The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.

AI/ML Overview

The provided text is a 510(k) summary for the sureone Insulin Syringe and focuses on substantial equivalence to predicate devices, particularly regarding the addition of a new needle size. It does not contain the detailed information required to answer all parts of your request about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement for a performance study.

Medical device submissions often refer to compliance with recognized standards rather than presenting new study data for every claim, especially for devices undergoing minor modifications. This appears to be the case here, as the device is stated to meet ISO standards.

However, based only on the provided text, I can infer and extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states the device "meets the following standards," implying these standards serve as the acceptance criteria. No specific performance metrics or their values are reported in a comparative table format within this document, only that the device meets the standards.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 8537, Sterile, Single-Use Syringes, with or without Needle, for Insulin	Device meets this standard.
ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices	Device meets this standard.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text, but given the nature of standards compliance, it would likely involve in-house testing by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable/not specified. The "ground truth" here is compliance with established international standards, not expert consensus on medical images or diagnoses.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., medical imaging), which is not described here. Device performance is assessed against engineering and material standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant to diagnostic or interpretative AI-powered devices, not typically for an insulin syringe.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

Not applicable. This is a physical medical device (insulin syringe), not an algorithm or AI product.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is compliance with the requirements specified in ISO 8537 (Sterile, Single-Use Syringes, with or without Needle, for Insulin) and ISO 9626 (Stainless Steel Needle Tubing for Manufacture of Medical Devices). These standards define performance characteristics such as volume accuracy, sterility, needle dimensions, material properties, etc.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set." The performance is validated against established international engineering and manufacturing standards.

Summary

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K021197

APR 2 6 2002

510(k) Summary

Submitter

Date Prepared April 5, 2002

Hosuk Company, Ltd. 52-6 Dukjeong-Ri, Samsung-Myun, Umsung-Gun Chungcheong Province, Korea Contact Person: Mr. Y. H. Kim, Manager, Quality Management Section

Telephone: +82-43-883-0411 Fax: +82-43-883-0414

Name of Device

Common Name:	Insulin Syringe
Proprietary Name:	sureone Insulin Syringe
Classification Name:	Piston Syringe, Hypodermic Single Lumen Needle
Regulation:	880.5860 and 880.5570
Class:	Class II
Product Code:	FMF and FMI

Predicate Devices

The sureone Insulin Syringe is substantially equivalent in intended use, function and composition to the currently marketed sureone Disposable Insulin Syringes, K002921, and to NovoFine® 31 GA needles, K002403.

Device Description

Intended Use

Insulin syringes are intended only for the injection of U-100 insulin.

Technological Characteristics

The only design change being incorporated into current sureone Insulin Syringes compared to currently marketed sureone Insulin Syringes is the addition of a new needle size - 31 GA x 5/16" length. This needle has a smaller diameter than the currently marketed sureone Insulin Syringes. All other aspects are identical to the currently marketed sureone Insulin Syringes. sureone Insulin Syringes meet the following standards:

ISO 8537, Sterile, Singe-Use Syringes, with or without Needle, for Insulin ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices

Special 510(k) Hosuk Company, Ltd.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2002

Hosuk Company Limited C/O Ms. Carole Stamp Regulatory & Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416

Re: K021197

Trade/Device Name: Sureone Insulin Syringe Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: April 5, 2002 Received: April 16, 2002

Dear Ms. Stamp:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Stamp

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); good manufacturing practice and insting (21 es tee restly 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Purner

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use K021197 sureone Insulin Syringe

510(k) Number (if known): Device Name:

Indications for Use:

Insulin syringes are intended only for the injection of U-100 insulin.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

Over-The-Counter Use

(Per 21 CFR 801.109)

Vile Hilliard for Ref. Cincinati.

Special 510(k) Hosuk Company, Ltd. (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 02 119

Page 15 of 20

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).