(127 days)
Not Found
No
The summary describes a simple mechanical delivery kit for fluids and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used for administration of substances, not for treating a disease or condition itself.
No
The device description and intended use state that the Instylla Delivery Kit is for the administration of substances, not for diagnosing conditions.
No
The device description explicitly lists physical components (syringes, syringe holder, plunger clip) and the performance studies describe bench and functional testing of these physical components, indicating it is a hardware device.
Based on the provided information, this device 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 radiographic contrast media, saline and other aqueous solutions." This describes a device used for delivering substances into the body, not for testing samples outside the body (which is the core function of an IVD).
- Device Description: The components (syringes, holder, clip) are consistent with a delivery system for fluids, not a system for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on testing in vitro.
Therefore, the Instylla Delivery Kit is a medical device used for administering substances, not an in vitro diagnostic device.
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
FMF
Device Description
The Instylla Delivery Kit is comprised of two 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
Performance testing of the final, sterilized Instylla Delivery Kit with 3mL syringes included bench testing and functional testing to verify specifications fundamental to the design of the device. The following tests were conducted:
- Visual Inspection
- Dimensional Verification
- Functional Testing
- Syringe Holder and Plunger Clip Disconnection Force
- Syringe Compatibility
- Syringe Glide Force and Break Force
- Fluids Compatibility
- Delivery Integrity
- Particulate Matter Testing per USP Particulate Matter in Injections
The Instylla Delivery Kit with 3mL syringes met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing. Further, the syringes of the subject device are complaint against FDA recognized standards ISO 7886-1 and ISO 594-2.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
January 7, 2021
Instylla, Inc. Jennifer Greer Regulatory Affairs Manager 201 Burlington Rd, North Building Bedford, Massachusetts 01730
Re: K202544
Trade/Device Name: Instylla Delivery Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: December 7, 2020 Received: December 8, 2020
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.
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,
Rumi Young, M.S., RAC. Acting 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
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Indications for Use
510(k) Number (if known) K202544
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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Image /page/3/Picture/0 description: The image shows the word "instylla" in black font. There is a red dot above the "i" and a red curved line that goes over the "t" and under the "lla". The background is white.
510(k) Summary
Submitter Information:
Instylla, Inc. 201 Burlington Rd North Building Bedford, MA 01730
Contact Person:
Jennifer Greer Regulatory Affairs Manager Phone: 781-622-9293 E-mail: jennyg@instylla.com
Date Prepared:
December 7, 2020
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 Devices:
| Proprietary Name: | Instylla Delivery Kit |
|---|---|
| Manufacturer: | Instylla, Inc. |
| 510(k) Number: | K191659 |
Device Description:
The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).
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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 for the modified Instylla Delivery Kit with 3mL syringes remain unchanged from the cleared predicate device.
Comparison of Technological Characteristics to the Predicate Devices:
The Instylla Delivery Kit with 3mL syringes 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 Delivery Kit with 3mL syringes compared with the predicate devices.
| Attribute | Subject Device:
Instylla Delivery Kit with 3mL
Syringes | Predicate Device:
Instylla Delivery Kit
(K191659) | Substantial
Equivalence
Comparison |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 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 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. | Same |
| Basic Design/
Components | Two standard delivery piston
syringes | Two standard delivery
piston syringes | Same |
| Components | Two syringes, syringe holder,
plunger clip | Two syringes, syringe
holder, plunger clip | Same |
| Material | Polycarbonate, silicone, ABS | Polycarbonate, silicone,
ABS | Same |
| Principle of
Operation | Manually operated by advancing
the dual syringe plungers
simultaneously with the aid of a
plunger clip. | Manually operated by
advancing the dual
syringe plungers
simultaneously with the
aid of a plunger clip. | Same |
| Operation Volume | 3mL | 1mL | The operational
volume of the
syringes differs. |
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| Attribute | Subject Device:
Instylla Delivery Kit with 3mL
Syringes | Predicate Device:
Instylla Delivery Kit
(K191659) | Substantial
Equivalence
Comparison |
|----------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|
| Gradation | Printed with accurate graduation
lines that are compliant with ISO
7886-1. | Printed with accurate
graduation lines that are
compliant with ISO 7886-
- | Same |
| Method of
Sterilization | Ethylene Oxide (EO) to a SAL of
10-6 | Ethylene Oxide (EO) to a
SAL of 10-6 | Same |
| Shelf Life | 6 months | 6 months | Same |
The modified Instylla Delivery Kit differs from the legally marketed predicate device in that it includes two 3mL syringes instead of two 1mL syringes. 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 Delivery Kit with 3mL syringes included bench testing and functional testing to verify specifications fundamental to the design of the device. The following tests were conducted:
- -Visual Inspection
- Dimensional Verification .
- -Functional Testing
- o Syringe Holder and Plunger Clip Disconnection Force
- Syringe Compatibility o
- Syringe Glide Force and Break Force o
- Fluids Compatibility o
- o Delivery Integrity
- Particulate Matter Testing per USP Particulate Matter in Injections -
The Instylla Delivery Kit with 3mL syringes met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during 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 on the Instylla Delivery Kit with 3mL syringes 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 Instylla Delivery Kit with 3mL syringes is classified as an external
6
communicating device, indirectly contacting blood for a limited duration (≤24 hours). The patient contact, materials and manufacturing processes remain identical between the Instylla Delivery Kit with 3mL syringes and the legally marketed predicate device. Therefore, per ISO 10993-1, the biocompatibility results of the predicate device are representative of the subject device and no additional biocompatibility testing was conducted on the subject device.
Sterility
The Instylla Delivery Kit with 3mL syringes 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 Delivery Kit with 3mL syringes 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 delivery kit endotoxin level will be