(115 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterility, and basic functionality of a pen needle for insulin injection. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a pen needle used for injecting insulin, which is a drug, but the needle itself does not have a therapeutic effect; it is a delivery mechanism for a therapeutic agent.
No
Explanation: The device description clearly states that the CareFine™ Pen Needle is "intended for use with a pen injector device for the subcutaneous injection of insulin." It is an accessory for drug delivery, not a device used to identify or diagnose a disease or condition.
No
The device description clearly details physical components (cannula, hub, shields, packaging) and manufacturing processes (injection molding, sterilization), indicating it is a hardware medical device. There is no mention of software as a component or function of the 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 the "subcutaneous injection of insulin" using a pen injector device. 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 assembly designed for injection. It focuses on the physical components and how they facilitate the delivery of insulin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
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 purely for the delivery of medication.
N/A
Intended Use / Indications for Use
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, 8mm, and 12.7mm). CareFine™ Pen Needles are sterile (EtO terminal sterilization), non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.
An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterility barrier and tamper evidence seal. The peel-away label is pre-printed with information, which includes the lot number and needle gauge and length.
The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.
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
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)
Non-Clinical Performance Data:
The CareFine™ Pen Needle is manufactured in accordance with the requirements of the current Current Good Manufacturing Practices for Medical Devices and the testing performed which support a determination of substantial equivalence includes:
- appropriate biocompatibility tests,
- sterility tests.
- predicate product comparative tests and
- performance tests.
The test results are in compliance with existing domestic and international standards. Based on the above test parameter results, the CareFine™ Pen Needles do not raise any new issues of safety and effectiveness.
Clinical Performance Data:
Clinical data is not required.
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
KI33100
Facet Technologies, LLC Traditional 510(k) for the CareFine™ Pen Needles Submitted Under 21 CFR § 807.87
JAN 2 3 2014
Confidential and Proprietary
9 510(k) Summary
55
1
510(k) Summary as Required by 21 CFR §807.92(c)
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92(a), the 510(k) summary provided below is of sufficient detailed to provide an understanding of the basis for a determination of substantial equivalence.
| Date
| Prepared | Summary | September 25, 2013 |
|---|---|---|
| 510(k) Sponsor | ||
| Address | Facet Technologies, LLC | |
| 112 Town Park Drive, Suite 300 | ||
| Kennesaw, Georgia 30144 | ||
| Contact Person | Mary Ann Kinard | |
| Senior Regulatory Affairs Manager | ||
| Phone: (770) 590-6462 | ||
| FAX: (770) 590-6412 | ||
| Email:MaryAnn_Kinard@facettechnologies.com | ||
| Trade Name | CareFine™ Pen Needles | |
| Common Name | Insulin Pen Needle | |
| Classification Name | Needle, Hypodermic, Single Lumen | |
| Regulation Number | 21 CFR §880.5570 | |
| Product Code | FMI | |
| Device Classification | II | |
| Review Panel | 80 General Hospital |
510(k) Summary
CORPORATE HEADQUARTERS 112 Town Park Drive, Suite 300 Kennesaw, GA 30144 Phone: 770-590-6400 Fax: 770-590-6461
MANUFACTURING CENTER 101 Liberty Industrial Parkway McDonough, GA 30253 Phone: 770-898-3223 Fax: 770-898-1535
EUROPEAN OFFICE Unit 7 Mobbs Miller House Christchurch Road Northampton NN1 5LL U.K. Phone: +44 1604 638340 Fax: +44 1604 636 901
Confidential and Proprietary Copyright ® 2013 Facet Technologies, LLC
2
Predicate Marketed Devices:
| [807.92(a)(3)] | ||
|---|---|---|
| Manufacturer | Trade Name | 510(k) Number |
| UltiMed, Inc. | UltiCare® Disposable Pen | K100812 |
| Novo Nordisk, Inc. | FlexPen® | K090111 |
| Becton Dickinson | BD Pen Needle | K100005 |
[(807.92(a)(4)] Description of Device:
CareFine™ Pen Needles are single use, sterile medical devices designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G and 32G) and lengths (4mm, 5mm, 6mm, 8mm, and 12.7mm). CareFine™ Pen Needles are sterile (EtO terminal sterilization), non-toxic and non-pyrogenic.
