Sungshim insulin pen needle consist of a Sterile cap, Needle, Hub and Sterile paper. The Primary container and Sterile paper function to sustain sterilization of the product. The Hub can be connected with pen type insulin syringe. The Needle cap protects the Needle. This device is single use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically an Insulin Pen Needle. It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of a novel AI/software-based device. Therefore, many of the requested criteria (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, ground truth for AI) are not applicable to this type of regulatory submission.

The "device" in this context is a physical medical device (an insulin pen needle), not an AI algorithm. The performance evaluation is based on bench testing against established international standards for physical medical devices and direct comparison of physical characteristics with a predicate device.

Here's the information that can be extracted and how it relates to the provided document, noting the limitations due to the nature of the device:

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

The document provides a table of "Test item," "Requirements," and "Results." These are the acceptance criteria and the reported performance for the physical device.

Test item	Acceptance Criteria (Requirements)	Reported Device Performance (Results)
Inner/out side and structure	When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 2, it should satisfy the requirements.	Pass
Measurement	When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 3, it should satisfy the requirements.	Pass
Elasticity test	When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 4, it should satisfy the requirements.	Pass
Draw test	When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 6, it should satisfy the requirements.	Pass
Package	When it was tested accordingly to the standard specifications for medical device-"sterile hypodermic needles for single use" clause 11, it should satisfy the requirements.	Pass
Ethylene oxide sterilization residuals	According to ISO 10993-7: ETO≤ 25ppm / ECH≤ 25ppm / EG≤250ppm	Pass
Sterility test	When it was tested accordingly to ISO 11135:2007	Pass
Extraction test - Appearance	The sample solution should be colorless and transparent and there should not be foreign materials.	Pass
Extraction test - pH	Difference in pH≤1.5	Pass (Implied, as no value provided, only 'Pass' in the table)
Extraction test - KMnO4 Reducing agents	Difference in titers≤ 2.0ml	Pass (Implied, as no value provided, only 'Pass' in the table)
Extraction test - Evaporating residue	Difference in extractable≤ 1.0mg	Pass (Implied, as no value provided, only 'Pass' in the table)
Extraction test - heavy Pb,Fe,Sn,Zn metal Cd	Not greater than a combined total of 5mg/L of Pb, Fe, Sn and Zn; Shall be less than 0.1mg/L of Cd	Pass
Extraction test - UV-vis spectrum	Difference in absorbance (250nm~350nm)≤ 0.1	Pass (Implied, as no value provided, only 'Pass' in the table)
Compatibility testing (with specific injectors)	Based on ISO 11608-2, ensuring compatibility with insulin injectors (Novo Nordisk A/S, Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S). (Specific quantitative criteria not detailed for "Pass")	Passed with all listed injectors

2. Sample sizes used for the test set and the data provenance

Sample sizes: The document does not specify the exact number of units/samples used for each bench test. It states that "Bench test were performed" and lists the standards. For physical device testing, sample sizes are typically determined by the relevant ISO standards (e.g., ISO 7864:1993, ISO 10993-7, ISO 11135:2007, ISO 11608-2). These standards outline the minimum number of samples for specific tests to achieve statistical confidence in performance.
Data provenance: The tests were performed by Sungshim Medicare Co., Ltd., based in Sejong-si, Korea. The data would therefore be prospective as it's generated specifically for this submission, and the country of origin for the testing data is Korea.

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

This question is not applicable as this is a physical medical device. "Ground truth" in the context of AI refers to verified labels or diagnoses used to evaluate algorithm performance. For a physical device, performance is measured against engineering specifications and international standards, not against expert human interpretations or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/imaging studies where inter-reader variability exists. The device here is evaluated through objective bench tests according to specified standards.

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

This question is not applicable. MRMC studies are used for evaluating the interaction of AI with human readers, typically in medical imaging diagnostics. This submission is for a physical medical device.

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

This question is not applicable. There is no "algorithm" to be evaluated in a standalone manner for this physical device.

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

The "ground truth" for this device's performance is the adherence to the specifications and requirements defined by international standards such as ISO 7864:1993, ISO 10993-7, ISO 11135:2007, and ISO 11608-2 for sterile hypodermic needles, biocompatibility, sterilization, and compatibility with pen injectors, respectively. This is a form of objective, standardized measurement rather than expert consensus on a diagnostic outcome.

8. The sample size for the training set

This question is not applicable. This is a physical device, and there is no "training set" in the machine learning sense. The manufacturing process is validated, and product quality is ensured through adherence to Good Manufacturing Practices (GMP) and testing against standards.

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

This question is not applicable for the same reason as above. There is no concept of "ground truth" for a training set for this type of physical product.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right, with flowing lines beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the circular seal.

