Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.

AI/ML Overview

The provided document describes a 510(k) premarket notification for "Sure-Fine Insulin Syringes." The submission is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (such as effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, and training set details) is not applicable to this type of medical device submission.

Here's the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly tied to various testing standards to demonstrate biocompatibility and performance. The reported performance is that the device complies with these standards, supporting its substantial equivalence.

Acceptance Criteria (Test)	Standard Applied	Reported Device Performance
Cytotoxicity Test	ISO 10993-5	Complies with standard
Animal Intracutaneous Reactivity Test	ISO 10993-10	Complies with standard
Guinea Pig Maximization Test	ISO 10993-10	Complies with standard
Acute Systemic Toxicity Test	ISO 10993-11	Complies with standard
Pyrogen Test	ISO 10993-11, USP <151>	Complies with standard
In-vitro Hemolysis Test	ISO 10993-4, ASTM F756-17	Complies with standard
Shelf Life Performance Test	ASTM F1980, ISO 8537, ISO 7864	Complies with standard

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for each specific test. These are typically determined by the requirements of the individual ISO and ASTM standards cited for each test. Data provenance is not specified, but these are laboratory tests performed on the device components or final product itself, not clinical data from countries of origin. The study described is a series of laboratory and biocompatibility tests, not a clinical study involving patients or data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for these tests comes from established scientific and engineering principles within each standard.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The results are typically quantitative measurements or qualitative assessments (e.g., presence/absence of cytotoxicity) as defined by the standard.

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. This device is not an AI-assisted diagnostic tool, but a medical syringe.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm.

7. The type of ground truth used:

The ground truth is based on recognized industry standards and scientific testing procedures (ISO 10993 series, ASTM F756-17, ASTM F1980, ISO 8537, ISO 7864, USP <151>) for biocompatibility and performance of syringes.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not a machine learning or AI-driven device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2022

Shina Med Corporation % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 1150 Roosevelt Ste 200 Irvine, California 92620

Re: K210848

Trade/Device Name: Sure-Fine Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 24, 2022 Received: February 2, 2022

Dear Priscilla Chung:

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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Indications for Use

510(k) Number (if known) K210848

Device Name Sure-Fine Insulin Syringes

Indications for Use (Describe)

Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

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 (K210848)

Date: Feb 23, 2022

1. Submitted by:

SHINA MED CORPORATION 455-30, Bogaewonsam-ro Bogae-myeon, Anseong-si, Gyeonggi-do, 17509, Republic of Korea Fax : + 82 31 8057 2150 Phone : +82 31 8057 2125

2. US Agent/ Official Correspondent:

Priscilla Chung

LK Consulting Group USA, Inc. 1150 Roosevelt Ste 200 Irvine, CA 92620 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com

3. Device Name:

- Trade Name	: Sure-Fine Insulin Syringes
- Classification	: Class II
- Classification Name	: Piston syringe
- Product Code	: FMF
- Regulation Number	: 21 CFR 880.5860
- Review Panel	: General Hospital

4. Predicate Device:

Sure-Fine Insulin Syringes (K191531) by SHINA MED CORPORATION

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5 Device Description:

Category	Insulin Syringe	Needle Gauge	Needle Length	Cap Color
				Needle Cap	Protective end cap
U-100	1 cc	27 Gauge	1/2"	Orange	Orange or White
	1/2cc and 1 cc	28 Gauge	1/2"
	3/10cc, 1/2cc and 1 cc	29 Gauge	1/2"
	3/10cc, 1/2cc and 1 cc	30 Gauge	1/2"
	3/10cc, 1/2cc and 1 cc	30 Gauge	5/16"
	3/10cc and 1/2cc	30 Gauge	1/4"
	3/10cc, 1/2cc and 1 cc	31 Gauge	5/16"
	3/10cc and 1/2cc	31 Gauge	1/4"

The syringes are available in the following size and cap color.

Indications for Use Statement റ

Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Substantial Equivalence Discussion: 7

The indications for use, labeling and all the other aspects are the same between the subject device and the cleared devices. The only difference is the gasket material.

