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.

AI/ML Overview

The provided document is a 510(k) summary for the CHIRANA Insulin Syringes. It details the device's characteristics, indications for use, and performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study results for an AI/ML-based device in the format requested.

The document discusses the physical characteristics, materials, and mechanical performance testing of an insulin syringe, which is a traditional medical device, not a software-driven or AI/ML-enabled diagnostic or therapeutic device. The performance testing section refers to standards for sterile single-use syringes, hypodermic syringes, and needles, as well as biocompatibility and sterilization validations. These are typical assessments for a Class II physical medical device.

Therefore, I cannot fully complete the requested table and answer all questions related to AI/ML device performance validation, as the information is not present in the provided text.

However, I can extract information relevant to a physical medical device's performance assessment where applicable, and highlight what is missing based on the prompt's requirements for an AI/ML device.

Information that is applicable to a traditional medical device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

For a physical device like an insulin syringe, acceptance criteria relate to physical and functional properties, manufacturing standards, and safety. The document states compliance with recognized ISO standards. While specific numerical acceptance criteria (e.g., maximum force to inject, specific flow rates) are not explicitly listed in a table, the document implies that the device met the requirements of these standards.

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance (Implied by Compliance)
ISO 8537 (Sterile single-use syringes, with or without needle, for insulin)	Device demonstrated conformance to this standard.
ISO 7886-1 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)	Device demonstrated conformance to this standard.
ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices)	Device demonstrated conformance to this standard.
ISO 7864 (Sterile hypodermic needles for single use)	Device demonstrated conformance to this standard.
Biocompatibility (per ISO 10993-1)	Cytotoxicity, Sensitization, Irritation, Intracutaneous Reactivity, Subacute/Sub-chronic Toxicity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility testing were conducted and implied to meet criteria.
Particulate Matter (per USP <788>)	Met USP acceptance criteria.
Sterilization Validation (per ISO 11135)	Validated to SAL=10^-6.
Package Integrity (per ASTM D4169-16)	Testing conducted on final, packaged, sterile devices (implied to pass).
Shelf-Life Single Unit (per ASTM F1980-16)	Validated for 5 years.
Shelf-Life Multi-Unit (Closure integrity test)	Validated for 2 years and four months.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of units tested. For mechanical testing, this would typically be a specific number of syringes/needles per test type.
Data Provenance: Not applicable in the context of "data provenance" for patient data in an AI/ML model. The testing is for manufactured physical goods. The testing was performed by "Empirical Testing Corp." (a consultant listed for the submitter).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable (N/A). This is a physical device, not one requiring expert interpretation of complex data for ground truth establishment. Validation relied on adherence to engineering and material standards.

4. Adjudication Method for the Test Set:

Not applicable (N/A). Adjudication (e.g., 2+1, 3+1) is a common practice for complex medical image interpretation or clinical outcome assessment in AI/ML studies to establish a consensus ground truth. For a physical device, compliance with established test methods and specifications is directly assessed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, not performed. This type of study is specific to AI/ML imaging or diagnostic devices where human readers' performance with and without AI assistance is evaluated. This device is a physical syringe.

6. Standalone (Algorithm Only) Performance:

Not applicable (N/A). This refers to the performance of a software algorithm without human interaction. The CHIRANA Insulin Syringe is a physical device.

7. Type of Ground Truth Used:

Not applicable in the AI/ML sense. For this physical device, "ground truth" would be defined by the specifications in the relevant ISO and ASTM standards (e.g., dimensional tolerances, material properties, injection force, leak rates, sterility assurance level). The device's performance was measured against these engineering standards. The phrase "expert consensus, pathology, outcomes data" is generally used for clinical ground truth in AI/ML or diagnostic studies.

8. The Sample Size for the Training Set:

Not applicable (N/A). This concept pertains to machine learning models. For a physical device, there isn't a "training set" in the AI/ML sense. Training involves manufacturing processes and quality control.

9. How the Ground Truth for the Training Set was Established:

Not applicable (N/A). As above, this is an AI/ML concept.

In summary: The provided document describes the substantial equivalence review for a traditional medical device (insulin syringe) and details its compliance with relevant engineering and quality standards. It does not provide the information typically requested for demonstrating the performance of an AI/ML-driven medical device.

Summary

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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

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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 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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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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K201044 510(K) SUMMARY

Preparation Date:	January 18, 2022
Submitter Name:	CHIRANA T. Injecta, a.s.Nám. Dr. Schweitzera 194916 01 Stará TuráSlovak
Contact Person:	Nathan WrightEngineer & 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 (ShanghaiKohope Medical Devices Co., Ltd)

Device Description

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

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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 DeviceShanghai Kohope Medical Devices Co., LtdSyringes for Single use, with needleK190002	Subject DeviceCHIRANA® Insulin SyringesK201044
Indications for Use	The sterile Insulin Syringe for Single usewith needle, with the calibration unit ofinsulin for U-100, is a device intended formedical purposes for the manual aspirationof insulin, and for the injection of insulininto parts of insulin into parts of the bodybelow the surface skin.	The CHIRANA® Insulin Syringes areintended for subcutaneous injection ofU100 insulin or U40 insulin.
Indications for Use	The sterile Insulin Syringe for Single usewith needle, with the calibration unit ofinsulin for U-40, is a device intended formedical purposes for the manual aspirationof insulin, and for the injection of insulininto parts of insulin into parts of the bodybelow the surface skin.
Prescription Only orOver 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 InsulinSyringe 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

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	CHIRANA® Insulin Syringes	Sterile InsulinSyringe for Single use, with needle
Materials	NeedleStainless Steel 304	Stainless Steel 304
	BarrelPolypropylene	Polypropylene
	PlungerPolypropylene	Polypropylene
	Hub Tip3Polystyrene	Isoprene rubber
	Needle CapPolyethylene	Polypropylene
	Protective End CapPolyethylene	Polypropylene
	Cannula Lubricant3Medical Grade Silicone	Unknown
	BiocompatibilityConforming to ISO 10993-1	Conforming to ISO 10993-1
	Sterilization4EO (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 <788> Particulate Matter in Injections and met the USP acceptance criteria.

Sterility, Shipping and Shelf-Life

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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.

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).