Who is the manufacturer of Instylla Delivery Kit?

Instylla, Inc. filed the 510(k) submission for Instylla Delivery Kit (K213632).

What is the FDA product code for Instylla Delivery Kit?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Instylla Delivery Kit?

510(k) clearance (submission type: Special).

What are the predicate devices for Instylla Delivery Kit?

Instylla Delivery Kit (K191659); Instylla Delivery Kit (K202544).

Who can help prepare an FDA 510(k) submission like Instylla Delivery Kit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Instylla Delivery Kit

K213632 · Instylla, Inc. · FMF · Feb 10, 2022 · General Hospital

Device Facts

Record ID	K213632
Device Name	Instylla Delivery Kit
Applicant	Instylla, Inc.
Product Code	FMF · General Hospital
Decision Date	Feb 10, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5860
Device Class	Class 2

Intended 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.

Device Story

The Instylla Delivery Kit is a manual, single-patient-use device designed for the simultaneous delivery of two distinct fluids. It consists of a double-barreled syringe holder, two commercially available needleless syringes (1 mL or 3 mL), and a plunger clip. The clinician attaches the plunger clip to both syringe plungers, allowing for simultaneous depression and injection. The device is used in clinical settings for the administration of radiographic contrast media, saline, or other aqueous solutions. By enabling the simultaneous delivery of two fluids, the device facilitates specific procedural workflows, potentially improving efficiency during interventional or diagnostic procedures. The device is manually operated by the healthcare provider.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including syringe force performance, fluid compatibility, delivery integrity, biocompatibility evaluation (per ISO 10993-1), sterilization validation (per ISO 11135), and packaging/shelf-life testing (per ISO 11607-1 and ISTA 3A).

Technological Characteristics

Materials: Polycarbonate (syringes), ABS (holder/clip), silicone. Design: Double-barreled manual piston syringe system. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 7886-1 (graduation), ISO 594-2, ISO 10993-1 (biocompatibility), ISO 11135 (sterilization), ISO 11607-1 (packaging).

Indications for Use

Indicated for intra-arterial or intra-venous administration of radiographic contrast media, saline, and other aqueous solutions in patients requiring such delivery.

Regulatory Classification

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.

Predicate Devices

Instylla Delivery Kit (K191659)
Instylla Delivery Kit (K202544)

