(151 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable insulin pen needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an insulin pen needle used for drug delivery, which assists in the treatment but does not directly provide a therapeutic effect itself.
No.
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. It is designed for drug delivery, not for diagnosing a medical condition.
No
The device description clearly outlines physical components like a sterile cap, needle hub, needle, and blister paper, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of insulin in the treatment of diabetes." This describes a device used for administering medication directly into the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a needle and hub designed to connect to an insulin pen for injection. This is consistent with a drug delivery device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.), reagents, or any process related to in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to deliver a substance into the body.
N/A
Intended Use / Indications for Use
These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The needle cap covers intended to provide physical protection to the needle tube.
Fine Ject insulin 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 variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.
The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.
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)
The Fine Ject insulin pen needles have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO 9626 and ISO 11608-2.
Biocompatibility testing: The materials of the Fine Ject insulin pen needles have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood.
Sterilization and Shelf-lifeTesting: Fine Ject insulin pen needles are sterile (gamma irradiation), non-toxic and nonpyrogenic. Shelf-life testing supports a shelf-life of 3-years after sterilization.
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).
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K112332 page 1 of 2
JAN 1 0 2012
5. 510(k) Summary
[as required by 807.92(c)]
A. Applicant:
Company: Twobiens Co., Ltd. #602, Ace High-end Tower 8, Gasan-dong, Geumcheon-gu, Seoul, 153-802, Korea TEL. 82-2 6123 3070 Mobile. 82 10 5355 8124 http://www.twobiens.com -Contact person: Peter Chung 412-687-3976 -Date: Aug 16, 2011
B. Proprietary and Established Names:
Trade Name: Fine Ject Insulin Pen Needle Common Name: Insulin Pen Needle. Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI Regulation: 880.5570 Class of device : Class II.
Device Description: ﺯ
Fine Ject insulin pen needle consists of a Sterile Cap, needle hub, which can be fixed with needle and blister paper. The sterile cap has function to sustain sterilization of needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The needle cap covers intended to provide physical protection to the needle tube.
Fine Ject insulin 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 variougauge sizes (29G, 30 G, 31G and 32G) and lengths (4mm, 5mm, 8mm and 12.7mm). Fine Ject insulin pen needles are sterile (gamma irradiation sterilization), non-toxic and non-pyrogenic.
The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge.
D Summary of the comparison of technological characteristics
Fine Ject insulin pen needles are substantially equivalent to the intended use, function, principle of operation, and basic composition of the predicate devices.
The non-clinical testing to voluntary standards and applicable FDA guidance provide evidence Fine Ject insulin pen needle are substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.
The minor differences between the Fine Ject insulin pen needle and the predicate devices, including needle gauge, needle length, and primary container material, raise no new issues of safety or effectiveness.
E. Brief discussion of non-clinical data
The Fine Ject insulin pen needles have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate devices.
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K112332 page 2 of 2
Results of the non-clinical testing supports the conclusion of substantial equivalence of the Fine Ject insulin pen needles to the predicate devices.
Performance-Testing:
The Fine Ject insulin pen needles have been designed and successfully tested to meet the applicable requirements outlined in ISO7864, ISO 9626 and ISO 11608-2.
Biocompatibility testing
The materials of the Fine Ject insulin pen needles have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External Communicating Devices, Circulating Blood,
Sterilization and Shelf-lifeTesting.
Fine Ject insulin pen needles are sterile (gamma irradiation), non-toxic and nonpyrogenic.
Shelf-life testing supports a shelf-life of 3-years after sterilization.
F. Conclusion that data demonstrates substantial equivalence
The results of above tests demonstrate that The Fine Ject insulin pen needles performs equivalent to the predicate device and is safe and effective when used as intended.
G. The legally marketed devices to which we are claiming equivalence:
Feel Fine Insulin Pen Needle. K080904 BD 32G x 4mim Pen Needle :K100005
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter Chung President Twobiens Company, Limited 300 Atwood Street Pittsburgh, Pennsylvania 15213
JAN 1 0 2012
Re: K112332
Trade/Device Name: Fine Ject Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 26, 2011 Received: December 14, 2011
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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Page 2 - Mr. Chung
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.
Th for
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
4
KI12332
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
- Device Name:Fine Ject Insulin Pen Needle
Indications For Use:
These disposable sterile Insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rill C. Chapman 1/3/12
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K112332