(69 days)
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 described as a "medical device designed to be used in conjunction with pen injectors and pen cartridges for the subcutaneous injection of insulin," which directly relates to the treatment of a medical condition (diabetes) by facilitating drug delivery.
No
This device is a pen needle, intended for the subcutaneous injection of insulin. It is an administering device, not a diagnostic one.
No
The device description clearly details a physical medical device (pen needles) made of materials like cannula, hub, and shields, and mentions manufacturing processes and sterilization. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with a pen injector device for the subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not a device used to examine specimens from the body to provide information for diagnosis, monitoring, or screening.
- 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.), reagents, or any process related to in vitro testing.
This device is a medical device used for drug delivery, specifically insulin injection.
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, and 12.7mm). CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are 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 sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle 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.
The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length.
It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™.
The intended use for the modified device remains the same as the predicate device.
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 was performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100). The CareFine™ Pen Needle with colored needle shields is manufactured in accordance with the requirements of the current Good Manufacturing Practices for Medical Devices and follows 21 CFR Subpart C "Design Controls". All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards. The principle device demonstrated equivalent performance to the predicate device during testing.
Based upon the risk analysis the following tests were performed:
Cytotoxicity Per ISO 10993-5
Sensitization Per ISO 10993-10
Intracutaneous Reactivity Per ISO 10993-10
Acute Toxicity Per ISO 10993-11
Hemocompatibility Per ISO 10993-4 ASTM F756-8
Needle Shield Assembly Strength Internal Test Method
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CareFine™ Pen Needle (K133100)
Reference Device(s)
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/2 description: The image shows the logo for Facet Technologies. The logo consists of a four-pointed star-like shape on the left, followed by the word "FACET" in a stylized font. Below "FACET" is the word "TECHNOLOGIES" in a smaller, simpler font. The logo is black and white.
K140568
510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, Content and Format of a 510(k) Summary, the following safety and effectiveness information is provided below:
| Date Prepared: | March 3, 2014 |
|---|---|
| Submitter: | Facet Technologies, LLC |
| 112 Town Park Dr. | |
| Suite 300 | |
| Kennesaw, GA 30144 | |
| Facility Registration Number: 2082882 | |
| Company Contact Person: | Jennifer Register |
| Senior Regulatory Affairs Specialist | |
| Phone: (770) 590-6455 | |
| FAX: (770) 590-6412 | |
| Email: jennifer_register@facettechnologies.com | |
| Common Name of Device | Insulin Pen Needle |
| Proprietary Name | CareFineTM Pen Needle with QuintaPointTM |
| and SuperPointTM | |
| Classification Name | Hypodermic Single Lumen Needle |
| Classification Regulation | 21 CFR §880.5570, Class 2 |
| Panel | 80 General Hospital |
| Product Code | FMI |
[807.92(a)(3)] Predicate Device:
CareFine™ Pen Needle (K133100) Manufactured by Facet Technologies, LLC
ジ
34
1
[(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, and 12.7mm). CareFine™ Pen Needles are sterile by EtO terminal sterilization, and they are 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 sterile barrier and tamper evident seal. The peel-away label is pre-printed with information, which includes the lot number, needle gauge and needle 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.
The purpose of this Special 510(k) is to request modification to our CareFine™ Pen Needles to include colored inner needle shields to distinguish the needle length.
It is also Facet's intent to notify the Agency of non-significant changes to the cannula point bevel geometry. There are two additional needle point geometries being offered: a 5 bevel configuration corresponding to the QuintaPoint™ marketed name, and a second needle tip geometry identified as the SuperPoint™.
The intended use for the modified device remains the same as the predicate device.
2
Special 510(k) for CareFine™ Pen Needle Family Including QuintaPoint™ and SuperPoint™ Submitted Under 21 CFR § 807.87
[(807.92(a)(5)] Intended Use / Indication for Use:
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
[(807.92(a)(6)] Technological Characteristics:
The CareFine™ Pen Needle with colored needle shields is identical in composition to the CareFine™ Pen Needle. The only differences are the needle point and colorant additive to the inner needle shield to distinguish needle length.
The CareFine™ Pen Needle with colored inner needle shields are equivalent given that they:
- Have the same indication for use, .
- Do not have any labeling changes that affect the intended use of the device, .
- Do not alter the fundamental scientific technology, .
- Incorporate the same basic design ●
- Use the same operating principles. ●
- Are manufactured from the same materials,
- Are sterilized with a resulting SAL of 10°, and .
- Are packaged using same unit and case materials. ●
Based on the comparisons described above to the predicate comparator device, the CareFine™ Pen Needle with colored inner needle shields do not raise any new issues of safety and effectiveness.
[(807.92(b)(1)] Non-Clinical Performance Data:
Non-clinical performance data was performed and submitted with The CareFine™ Pen Needle Traditional 510(k) (K133100). The CareFine™ Pen Needle with colored needle shields is manufactured in accordance with the requirements of the current Good Manufacturing Practices for Medical Devices and follows 21 CFR Subpart C "Design Controls". All verification and validation activities identified by the risk analysis were performed to demonstrate continued conformance with applicable conformance standards. The principle device demonstrated equivalent performance to the predicate device during testing.
રૂદ
3
Special 510(k) for CareFine™ Pen Needle Family Including QuintaPoint™ and SuperPoint™ Submitted Under 21 CFR § 807.87
| Based upon the risk analysis the following tests were performed. | |
|---|---|
| Cytotoxicity | Per ISO 10993-5 |
| Sensitization | Per ISO 10993-10 |
| Intracutaneous Reactivity | Per ISO 10993-10 |
| Acute Toxicity | Per ISO 10993-11 |
| Hemocompatibility | Per ISO 10993-4 |
| ASTM F756-8 | |
| Needle Shield Assembly Strength | Internal Test Method |
Based upon the risk analysis the following tests were performed:
[(807.92(b)(2)] Clinical Performance Data:
Clinical data is not required.
[(807.92(b)(3)] Conclusion:
Based on the design equivalency and the verification activities performed, Facet Technologies, LLC has determined that CareFine™ Pen Needle family 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
Confidential and Proprietary Copyright @ 2014 Facet Technologies, LLC
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Control Conter - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
Facet Technologies, LLC Ms. Jennifer Register Senior Regulatory Affairs Specialist 112 Town Park Drive Suite 300 Kennesaw, GA 30144
Re: K140568
Trade/Device Name: Carel"ine™ Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 15, 2014 Received: April 17, 2014
Dear Ms. Register:
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 cither 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.
5
Page 2 - Ms. 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 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 (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" (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 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,
Mary S. Runner -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140568
Device Name CareFine™ Pen Needle
Indications for Use (Describe)
The CareFine™ Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin.
Type of Use (Select one or both, as applicable)
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.
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