Related Devices

K253769 — Instylla Delivery Kit · Instylla, Inc. · Dec 22, 2025
K202544 — Instylla Delivery Kit · Instylla, Inc. · Jan 7, 2021
K191659 — Instylla Delivery Kit · Instylla, Inc. · Oct 10, 2019
K964833 — RMI DUAL FLUID IRRIGATING SYRINGE · Research Medical, Inc. · Feb 19, 1997
K020147 — MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP · Medtronic Perfusion Systems · Apr 3, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out in a clear, sans-serif font. February 10, 2022 Instylla, Inc. Jennifer Greer Regulatory Affairs Manager 201 Burlington Road, North Building Bedford, Massachusetts 01730 ## Re: K213632 Trade/Device Name: Instylla Delivery Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 12, 2022 Received: January 13, 2022 ## 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 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 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, CAPT Alan M. 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) K213632 Device Name Instylla Delivery Kit Indications for Use (Describe) The Instylla Delivery Kit is intended to be used for the intra-venous administration of radiographic contrast media, saline and other aqueous solutions. 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. There is a red dot above the "i" in "instylla". A red curved line goes over the "sty" in "instylla" and under the "lla" in "instylla". The red curved line is thinner at the top and bottom. #### 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: January 12, 2022 #### Subject Device | Proprietary Name: | Instylla Delivery Kit with 1 mL Syringe | |------------------------|-----------------------------------------| | | Instylla Delivery Kit with 3 mL Syringe | | Common Name: | Syringe, Piston | | Classification Name: | Piston syringe | | | (21 CFR 880.5860, Product Code FMF) | | Device Classification: | Class II | | Classification Panel: | General Hospital | #### Primary Predicate Device: | Proprietary Name: | Instylla Delive | |-------------------|-----------------| | Manufacturer: | Instylla, Inc. | | 510(k) Number: | K191659 | ery Kit (with 1 mL syringes) #### Secondary Predicate Device: | Proprietary Name: | Instylla Delivery Kit (with 3 mL syringes) | |-------------------|--------------------------------------------| | Manufacturer: | Instylla, Inc. | | 510(k) Number: | K202544 | {4}------------------------------------------------ ## Device Description: The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link). The Instylla Delivery Kit with modified packaging is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed. The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS). #### 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. The indications for use statement for the modified Instylla Delivery Kit remains unchanged from the cleared predicate devices. ## Comparison of Technological Characteristics to the Predicate Devices: The subject Instylla Delivery Kit is substantially equivalent in intended use and fundamental technological characteristics to the predicate devices. The below table summarizes the similarities in design and configuration of the subject Instylla Delivery Kit compared with the predicate devices. | Attribute | Subject Device: Instylla Delivery Kit (with 1 mL Syringes or 3 mL Syringes) | Primary Predicate Device: Instylla Delivery Kit with 1mL Syringes (K191659) | Secondary Predicate Device: Instylla Delivery Kit with 3 mL Syringes (K202544) | Substantial Equivalence | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | 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. | 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 | Two standard delivery piston syringes | Two standard delivery piston syringes | Two standard delivery piston syringes | Same | | Attribute | Subject Device: | Primary Predicate Device: | Secondary Predicate Device: | Substantial Equivalence | | | Instylla Delivery Kit (with 1 mL Syringes or 3 | Instylla Delivery Kit with | Instylla Delivery Kit with | | | | mL Syringes) | 1mL Syringes (K191659) | 3 mL Syringes (K202544) | | | Components | Two syringes, syringe holder, plunger clip | Two syringes, syringe holder, plunger clip | Two syringes, syringe holder, plunger clip | Same | | Materials | Polycarbonate, silicone, ABS | Polycarbonate, silicone, ABS | Polycarbonate, silicone, ABS | Same | | Syringe color | One yellow One blue | One white One blue | One white One blue | The subject device has one yellow syringe instead of one white syringe. | | Pad printed symbol | Present | Absent | Absent | The subject device has a pad printed symbol on the outside of the syringe barrel. | | 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. | Manually operated by advancing the dual syringe plungers simultaneously with the aid of a plunger clip. | Same | | Operation Volume | 1 mL or 3mL | 1mL | 3mL | The subject device is available with both operational volumes. | | Gradation | Printed with accurate graduation lines that are compliant with ISO 7886-1. | Printed with accurate graduation lines that are compliant with ISO 7886-1. | Printed with accurate graduation lines that are compliant with ISO 7886-1. | Same | | Packaging | Device is packed with die card and placed into a tray with Tyvek lid | Device is packaged into a Tyvek pouch | Device is packaged into a Tyvek pouch | The subject device packaging has been modified. | | Method of Sterilization | Ethylene Oxide (EO) to a Sterility Assurance Level (SAL) of 10-6 | EO to a SAL of 10-6 | EO to a SAL of 10-6 | Same | | Shelf Life | 6 months | 6 months | 6 months | Same | {5}------------------------------------------------ {6}------------------------------------------------ The modified Instylla Delivery Kit differs from the legally marketed predicate devices in packaging. 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 modified packaging included bench testing and functional testing to verify specifications fundamental to the design of the device. The following tests were conducted: - . Syringe Force Performance - . Fluids Compatibility - . Delivery Integrity The Instylla Delivery Kit with modified packaging met the predetermined acceptance criteria ensuring substantial equivalence to the predicate devices. 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 modified packaging 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 is classified as an external communicating device, indirectly contacting blood for a limited duration (≤24 hours). The patient contact, materials and manufacturing processes remain identical between the subject Instylla Delivery Kit and the legally marketed predicate devices. 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 modified packaging 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 modified packaging 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) validation, also known as the Limulus amebocyte lysate (LAL) test, was also repeated to establish that the delivery kit endotoxin level will be <20 endotoxin units (EU)/device. {7}------------------------------------------------ ## Packaging Packaging testing was conducted on sterilized Instylla Delivery Kit with modified packaging to evaluate the effectiveness of the packaging configuration the sterile barrier in accordance with ISO 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. The subject device and packaging were subjected to simulated distribution challenge conditions in accordance with International Safe Transit Association (ISTA) 3A and evaluated for performance of the sterile barrier and product performance. ## Shelf Life The Instylla Delivery Kit with modified packaging has a 6-month shelf life. Shelf-Life testing was conducted on the subject Instylla Delivery Kit to demonstrate that the device maintains its performance and the packaging will maintain its sterile barrier over the entirety of its intended shelf life. ## Clinical Performance Data The 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. #### Conclusion Instylla has demonstrated that the Instylla Delivery Kit with modified packaging is substantially equivalent in fundamental design, function, device materials, sterilization, operating principle, intended use/indication for use and technology as the legally marketed predicate devices, the Instylla Delivery Kit with 1mL syringes which was cleared under 510(k) Premarket Notification K191659 on October 11, 2019 and the Instylla Delivery Kit with 3 mL syringes which was cleared under 510(k) Premarket Notification K202544 on January 7, 2021.