(95 days)
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No
The 510(k) summary describes standard hypodermic and pen needles, which are mechanical devices and do not mention any AI/ML components or functionalities.
No
The device is used to inject or withdraw fluids, including insulin, not to treat a condition itself.
No
Explanation: The device is described as hypodermic needles and pen needles used for injecting or withdrawing fluids, or for subcutaneous injection of insulin. These are interventional/therapeutic actions, not diagnostic ones. Diagnostic devices are used to identify or determine a disease or condition.
No
The device description clearly indicates the device is a physical product (hypodermic needles and pen needles) used for injection, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the needles are for injecting or withdrawing fluids from parts of the body below the surface of the skin and for subcutaneous injection of insulin. This involves interacting directly with the human body.
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
Since the device is used on the body for injection and withdrawal, it falls under the category of a medical device used for therapeutic or diagnostic procedures performed in vivo (within the living body), not in vitro.
N/A
Intended Use / Indications for Use
Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Product codes
FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
OCT 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Artsana S.P.A. C/O Ms. Lara N. Simmons Official Correspondent Simcon International 22411 60th Street Bristol, Wisconsin 53104
Re: K051783
Trade/Device Name: Artsana Hypodermic Needles, Artsana InsuPen® Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: September 20, 2005 Received: September 23, 2005
Dear Ms. Simmons:
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 such 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
Page 2 - Ms. Simmons
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sustie Y. Michau O.M.D.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (if known): K051783
Device Name: Artsana Hypodermic Needles
Indications for Use:
Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use (Per 21 CFR 801 Subpart C) (Part 21 CFR 901 Subpart D)
AND/OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Umberto D,n
Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthosision Control. Devices
510(k) Number
(Optional Format 12-96)
3
of Page
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Artsana InsuPen® Insulin Pen Needles
Indications for Use:
Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
ﮯ۔ Prescription Use (Per 21 CFR 801 Subpart C) (Part 21 CFR 901 Subpart D)
AND/OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 12-96)
Chm vem
(Division Sign-Off) (britision Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices and them of Anesthesiology, Gene Infection Control, Dental Devices
510(k) Number: K951283
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