BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237

K081446 · Becton, Dickinson & CO · BSP · Jul 17, 2008 · Anesthesiology

Device Facts

• Record ID: K081446
• Device Name: BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
• Applicant: Becton, Dickinson & CO
• Product Code: BSP · Anesthesiology
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

BD Spinal needle consists of non-lubricated stainless steel cannula and stylet; components joined with epoxy adhesive; protected by polypropylene shield. Device used by clinicians to inject local anesthetics for regional anesthesia. Single-use, sterile or non-sterile packaging.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel cannula and stylet; epoxy adhesive; polypropylene shield. Manual conduction needle for anesthetic injection.

Indications for Use

Indicated for patients requiring regional anesthesia via injection of local anesthetics. Prescription use only.

Regulatory Classification

Identification

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

Predicate Devices

• BD Spinal Needle (K081446)
• BD Precisionglide Needle (K081446)
• BD Hypoint Needle (K081446)

Submission Summary (Full Text)

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K081446

# 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: [phone] 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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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 [phone]. 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 [phone] or [phone] 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

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

1081446 510(k) Number:

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