(167 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterility, and mechanical performance of a disposable pen needle, with no mention of AI or ML.
No.
A therapeutic device actively treats a condition or disease. The ShinaPen® is a pen needle, a single-use accessory connecting to a pen injector to deliver insulin (the therapeutic agent). It facilitates delivery but does not itself provide therapy.
No
The ShinaPen is explicitly described as a device for the subcutaneous injection of insulin, which is a therapeutic function, not a diagnostic one. It facilitates the delivery of medication.
No
The device description clearly outlines physical components (needle, hub, shield assembly, blister paper) and mentions sterilization and biocompatibility testing, indicating it is a physical medical device, not software-only.
Based on the provided information, the ShinaPen® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of insulin" using a pen injector. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The description details a needle, hub, and shield assembly designed for injection. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis
The ShinaPen® is a medical device used for drug delivery, specifically insulin injection.
N/A
Intended Use / Indications for Use
The ShinaPen® is designed for use with a pen injector for the subcutaneous injection of insulin.
ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
The ShinaPen® are designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.
The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
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)
Performance Testing:
ShinaPen® have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO9626 and ISO11608-2.
Additional performance testing to internal standards include: Needle shield assembly force and Needle sharpness testing.
Biocompatibility Testing:
The material of the ShinaPen® have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
Sterilization and Shelf-life Testing:
Sterilization of the ShinaPen® has been validated using the half-cycle method as outlined in ISO11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrins will not exceed the limits presented in ISO10993-7. Shelf-life testing supports a shelf-life of 3-years after sterilization.
Clinical Data:
No prospective clinical trials were conducted in support of this Traditional 510(k).
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
1-2-2012
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitted by :
Jan /05/2012
Jiseop Jeong / Manager / Regulatory affairs SHINA CORPORATION 691-1, boheung-ri useong-myeon, gongju-si, chungchengnam-do, 314-864, Korea Phone : +82 41 853 8571 Fax : +82 41 853 0872
2. Device Name :
| Trade Name | : ShinaPen® |
|---|---|
| Common Names | : Insulin pen needle |
| Classification Name | : Hypodermic single lumen needle |
3. Predicate Device :
UltiMed UltiCareTm Disposable Pen Needles Manufactured by UltiMed Inc.
FlexPen Needle 32G Tip x 6mm (1/4") Disposable Needle Manufactured by Novo Nordisk Inc.
BD 32G x 4mm Pen Needle
Manufactured by Bceton, Dickinson and Company
4. Device Description :
The ShinaPen® are designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility the of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.
The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
1
The ShinaPen® are offered various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
5. Intended For Use :
The ShinaPen® is designed for use with a pen injector for the subcutaneous injection of insulin.
6. Technological Characteristics :
The ShinaPen® and the predicate device have the identical technological characteristics and perform equivalently.
| Device Name | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
|---|---|---|---|---|---|
| Manufacturer | SHINA | ||||
| CORPORATION | UltiMed Inc. | Novo Nordisk Inc. | Becton, Dickinson and | ||
| company | |||||
| 510(k) Number | N/A | K100812 | K090111 | K100005 | |
| Intended for use | The ShinaPen® is | ||||
| designed | |||||
| for use with a pen | |||||
| injector for the | |||||
| subcutaneous | |||||
| injection of insulin. | The UltiCare Disposable | ||||
| Pen needles are used | |||||
| with insulin pen injector | |||||
| devices for the | |||||
| subcutaneous injection | |||||
| of insulin in the | |||||
| treatment of diabetes. | FlexPen needle is | ||||
| Intended for use with | |||||
| pen injector devices for | |||||
| the subcutaneous | |||||
| injection of insulin, | |||||
| liraglutide and | |||||
| somatropin | BD pen Needle is | ||||
| intended for use with | |||||
| pen injector device for | |||||
| subcutaneous injection | |||||
| of drugs, including | |||||
| insulin and exenatide. | |||||
| Gauge | 29G 30G 31G 32G | 29G 31G | 30G , 32G | 32G | |
| M | |||||
| A | |||||
| T | |||||
| E | |||||
| R | |||||
| I | |||||
| A | |||||
| L | Needle tube | STS304 | STS304 | STS304 | STS304 |
| Hub | Polypropylene | Polypropylene | Polypropylene | Polypropylene | |
| Primary | |||||
| container | Polyethylene | Polyethylene | Polypropylene | Polypropylene | |
| Silicon | Poly di-methyl siloxane | Poly di-methyl siloxane | Poly di-methyl siloxane | Poly di-methyl siloxane | |
| Sterilization | Ethylene oxide gas | ||||
| (SAL 10-6) | Ethylene oxide gas | ||||
| (SAL 10-6) | Ethylene oxide gas | ||||
| (SAL 10-6) | Gamma irradiation | ||||
| sterilization | |||||
| (SAL 10-6) |
7. Testing
The ShinaPen® have been designed and tested to meet the requirements of voluntary standards and FDA Guidance documents applicable to the subject and predicate devices. Results of the non-clinical tesing Supports the conlusion of substantial equivalence of
2
Performance Testing
ShinaPen® have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO9626 and ISO11608-2.
Additional performance testing to internal standards include:
Needle shield assembly force and Needle sharpness testing
Biocompatibility Testing
The material of the ShinaPen® have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
Sterilization and Shelf-life Testing
Sterilization of the ShinaPen® has been validated using the half-cycle method as outlined in ISO11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrins will not exceed the limits presented in ISO10993-7. Shelf-life testing supports a shelf-life of 3-years after sterilization
Clinical Data
No prospective clinical trials were conducted in support of this Traditional 510(k)
8. Conclusion
Based on the information provided in this premarket notification of SHINA CORPORATION. Concludes that ShinaPen® is substantially equivalent to predicate devices
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
APR 1 2 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jiseop Jeong Regulatory Affairs Shina Corporation 691-1. Boheung-Ri Useong-Myeon, Gongju-Si Chungchengnam-Do Republic of Korea 314864
Re: K113186
Trade/Device Name: ShinaPen® Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 23, 2012 Received: April 2, 2012.
Dear Mr. Jeong:
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.
4
Page 2 - Mr. Jeong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Max
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SHINA CORPORATION
Indication for use Statement
510(k) Number ( If known ) :
Device Name : ShinaPen®
Indication for use :
ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4/11/12
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113181
Indication for use statement