(111 days)
No
The summary describes a simple mechanical delivery kit for fluids and does not mention any AI/ML components or image processing. The performance studies focus on mechanical and biological properties.
No
The device is intended for the administration of substances, not for treating a disease or condition itself.
No
The product is an Instylla Delivery Kit used for the administration of solutions such as contrast media, saline, and other aqueous solutions. It is designed to administer substances rather than to diagnose medical conditions or diseases.
No
The device description explicitly states it is comprised of physical components (syringes, syringe holder, plunger clip) and the performance studies focus on bench and functional testing of these physical components, as well as biocompatibility and sterility. There is no mention of software.
Based on the provided information, the Instylla Delivery Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the intra-arterial or intra-venous administration of substances like contrast media and saline. This is a direct interaction with the patient's body for therapeutic or diagnostic imaging purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is a kit for delivering fluids, consisting of syringes, a holder, and a clip. These are tools for administration, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for direct patient use for the delivery of substances, which falls under the category of medical devices used for treatment or imaging procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Delivery Kit included bench testing and functional testing to verify specifications fundamental to the device. Testing included the following:
- . Visual Inspection
- . Dimensional Verification
- . Functional Testing
- o Syringe Holder and Plunger Clip Connection Force
- Syringe Holder and Plunger Clip Disconnection Force o
- Syringe Compatibility o
- Syringe Glide Force and Break Force о
- Fluids Compatibility о
- o Delivery Integrity
- Particulate Matter Testing
Further, the syringes of the subject device are complaint against FDA recognized standards ISO 7886-1 and ISO 594-2.
Biocompatibility Testing: A biocompatibility evaluation was conducted in accordance with the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," consistent with a device indirectly contacting blood for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final, sterilized Instylla Delivery Kit:
- . Cytotoxicity
- Sensitization
- Irritation or Intracutaneous toxicity ●
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Hemolysis
Sterility: The Instylla Delivery Kit is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10-6. 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 delivery kit endotoxin level will be
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
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October 11, 2019
Instylla, Inc. Amita Smith Vice President Regulatory and Quality Affairs 204 Second Avenue Waltham, Massachusetts 02451
Re: K191659
Trade/Device Name: Instylla Delivery Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: September 12, 2019 Received: September 13, 2019
Dear Amita Smith:
This letter corrects our substantially equivalent letter of October 10. 2019.
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 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.
1
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 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.
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Rumi Young -S c=US, o=U.S. Government, ou=HHS, ou=FDA. ou=People. cn=Rumi Young -0.9.2342.19200300.100.1.1=200246791
2019.10.11 08:34:51 -04'00'
For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191659
Device Name Instylla Delivery Kit
Indications for Use (Describe)
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
| 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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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:
October 9, 2019
Subject Device:
| Proprietary Name: | Instylla Delivery Kit |
|---|---|
| Common Name: | Syringe, Piston |
| Classification Name: | Piston syringe |
| (21 CFR 880.5860, Product Code FMF) | |
| Device Classification: | Class II |
| Classification Panel: | General Hospital |
Predicate Device:
| Proprietary Name: | NAMIC RCS |
|---|---|
| Manufacturer: | Navilyst Medical, Inc. |
| 510(k) Number: | K140194 |
The FibriJet Aerosol Applicator cleared under 510(k) Premarket Notification K012868 was used as a secondary predicate device in this submission.
Device Description:
The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).
4
Indications for Use:
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
The indications for use statement is similar to the predicate device, NAMIC RCS.
Comparison of Technological Characteristics to the Predicate Device:
The Instylla Delivery Kit 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 Delivery Kit compared with the predicate devices.
| Attribute | Subject Device:
Instylla Delivery Kit | Primary Predicate
Device:
NAMIC RCS (K140194) | Secondary Predicate
Device:
FibriJet Aerosol Applicator
(K012868) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Instylla Delivery Kit is
intended to be used for the
intra-arterial or intra-
venous administration of
radiographic contrast
media, saline and other
aqueous solutions. | The NAMIC RCS is
intended to be used for
the intra-arterial or intra-
venous administration of
radiographic contrast
media and saline
solutions during an
angiographic procedure. | The Micromedics FibriJet
Aerosol Applicator is
intended for use in
applying two non-
homogenous fluids to a
treatment site. |
| Basic Design | Two standard delivery
piston syringes | One standard delivery
piston syringe | Two standard delivery
piston syringes |
| Components | Two syringes, syringe
holder, plunger clip | One syringe | Two syringes, syringe
holder, plunger link |
| Material | Polycarbonate, silicone,
ABS | Polycarbonate | Polypropylene, silicone,
ABS |
| Principle of
Operation: | Manually operated by
advancing dual syringe
plungers simultaneously
with the aid of a plunger
clip. | Manually operated by
advancing the single
syringe plunger. | Manually operated by
advancing dual syringe
plungers simultaneously
with the aid of a plunger
link. |
| Operation
Volume | 1 mL | 7, 8, 10, 12 and 20 mL | 1-12 mL |
| Gradation | Printed with accurate
graduation lines that are
compliant with ISO 7886-1. | Printed with graduation
lines. | Printed with accurate
graduation lines that are
compliant with ISO 7886-1. |
The intended use and principal of operation are the same between the subject and both predicate devices. Both devices are standard piston syringes that are manually operated by advancing a plunger.
5
Performance Data
Performance testing of the final sterilized Instylla Delivery Kit included bench testing and functional testing to verify specifications fundamental to the device. Testing included the following:
- . Visual Inspection
- . Dimensional Verification
- . Functional Testing
- o Syringe Holder and Plunger Clip Connection Force
- Syringe Holder and Plunger Clip Disconnection Force o
- Syringe Compatibility o
- Syringe Glide Force and Break Force о
- Fluids Compatibility о
- o Delivery Integrity
- Particulate Matter Testing
Further, the syringes of the subject device are complaint against FDA recognized standards ISO 7886-1 and ISO 594-2.
Biocompatibility Testing
A biocompatibility evaluation was conducted in accordance with the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," consistent with a device indirectly contacting blood for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final, sterilized Instylla Delivery Kit:
- . Cytotoxicity
- Sensitization
- Irritation or Intracutaneous toxicity ●
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Hemolysis
Sterility
The Instylla Delivery Kit is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10-6. 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 delivery kit endotoxin level will be