(211 days)
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.
1
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
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- Company : Sungshim Medicare Co.,Ltd.
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- Address : 190, Maesil-ro, Sojeong-myeon, Sejong-si, Korea
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- Tel : 82-32-676-7066
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- Fax : 82-32-676-7063
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- Prepared date : Oct. 7, 2015
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- Contact person : Peter Chung, 412-687-3976
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- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
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- Submission date : Aug. 10, 2015
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- 510(k) number : K152334
2. Device Information
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- Trade name : Sungshim Insulin Pen Needle
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- Common name : Hypodermic single lumen needle
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- Classification name : Needle, Hypodermic, Single Lumen
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- Product code : FMI
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- Regulation number : 880.5570
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- Class of device : Class II
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- 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 item | Requirements | 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 shouled be colorless and transparent and | |
there should not be foreign materials. | Pass | |
pH | Difference in pH≤1.5 | |
KMnO4 Reducing | ||
adents | Difference in titiers≤ 2.0ml | |
Evaporating residue | Difference in extractable≤ 1.0mg | |
heavy Pb,Fe,Sn,Zn | ||
metal Cd | Not 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 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 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 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-29 | |||||||||||||||||||||
Feel Fine Insulin Pen Needle-30 | |||||||||||||||||||||||
Feel Fine Insulin Pen Needle-31 | |||||||||||||||||||||||
Appearance | Image: Sungshim needle | Image: Feeltech needle | |||||||||||||||||||||
Product | |||||||||||||||||||||||
configuration | Hub | ||||||||||||||||||||||
Needle cap | |||||||||||||||||||||||
Primary container | |||||||||||||||||||||||
Needle | |||||||||||||||||||||||
Sterile paper | Hub | ||||||||||||||||||||||
Needle cap | |||||||||||||||||||||||
Sterile cap | |||||||||||||||||||||||
Needle | |||||||||||||||||||||||
Sterile 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 of | |||||||||||||||||||||||
assembly | 29.8 | 28.8 | |||||||||||||||||||||
Side length of | |||||||||||||||||||||||
assembly(max) | 15.2 | 15.5 | |||||||||||||||||||||
Inner diameter of | |||||||||||||||||||||||
sterile 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.