(85 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid delivery aspects of a syringe kit, with no mention of AI or ML technologies.
No
The device is intended for the administration of solutions, not for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device is described as a kit for administering solutions (e.g., radiographic contrast media, saline) for imaging, not for diagnosing conditions. Its primary function is delivery, not analysis or interpretation of health data.
No
The device description explicitly details physical components made of polycarbonate and ABS, indicating it is a hardware device, not software-only.
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 administration of substances (contrast media, saline, aqueous solutions) into the body (intra-venous or intra-arterial). This is a delivery function, not a diagnostic function.
- Device Description: The device is a delivery kit consisting of syringes, a holder, and a plunger clip. These are tools for injecting fluids.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue), nor does it perform any tests or measurements to diagnose a condition.
- Performance Studies: The performance studies focus on the physical and functional aspects of the delivery system (syringe force, fluids compatibility, delivery integrity), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivering substances into the body.
N/A
Intended Use / Indications for Use
The Instylla Delivery Kit is intended to be used for the 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 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).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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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)
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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