(46 days)
No
The 510(k) summary describes a physical microcatheter device and its mechanical properties and performance. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
No
The device is a microcatheter for delivering diagnostic, embolic, or therapeutic materials, but it is not therapeutic itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Instylla Microcatheter is "intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures." It also mentions that the device "can be used for the infusion of diagnostic... materials into vessels."
No
The device description clearly details a physical catheter with specific dimensions, materials, and accessories (luer hub, strain relief, radiopaque marker, Tuohy-Borst adapter, extensions). The performance studies focus on bench and functional testing of these physical components (trackability, kink resistance, tensile strength, etc.). There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Instylla Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Instylla Microcatheter Function: The description clearly states the Instylla Microcatheter is used within the body (in small vessels or super selective anatomy) for peripheral diagnostic and interventional procedures. It's used to deliver materials into vessels, not to analyze samples taken from the body.
The device is an invasive medical device used for diagnostic and therapeutic purposes within the vascular system.
N/A
Intended Use / 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.
Product codes
KRA
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
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
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
1
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
2
Indications for Use
510(k) Number (if known) K191731
Device Name Instylla Microcatheter
Indications for Use (Describe)
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.
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) |
|---|---|
| ------------------------------------------------------------------------------------------------ | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
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
4
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.
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 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 Support
Catheter (K093052) | Reference Device:
Renegade HI-FLO
Microcatheter (K140329) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The CrossCath Support
Catheter is intended
for use in small vessel
or super selective
anatomy for diagnostic
and interventional
procedures, including
peripheral use. | The Renegade HI-FLO
Microcatheter is intended
for peripheral vascular
use. The microcatheter
can be coaxially tracked
over a steerable
guidewire in order to
access distal, tortuous
vasculature. Once the
subselective region has
been accessed, the
microcatheter can be
used for the controlled |
| Attribute | Subject Device:
Instylla Microcatheter | Predicate Device:
CrossCath Support
Catheter (K093052) | Reference Device:
Renegade HI-FLO
Microcatheter (K140329) |
| | | | diagnostic, embolic, or
therapeutic materials into
vessels. Diagnostic,
embolic, or therapeutic
agents to be used in
accordance with
specifications outlined by
the manufacturer. |
| Basic Design/
Components | Instylla Microcatheter
4Fr Tuohy Borst with
Side Port Adaptor,
Short Extension
Adapter, and Long
Extension Adapter | Microcatheter | Renegade HI-FLO
Microcatheter, Rotating
hemostatic valve, Shaping
mandrel |
| Material | Thermoplastic
elastomers (PEBAX),
PTFE (inner layer),
platinum/iridium
marker, polycarbonate
(hub) | Catheter material not
known,
platinum/iridium
marker | Fiber Palladium Braid
Outer surface coated with
Hydro Pass™ Hydrophilic
Coating, platinum-
tungsten tip |
| Principle of
Operation | Manually tracked over
a steerable guidewire
to access vasculature. | Manually tracked over
a steerable guidewire
to access vasculature. | Manually tracked over a
steerable guidewire to
access vasculature. |
| Inner
Diameter | 0.016 in (0.41mm) | Not known, 0.014-
0.035 in guidewire
compatibility
dependent on catheter
configuration | 0.027 in (0.69 mm) |
| Outer
Diameter | 1.7 Fr (0.56mm) | 1.9-3.7 Fr, dependent
on catheter
configuration | 2.8 Fr (0.93 mm) to 3.0 Fr
(1.00 mm) (tapered
design) |
| Usable
Lengths | 122 cm, 142 cm, 162
cm | 65cm, 90 cm, 135 cm,
150 cm | 80 cm, 105 cm, 115 cm,
135 cm, 150 cm |
| Guidewire
Compatibility
(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) |
| Radiopaque
Marker | Yes | Yes | Yes |
5
6
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
7
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