(72 days)
The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Bifurcated Allergy Skin Testing Needle. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for a typical AI/software device.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance. This type of clearance generally relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different characteristics that do not raise new questions of safety and effectiveness. It does not involve a multi-reader multi-case study, standalone algorithm performance, or detailed ground truth establishment as would be seen for more complex AI-driven medical devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria in the context of an AI-driven device.
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November 1, 2024
Precision Medical Products, Incorporated Ronald D. Wolfe Manager, Regulatory Affairs 12 Industrial Way Denver, Pennsylvania 17517
Re: K031630
Trade/Device Name: Bifurcated Allergy Skin Testing Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear Ronald D. Wolfe:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 7, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.
Sincerely,
David Wolloscheck -S
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Public Health Service
AUG - 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald D. Wolfe Manager, Regulatory Affairs Precision Medical Products, Incorporated 12 Industrial Way Denver, Pennsylvania 17517
Re: K031630
Trade/Device Name: Bifurcated Allergy Skin Testing Needle Regulatory Class: Unclassified Product Code: LDH Dated: May 21, 2003 Received: May 27, 2003
Dear Mr. Wolfe:
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 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
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Page 2 - Mr. Wolfe
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Ruanes
Susan Runner, DDS, MA Interim 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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ミ INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K031430
Bifurcated Allergy Skin Testing Needle Device Name:
Indications for Use:
The bifurcated allergy skin testing needle is indicated for in-vivo diagnostic skin testing using the puncture technique.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patuxo Cuccento
510(k) Number: K031630
5
§ 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).