BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757

K020523 · Bd · SCL · Mar 20, 2002 · General Hospital

Device Facts

• Record ID: K020523
• Device Name: BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757
• Applicant: Bd
• Product Code: SCL · General Hospital
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

Device Story

BD Bifurcated Needle is a manual, single-use, sterile device used by healthcare professionals for vaccine administration via scarification or delivery of epidermal allergens. The device functions as a mechanical tool for skin-surface application. It is used in clinical settings. The healthcare provider uses the needle to deliver substances into the epidermis; this method facilitates immunization or allergy testing. The device is a simple, non-powered instrument.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, single-use, sterile needle. Designed for scarification or epidermal allergen administration. No energy source, software, or complex electronics.

Indications for Use

Indicated for administration of vaccines via scarification or administration of epidermal allergens in patients requiring such procedures.

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.

Predicate Devices

• Precision Medical Products (K012515)
• BD Vacutainer® Brand Blood Collection Needle (Pre-Amendment)

Submission Summary (Full Text)

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November 1, 2024

BD Medical Surgical Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical One Becton Drive MC226 Franklin Lakes, New Jersey 07417

Re: K020523

Trade/Device Name: BD Bifurcated Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Pasquale Amato:

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 March 20, 2002. 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.

Sincerelv.

# 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical One Becton Drive MC226 Franklin Lakes, New Jersey 07417

Re: K020523

Trade/Device Name: BD Bifurcated Needle Regulation Number: None Regulation Name: Bifurcated Needle Regulatory Class: Unclassified Product Code: LDH Dated: February 15, 2002 Received: February 19, 2002

Dear Mr. Amato:

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. Amato

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 [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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Surzo Quara

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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### REVISED

#### Indications for Use

The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

Patricia Ciascenite

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

3

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1 Perton Drive Franklin Lakes, New Jersey 07417 tel: [phone] fax: [phone]

### MAR 2 0 2002

## REVISED

Image /page/4/Picture/4 description: The image shows the BD logo. The logo consists of a circle with a stylized image of a person with rays emanating from their head. To the right of the circle are the letters "BD" in a bold, sans-serif font. The logo is black and white.

Indispensable to human health

#### Summary of Safety and Effectiveness for the BD Bifurcated Needle

BD Contact person: 1

> Pasquale Amato Requiatory Affairs Coordinator BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone [phone] (201) 847- 4855 Fax

Device Name: BD Bifurcated Needle

- 2 Predicate Device(s):
2.1 Precision Medical Products - K012515 2.2 BD Vacutainer® Brand Blood Collection Needle - Pre-Amendment

- Product Description / Function: 3
Product sizes/reorder numbers: The BD Bifurcated Needle will be offered in the following reorder numbers: 301754; 301755; 301756; 301757.

Intended Uses: The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

- Equivalence determination: 4
The elements of comparison between the BD Bifurcated Needle and the Precision Medical Products predicate device are as follows:

Labeling: The performance claims on the BD Bifurcated needle are equivalent to those of the predicated device, i.e .:

- Intended use ロ
- Single use o
- Sterile (including statement on package integrity) 0
- 0 Package open instruction

Summary of Safety and Effectiveness Gecton, Dickinson and Company