(146 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a pen needle for insulin injection, with no mention of AI or ML.
No
A therapeutic device is one that treats or manages a disease or condition. This device, a pen needle, aids in the delivery of insulin (a drug) but does not itself provide a therapeutic effect. It's an accessory to a therapeutic process rather than a therapeutic device itself.
No
Explanation: The device is a pen needle intended for the subcutaneous injection of insulin, which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines physical components (needle, hub, shield assembly, blister paper) and performance studies focus on physical characteristics and compatibility with hardware (pen injector device). There is no mention of software as the primary or sole component.
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 to diagnose a condition.
- Device Description: The description details a needle and hub assembly designed for injection, not for collecting or analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the needle for injection (dimensions, flow rate, bond strength, compatibility with pen injectors), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver medication, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
The Medifine Pen Needle consists of a needle with hub, and shield assembly. The need to provide physical protection to the needle with the hub. Blister paper covers the primary container. The primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.
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
The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel and the test results show that the subject device is substantially equivalent to the predicate devices in the market.
Test item / Test Method
- Dimensions / ISO 11608-2:2012 Clause 4.2.1 General ISO 9626 1991_Amd2001, clause8
- Dimensions for needles / ISO 11608-2:2012 Clause 4.2.2 Dimensions for needles
- Determination of flow rate through the needle / ISO 11608-2:2012 Clause 4.3 Determination of flow rate through the needle
- Bond between hub and needle tube / ISO 11608-2:2012 Clause 4.4 Bond between hub and needle tube ISO 7864 Clause 13.1
- Needle points / ISO 11608-2:2012 Clause 4.5 Needle point
- Freedom from defects / ISO 11608-2:2012 Clause 4.6 Freedom from defects ISO 7864 Clause 11.3
- Lubrication / ISO 11608-2:2012 Clause 4.7 Lubrication
- Dislocation of measuring point at patient end / ISO 11608-2:2012 Clause 4.8 Dislocation of measuring point at patient end
- Determination of functional compatibility with needle-based injection systems / ISO 11608-2:2012 Clause 4.9 Test Method - Clause 11.
- Ease of assembly and disassembly / ISO 11608-2:2012 Clause 4.10 Test Method - Clause 11
- Compatibility of Needles and Injector systems / ISO 11608-2:2012 Clause 11 Test Method - Clause 11
- Cannula Test / ISO 9626 Clause 4,5,6,7,8,9,10,11
- Extraction Test / ISO 7864 Clause 6
- Corrosion Test / ISO 9626 Clause 11
Key Metrics
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2017
Medbio LLC. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc 690 Roosevelt Irvine, California 92620
Re: K171144
Trade/Device Name: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 1, 2017 Received: August 8, 2017
Dear Priscilla 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.
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
Image /page/0/Picture/11 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
1
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 (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 Industry and Consumer Education (DICE) 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 (DICE) 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,
Tara A. Ryan -S 2017.09.12 19:46:14 -04'00"
for Lori Wiggins, MPT, CLT 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) K171144
Device Name
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
Indications for Use (Describe)
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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| 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 | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of |
3
510(K) SUMMARY (K171144)
1. 510k Submitter
September 8, 2017
MEDBIO LLC. 4846 Citrus Way Cooper City, Florida 33330, U.S.A
2. US Agent/Contact Person:
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Email: juhee.c@lkconsultinggroup.com
3. Device Name:
| • Trade Name | : Medifine Pen Needle 3 Bevel
Medifine Pen Needle Quinta 5 Bevel |
|--------------------------|---------------------------------------------------------------------|
| • Classification | : Class II |
| • Regulation Description | : Hypodermic single lumen needle |
| • Product Code | : FMI |
| • Regulation Number | : 21 CFR 880.5570 |
| • Review Panel | : General Hospital |
3. Predicate Device:
CareFine Pen Needle (K140568) manufactured by Facet Technologies, LLC
Device Description: 4.
The Medifine Pen Needle consists of a needle with hub, and shield assembly. The need to provide physical protection to the needle with the hub. Blister paper covers the primary container. The primary container maintains sterility of the needle covering the hub and the shield with the blister paper. The needle hub can be connected onto the pen injector device for the subcutaneous injection of insulin. The device offers two compatible types of needle (patient contact point) as below. The user can choose the needle as per their preference.
5. Indications For Use:
The Medifine Pen Needle 3 Bevel and the Medifine Pen Needle Quinta 5 Bevel are indicated for use with a pen injector device for the subcutaneous injection of insulin.
4
6.
The Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel is substantially equivalent to the CareFine Pen Needle (K140568) by Facet Technologies, LLC. The manufacturer of the predicate device and the subject device is the same, TAE-CHANG INDUSTRIAL CO., LTD. The subject device and the predicate device are identical including manufacturing facility and manufacturing processes.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | Medifine Pen Needle | |
| 3 Bevel | ||
| Medifine Pen Needle Quinta | ||
| 5 Bevel | CareFine Pen Needle | |
| Manufacturer | TAE-CHANG | |
| INDUSTRIAL CO.,LTD | TAE-CHANG | |
| INDUSTRIAL CO.,LTD | ||
| 510k Applicant | MEDBIO LLC. | Facet Technologies, LLC |
| Product Code | FMI | FMI |
| 510k Number | K171144 | K140568 |
| Indications for use | The Medifine Pen Needle | |
| 3 Bevel and the Medifine | ||
| Pen Needle Quinta 5 Bevel | ||
| are indicated for use with a | ||
| pen injector device for the | ||
| subcutaneous injection of | ||
| insulin. | The CareFinePen Needle is | |
| intended for use with a pen | ||
| injector device for the | ||
| subcutaneous injection of | ||
| insulin. | ||
| Structure | Cannula / Hub / Needle Cap | |
| / Primary Container | Cannula / Hub / Needle | |
| Cap / Primary Container | ||
| Principle of | ||
| Operation | Pen needle is indicated for | |
| use with pen injector | ||
| devices for the | ||
| subcutaneous injection of | ||
| insulin. | Pen needle is intended for | |
| use with pen injector | ||
| devices for the | ||
| subcutaneous injection of | ||
| insulin. | ||
| Shape | Image: Medifine Pen Needle | Image: CareFine Pen Needle |
| Needle Diameter | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G |
| Needle Tube | ||
| Length | 4mm, 5mm, 6mm, 8mm, | |
| 12.7mm | 4mm, 5mm, 6mm, 8mm, | |
| 12.7mm | ||
| Needle Tube | ||
| Material | Stainless steel | Stainless steel |
| Needle Hub | ||
| Material | Polypropylene | Polypropylene |
| Needle shield | ||
| Material | Polyethylene | Polyethylene |
| Primary container | ||
| Material | Polypropylene | Polypropylene |
| Tip Configuration | ||
| (Patient Side) | Image: 3 Bevel | Image: 3 Bevel |
| Image: 5 Bevel | Image: 5 Bevel | |
| Primary Container | ||
| Length | 29.93[mm] | 29.93 [mm] |
| Primary Container | ||
| Color | Transparent | Transparent |
| Primary Container | ||
| Removal Force | 220~1100 [gf] | 220~1100 [gf] |
| Needle Hub/needle | ||
| Tube bond | ||
| Strength | Min. 22 [N] | Min. 22 [N] |
| Lubricant | ||
| Composition | Patient-end point: | |
| Dow Corning®Mdx4-4159 | ||
| 50% Medical Grade | ||
| Cartridge-end point : | ||
| Dow Corning®360 Medical | ||
| Fluid, 100CST | Patient-end point: | |
| Dow Corning®Mdx4-4159 | ||
| 50% Medical Grade | ||
| Cartridge-end point : | ||
| Dow Corning®360 Medical | ||
| Fluid, 100CST | ||
| Sterilization | ||
| method | EO Gas | EO Gas |
5
7. Testing
The following tests were performed on the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel and the test results show that the subject device is substantially equivalent to the predicate devices in the market.
| No | Test item | Test Method |
|---|---|---|
| 1 | Dimensions | ISO 11608-2:2012 Clause 4.2.1 General |
| ISO 9626 1991_Amd2001, clause8 | ||
| 2 | Dimensions for needles | ISO 11608-2:2012 Clause 4.2.2 Dimensions |
| for needles | ||
| 3 | Determination of flow | |
| rate through the needle | ISO 11608-2:2012 Clause 4.3 | |
| Determination of flow rate through the | ||
| needle | ||
| 4 | Bond between hub and | |
| needle tube | ISO 11608-2:2012 Clause 4.4 Bond | |
| between hub and needle tube | ||
| ISO 7864 Clause 13.1 | ||
| 5 | Needle points | ISO 11608-2:2012 Clause 4.5 Needle point |
| 6 | Freedom from defects | ISO 11608-2:2012 Clause 4.6 Freedom |
| from defects | ||
| ISO 7864 Clause 11.3 | ||
| 7 | Lubrication | ISO 11608-2:2012 Clause 4.7 Lubrication |
| 8 | Dislocation of | |
| measuring point at | ||
| patient end | ISO 11608-2:2012 Clause 4.8 Dislocation | |
| of measuring point at patient end | ||
| 9 | Determination of | |
| functional compatibility | ||
| with needle-based | ||
| injection systems | ISO 11608-2:2012 Clause 4.9 | |
| Test Method - Clause 11. | ||
| 10 | Ease of assembly and | |
| disassembly | ISO 11608-2:2012 Clause 4.10 | |
| Test Method - Clause 11 | ||
| 11 | Compatibility of | ISO 11608-2:2012 Clause 11 |
6
| | Needles and Injector
systems | Test Method - Clause 11 |
|----|---------------------------------|-----------------------------------|
| 12 | Cannula Test | ISO 9626 Clause 4,5,6,7,8,9,10,11 |
| 13 | Extraction Test | ISO 7864 Clause 6 |
| 14 | Corrosion Test | ISO 9626 Clause 11 |
8. Conclusion
Based on the information provided in this premarket notification, MEDBIO LLC. concludes that the Medifine Pen Needle 3 Bevel and Medifine Pen Needle Quinta 5 Bevel are substantially equivalent to predicate device.