(88 days)
No
The device description focuses on the physical components and manufacturing process of a pen needle for insulin injection. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The modification described is a change in silicon coating application and labeling.
No.
The Stat Medical Pen Needle is used for drug delivery (subcutaneous injection of insulin) and does not inherently provide therapy.
No
The device is a pen needle intended for subcutaneous injection of insulin, which is a delivery mechanism, not a diagnostic tool.
No
The device description clearly outlines physical components (needle hub, needle protector, outer cover, cannula) made of materials like stainless steel and polypropylene, indicating it is a hardware device.
Based on the provided text, 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 medication directly into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a needle and its components, designed for injection. There is no mention of reagents, test strips, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Stat Medical Pen Needle is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.
The Stat Medical Super-Fine Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula.
The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized.
The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.
The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.
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)
Not Found
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
OCT - 2 2009
6.0 510(k) Summary
Date of Submission: June 12, 2009
Submitted by:
Mary L. Jean Director QARA Tel: 305-949-7828 Fax: 305-949-7370
Stat Medical Devices, Inc. 2056 NE 153rd Street North Miami Beach, Florida 33162
| Name of Device: | Stat Medical Pen Needle |
|---|---|
| Common or Usual Name: | Sterile disposable hypodermic needle |
| Proprietary Name: | Super-Fine Pen Needle |
| Classification Name: | Hypodermic single lumen needle |
| Classification Product Code: | FMI |
| Class: | II |
Intended use:
The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.
Description of Device:
The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula.
The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized.
The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.
The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.
Substantial Equivalence:
The modified Stat Medical Pen Needles have the same following similarities to devices that previously received 510(k) clearance:
- same indication for use t
- . same operating principle
1
- . incorporation of same materials
- ◆ same sterilization and packaging materials and processes
- . same basic design
In summary, the Stat Medical Super Fine Pen Needle described in this submission are, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, alongside the department's name in a circular arrangement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Ms. Mary L. Jean Director of Quality Assurance/Regulatory Affairs Stat Medical Devices, Incorporated 2056 North East 153td Street North Miami Beach, Florida 33162
OCT - 2 2009
Re: K092016
Trade/Device Name: Super-Fine Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 3, 2009 Received: September 4, 2009
Dear Ms. Jean:
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.
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.
3
Page 2- Ms. Jean
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 a 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 vours.
Susan Burns
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Name:
K092016 Super-Fine Pen Needles
Indications for Use:
The Stat Medical Super-Fine Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Prescription Use X . . (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Cintham V. Anm
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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