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 Description

The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).

AI/ML Overview

This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.

However, I can extract information related to the device's non-AI performance testing, as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."

Performance Test	Acceptance Criteria (Not explicitly stated with values in document, generally "meets specifications" or "compliant")	Reported Device Performance
Visual Inspection	To verify specifications fundamental to the device	Performed
Dimensional Verification	To verify specifications fundamental to the device	Performed
Functional Testing:
- Syringe Holder and Plunger Clip Connection Force	To verify specifications fundamental to the device	Performed
- Syringe Holder and Plunger Clip Disconnection Force	To verify specifications fundamental to the device	Performed
- Syringe Compatibility	To verify specifications fundamental to the device	Performed
- Syringe Glide Force and Break Force	To verify specifications fundamental to the device	Performed
- Fluids Compatibility	To verify specifications fundamental to the device	Performed
- Delivery Integrity	To verify specifications fundamental to the device	Performed
Particulate Matter Testing	To verify specifications fundamental to the device	Performed
Syringe Compliance	FDA recognized standards ISO 7886-1 and ISO 594-2	Compliant
Biocompatibility Testing:	In accordance with ISO 10993-1 for indirect blood contact (≤24 hours)	Successfully completed
- Cytotoxicity	Meets ISO 10993-1 requirements	Performed
- Sensitization	Meets ISO 10993-1 requirements	Performed
- Irritation or Intracutaneous toxicity	Meets ISO 10993-1 requirements	Performed
- Acute Systemic Toxicity	Meets ISO 10993-1 requirements	Performed
- Material-Mediated Pyrogenicity	Meets ISO 10993-1 requirements	Performed
- Hemolysis	Meets ISO 10993-1 requirements	Performed
Sterility	Sterility Assurance Level (SAL) of 10-6 (validated per ISO 11135)	Achieved
Endotoxin Level	<20 endotoxin units (EU)/device (validated LAL test)	Achieved
Shelf Life	Maintains performance and sterile barrier for 6-months	Demonstrated

2. Sample size used for the test set and the data provenance:
Not applicable, as this is bench and functional testing of a physical device, not an AI/algorithm test set. No "data provenance" in the sense of patient data is mentioned for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for physical device testing typically involves laboratory measurements and adherence to engineering specifications and standards.

4. Adjudication method for the test set:
Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document explicitly states: "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device" due to its substantial equivalence to predicate devices and the nature of the device (a piston syringe).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used:
For the non-AI performance tests, the "ground truth" would be established by:

Engineering specifications and design requirements: For visual inspection, dimensional verification, and functional testing.
International Standards: ISO 7886-1, ISO 594-2 for syringe compliance.
Biocompatibility Standards: ISO 10993-1 for biocompatibility tests.
Sterilization Standards: ISO 11135 for sterility.
Established Test Methods: For particulate matter, endotoxin, and shelf life.

8. The sample size for the training set:
Not applicable, as this is not an AI/algorithm device.

9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/algorithm device.

Summary

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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.

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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

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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).

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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 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 PredicateDevice:NAMIC RCS (K140194)	Secondary PredicateDevice:FibriJet Aerosol Applicator(K012868)
Indicationsfor Use	The Instylla Delivery Kit isintended to be used for theintra-arterial or intra-venous administration ofradiographic contrastmedia, saline and otheraqueous solutions.	The NAMIC RCS isintended to be used forthe intra-arterial or intra-venous administration ofradiographic contrastmedia and salinesolutions during anangiographic procedure.	The Micromedics FibriJetAerosol Applicator isintended for use inapplying two non-homogenous fluids to atreatment site.
Basic Design	Two standard deliverypiston syringes	One standard deliverypiston syringe	Two standard deliverypiston syringes
Components	Two syringes, syringeholder, plunger clip	One syringe	Two syringes, syringeholder, plunger link
Material	Polycarbonate, silicone,ABS	Polycarbonate	Polypropylene, silicone,ABS
Principle ofOperation:	Manually operated byadvancing dual syringeplungers simultaneouslywith the aid of a plungerclip.	Manually operated byadvancing the singlesyringe plunger.	Manually operated byadvancing dual syringeplungers simultaneouslywith the aid of a plungerlink.
OperationVolume	1 mL	7, 8, 10, 12 and 20 mL	1-12 mL
Gradation	Printed with accurategraduation lines that arecompliant with ISO 7886-1.	Printed with graduationlines.	Printed with accurategraduation lines that arecompliant 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.

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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 <20 endotoxin units (EU)/device.

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Shelf Life

The Instylla Delivery Kit has a shelf life of 6-months. Shelf life studies have been conducted to demonstrate that the device maintains its performance and the packaging will maintain its sterile barrier over the entirety of the intended shelf life.

Clinical Performance Data

The technological characteristics, indications for use, material, manufacturing and sterilization processes are the same as the predicate device 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 is substantially equivalent in fundamental design, function, device materials, packaging, sterilization, operating principle, intended use/ indication for use and fundamental technology as the legally marketed predicate device, NAMIC RCS, which was cleared under 510(k) Premarket Notification K140194 on April 14, 2014.

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).