Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

AI/ML Overview

This document is a 510(k) Summary for the Sure-Fine Insulin Syringes, which is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe an acceptance criteria or a study designed to establish clinical performance of a novel device in the same way one might describe for a diagnostic AI algorithm.

Instead, the document details non-clinical testing to demonstrate that the Sure-Fine Insulin Syringes meet established performance and safety standards, proving substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific numerical thresholds for accuracy, sensitivity, or specificity as one would expect for an AI/diagnostic device. Instead, it lists the voluntary standards and clauses from those standards that the device was designed and tested to meet. The "reported device performance" is the conclusion that the device successfully met these requirements, thus demonstrating substantial equivalence.

| Standard/Test | Acceptance Criteria (implied by standard) | Reported Device Performance |
| :----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------- |
| Performance Testing (per ISO 8537:2007) | Compliance with physical and functional requirements for sterile single-use hypodermic syringes for insulin. (e.g., freedom from extraneous matter, extraction, lubrication, range of sizes, graduated scale, barrel, piston/plunger, nozzle, needles, assembled syringe performance). | Successfully met the applicable requirements. |
| Biocompatibility Testing (per ISO 10993 Series) | Compliance with biological safety requirements for devices in contact with patients (e.g., in vitro cytotoxicity, irritation, sensitization, acute systemic toxicity, interaction with blood, pyrogenicity). | Successfully passed testing as outlined. |
| Sterilization & Shelf-life Testing (per ISO 11135, ISO 10993-7) | Sterility Assurance Level (SAL) of 10-6; maximum levels of ethylene oxide and ethylene chlorohydrins within limits; a 5-year shelf-life. | Validated sterilization with SAL = 10-6; EO/ECH levels did not exceed limits; 5-year shelf-life supported. |

Important Note: This is a traditional medical device (insulin syringe), not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and MRMC studies are not applicable. The device's performance is assessed through engineering and biological safety tests against established standards for its mechanical function and material safety.

The following questions are not applicable to this specific submission as it pertains to a physical medical device (insulin syringe) and not an AI or diagnostic software. Therefore, there are no details on test sets, ground truth establishment by experts, or MRMC studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a physical medical device. Testing involved physical samples of the syringe, not a "data test set." The document does not specify the number of samples tested for each engineering or biological test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" to be established by experts in the context of an insulin syringe's physical and functional properties.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This is a physical medical device, not an AI or diagnostic software. No human readers or AI assistance are involved in its primary function or evaluation for substantial equivalence.

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

Not Applicable. This is a physical medical device; no algorithm is present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable.

8. The sample size for the training set

Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI or machine learning model.

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

Not Applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2016

Shina Med Corporation c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Irvine, California 92831

Re: K152879

Trade/Device Name: Sure-Fine Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 4, 2016 Received: August 10, 2016

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152879

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)

Registration (Part 21 CFR 201.1 Subpart D)	Drug Use Compounding (21 CFR 201.1 Subpart G)
---------------------------------------------------------------------	------------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

(K152879)

September 07, 2016

1. Submitted by:

Il-hwan, Jeong / Quality Management Representative SHINA MED CORPORATION 455-30, Bogaewonsam-ro, Bogae-myun, Anseong-si, Gyeonggido, 456-871, Republic of Korea Phone: +82 31 8057 2125 Fax : + 82 31 8057 2150

2. US Agent/Contact Person:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831

Device Name : 3.

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

Predicate Device : 4.

Accu-Sure Insulin syringe (K091167) manufactured by SHINA CORPORATION

5. Device Description:

Category	Insulin syringe	NeedleGauge	NeedleLength	Cap color
				Needle cap	Plunger Cap
U-100	1/2cc and 1cc	28Gauge	1/2"	Orange	Orange or white
U-100	3/10cc, 1/2cc and 1cc	29Gauge	1/2"	Orange	Orange or white
U-100	3/10cc, 1/2cc and 1cc	30Gauge	1/2"	Orange	Orange or white
U-100	3/10cc, 1/2cc and 1cc	30Gauge	5/16"	Orange	Orange or white
U-100	3/10cc, 1/2cc and 1cc	31Gauge	5/16"	Orange	Orange or white

This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.

