(160 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a pen needle, with no mention of AI or ML.
Yes.
The device is intended for the subcutaneous injection of insulin, which is a treatment for a medical condition, thus making it a therapeutic device.
No
The device is a pen needle, intended for the subcutaneous injection of insulin, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical medical device (pen needles) and describes its physical components and bench testing related to physical properties. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing happens outside of the body (in vitro).
- Top Fine® Pen Needle Function: The Top Fine® Pen Needle is used for the subcutaneous injection of insulin. This is a direct administration of a substance into the body, not the analysis of a specimen taken from the body.
The description clearly states its purpose is for delivering medication, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.
Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumers, caregivers and health care professionals
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 tests relating to the performance of the Top Fine® Pen Needles were conducted.
The principal device demonstrated equivalent performance to the predicate devices during bench testing.
Bench testing consisted of:
- Inside and outside dimensions of needles
- Size designation
- Elasticity of the needle tube
- The flexural rigidity
- Pull
- Lubricant
- Compatibility test
- Needle dose accuracy
- Needle hub torque removal
The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864.
Endotoxin Test was based on USP 39: Bacterial Endotoxin test and KP 11: Endotonix Test Method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures in profile, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2016
MedExel Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K152410
Trade/Device Name: Top Fine® Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 16, 2015 Received: December 31, 2015
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 (OS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152410
Device Name
Top Fine® Pen Needle
Indications for Use (Describe)
Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.
Type of Use (Select one or both, as applicable)
الص 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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3
510(k) Summary (K152410)
[as required by 807.92(c)]
Applicant
Company : MedExel Co.,Ltd. Address : 252, Geumgwangosan-ro, Geumgwang-myeon, Anseong-si, Gyeonggi-do, Korea Tel : 82-31-677-8004 Fax : 82-31-677-8087 Prepared date : Dec. 15, 2015 Contact person : Peter Chung, 412-687-3976 Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA Current date : Jan. 15, 2016 510(k) Number : K152410
Device Information
Trade name : Top Fine® Pen Needle Common name : Hypodermic single lumen needle Classification name : Needle, Hypodermic, Single Lumen Product code : FMI Regulation number : 880.5570 Class of device : Class II Panel : General Hospital Model codes : 13 model codes including Top Fine® Pen Needle 29GX12mm
| Top Fine® Pen Needle 29G X 12mm, 12.7mm |
|---|
| Top Fine® Pen Needle 30G X 8mm |
| Top Fine® Pen Needle 31G X 5mm, 6mm, 8mm |
| Top Fine® Pen Needle 32G X 4mm, 5mm, 6mm |
| Top Fine® Pen Needle 33G X 4mm, 5mm |
| Top Fine® Pen Needle 34G X 4mm, 5mm |
The legally marketed device to which we are claiming equivalence
K080904 Feel Fine Insulin Pen Needle
Device description
Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.
Top Fine® Pen Needle assembly consists of hub, needle cap, sterile cap and sterile paper.
Indications for Use :
Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin.
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Performance data:
Bench tests relating to the performance of the Top Fine® Pen Needles were conducted.
The principal device demonstrated equivalent performance to the predicate devices during bench testing.
Bench testing consisted of:
| Inside and outside dimensions of needles | |
|---|---|
| Size designation | |
| Elasticity of the needle tube | |
| The flexural rigidity | Test standard |
| Pull | ISO 11608-2:2012 |
| Lubricant | ISO 7864:1993 |
| Compatibility test | |
| Needle dose accuracy | |
| Needle hub torque removal |
COMPATIBLE Pens
| PEN NAME | |||
|---|---|---|---|
| BD Pen | InDuo | Novopen 3ml | Novopen Junior |
| FlexPen | InnoLet | Sanofi SoloStar | Sanofi Optiset |
| HumalogPen | Humulin Pen | Sanofi OptiPen | Owen Autopen |
Predicate device comparison table
| Manufacturer | MedExel Co.,Ltd. | Feel Tech | Remark | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) No. | K152410 | K080904 | N/A | |||||||||||||||||||||
| Indication for use | Top Fine® Pen Needle is intended for use with insulin pens for the subcutaneous injection of insulin. | These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes. | Similar | |||||||||||||||||||||
| Product name | Hypodermic single lumen needle | Hypodermic single lumen needle | Same | |||||||||||||||||||||
| Trade name | Top Fine® Pen Needle | Feel Fine Insulin Pen Needle | N/A | |||||||||||||||||||||
| Model/type | 13 model codes including Top Fine® Pen Needle 29GX12mm | Feel Fine Insulin Pen Needle-29 | ||||||||||||||||||||||
| Feel Fine Insulin Pen Needle-30 | ||||||||||||||||||||||||
| Feel Fine Insulin Pen Needle-31 | N/A | |||||||||||||||||||||||
| Appearance | Image: MedExel Co.,Ltd. needle | Image: Feel Tech needle | Similar | |||||||||||||||||||||
| Product configuration | Hub | |||||||||||||||||||||||
| Needle cap | ||||||||||||||||||||||||
| Sterile cap | ||||||||||||||||||||||||
| Needle | ||||||||||||||||||||||||
| Sterile paper | Hub | |||||||||||||||||||||||
| Needle cap | ||||||||||||||||||||||||
| Sterile cap | ||||||||||||||||||||||||
| Needle | ||||||||||||||||||||||||
| Sterile paper | Similar | |||||||||||||||||||||||
| 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 | Same or | |||||||||||||||||||||
| Similar | ||||||||||||||||||||||||
| Length of parts (mm) | ||||||||||||||||||||||||
| Total length of assembly | 29.8 | 28.8 | Similar | |||||||||||||||||||||
| Side length of | 15.2 | 15.5 |
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| Manufacturer | MedExel Co.,Ltd. | Feel Tech | Remark |
|---|---|---|---|
| assembly(max) | |||
| Inner diameter of | |||
| sterile cap | 11.2 | 12.95 | Similar |
| Gauge | 29G, 30G, 31G, 32G, 33G, 34G | 29, 30, 31G | Similar |
| Length of needle | 4 mm, 5 mm, 6 mm, 8 mm, 12 mm, 12.7 mm | 5 mm, 8 mm, 12.7 mm | Similar |
| Sterilization | EO Gas sterilization | ||
| According to ISO 11135: 2007 | EO Gas sterilization | Same | |
| Packaging | Sterile cap(PP or PE)+sterile paper | Sterile cap(PP)+sterile paper | Similar |
The bench tests of Needles with 32G, 33G, 34G demonstrated conformances to ISO 11608-2 and ISO 7864. Therefore the differences do not raise new concerns to establish substantial equivalence to the predicate.
Endotoxin Test was based on USP 39: Bacterial Endotoxin test and KP 11: Endotonix Test Method.
Conclusion:
The vast similarities of the Top Fine® Pen Needle to the predicate devices support the substantial equivalence in indications for use, function and basic composition.
The differences between the Top Fine® Pen Needle and the predicate device do not raise new issues.
The testing that conformance with ISO 11608-2 and ISO 7864 provides additional evidence that the Top Fine® Pen Needle is substantially equivalent to the predicate device in terms of efficacy and performance.