(342 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple medical device (insulin pen needle) and do not mention any AI/ML components or functionalities.
No
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. While it facilitates the administration of a therapeutic drug (insulin), the needle itself is a delivery device and not the therapeutic agent.
No
Explanation: The device description clearly states it is an "insulin pen needle," which is used for injection and delivery of insulin, not for diagnosis. Its intended use is for "subcutaneous injection of insulin."
No
The device description clearly outlines physical components (cap, needle, hub, paper) and manufacturing processes (sterilization, screwing onto a pen). There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of insulin." This is a direct medical 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 hub designed for delivering medication, not for collecting or analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) to administer medication.
N/A
Intended Use / Indications for Use
JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Product codes
FMI
Device Description
JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas.
The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle.
This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.
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
All ages
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)
Biocompatibility Testing:
- Cytotoxicity test (ISO10993-5): Non-cytotoxicity (Pass)
- Hemolysis test (ISO10993-4): Hemolytic index was 0.158%. Non-hemolytic (Pass)
- Acute systemic toxicity test (ISO10993-11): Non-acute systemic toxicity (Pass)
- Skin sensitization test (ISO10993-10): Non-skin hypersensitivity reaction (Pass)
- Pyrogen Test (ISO 10993): Non-pyrogenicity (Pass)
- Intracutaneous reactivity test (ISO 10993-10): Non-intracutaneous (Pass)
Testing Performance to ISO 7864 (1993):
- Inner/outside and structure: Passed (No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerin untinged, no lubricant on the surface)
- Measurement: Passed (Outside diameter and length of needle within criteria)
- Elasticity test: Passed (Needle returned after remove weight)
- Draw test: Passed (The union of the hub and needle tube was not broken)
Testing Performance to ISO 11608-2 (2012) and ISO 9626 (1991):
- Flow rate testing: Passed (Calculation for flow rate provided for various gauges and lengths)
- Bond between hub and needle tube testing: Passed (The union of the hub and needle tube was not broken per each gauge by the minimum force (22N))
- Needle point testing: Passed (Needle points appeared sharp and free from feather edges, burrs and hooks)
- Freedom from defects: Passed (Needle tube appeared straight and regular cross-section and wall thickness)
- Lubrication testing: Passed (Lubricant not visible as droplets)
- Dislocation of measuring point at patient end: Not directly stated as Pass/Fail, but criteria for maximum allowable dislocation provided.
- Needle hub-assembly testing: Passed (Needle assembly torque values within range of 0.06Nm to 0.080Nm)
- Needle dose accuracy testing: Passed (Two conditions met)
- Needle hub torque removal testing: Passed (Needle hub removal torque less than 0.1000Nm)
- Inner/outside and structure: Passed (No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerin untinged, no lubricant on the surface)
- Dimension: Passed (Needle outside diameter, Needle length, Needle cap Inner diameter for various gauges passed)
- Flexural strength: Passed (When needle bended to 90 degrees, it should not be broken)
- Elasticity test: Passed (Needle returned after remove weight)
- Draw test: Passed (The union of the hub and needle tube was not broken)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
Jeesung Medical Co Ltd % Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K152166
Trade/Device Name: JSM Insulin Pen Needle Regulation Number: 21 CFR 880.5770 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 27, 2016 Received: June 7, 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 device-related 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" (21CFR 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,
Tina Kiang -
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152166
Device Name JSM Insulin Pen Needle
Indications for Use (Describe)
JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Type of Use (Select one or both, as applicable)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
3
510(k) Summary
[as required by 807.92]
1. Applicant
-
- Company : JeeSung Medical Co.,Ltd.
-
- Address : 54, Mujini 1-gil, Daedeok-gu, Daejeon, Korea
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- Tel : 82-42-932-6061
-
- Fax : 82-42-932-6063
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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
-
- Date of preparation : July 8, 2016
-
- 510(k) number : K152166
2. Device Information
-
- Trade Name : JSM Insulin Pen Needle
-
- Common Name : Insulin Pen Needle
-
- Classification Name : Needle, Hypodermic, Single Lumen
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- Product Code : FMI
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- Regulation Number : 880.5570
-
- Class of device : Class II
-
- Panel : General Hospital
3. The legally marketed device to which we are claiming equivalence
K080904 Feel Fine Insulin Pen Needle
4. Device description
JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas.
The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle.
This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.
5. Indication for Use
JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
| Manufacturer | JeeSung Medical Co.,Ltd. | Feel Tech Co.,Ltd. |
|---|---|---|
| Element of Comparison | Submission Device | Predicate Device |
| K080904 | ||
| Indication for use | JSM insulin pen needle is intended for | |
| use with pen injector devices for the | ||
| subcutaneous injection of insulin in the | ||
| treatment of diabetes. | These disposable sterile insulin pen | |
| needles are intended for | ||
| subcutaneous injection of insulin in | ||
| the treatment of diabetes. | ||
| Trade name | JSM Insulin Pen Needle | Feel Fine Insulin Pen Needle |
| Model/type | JSPN-29, JSPN-30, | Feel Fine Insulin Pen Needle-29 |
6. Predicate device comparison table
4
| Manufacturer | JeeSung Medical Co.,Ltd.
