(265 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 AI or ML.
Yes
The device is described as an "insulin pen needle" intended for "subcutaneous injection of insulin in the treatment of diabetes," which directly indicates its use in therapy.
No
The device is an insulin pen needle used for injecting insulin, not for diagnosing a condition.
No
The device description clearly outlines physical components made of polypropylene and stainless steel, and the performance studies involve testing of these physical attributes (shelf life, sterilization, biocompatibility, mechanical testing). This is a hardware device, not software.
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 to administer a substance into the body for therapeutic purposes.
- Device Description: The description details a needle and hub designed for connecting to an insulin pen and delivering insulin. This is consistent with a device used for drug delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. IVDs are used to perform tests in vitro (outside the body).
Therefore, this device is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These disposable sterile insulin pen needles are intended for subcutaneous injection of dental.
Product codes
FMI
Device Description
The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following table defines the nonclinical performance testing submitted. All pre-determined acceptance criteria were met:
| Performance Test | Normative References/ Description |
|---|---|
| Accelerated Shelf Life | ASTM F 1980-07 |
| ISO 11607-1 | |
| ISO 11608-2 | |
| ASTM F 1929 | |
| ASTM F88 | |
| EO Sterilization Validation | The validation process used a standard half |
| cycle method to demonstrate the efficacy of | |
| the EO sterilization process. | |
| EO Residual | Sterilant residual limit for limited exposure |
| met of EO |
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Diabetic Supply of Suncoast, Inc. c/o Matt Hedlund 510k Consultant 3924 NE 157th Place Lake Forest Park, Washington 98155
Re: K160199
Trade/Device Name: Advocate Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 21, 2016 Received: September 22, 2016
Dear Matt Hedlund:
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.
1
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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". Below the name, there is a small "-s". The signature is complex and illegible. The text is in a clear, sans-serif font.
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
2
Indications for Use
510(k) Number (if known)
K160199
Device Name Advocate Insulin Pen Needles
Indications for Use (Describe)
These disposable sterile insulin pen needles are intended for subcutaneous injection of diabetes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Z Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for K160199
Diabetic Supply of Suncoast, Inc. PO Box 2102 Vega Alta, PR 00692 1-866-373-2824 Contact: Victoria Thuss Date Prepared: October 11, 2016
-
- Subject Device Trade Name: Advocate Insulin Pen Needles Common Name: Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Requlatory Class: Class II Product Code: FMI
-
- Predicate Device Trade Name: Comfort EZ Pen Needle 510(k) Number: K121632 Common Name: Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Requlatory Class: Class II Product Code: FMI
-
- Description of Device: The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
-
- Indications for Use: These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes. This is the same indication for use statement as the statement for the predicate device, K121632.
4
-
- Technological characteristics: The following is a comparison of the technological characteristics of the subject device with the predicate device:
| Technological
Characteristic | Subject Device
Advocate Insulin Pen Needle | Predicate Device
Comfort EZ Pen Needle -
K121632 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Size | 31G 5 mm; 31G 6 mm;
31G 8 mm; 32G 4 mm;
33 G 4 mm; 29G 12mm | 31 G 5 mm; 31 G 6 mm;
31 G 8 mm; 32 G 4 mm;
32 G 5 mm; 32 G 6 mm |
| Design | Outer Cap; Inner Cap; Cannula;
Hub; Paper Seal | Outer Cap; Inner Cap;
Cannula; Hub; Paper Seal |
| Material | Polypropylene; Stainless Steel;
Dialyzing Paper; Glue; Silicone
Oil | Polypropylene; Stainless
Steel; Dialyzing Paper; Glue;
Silicone Oil |
| Sterilization | EO Sterilization | EO Sterilization |
| | SAL of 10-6 | SAL of 10-6 |
| Labeling | Primary Packaging Label-
Size; EO Sterile; Use By Date;
Lot; Single Use; Manufacturer
Information;
Warnings; Enclosed Package
Insert. | Primary Packaging Label-
Size; EO Sterile; Use By Date;
Lot; Single Use; Manufacturer
Information;
Warnings. |
| Performance Testing | Biocompatibility
Pen Injector (NIS) Compatibility
Mechanical Testing
Sterility Validation
EO Residue
Shelf Life Testing | Biocompatibility
Pen Injector (NIS) Compatibility
Mechanical Testing
Sterility Validation
EO Residue
Shelf Life Testing |
Conclusion: The technological characteristics of the Advocate Insulin Pen Needles are the same as the Predicate Device. The differences of certain pen sizes (33 G 4 mm; 29G 12mm) with the Predicate Device do not raise new questions of safety and/or effectiveness as these two pen sizes have the same intended use, material, design, sterilization, labeling, and performance testing as the Predicate Device.
5
-
- Performance testing: The following table defines the nonclinical performance testing submitted. All pre-determined acceptance criteria were met:
| Performance Test | Normative References/ Description |
|---|---|
| Accelerated Shelf Life | ASTM F 1980-07 |
| ISO 11607-1 | |
| ISO 11608-2 | |
| ASTM F 1929 | |
| ASTM F88 | |
| EO Sterilization Validation | The validation process used a standard half |
| cycle method to demonstrate the efficacy of | |
| the EO sterilization process. | |
| EO Residual | Sterilant residual limit for limited exposure |
| met of EO |