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

March 17, 2016

Sungshim Medicare Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152334

Trade/Device Name: Sungshim Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 4, 2016 Received: February 10, 2016

Dear Mr. 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,

Tina Kiang -S

for Erin I. Keith, M.S. 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) K152334

Device Name Sungshim Insulin Pen Needle

Indications for Use (Describe)

This product to be used with insulin injector is a single use sterile insulin pen needle to be used for injecting insulin to patient with diabetes.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

[as required by 807.92(c)]

1. Applicant

1. Company : Sungshim Medicare Co.,Ltd.
1. Address : 190, Maesil-ro, Sojeong-myeon, Sejong-si, Korea
1. Tel : 82-32-676-7066
1. Fax : 82-32-676-7063
1. Prepared date : Oct. 7, 2015
1. Contact person : Peter Chung, 412-687-3976
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : Aug. 10, 2015
1. 510(k) number : K152334

2. Device Information

1. Trade name : Sungshim Insulin Pen Needle
1. Common name : Hypodermic single lumen needle
1. Classification name : Needle, Hypodermic, Single Lumen
1. Product code : FMI
1. Regulation number : 880.5570
1. Class of device : Class II
1. Panel : General Hospital

3. The legally marketed device to which we are claiming equivalence

K080904 Feel Fine Insulin Pen Needle

4. Device description

5. Intended Use :

This product is a single use sterile insulin pen needle intended for subcutaneous injection of insulin to patient with diabetes. It is to be used with compatible insulin injectors.

6. Performance data:

(1) Bench test were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Test criteria : ISO 7864:1993 Sterile hypodermic needles for single use

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Test item	Requirements	Results
Inner/out sideand structure	When it was tested accordingly to the standard specifications formedical device-"sterile hypodermic needles for single use" clause 2,it should satisfy the requirements.	Pass
Measurement	When it was tested accordingly to the standard specifications formedical device-"sterile hypodermic needles for single use" clause 3,it should satisfy the requirements.	Pass
Elasticity test	When it was tested accordingly to the standard specifications formedical device-"sterile hypodermic needles for single use" clause 4,it should satisfy the requirements.	Pass
Draw test	When it was tested accordingly to the standard specifications formedical device-"sterile hypodermic needles for single use" clause 6,it should satisfy the requirements.	Pass
Package	When it was tested accordingly to the standard specifications formedical device-"sterile hypodermic needles for single use" clause 11,it should satisfy the requirements.	Pass
Ethylene oxidesterilizationresiduals	According to ISO 10993-7ETO≤ 25ppm / ECH≤ 25ppm / EG≤250ppm	Pass
Sterility test	When it was tested accordingly to ISO 11135:2007	Pass
Extraction test
Appearance	The sample solution shouled be colorless and transparent andthere should not be foreign materials.	Pass
pH	Difference in pH≤1.5
KMnO4 Reducingadents	Difference in titiers≤ 2.0ml
Evaporating residue	Difference in extractable≤ 1.0mg
heavy Pb,Fe,Sn,Znmetal Cd	Not greater than a comined total of 5mg/L of Pb, Fe, Sn and ZnShall be less than 0.1mg/L of Cd
UV-vis spectrum	Difference in absorbance (250nm~350nm)≤ 0.1

Compatibility testing was performed according to ISO 11608-2 and passed with the following injectors:

Novo Nordisk A/S, Flex Pen / 3ml / Insulin sprat .
Sanofi-Aventis Deutschland GmbH. LANTUS / 3ml / Insulin glargine ●
Novo Nordisk A/S, Novo Let N / 3ml / Isophane insulin .

The performance tests demonstrated that Sungshim insulin pen needle performs in a substantially equivalent manner to the predicate device.

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7. Predicate device comparison table

Manufacturer	Sungshim Medicare Co.,Ltd.		Feel Tech
510(k) No.		K080904
Indication for use	This product is a single use sterile insulinpen needle intended for subcutaneousinjection of insulin to patient withdiabetes. It is to be used with compatibleinsulin injectors.	These disposable sterile insulin penneedles are intended for subcutaneousinjection of insulin in the treatment ofdiabetes.
Product name	Hypodermic single lumen needle	Hypodermic single lumen needle
Trade name	Sungshim Insulin Pen Needle	Feel Fine Insulin Pen Needle
Model/type	20 model codes including 29Gx4mm	Feel Fine Insulin Pen Needle-29Feel Fine Insulin Pen Needle-30Feel Fine Insulin Pen Needle-31
Appearance	Image: Sungshim needle	Image: Feeltech needle
Productconfiguration	HubNeedle capPrimary containerNeedleSterile paper	HubNeedle capSterile capNeedleSterile paper
Material	Part Material Sterile cap Polypropylene Needle cap Polyethylene Needle Stainless steel 304 Hub Polypropylene			Part Material Sterile cap Polypropylene Needle cap Polypropylene Needle Stainless steel 304 Hub Polypropylene
Length of parts (mm)
Total length ofassembly	29.8	28.8
Side length ofassembly(max)	15.2	15.5
Inner diameter ofsterile cap	11.2	12.95
Gauge	29G, 30G, 31G, 32G	29, 30, 31G
Length of needle	4 mm, 5 mm, 6 mm, 8 mm, 13 mm	5 mm, 8 mm, 12.7 mm
Sterilization	EO Gas sterilization	EO Gas sterilization
Packagine	Sterile cap(PP)+sterile paper		Sterile cap(PP)+sterile paper

Although the Indications for Use is not identical to that of the predicate device, it does not change the intended use because both are single use sterile needles intended for subcutaneous injection of insulin for diabetes patients.

9. Conclusion:

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.

Therefore, it is concluded that Sungshim insulin pen needle is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).