BIFURCATED VACCINATING NEEDLE

K012515 · Precision Medical Products, Inc. · SCL · Sep 19, 2001 · General Hospital

Device Facts

• Record ID: K012515
• Device Name: BIFURCATED VACCINATING NEEDLE
• Applicant: Precision Medical Products, Inc.
• Product Code: SCL · General Hospital
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.

Device Story

Bifurcated vaccinating needle; manual instrument used for vaccine administration via scarification method. Device facilitates delivery of vaccine into skin through scratching or pricking. Used by healthcare professionals in clinical settings. Simple mechanical design; no electronic components or software.

Clinical Evidence

No clinical data provided; device is a traditional manual instrument.

Technological Characteristics

Manual bifurcated needle; single-lumen design; intended for scarification. No electronic components, software, or energy source.

Indications for Use

Indicated for administration of vaccines via scarification method in patients requiring vaccination.

Regulatory Classification

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.

Submission Summary (Full Text)

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November 1, 2024

Precision Medical Products, Incorporated Ronald D. Wolfe Manager of Regulatory Affairs 12 Industrial Way Denver, Pennsylvania 17517

Re: K012515

Trade/Device Name: Bifurcated Vaccinating 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 September 19, 2001. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Mr. Ronald D. Wolfe Manager of Regulatory Affairs Precision Medical Products, Incorporated 12 Industrial Way Denver, Pennsylvania 17517

Re: K012515

Trade/Device Name: Bifurcated Vaccinating Needle Regulation Number: None Regulation Name: Bifurcated Needle Regulatory Class: Unclassified Product Code: LDH Dated: August 2, 2001 Received: August 6, 2001

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.

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Page 2 - Mr. Wolfe

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 (section 531-542 of the Act; 21); CFR 1000-1050.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely you

Timothy A. Ulatowski 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 STATEMENT 5.

510(k) Number (if known): K012515

> Bifurcated Vaccinating Needle Device Name:

Indications for Use:

The bifurcated vaccinating needle is indicated for use in administering vaccine by the scarification method.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuccinate

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _