(95 days)
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.
Not Found
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for Artsana Hypodermic Needles and InsuPen® Insulin Pen Needles:
Important Note: The provided document is an FDA letter of substantial equivalence, not a detailed technical report or study summary. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, and detailed study designs) is not available within these pages. The FDA 510(k) process for these types of devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics as might be seen for novel or high-risk devices.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Hypodermic Needles: | |
| * Sterility | Met (as implied by regulatory compliance) |
| * Ability to inject fluids | Met (intended use) |
| * Ability to withdraw fluids | Met (intended use) |
| * Compatibility with intended use (general medical procedures) | Substantially equivalent to predicate devices |
| Insulin Pen Needles: | |
| * Sterility | Met (as implied by regulatory compliance) |
| * Ability to inject insulin | Met (intended use) |
| * Compatibility with insulin pen injector devices | Met (intended use) |
| * Subcutaneous injection | Met (intended use) |
| General: | |
| * Biocompatibility | Met (implied by material and process controls) |
| * Physical/Mechanical integrity | Met (implied by manufacturing controls) |
| * Safety & Effectiveness (comparable to predicate) | Established through substantial equivalence |
Note: The "acceptance criteria" for these types of devices are generally established by recognized standards (e.g., ISO for sterility, needle dimensions, penetration force) and the performance of the predicate device. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets similar performance and safety profiles. Specific numerical criteria and corresponding data are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The 510(k) process for hypodermic needles often relies on bench testing and comparison to predicate devices, rather than large-scale clinical test sets.
- Data Provenance: Not specified, but generally, for substantial equivalence, the data would come from internal testing conducted by the manufacturer (Artsana S.P.A.) or from established performance data of the predicate device. It is generally retrospective in the sense that it relies on existing knowledge and testing methodologies. Country of origin for testing is not stated, but the manufacturer is Artsana S.P.A. (an Italian company).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified in the context of this 510(k) submission. "Ground truth" in this context usually refers to objective measurements against established standards for physical and material properties (e.g., needle sharpness, sterility validation). Human expert consensus is typically not the primary method for establishing "ground truth" for basic medical devices like needles, unless it involves usability or patient feedback studies, which are not outlined here.
4. Adjudication method for the test set
- Not applicable/Not specified. The assessment is primarily against technical specifications and predicate device equivalence, not through expert adjudication in the classic sense.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-enabled device. This question is not relevant to a hypodermic needle or insulin pen needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI-enabled device and does not involve an algorithm in the sense of a diagnostic or therapeutic AI.
7. The type of ground truth used
- The ground truth would be based on objective technical standards (e.g., ISO standards for medical devices, specifically needles), bench testing results (e.g., injection force, integrity, flow rates, sterility tests), and data demonstrating equivalence to the performance characteristics of predicate devices. It would likely incorporate pathology indirectly through biocompatibility testing (e.g., materials not causing adverse tissue reactions). Outcomes data would typically not be a primary ground truth for basic device clearance unless significant clinical safety or efficacy questions were raised.
8. The sample size for the training set
- Not applicable/Not specified. For medical devices like needles, there isn't a "training set" in the machine learning sense. Performance is typically established through manufacturing process controls, quality assurance testing, and adherence to design specifications and standards.
9. How the ground truth for the training set was established
- Not applicable. As there's no "training set" in the machine learning context, this question is not relevant. The performance and safety of these devices are assured through design validation, verification testing (against established standards), and manufacturing quality systems rather than through data training.
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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.
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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
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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)
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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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§ 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).