Fr (0.56mm) | Same |
| Usable Lengths | 122cm, 142cm, 162cm | Same |
| Guidewire
Compatibility (Size) | 0.014in (0.36mm) | Same |
| Radiopaque
Marker | 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
6
- 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