(6 days)
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.
The provided document is a 510(k) summary for the Disetronic Penfine® Insulin Injection Pen Needle, seeking Over-The-Counter (OTC) use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with specific acceptance criteria in the same way a novel device might.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion/Requirement | Reported Device Performance (vs. Predicate) |
|---|---|
| Design Equivalency | The Disetronic Penfine® Insulin Injection Pen Needles are described as the "same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles" as the predicate devices (K982399, K994197, K992399). |
| Technological Characteristics | "The technological characteristics are the same as the predicate devices." |
| Functional and Safety Testing | "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." |
| Indications for Use | Intended for hypodermic injection of insulin into the body when attached to an injector pen, which is assumed to be equivalent or consistent with the predicate device's indications. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of human subject testing (e.g., patient data). It refers to "Performance data... generated in compliance with existing international standards and protocols." For a device like an injection pen needle, this typically involves bench testing for aspects such as needle strength, flow rate, sterility, penetration force, and compatibility with injection pens.
- Sample Size: Not explicitly stated for bench testing, but would be determined by the relevant international standards and protocols.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data would be generated from lab tests, not human data, so "retrospective or prospective" does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. A 510(k) for a device like an insulin pen needle relies on engineering specifications, material properties, and performance standards, not expert consensus on human-derived data for establishing ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts when establishing ground truth on image analysis or clinical data. Since the performance data refers to bench testing against standards, human adjudication is not relevant.
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
This information is not applicable. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. The Disetronic Penfine® Insulin Injection Pen Needle is a mechanical medical device, not an AI or diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question pertains to AI algorithms. The Disetronic Penfine® Insulin Injection Pen Needle is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be defined by engineering specifications, material standards (e.g., for biocompatibility, sterility), and performance standards for hypodermic needles. For instance, needle sharpness might be "ground-truthed" against a specific force measurement standard, or flow rates against a volumetric standard.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of an AI algorithm or model development for this type of medical device.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows the text 'K013782' in a handwritten style. The text appears to be a code or identifier, with the letter 'K' followed by a series of numerical digits. The handwriting is clear and legible, with a slight slant to the right.
Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
NOV 2 0 2001
"510(k) SUMMARY"
| Trade/Proprietary Name: | Disetronic Penfine® Insulin Injection PenNeedle |
|---|---|
| Common/Usual Name: | Insulin Injection Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle |
Comparison to Currently Marketed Devices
The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399).
Device Description
The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.
Indications for Use
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hyoodermic injection of insulin into the body when attached to an injector pen.
Technological Characteristics
The technological characteristics are the same as the predicate devices.
Performance Data
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
Conclusion
Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the Penfine® Insulin Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. David E. Chadwick Director, Regulatory Affairs/Quality Assurance Disetronic Medical Systems 5151 Program Avenue Saint Paul. Minnesota 55112-1014
Re: K013782
Trade/Device Name: Disetronic Penfine Insulin Injection Pen Needle Regulation Number: 880.5570 Regulation Name: Insulin Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: November 12, 2001 Received: November 14, 2001
Dear Mr. Chadwick:
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.
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
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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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Kj Wlatust
Timoth A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use
NOV 2 0 2001
INDICATIONS FOR USE STATEMENT
510(k) File Number:
Device Name:
Insulin Injection Pen Disetronic Penfine® Needle
Indications For Use:
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| 'Division Sign-Off | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| Number | K013782 |
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_ OR
§ 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).