(637 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML technologies.
No
The device is an insulin syringe used for drug delivery, not for treating or diagnosing a medical condition itself.
No
The device is an insulin syringe, used for administering insulin, not for diagnosing a condition. Its function is to inject, rather than to detect or characterize physical or physiological properties.
No
The device description clearly outlines physical components (barrel, plunger rod, needle/hub assembly) and mentions performance testing related to physical characteristics and materials, 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 "subcutaneous injection of U100 insulin or U40 insulin." This describes a device used to administer a substance into the body, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a syringe designed for injecting insulin. It focuses on the physical components and function of delivering a substance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health conditions, or determine compatibility (like blood typing). This device is for delivering medication.
N/A
Intended Use / Indications for Use
The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.
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
Over-The Counter Use
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:
The sterile CHIRANA® Insulin Syringes described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 8537 Third edition: Sterile single-use syringes, with or without needle, for insulin
- ISO 7886-1 Second edition: Sterile hypodermic syringes for single use Part 1: Syringes for manual use
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition: Sterile hypodermic needles for single use - Requirements and test methods
Biocompatibility:
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (24 hours to 30 days). The following testing was conducted:
- Cytotoxicity
- Sensitization
- Irritation and Intracutaneous Reactivity
- Subacute/Sub-chronic Toxicity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Hemocompatibility
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life:
- Sterilization validation per ISO 11135 Second edition: Sterilization of health-care products Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems was conducted on the final, packaged, and sterile devices
- Shelf life of 5 years for single unit packaging is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- Shelf life of 2 years and four months for multi-unit packaging is validated with closure integrity test
Key results: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The CHIRANA® Insulin Syringes are substantially equivalent to the Syringe for Single use, with needle (K190002) with respect to the indications for use, target populations, treatment method, and technological characteristics.
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
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 logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
January 18, 2022
CHIRANA T. Injecta % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201044
Trade/Device Name: CHIRANA Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: December 14, 2021 Received: December 15, 2021
Dear Nathan Wright:
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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201044
Device Name CHIRANA® Insulin Syringes
Indications for Use (Describe)
The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
Type of Use (Select one or both, as applicable) □ Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The Counter Use (21 CFR 801 Subpart C)
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3
K201044 510(K) SUMMARY
| Preparation Date: | January 18, 2022 |
|---|---|
| Submitter Name: | CHIRANA T. Injecta, a.s. |
| Nám. Dr. Schweitzera 194 | |
| 916 01 Stará Turá | |
| Slovak | |
| Contact Person: | Nathan Wright |
| Engineer & Regulatory Specialist, Empirical Testing Corp. | |
| Telephone Number: | 719-351-0248 |
| Fax Number: | N/A |
| E-mail Address: | nwright@empiricaltech.com |
| Trade Name: | CHIRANA® Insulin Syringes |
| Regulation Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Device Class: | Class II |
| Regulation Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Device Class: | Class II |
| Predicate Device: | K190002, Sterile Insulin Syringe for Single use, with needle (Shanghai |
| Kohope Medical Devices Co., Ltd) |
Device Description
The CHIRANA® Insulin Syringes are a 0.3mL, 0.5mL, or 1.0mL syringes designed for subcutaneous injection of a desired dose of insulin. The CHIRANA® Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, and 12.7mm). The CHIRANA® Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe. The following are the list of syringe and needle combinations offered.
| Insulin Type | Syringe Volume | Needle Gauge | Needle Diameter |
|---|---|---|---|
| Insulin U40 | 1 mL | 29G | 12.7 mm |
| Insulin U100 | 1 mL | 27G | 12.7 mm |
| 29G | 8 mm | ||
| 29G | 12.7 mm | ||
| 30G | 12.7 mm | ||
| 30G | 8 mm | ||
| 31G | 8 mm | ||
| 31G | 6 mm | ||
| Insulin 100 | 0.5 mL | 29G | 12.7 mm |
| 30G | 12.7 mm | ||
| 30G | 8 mm | ||
| 31G | 8 mm | ||
| 31G | 6 mm |
4
| Insulin Type | Syringe Volume | Needle Gauge | Needle Diameter |
|---|---|---|---|
| Insulin 100 | 0.3 mL | 29G | 12.7 mm |
| 30G | 12.7 mm | ||
| 31G | 8 mm | ||
| 31G | 6 mm |
Indications for Use
The CHIRANA® Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.