Device Name	Subject Device	Cleared Device
Manufacturer	SHINA MED CORPORATION	SHINA MED CORPORATION
510(k) Number	K210848	K191531
Product Code	FMF	FMF
Intended Use	Sure-fine Insulin Syringes are hypodermic insulin syringes forsubcutaneous injection of U100 insulin.	Sure-fine Insulin Syringes are hypodermic insulin syringes forsubcutaneous injection of U100 insulin.
Design(Syringe)	Image: syringe	Image: syringe
	Needle / Barrel

	Gasket / Plunger
	Needle Cap
	Protective end cap
	Volume	0.3cc, 0.5cc, 1.0cc	0.3cc, 0.5cc, 1.0cc
Design (Needle)	Needle Tip shape
	Gauge	27, 28, 29, 30,31Gauge	27, 28, 29, 30,31Gauge
	Length	1/2", 5/16", 1/4"	1/2", 5/16", 1/4"
	Needle	STS304	STS304
Materials	Barrel	Polypropylene	Polypropylene
	Plunger	Polypropylene	Polypropylene
	Piston	Hydrogenated styrene isoprene butadiene block copolymer compound (TPE)	Isoprene Rubber
	Needle Cap	Polyethylene	Polyethylene
	Protective end cap	Polyethylene	Polyethylene
	Silicon	Polydimethylsiloxane	Polydimethylsiloxane

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						Cap Color						Cap Color
	Category	InsulinSyringe	NeedleGauge	NeedleLength	NeedleCap	Protectiveend cap	Category	InsulinSyringe	NeedleGauge	NeedleLength	NeedleCap	Protectiveend cap
Available Configurations	U-100	1 cc	27Gauge	1/2"	Orange(U-100)	Orange/White(U-100)		1 cc	27Gauge	1/2"	Orange(U-100)	Orange/White(U-100)
		1/2ccand 1cc	28Gauge	1/2"				1/2ccand 1cc	28Gauge	1/2"
		3/10cc,1/2ccand 1cc	29Gauge	1/2"			U-100	3/10cc,1/2ccand 1cc	29Gauge	1/2"
		3/10cc,1/2ccand 1cc	30Gauge	1/2"				3/10cc,1/2ccand 1cc	30Gauge	1/2"
		3/10cc,1/2ccand 1cc	30Gauge	5/16"				3/10cc,1/2ccand 1cc	30Gauge	5/16"
		3/10ccand1/2cc	30Gauge	1/4"				3/10ccand1/2cc	30Gauge	1/4"
		3/10cc,1/2ccand 1cc	31Gauge	5/16"				3/10cc,1/2ccand 1cc	31Gauge	5/16"
		3/10ccand1/2cc	31Gauge	1/4"				3/10ccand1/2cc	31Gauge	1/4"
Biocompatibility	Conform ISO10993-1						Conform ISO10993-1
Sterilizationmethodand S.A.L	Sterilized by ethyleneoxide gas SAL = 10-6						Sterilized by ethyleneoxide gas SAL = 10-6

8. Technological Characteristics:

The Sure-fine insulin syringe and the predicate device have the substantially equivalent technological characteristics and perform as piston syringes. Risks associated with the changes were identified and appropriate design controls implemented to mitigate the risks.

Based on the change assessment, it is concluded that the risks are associated with the biocompatibility of the new gasket material and the performance. To mitigate risks, appropriate testing was completed to demonstrate that the syringes comply with the following FDA recognized standards:

No	Test	Standard
1	Cytotoxicity Test	ISO 10993-5
2	Animal intracutaneous ReactivityTest	ISO 10993-10
3	Guinea pig maximization test	ISO 10993-10
4	Acute systemic toxicity test	ISO 10993-11

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5	Pyrogen test	ISO 10993-11, USP <151>
6	In-vitro hemolysis test	ISO 10993-4, ASTM F756-17
7	Shelf Life Performance Test	ASTM F1980, ISO 8537, ISO7864

9. Conclusion:

Based on the information provided in this special 510(k), the Sure-fine insulin syringes are substantially equivalent to the previous devices (K191531).

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).