(10 days)
The K-Pack II needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
The 29 Gauge or 30 Gauge K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
The provided text is a 510(k) summary for a medical device (29 Gauge and 30 Gauge K-Pack II Needle) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML system.
The document describes a submission to extend an existing product line of hypodermic needles. It focuses on demonstrating substantial equivalence to previously cleared devices based on intended use, design, technology, materials, and performance, along with safety information regarding sterility, biological evaluation, and expiration dating.
Therefore, I cannot fulfill your request for the specific details outlined (such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this information is not present in the provided text. The document is for a physical medical device, not an AI/ML diagnostic or predictive system.
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510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
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- Device Name
Proprietary Name
SEP 1 5 2006
29 Gauge & 30 Gauge K-Pack II Needle Classification Name Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II
- Reason for Submission
This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line. The size of the 29 Gauge needle and the 30 Gauge needle is smaller than what is currently cleared under the current K-Pack II Needle 510k (K984576). This Special 510k is being submitted because of potential issues of safety and effectiveness specific for a smaller/thinner needle. This 510k will provide supporting information that the 29 Gauge & 30 Gauge K -Pack II Needles are safe and effective and an acceptable extension of the current K-Pack II Needle product line.
3. Intended Use
The 29 Gauge & 30 Gauge K-Pack II Needle being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Note: This is the same intended use as the predicate device, K-Pack II Needle - K984576.
4. Description
The 29 Gauge or 30 Gauge K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
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- Substantial Equivalence
The 29 Gauge and 30 Gauge K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:
- Substantial Equivalence
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I . K-Pack II Needles (K984576)
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- Neolus Needles (K001572)
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TERUMO 30 Gauge Hypodermic Needle (K012646) 3.
Differences between the devices do not raise any significant issues of safety and effectiveness.
6. Additional Safety Information
The sterility of the 29 Gauge and 30 Gauge K-Pack II Needles is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 100 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices".
Ethylene oxide residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"
The 29 Gauge & 30 Gauge K-Pack II Needle, like the standard K-Pack II Needle (K984576), is an Externally Communicating device, Circulating Blood, Limited Exposure (24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing".
The expiration dating for the 29 Gauge & 30 Gauge K-Pack II Needle has been established at 5 years which is the same as the cleared K-Pack II Needles.
7. Conclusion
In summary, the 29 Gauge & 30 Gauge K-Pack II Needles are substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:
Differences between the devices do not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
SEP 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. M. J. Aerts Manager Regulatory Affairs Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 LEUVEN-BELGIUM
Re: K062608
Trade/Device Name: 29 Gauge and 30 Gauge K-Pack II Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 31, 2006 Received: September 5, 2006
Dear Mrs. Aerts:
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 adultcration.
If vour 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 - Mrs. Aerts
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 (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). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chih-Lin, Ph.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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Indications for Use
K 0626 510(k) Number (if known):
Device Name: 29 Gauge and 30 Gauge K-Pack II needle
Indications for Use:
The K-Pack II needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
Cuth D. V.
Jun Sign-Cff) on of Anesthesiology, General Hospital, Jion Control, Dental Devices in ber
§ 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).