| Characteristic | Predicate Device
Shanghai Kohope Medical Devices Co., Ltd
Syringes for Single use, with needle
K190002 | Subject Device
CHIRANA® Insulin Syringes
K201044 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Indications for Use | The sterile Insulin Syringe for Single use
with needle, with the calibration unit of
insulin for U-100, is a device intended for
medical purposes for the manual aspiration
of insulin, and for the injection of insulin
into parts of insulin into parts of the body
below the surface skin. | The CHIRANA® Insulin Syringes are
intended for subcutaneous injection of
U100 insulin or U40 insulin. |
| Indications for Use | The sterile Insulin Syringe for Single use
with needle, with the calibration unit of
insulin for U-40, is a device intended for
medical purposes for the manual aspiration
of insulin, and for the injection of insulin
into parts of insulin into parts of the body
below the surface skin. | |
| Prescription Only or
Over the Counter | Over the Counter | Over the Counter |
Discussions of differences in Indications for Use statement
There are only editorial differences to the indications for use statement between the subject device which do not change the indications.
Technological Characteristics
The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:
| | | CHIRANA® Insulin Syringes | Sterile Insulin
Syringe for Single use, with needle |
|--------|---------------|-------------------------------------------------------|--------------------------------------------------------|
| Design | Manufacturer | CHIRANA T. Injecta | Shanghai Kohope Medical Devices Co., Ltd |
| | 510(k) Number | Subject | K190002 |
| | Product Code | FMF, FMI | FMF, FMI |
| | Design | graduated barrel, plunger rod and needle/hub assembly | graduated barrel, plunger rod and needle/hub assembly |
| | Volume | 0.3mL, 0.5mL, 1mL | 0.3mL, 0.5mL, 1mL |
| | Gauge1 | 27G, 29G, 30G, 31G | 29G, 30G, 31G |
| | Length2 | 6mm, 8mm, 12.7mm | 8mm, 13mm |
5
| | CHIRANA® Insulin Syringes | Sterile Insulin
Syringe for Single use, with needle |
|-----------|-------------------------------------------------|--------------------------------------------------------|
| Materials | Needle
Stainless Steel 304 | Stainless Steel 304 |
| | Barrel
Polypropylene | Polypropylene |
| | Plunger
Polypropylene | Polypropylene |
| | Hub Tip3
Polystyrene | Isoprene rubber |
| | Needle Cap
Polyethylene | Polypropylene |
| | Protective End Cap
Polyethylene | Polypropylene |
| | Cannula Lubricant3
Medical Grade Silicone | Unknown |
| | Biocompatibility
Conforming to ISO 10993-1 | Conforming to ISO 10993-1 |
| | Sterilization4
EO (ethylene gas) to SAL=10-6 | SAL=10-6 |
'The subject offers additional needle gauges than the predicate to accommodate a wider range of patient needs. This difference does not affect the safety and effectiveness of the subject needle gauges are standard syringe needle gauges. ?The subject offers additional needle lengths than the predicate to accommodate a wider range of patient needs. This difference does not affect the safety and effectiveness of the subject needle lengths are standard syring needle lengths. 3The subject hub tip and cannula lubricant materials are similar but not identical to that of the predicate components. Biocompatibility testing and performance testing confirmed that all materials of subject are safe and effective for use.
4The subject and predicate are provided sterile to the SAL of 10 . The sterilization method of the predicate is not publically known. but this does not introduce any questions for safety and effectiveness because the subject sterilization method has been validated per ISO 11135.
Performance Testing
The sterile CHIRANA® Insulin Syringes described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 8537 Third edition: Sterile single-use syringes, with or without needle, for insulin
- ISO 7886-1 Second edition: Sterile hypodermic syringes for single use Part 1: Syringes for manual use ●
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition: Sterile hypodermic needles for single use - Requirements and test methods
Biocompatibility
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (24 hours to 30 days). The following testing was conducted:
- Cytotoxicity ●
- Sensitization ●
- Irritation and Intracutaneous Reactivity ●
- Subacute/Sub-chronic Toxicity
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogenicity ●
- Hemocompatibility
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life
6
- Sterilization validation per ISO 11135 Second edition: Sterilization of health-care products Ethylene oxide -● Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ● ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems was conducted on the final, packaged, and sterile devices
- . Shelf life of 5 years for single unit packaging is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- Shelf life of 2 years and four months for multi-unit packaging is validated with closure integrity test
Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The CHIRANA® Insulin Syringes are substantially equivalent to the Syringe for Single use, with needle (K190002) with respect to the indications for use, target populations, treatment method, and technological characteristics.