JSPN-31, JSPN-32 | | | Feel Tech Co.,Ltd.
Feel Fine Insulin Pen Needle-30
Feel Fine Insulin Pen Needle-31 | | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------|-------------------------|
| Principle of operation | To inject insulin into body, Pen needle is connected and used with pen injector. By pen injector, the dosage of insulin is regulated. After injection, pen needle is connected with the sterile cap and unscrewed from pen injector and discarded. | | | To inject insulin into body, Pen needle is connected and used with pen injector. By pen injector, the dosage of insulin is regulated. After injection, pen needle is connected with the sterile cap and unscrewed from pen injector and discarded. | | | |
| Appearance | Image: [purple pen needle] | | | Image: [orange pen needle] | | | |
| Product configuration | Hub
Needle cap
Sterile cap
Needle
Sterile paper | | | Hub
Needle cap
Sterile cap
Needle
Sterile paper | | | |
| Material | Sterile cap | Polypropylene | | Hub | Polypropylene | | |
| | Needle cap | Polyethylene | | Needle cap | Polyethylene | | |
| | Needle | Stainless steel 304 | | Needle | Stainless steel 304 | | |
| | Hub | Polypropylene | | Hub | Polypropylene | | |
| Gauge | 29G | 30G | 31G | 32G | 29G, | 30G, | 31G |
| Length of needle tube
(specified length ±1.25mm) | 5 mm
8 mm
10 mm
12 mm | 5 mm
8 mm
10 mm
12 mm | 4 mm
5 mm
6 mm
8 mm | 4 mm
5 mm
6 mm
8 mm | 5 mm
8 mm
12.7 mm | 5 mm
8 mm
12.7 mm | 5 mm
8 mm
12.7 mm |
| Performances | Conforms to ISO7864, ISO 11608-2, ISO9626 | | | Conforms to ISO7864, ISO 11608-2, ISO9626 | | | |
| Biocompatibility | Conforms to ISO10993 | | | Conforms to ISO10993 | | | |
| Shelf life | 3years | | | 3years | | | |
| Sterilization | EO Gas sterilization | | | EO Gas sterilization | | | |
| Labeling | Meet the requirements of 21 CFR 801 | | | Meet the requirements of 21 CFR 801 | | | |
| Packaging | Sterile cap(PP)+sterile paper | | | Sterile cap(PP)+sterile paper | | | |
| Intended population | All ages | | | All Ages | | | |
The proposed and predicate devices have the similar indications for use, principle of operation, product configuration, material, performance, biocompatibility, shelf life, sterilization. Although the indications for use are not identical, the intended uses are as both are for the subcutaneuous injection of insulin and does not raise new questions of safety or effectiveness.
The testing in conformance with ISO 11608-2, ISO 7864 and ISO 9626 provides additional evidence that the proposed device is substantially equivalent to the predicate device
The pen injectors to be used with our pen needles are FlexPen
7. Performance data:
The JSM Pen Needle has been designed and tested to meet applicable requirements of the standards listed below.
5
Biocompatibility Testing
| No | Test
identification | Test method | Test criteria | Test result |
|----|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| 1 | Cytotoxicity test | ISO10993-5
Tests for in vitro cytotoxicity,
Test on extracts method | Cytotoxicity reactivity is 0 | Non- cytotoxicity (Pass) |
| 2 | Hemolysis test | ISO10993-4
Tests for interactions with
blood, Evaluation of hemolytic
properties of medical and their
components | Hemolytic index :0-2% | Hemolytic index was
0.158%. As a result, there
was non-hemolytic to the
extraction solution
(Pass) |
| 3 | Acute systemic
toxicity
test | ISO10993-11
Tests for systemic toxicity, Acute
systemic toxicity | No adverse clinical signs in
animals and no animals lost
in excess of 10% of body
weight. | Non-acute systemic
toxicity (Pass) |
| 4 | Skin sensitization
test | ISO10993-10
Test for Irritation and
sensitization, Guinea pig
Maximization test (GPMT) | Non-skin hypersensitivity
reaction to negative control
and test substance material. | Non-skin hypersensitivity
reaction (Pass) |
| 5 | Pyrogen Test | ISO 10993
Test for systemic, Annex(F)
Information on material-
mediated pyrogens | No animal show an individual
temperature rise of 0.5°C or
above its respective control
temperature. | Non-pyrogenicity (Pass) |
| 6 | Intracutaneous
reactivity test | ISO 10993-10
Test for irritation and skin
sensitization, Animal
Intracutaneous(intradermal)
reactivity Test | The calculated final test
sample scores of polar and
non-polar extract is 0.0 | Non-intracutaneous
(Pass) |
Testing Performance to ISO 7864 (1993)
| Test items | Criteria and Result summary | |
|---|---|---|
| 1 | Inner/outside and structure | No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerin untinged, no lubricant on the surface |
| Passed | ||
