(56 days)
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an epoxy adhesive. When appropriate for the procedure, this needle includes a stylet. This stylet consists of non-lubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an epoxy adhesive. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or nonsterile, single use, purposes.
This document is a 510(k) summary for the BD Spinal Needle. It asserts substantial equivalence to existing predicate devices rather than presenting a study demonstrating it meets specific acceptance criteria based on novel performance.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text, as this type of submission focuses on equivalence to already approved devices rather than a de novo performance study against defined criteria.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the BD Spinal Needle in the typical sense of a de novo device study. Instead, it claims "identical technological characteristics and perform equivalently" to predicate devices. There are no quantitative measures or thresholds mentioned that the device needed to meet.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No specific test set or data provenance details are provided in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices based on design and intended use, not on a new comparative performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not Applicable. No test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set
Not Applicable. No test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done, as this submission is for a spinal needle, which is a physical medical device, not a diagnostic imaging or AI system typically subject to MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. This device is a physical spinal needle; there is no algorithm or AI component to evaluate.
7. The Type of Ground Truth Used
Not Applicable. No ground truth establishment is described for performance evaluation. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not a machine learning model, so there is no training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set mentioned or implied.
Summary of Device's Argument for Meeting "Acceptance Criteria" (Substantial Equivalence):
The "acceptance criteria" for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices: BD Spinal Needle, BD Precisionglide Needle, BD Hypoint Needle (all manufactured by Becton, Dickinson and Company).
- Method of Proof: Comparison of device features, materials, intended use, and existing device performance.
- Conclusion: The sponsor states that "The BD Spinal Needle and the predicate device have the same identical technological characteristics and perform equivalently." This assertion is the primary "proof" for this type of submission.
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination signifies that the device has met the "acceptance criteria" for marketing under a 510(k) pathway, which is substantial equivalence.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
l . Submitted By:
JUL 1 7 2008
Pasquale Amato, RAC, CQA Senior Regulatory Affairs Specialist
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
Classification Name: Needle, Conduction, Anesthetic w/wo Introducer
Classification: Class II
3. Predicate Device:
BD Spinal Needle BD Precisionglide Needle BD Hypoint Needle Manufactured by: Becton, Dickinson and Company
4. Device Description:
The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an epoxy adhesive. When appropriate for the procedure, this needle includes a stylet. This stylet consists of non-lubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an epoxy adhesive. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or nonsterile, single use, purposes.
റ 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.
i
000017
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge to form the shape of a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Pasquale Amato, RAC, CQA Senior Regulatory Affairs Specialist Becton, Dickinson and Company BD Medical Surgical Systems 1 Becton Drive Franklin Lakes, New Jersey 07417
JUL 1 7 2008
Re: K081446
Trade Davice Namo: BD Spinal Noodle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: May 21, 2008 Received: May 22, 2008
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 promarket 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.
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Page 2 - Mr. Simon
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); 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 lecally 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric® s (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
f Susa Rumnes
Chiu Lin, Ph.D.
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
14081446 510(k) Number (if known):
Device Name: BD Spinal Needle
Indications For Use:
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anosthesia.
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)
W. Maly fn M. Husband
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1081446 510(k) Number:
000020
§ 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).