(29 days)
Not Found
No
The summary describes a simple needle for administering vaccines or allergens and contains no mention of AI or ML.
No.
The device is described as a needle for administering vaccines or allergens, which are diagnostic or preventative rather than therapeutic.
No
Explanation: The device is intended for administering vaccines or epidermal allergens, not for diagnosing a condition.
No
The device description clearly states it is a "BD Bifurcated Needle," which is a physical medical device used for administering vaccines or allergens. There is no mention of software components or functionality.
Based on the provided information, the BD Bifurcated needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for administering vaccines and epidermal allergens by scarification. This is a direct application to the patient's skin for therapeutic or diagnostic purposes on the patient, not for testing samples outside the body.
- Device Description: The description is of a needle, a tool for administering substances.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The BD Bifurcated needle is a tool for administering substances to the body.
N/A
Intended Use / Indications for Use
The BD Bifurcated needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.
Product codes (comma separated list FDA assigned to the subject device)
SCL, LDH
Device Description
The BD Bifurcated Needle will be offered in the following reorder numbers: 301754; 301755; 301756; 301757.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
1
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.
2
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
3
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
4
1 Perton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 fax: 701 847 4896
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 (201) 847- 4513 (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