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6. Indications for Use :

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

7. Technological Characteristics :

The Sure-Fine Insulin Syringes are substantially equivalent to previously marketed device, Accu-Sure Insulin Syringe (K091167) manufactured by Shina Corporation. The device design, materials of construction, manufacturing method, release specifications and performance specifications are the same as the predicate device.

Device Name	Subject Device	Predicate Device
Manufacturer	SHINA MED CORPORATION	SHINA CORPORATION
510(k) Number	K152879	K091167
Product Code	FMF	FMF
Intended Use	Sure-Fine Insulin Syringes arehypodermic insulin syringes forsubcutaneous injection of insulin.	Accu-Sure Insulin Syringe is ahypodermic insulin syringe forsubcutaneous injection of insulin
Design (Syringe)	Design	Needle / Barrel / Gasket /Plunger / Needle Cap /Protective end cap	Needle / Barrel / Gasket /Plunger / Needle Cap /Protective end cap
	Volume	0.3cc, 0.5cc, 1.0cc	0.3cc, 0.5cc, 1.0cc
	Gauge	28, 29, 30,31Gauge	28, 29, 30,31Gauge
	Length	1/2", 5/16"	1/2", 5/16"
Materials	Needle	STS304	STS304
	Barrel	Polypropylene	Polypropylene
	Plunger	Polypropylene	Polypropylene
	Piston	Isoprene Rubber	Isoprene Rubber
	Needle Cap	Polyethylene	Polyethylene
	Protective end cap	Polyethylene	Polyethylene
	Silicone	Polydimethylsiloxane	Polydimethylsiloxane
	Biocompatibility	Conform ISO10993-1	Conform ISO10993-1
Sterilization methodand S.A,L	Sterilized by ethyleneoxide gas SAL = 10-6	Sterilized by ethyleneoxide gas SAL = 10-6

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8. Non-clinical testing

The Sure-Fine Insulin Syringes have been designed and tested to meet the requirements of voluntary standards (listed below) and FDA Guidance documents (Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes) applicable to the subject and predicate devices. The results of the non-clinical testing supported the conclusion of substantial equivalence.

Performance Testing

The Sure-Fine Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO8537.

Test performed per ISO8537:2007
· ISO 8537-2007 Clause 5 Freedom from extraneous matter
· ISO 8537-2007 Clause 6.Extraction testing
· ISO 8537-2007 Clause 7 Lubrication of syringes and needles
· ISO 8537-2007 Clause 8 Range of sizes
ISO 8537-2007 Clause 9 Graduated scale
ISO 8537-2007 Clause 10 Barrel
· ISO 8537-2007 Clause 11 Piston/Plunger assembly
· ISO 8537-2007 Clause 12 Nozzle
· ISO 8537-2007 Clause 13 Needles tubing and needles
· ISO 8537-2007 Clause 14 Performance of assembled syringe

Biocompatibility Testing

The material of the Sure-Fine Insulin Syringes have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.

· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization 5.4 Intracutaneous reactivity test
· ISO 10993-10 2010 Biological evaluation of medical devices Part 10: Teat for Irritation and Sensitization 6.2 Maximization sensitization test
· ISO 10993-11 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 6.5 Acute systemic toxicity
ISO 10993-4:2002 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood.
· The United States Pharmacopeia <151> (Pyrogen test)

Sterilization and Shelf-life Testing

Sterilization of the Sure-Fine Insulin Syringes has been validated using the half-cycle method as outlined in ISO11135. Testing demonstrated maximum levels of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in IS010993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.

Clinical Data

No prospective clinical trials were conducted in support of this Traditional 510(k)

9. Discussion

Sure-Fine Insulin Syringes have the same intended use, technological characteristics, materials of construction and performance specifications as the predicate device, Accu-Sure Insulin Syringe (K091167), and thus it performs in a substantial equivalent manner to the predicate device.

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10. Conclusion

Based on the information provided in this premarket notification, SHINA MED CORPORATION concludes that the Sure-Fine Insulin Syringes are substantially equivalent to predicate device.

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).