The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection molded hub using adhesive. The hub has internal threads, which allow it to be screwed onto the pen injector device. This allows the cartridge end of the cannula to penetrate through the rubber septum of the cartridge. The patient-end and the cartridgeend of the cannula are lubricated using a silicone based lubricant for ease of injection and rubber septum penetration.
An injection-molded inner shield is assembled over the patient-end of the cannula to protect the point from damage and accidental needle-sticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away label to provide a sterility barrier and tamper evidence seal. The peel-away label is pre-printed with information, which includes the lot number and needle gauge and length.
The individual needle assemblies are packaged in cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized to a SAL of 10° by EtO terminal sterilization.
[(807.92(a)(5)] Indication for Use:
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
3
[(807.92(a)(6)] Technological Characteristics:
The CareFine™ Pen Needles are substantially equivalent to the UltiCare®, Flex Pen® and BD Pen Needles in terms of indications for use, compositions, material and design. Specifically, the following comparisons were made to determine equivalence of the CareFine™M Pen Needle to the referenced predicate pen needles:
- Needle sharpness, .
- . length, gauge,
- needle shield color(s), .
- needle shield dimensions, .
- . needle shield strength,
- hub/needle bond strength, .
- . biocompatibility, materials and
- . sterility
The CareFine™ Pen Needle product family is equivalent to the predicate devices, given that it:
- . Does not modify the indication for use or any labeling change that affects the intended use of the device,
- Does not alter the fundamental scientific technology, .
- Uses the same operating principles, .
- . Is manufactured from the same/similar materials,
- Is sterilized with a resulting SAL of 10-6, and .
- Is packaged using same/similar unit and case materials. .
Based on the comparisons described above to the predicate comparator devices, the CareFineTM Pen Needles do not raise any new issues of safety and effectiveness.
[(807.92(b)(1)] Non-Clinical Performance Data:
The CareFine™ Pen Needle is manufactured in accordance with the requirements of the current Current Good Manufacturing Practices for Medical Devices and the testing performed which support a determination of substantial equivalence includes:
- . appropriate biocompatibility tests,
- sterility tests. . ●
- predicate product comparative tests and ●
Confidential and Proprietary Copyright " 2013 Facet Technologies, LLC
4
Facet Technologies, LLC Traditional 510(k) for the CareFine™ Pen Needles Submitted Under 21 CFR § 807.87
. performance tests.
The test results are in compliance with existing domestic and international standards. Based on the above test parameter results, the CareFine™ Pen Needles do not raise any new issues of safety and effectiveness.
· [(807.92(b)(2)] Clinical Performance Data:
Clinical data is not required.
[(807.92(b)(3)] Conclusion:
Based on the design equivalency and the functional testing performed, Facet Technologies has determined that CareFine™ Pen Needles are equivalent to the predicate comparator devices currently cleared for marketing in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.
[(807.92(d)] Other Information:
None
End of 510(k) Summary
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2014
Facet Technologies, LLC Ms. Mary Ann Kinard Senior Regulatory Affairs Manager 112 Town Park Drive, Suite 300 Kennesaw, GA 30144
Re: K133100
Trade/Device Name: CareFine™ Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 19, 2013 Received: December 20, 2013
Dear Ms. Kinard:
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.
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
6
Page 2 - Ms. Kinard
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133100
Device Name
CareFine™ Pen Needles
Indications for Use (Describe)
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcuraneous injection of insulin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
(2) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE THE THE PEORIFDAIUSE ONLY ONLY ONLY CLI , "게 대표 프 .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)
PSC Publishing Services (131) 1434722 Fir
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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