K Number
K152334
Device Name
Sungshim Insulin Pen Needle
Date Cleared
2016-03-17

(211 days)

Product Code
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on the physical components and mechanical/sterility testing of a simple insulin pen needle, with no mention of AI or ML.

No.
The device is an insulin pen needle used for injecting insulin, which is a drug, and therefore it is a drug delivery device, not a therapeutic device.

No
This device is an insulin pen needle, which is used for injecting insulin, not for diagnosing a medical condition.

No

The device description clearly outlines physical components (Sterile cap, Needle, Hub, Sterile paper) and bench testing related to physical properties (biocompatibility, mechanical testing, sterility). There is no mention of software as a component or function of the device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "injecting insulin to patient with diabetes." This is a direct therapeutic intervention on a patient, not a test performed on a sample taken from the body to diagnose or monitor a condition.
  • Device Description: The description details a needle and components for connecting to an insulin pen. This aligns with a device used for drug delivery, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver medication directly into the body.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
Test item: Inner/out side and structure; Requirements: 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.; Results: Pass
Test item: Measurement; Requirements: 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.; Results: Pass
Test item: Elasticity test; Requirements: 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.; Results: Pass
Test item: Draw test; Requirements: 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.; Results: Pass
Test item: Package; Requirements: 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.; Results: Pass
Test item: Ethylene oxide sterilization residuals; Requirements: According to ISO 10993-7 ETO

§ 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).

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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

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.

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 itemRequirementsResults
Inner/out side
and structureWhen 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
MeasurementWhen 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 testWhen 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 testWhen 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
PackageWhen 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
residualsAccording to ISO 10993-7
ETO≤ 25ppm / ECH≤ 25ppm / EG≤250ppmPass
Sterility testWhen it was tested accordingly to ISO 11135:2007Pass
Extraction test
AppearanceThe sample solution shouled be colorless and transparent and
there should not be foreign materials.Pass
pHDifference in pH≤1.5
KMnO4 Reducing
adentsDifference in titiers≤ 2.0ml
Evaporating residueDifference in extractable≤ 1.0mg
heavy Pb,Fe,Sn,Zn
metal CdNot greater than a comined total of 5mg/L of Pb, Fe, Sn and Zn
Shall be less than 0.1mg/L of Cd
UV-vis spectrumDifference 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

ManufacturerSungshim Medicare Co.,Ltd.Feel Tech
510(k) No.K080904
Indication for useThis 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.These disposable sterile insulin pen
needles are intended for subcutaneous
injection of insulin in the treatment of
diabetes.
Product nameHypodermic single lumen needleHypodermic single lumen needle
Trade nameSungshim Insulin Pen NeedleFeel Fine Insulin Pen Needle
Model/type20 model codes including 29Gx4mmFeel Fine Insulin Pen Needle-29
Feel Fine Insulin Pen Needle-30
Feel Fine Insulin Pen Needle-31
AppearanceImage: Sungshim needleImage: Feeltech needle
Product
configurationHub
Needle cap
Primary container
Needle
Sterile paperHub
Needle cap
Sterile cap
Needle
Sterile paper
MaterialPart Material Sterile cap Polypropylene Needle cap Polyethylene Needle Stainless steel 304 Hub PolypropylenePart Material Sterile cap Polypropylene Needle cap Polypropylene Needle Stainless steel 304 Hub Polypropylene
Length of parts (mm)
Total length of
assembly29.828.8
Side length of
assembly(max)15.215.5
Inner diameter of
sterile cap11.212.95
Gauge29G, 30G, 31G, 32G29, 30, 31G
Length of needle4 mm, 5 mm, 6 mm, 8 mm, 13 mm5 mm, 8 mm, 12.7 mm
SterilizationEO Gas sterilizationEO Gas sterilization
PackagineSterile cap(PP)+sterile paperSterile 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.