The Instylla Delivery Kit is intended to be used for the intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

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).

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to construct the complete response regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and summary for a delivery kit, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed study parameters as requested.

While the document mentions "Performance testing... met the predetermined acceptance criteria," it does not explicitly list these criteria in a table or describe the study in the comprehensive manner you've outlined (e.g., sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance details, ground truth specifics, training set details).

Based on the available text, I can only provide the following:

Device: Instylla Delivery Kit

Regulatory Class: Class II

Product Code: FMF (Piston Syringe)

Intended Use: For the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

Performance Data Summary (from the text):

Performance testing of the final, sterilized Instylla Delivery Kit with modified packaging included bench testing and functional testing.
Tests Conducted:
- Syringe Force Performance
- Fluids Compatibility
- Delivery Integrity
Outcome: "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."
Standards Compliance: The syringes are compliant with FDA recognized standards ISO 7886-1 and ISO 594-2.
Biocompatibility: Evaluation conducted per FDA Guidance Document Use of International Standard ISO 10993-1. No new testing was performed on the subject device as contact materials and manufacturing processes were identical to predicate devices.
Sterility: Sterilized via validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10^-6, per ISO 11135. EO and ECH levels acceptable per ISO 10993-7. Bacterial endotoxin test (BET) validated for <20 EU/device.
Packaging: Testing conducted per ISO 11607-1, subjected to simulated distribution challenge conditions per ISTA 3A.
Shelf Life: 6 months. Shelf-life testing conducted to demonstrate performance and sterile barrier maintenance.

Missing Information (not found in the provided text):

A detailed table of acceptance criteria and reported device performance (with specific numerical values for criteria and results).
Sample size used for the test set.
Data provenance (e.g., country of origin, retrospective/prospective).
Number of experts and their qualifications for establishing ground truth.
Adjudication method.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and its effect size.
If a standalone (algorithm only) performance study was done. (This device is a physical medical device, not an AI algorithm, so this question is not applicable in this context).
Type of ground truth used.
Sample size for the training set. (Not applicable for a physical device).
How the ground truth for the training set was established. (Not applicable for a physical device).
Clinical Performance Data: "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device" due to identical technological characteristics, indications for use, material, manufacturing, and sterilization processes as the predicate devices.

Summary

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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

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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

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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)

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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" 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

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Device Description:

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).

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)	SubstantialEquivalence
Indications for Use	The Instylla Delivery Kit is intended to be usedfor the intra-arterial or intra-venousadministration of radiographic contrastmedia, saline and other aqueous solutions.	The Instylla Delivery Kit is intended to be usedfor the intra-arterial or intra-venousadministration of radiographic contrastmedia, saline and other aqueous solutions.	The Instylla Delivery Kit is intended to be usedfor the intra-arterial or intra-venousadministration of radiographic contrastmedia, saline and other aqueous solutions.	Same
Basic Design	Two standard deliverypiston syringes	Two standard deliverypiston syringes	Two standard deliverypiston syringes	Same
Attribute	Subject Device:	Primary PredicateDevice:	Secondary PredicateDevice:	SubstantialEquivalence
	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, syringeholder, plunger clip	Two syringes, syringeholder, plunger clip	Two syringes, syringeholder, plunger clip	Same
Materials	Polycarbonate, silicone,ABS	Polycarbonate, silicone,ABS	Polycarbonate, silicone,ABS	Same
Syringe color	One yellowOne blue	One whiteOne blue	One whiteOne blue	The subjectdevice has oneyellow syringeinstead of onewhite syringe.
Pad printedsymbol	Present	Absent	Absent	The subjectdevice has apad printedsymbol on theoutside of thesyringe barrel.
Principle ofOperation	Manually operated byadvancing the dualsyringe plungerssimultaneously with theaid of a plunger clip.	Manually operated byadvancing the dualsyringe plungerssimultaneously with theaid of a plunger clip.	Manually operated byadvancing the dualsyringe plungerssimultaneously with theaid of a plunger clip.	Same
OperationVolume	1 mL or 3mL	1mL	3mL	The subjectdevice isavailable withbothoperationalvolumes.
Gradation	Printed with accurategraduation lines that arecompliant with ISO7886-1.	Printed with accurategraduation lines that arecompliant with ISO7886-1.	Printed with accurategraduation lines that arecompliant with ISO7886-1.	Same
Packaging	Device is packed withdie card and placed intoa tray with Tyvek lid	Device is packaged intoa Tyvek pouch	Device is packaged intoa Tyvek pouch	The subjectdevicepackaging hasbeen modified.
Method ofSterilization	Ethylene Oxide (EO) to aSterility 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

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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.

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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.

Regulation Number and Section

§ 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).