(517 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a simple medical device (insulin pen needle), with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "insulin pen-injector needle" for injecting insulin. While insulin is a therapeutic agent for diabetes, the needle itself is a delivery device and not a therapeutic agent or a device that directly performs a therapeutic function (like treating, curing, preventing, or mitigating disease through its inherent properties beyond delivery).
No
This device is an insulin pen-injector needle designed for administering insulin, not for diagnosing a condition.
No
The device description clearly outlines physical components (sterile cap, needle, hub, blister paper) and bench testing related to the performance of these physical components, indicating it is a hardware 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" into a diabetic patient. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a needle and its components for delivering a substance (insulin) into the body. It does not describe any components or processes for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a medication, which falls under the category of a therapeutic or drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
This is a single use sterile insulin pen-injector need by diabetic patients for the purpose of injecting insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
CPL insulin pen needle consist of a sterile cap, needle, hub and blister paper. The sterile cap and blister 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
diabetic patients
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:
In accordance with ISO 10993-1, CPL Insulin Pen Needle is classified as: Externally Communicating Device, Blood Path Indirect, Short Term (
§ 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
CPL Co., Ltd. c/o Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K151090
Trade/Device Name: CPL Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 16, 2016 Received: August 23, 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.
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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
Tina Kiang, Ph.D. Acting 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) K151090
Device Name
CPL Insulin Pen Needle
Indications for Use (Describe)
This is a single use sterile insulin pen-injector need by diabetic patients for the purpose of injecting 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)
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
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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510(k) Summary
[as required by 807.92(c)] K151090
1. Applicant
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- Company : CPL Co.,Ltd.
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- Address : 36, Yongteurim-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
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- Tel : 82-31-483-7301
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- Fax : 82-31-483-7351
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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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- Date prepared : September 16, 2016
2. Device Information
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- Trade Name : CPL 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 (Company : Feel Tech)
4. Device description
CPL insulin pen needle consist of a sterile cap, needle, hub and blister paper. The sterile cap and blister 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.
| Model | Needle length (mm) : | ||
|---|---|---|---|
| Patient-side tip | CPLPN-29 | 8mm, 10mm, 12mm | |
| CPLPN-30 | 5mm, 8mm, 10mm, 12 mm | ||
| CPLPN-31 | 4mm, 5mm, 6mm, 8mm | ||
| CPLPN-32 | 4mm, 5mm, 6mm, 8mm | ||
| Cartridge-side tip | CPLPN-29 | ||
| CPLPN-30 | 5mm, | ||
| CPLPN-31 | |||
| CPLPN-32 | |||
| Needle taper | 3.5mm | ||
| Wall type | |||
| (Thin-walled) | Needle gauge | Range of out diameters | Inside diameter of tubing |
| CPLPN-29 | 29G(0.324mm~0.351mm) | 29G (0.190) | |
| CPLPN-30 | 30G (0.298mm~0.320mm) | 30G (0.165) | |
| CPLPN-31 | 31G (0.254mm~0.267mm) | 31G (0.125) | |
| CPLPN-32 | 32G (0.229mm~0.241mm) | 32G (0.105) |
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5. Intended Use :
This is a single use sterile insulin pen-injector needle to be used by diabetic patients for the purpose of injecting insulin.
6. Performance data:
In accordance with ISO 10993-1, CPL Insulin Pen Needle is classified as : Externally Communicating Device, Blood Path Indirect, Shor Term (