(19 days)
The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.
The Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens. They will be offered with a 29 and 30 gauge needle in an 8, 10 and 12 mm length.
The PenFine® Pen Needle is comprised of a siliconized stainless steel cannula welded into in a polyethyleneterapthalate (PETP) hub. A polyethylene protective cap snaps onto the hub over the needle. This assembly fits into a K-Resin outer protective container which provides the sterile barrier along with the peel tab.
The PenFine® has a patented design feature that differs from currently available pen needles. Existing pen needles must be screwed onto the threaded male extension of the injection pen. The PenFine® uses a single motion "snap on" mechanism.
The needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the Injection Pen. The back end of the cannula punctures the rubber injection port on the drug reservoir in the Injection Pen. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected.
When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The Injector Pen automatically delivers the drug through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
This document is a 510(k) summary for the Disetronic PenFine® Injection Pen Needle. It establishes substantial equivalence to existing predicate devices but does not provide a study to prove acceptance criteria. Instead, it relies on "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." Therefore, many of the requested fields cannot be filled.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document states: "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the acceptance criteria are met by virtue of being equivalent to existing, approved devices and conforming to standards, but the specific criteria and their measured performance are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. The document only vaguely mentions "Performance data has been generated".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of device (injection pen needle) does not typically involve expert review for "ground truth" in the way a diagnostic imaging device would. Performance is typically assessed through engineering tests and adherence to standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This device is a pen needle, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a pen needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated or applicable in the traditional sense for this device. Performance would likely be measured against engineering specifications, biocompatibility standards, and sterility testing, rather than a clinical "ground truth." The "ground truth" in this context is adherence to established standards for mechanical performance, sterility, and material safety.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not a machine learning model.
Summary of what is provided in the document regarding validation:
The document relies on "design equivalency and the functional and safety testing" to establish substantial equivalence to predicate devices (Novo Nordisk NovoFine 30 Injection Pen Needles and Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Injection Pen Needles).
The core of the "proof" for this device's acceptance seems to be:
- Comparison to Currently Marketed Devices: The Disetronic PenFine® Injection Pen Needles are stated to be substantially equivalent to established products on the market.
- Technological Characteristics: The document claims "The technological characteristics are the same as the predicate devices."
- Performance Data: It broadly states that "Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices." This implies that the device was tested against relevant industry standards (e.g., for needle sharpness, sterility, flow rates, compatibility with pens, material safety) and met the requirements, thus demonstrating equivalency to already approved devices.
In essence, this 510(k) summary indicates that the device meets acceptance criteria by demonstrating conformance to established standards and substantial equivalence to existing, approved devices, rather than through a novel clinical study with explicit acceptance metrics and performance results. Specific numerical performance metrics or detailed study methodologies are not included in this summary.
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SUMMARY OF SAFETY AND EFFECTIVENESS 8.0
"510(k) SUMMARY"
L L. 1097
Disetronic PenFine® Injection Pen Needle 8.1 Trade/Proprietary Name:
Injection Pen Needle 8.2 Common/Usual Name:
8.3 Classification Name: Hypodermic Single Lumen Needle
8.4 Comparison to Currently Marketed Devices
The Disetronic PenFine® Injection Pen Needles are substantially equivalent to the Novo Nordisk NovoFine 30 Injection Pen Needles and the Becton Dickinson B-D Micro-Fine, Ultra-Fine and Ultra-Fine II Iniection Pen Needles.
8.5 Device Description
The Disetronic PenFine® Injection Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens. They will be offered with a 29 and 30 gauge needle in an 8, 10 and 12 mm length.
The PenFine® Pen Needle is comprised of a siliconized stainless steel cannula welded into in a polyethyleneterapthalate (PETP) hub. A polyethylene protective cap snaps onto the hub over the needle. This assembly fits into a K-Resin outer protective container which provides the sterile barrier along with the peel tab.
The PenFine® has a patented design feature that differs from currently available pen needles. Existing pen needles must be screwed onto the threaded male extension of the injection pen. The PenFine® uses a single motion "snap on" mechanism.
The needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the Injection Pen. The back end of the cannula punctures the rubber injection port on the drug reservoir in the Injection Pen. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected.
When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The Injector Pen automatically delivers the drug through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
8.6 Indications for Use
The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen.
8.7 Technological Characteristics
The technological characteristics are the same as the predicate devices.
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8.8 Performance Data
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
8.9 Conclusion ﺴﮯ
Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the PenFine® Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle, with its wings spread and its head turned to the left. The eagle is composed of three curved lines, giving it a stylized and modern appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1997
Mr. Patrik De Haes President and CEO Disetronic Medical Systems, Incorporated C/O P/L Biomedical 7690 Cameron Circle Fort Myers, Florida 33912
Re : K973339 Disetronic Penfine™ Injection Pen Needle Trade Name: Requlatory Class: II Product Code: FMI September 5, 1997 Dated: September 5, 1997 Received:
Dear Mr. De Haes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Mr. De Haes
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) File Number:
(
Disetronic PenFine® Injection Pen Needle evice Name:
The Disetronic PenFine® Injection Pen Needles are intended for the Indications For Use: hypodermic injection of fluids 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) Patricia Cucenti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K973339
Prescription Use (Per 21 CFR 801.109)
ﺮ
OR
Over-The-Counter Use
..
(Optional Format 1-2-96)
§ 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).