The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an insert molding process. When appropriate for the procedure, this needle includes a stylet. This stylet consists of nonlubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an insert molding process. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or non-sterile, single use, purposes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (BD Spinal Needle) seeking substantial equivalence to a predicate device. It is a regulatory submission, not a study report that details acceptance criteria and performance data for a new device's efficacy or safety. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document.

The document discusses the substantial equivalence of the BD Spinal Needle to existing predicate devices based on identical technological characteristics and intended use. This type of submission relies on the established safety and effectiveness of the predicate, rather than conducting new clinical performance studies for the new device itself.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently.
	Based on comparison of device features, materials, intended use, and performance, the BD Spinal Needle has shown to be substantially equivalent to the commercially available predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable and not provided. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new performance study with a test set of data.
Data provenance: Not applicable. No new data from a test set is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable and not provided. No ground truth for a test set was established as part of this submission. The regulatory review process involves FDA experts evaluating the submission for substantial equivalence.

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

Not applicable and not provided. No test set requiring adjudication was used.

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:

No MRMC or AI-related study was done. This device is a physical medical instrument (spinal needle), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithmic device.

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

Not applicable. The "ground truth" in this context refers to the established safety and effectiveness of the predicate device, which is assumed by the FDA for substantial equivalence evaluations. No new ground truth needed to be established for the submitted device's performance.

8. The sample size for the training set:

Not applicable and not provided. This is not an AI/machine learning device that requires a training set.

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

Not applicable and not provided. No training set was used.

Summary

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1091758

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Submitted By:

Pasquale Amato, RAC, CQA Senior Regulatory Affairs Specialist

OCT - 9 2009

Becton, Dickinson and Company BD Medical Surgical Systems 1 Becton Drive MC 237 Franklin Lakes, NJ 07417

201-847-4513 Phone: 201-847-5307 Fax:

2. Device Name:

BD Spinal Needle Trade Name: Common Names: Spinal Needle Needle, Conduction, Anesthetic w/wo Introducer Classification Name: Classification: Class II

3. Predicate Device:

BD Spinal Needle 25G BD Spinal Needle 27G Manufactured by: Becton, Dickinson and Company

4. Device Description:

న్. Intended Use:

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

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6. Technological Characteristics:

The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently.

7. Substantial Equivalence:

Based on comparison of the device features, materials, intended use and performance, the BD Spinal Needle has shown to be substantially equivalent to the commercially available predicate devices.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug. Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002

Pasquale Amato, RAC, CQA Senior Regulatory Affairs Specialist Becton, Dickinson and Company BD Medical Surgical 1 Becton Drive MC237 Franklin Lakes, New Jersey 07417

OCT - 9 2009

Re: K091758

Trade/Device Name: BD Spinal Needle 27G Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: September 10, 2009 Received: September 16, 2009

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 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.

. ...

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Page 2 - Mr. Amato

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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting Division 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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Indications for Use

510(k) Number (if known):

Device Name: BD Spinal Needle 27G

Indications For Use:

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulte

Page 1 of _ 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091758

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).