| Measurement | Outside diameter of needle : 0.267mm for criterial 0.254-0.267 | |
| Length of needle : 7.6mm for criteria 8(+1/-2) | ||
| Passed | ||
| Elasticity test | Fix A point randomly and bend 12° with weight and 1 minutes at B point | |
| Needle returned after remove weight | ||
| Passed | ||
| Draw test | Pulled in the direction of the needle axis by minimum force (22N) | |
| The union of the hub and needle tube was not broken | ||
| Passed |
6
Testing Performance to ISO 11608-2 (2012) and ISO 9626 (1991)_
- The pen injectors tested under 11608-2 : FlexPen
| Test items | Criteria and Result summary | |||||
|---|---|---|---|---|---|---|
| Model code | 29Gx8mm | 29Gx10mm | 29Gx12mm | |||
| Average | 8.2414mL/min | 8.1687mL/min | 7.8848mL/min | |||
| Model code | 30Gx5mm | 30Gx8mm | 30Gx10mm | 30Gx12mm | ||
| Average | 6.1566mL/min | 6.1154mL/min | 5.8387mL/min | 5.738mL/min | ||
| Flow rate testing | Model code | 31Gx4mm | 31Gx5mm | 31Gx6mm | 31Gx8mm | |
| Average | 4.298mL/min | 4.250mL/min | 4.162mL/min | 4.149mL/min | ||
| Model code | 32Gx4mm | 32Gx5mm | 32Gx6mm | 32Gx8mm | ||
| Average | 4.189 mL/min | 4.216 mL/min | 4.135 mL/min | 4.094 mL/min | ||
| The calculation for flow rate is as above. | ||||||
| 1 | Bond between hub | |||||
| and needle tube | ||||||
| testing | Passed | |||||
| The force min. (N) for nominal outside diameter of needle (29G, 30G, 31G, 32G) is | ||||||
| 22 N. | ||||||
| The union of the hub and needle tube was not broken per each gauge by the | ||||||
| minimum force (22N) | ||||||
| Needle point | ||||||
| testing | Passed | |||||
| When examined under a magnification of x2.5, needle points shall appear sharp | ||||||
| and free from feather edges, burrs and hooks. | ||||||
| The needle points per each gauge appeared sharp and free from feather edges, | ||||||
| burrs and hooks. | ||||||
| Freedom from | ||||||
| defects | Passed | |||||
| When examined by normal or corrected vision, the needle tube shall appear | ||||||
| straight and of regular cross-section and wall thickness. | ||||||
| The needle tube per each gauge appeared straight and regular cross-section and | ||||||
| wall thickness. | ||||||
| Lubrication testing | Passed | |||||
| If the hypodermic needle tube is lubricated, the lubricant shall not be visible, | ||||||
| under or corrected vision, as droplets of fluid on the outside or inside surfaces of | ||||||
| the needle tube. | ||||||
| The lubricant was not visible, under or corrected vision, as droplets of fluid on the | ||||||
| outside or inside surfaces of the needle tube. | ||||||
| Dislocation of | ||||||
| measuring point at | ||||||
| patient end | Patient-end needle length, /1, mm | Maximum allowable dislocation | ||||
| Dmax , mm | ||||||
| 8 | 0,9 | |||||
| 12 | 1,1 | |||||
| 16 | 1,4 | |||||
| Others | $0.07 x/1 + 0.3$ | |||||
| Needle hub- | ||||||
| assembly testing | For 12mm, 10mm, 8mm, 6mm, 5mm, 4mm, the test is performed and the test | |||||
| result was passed. | ||||||
| The needle assembly torque values shall all be within the range of 0.06Nm to | ||||||
| 0.080Nm. The needle assembly torque values is 0.070Nm | ||||||
| Passed | ||||||
| Needle dose | ||||||
| accuracy testing | The following two conditions shall be met: | |||||
| $S+(k \times S_{sd}) \leq UL$ and $S-(k \times S_{sd}) \geq LL$ | ||||||
| The two conditions were met | ||||||
| Passed |
7
| | Needle hub torque
removal testing | The needle hub removal torque shall be less than 0.1000Nm.
The needle hub removal torque is 0.071Nm
Passed |
|---|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Inner/outside and
structure | No scratch, no crack, smooth, no foreign materials, sharped needle edge, glycerin
untinged, no lubricant on the surface
Passed |
| | Dimension | Needle outside diameter, Needle length, Needle cap Inner diameter
29G, 30G, 31G, 32G
Passed |
| 2 | Flexural strength | When the needle is bended to 90° the center of the cannula according to the
radius of curvature of 5mm radius, it should not be broken
Passed |
| | Elasticity test | Fix A point randomly and bend 12° with weight and 1 minutes at B point
Needle returned after remove weight
Passed |
| | Draw test | Pulled in the direction of the needle axis by minimum force (22N)
The union of the hub and needle tube was not broken
Passed |
8. Conclusion
Based on the comparison and analysis above, the JSM Pen Needle has the same intended use, technological characteristics, materials of construction and performance specifications as the predicate device. The subject device is determined to be Substantially Equivalent (SE) to the predicate device