The provided text is a 510(k) premarket notification for a medical device: the BD Bifurcated Needle. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with detailed acceptance criteria, sample sizes, and ground truth methodologies as might be found in a PMA (Premarket Approval) application or a more complex de novo classification request.

Based on the provided document, the device is a BD Bifurcated Needle, which is intended for "administering vaccines by the scarification method or administering epidermal allergens."

Therefore, much of the requested information regarding acceptance criteria and performance studies, particularly related to AI/algorithm performance, multi-reader studies, and detailed ground truth establishment, is not applicable to this type of device and submission.

Here's an attempt to answer the questions based only on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or report specific performance metrics from a formal study for the BD Bifurcated Needle. The equivalence determination is based on comparing "Labeling" and "performance claims" to a predicate device.

Table:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The equivalence determination is based on:	"The performance claims on the BD Bifurcated needle are equivalent to those of the predicated device"
- Intended use	Intended use is equivalent.
- Single use	Single-use status is equivalent.
- Sterile (including statement on package integrity)	Sterility and package integrity claims are equivalent.
- Package open instruction	Package open instruction is equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specified sample size for performance evaluation.
Data Provenance: Not specified. The submission relies on "equivalence determination" to a predicate device rather than novel clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The submission does not describe a study involving expert-established ground truth for a test set. This type of device (a needle) does not typically require such a ground truth establishment process for a 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (needle), not an AI-powered diagnostic or assistive tool. MRMC studies or AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to AI algorithms, which is not what the BD Bifurcated Needle is.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established in the context of a new performance study. The "ground truth" for this 510(k) is implicitly the established safety and effectiveness of the predicate device to which it is being compared.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets "acceptance criteria" (in the context of a 510(k) for this type of device) is an equivalence determination to a legally marketed predicate device.

The document states:
"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... to legally marketed predicate devices..."

And in the "Summary of Safety and Effectiveness":
"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, Single use, Sterile (including statement on package integrity), Package open instruction."

This means the submission relies on the established safety and effectiveness of the predicate device(s):

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

The "study" here is essentially the comparison and justification of substantial equivalence based on characteristics like intended use, design (implied by the device name, but not detailed in the provided snippets), and labeling claims, rather than a de novo clinical trial with specific performance metrics and acceptance criteria.

Summary

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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

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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 (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

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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 ___________________________________________________________________________________________________________________________________

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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

Regulation Number and Section

§ 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).