SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)

K061394 · Busse Hospital Disposables, Inc. · BSP · Sep 6, 2006 · Anesthesiology

Device Facts

• Record ID: K061394
• Device Name: SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Sep 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Specialty needles (Spinal Needle, Pencil Point Needle, and Epidural Needle) are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Device Story

Specialty needles (Spinal, Pencil Point, Epidural) consist of stainless steel cannula with plastic hub; some models include wings for stability; stylets made of steel or plastic. Used by clinicians in clinical settings for regional anesthesia delivery or epidural catheter placement. Device facilitates anesthetic administration; provides physical access to target anatomical space. Sterile, single-use, disposable; provided individually or in regional anesthesia trays.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: L929 MEM Elution, Kligman Maximization, Intracutaneous Injection, Systemic Injection, and Salmonella Typhimurium/Escherichia Coli Reverse Mutation Assay. All materials met safety requirements.

Technological Characteristics

Stainless steel cannula; plastic hub; optional plastic or steel stylets; optional wings. Tip styles: Quincke (sharp), Whitacre (pencil-point), Tuohy/Hustead (curved/sharp). Gauge range: 16g-25g; Length range: 1.5"-6". Sterile, single-use, disposable.

Indications for Use

Indicated for patients requiring regional anesthesia or epidural catheter placement via transient delivery of anesthetics. No specific age or gender restrictions noted.

Regulatory Classification

Identification

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

Predicate Devices

• Exel Spinal Needle (K895771)

Submission Summary (Full Text)

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K 061394

# SUMMARY

## SEP - 6 2006

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SPECIALTY NEEDLE

| Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>PO Box: 11067<br>75 Arkay Dr.<br>Hauppauge NY 11788 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary prepared: | May 16, 2006 |
| Product Trade Name: | Specialty Needles (Spinal Needle, Pencil Point<br>Spinal Needle, Epidural Needle) |
| Common Name: | Anesthesia Conduction Needle. |
| Classification: | Class II, 21 CFR 868.5150 |
| Product Code: | BSP |
| Predicate Device: | Exel Spinal Needle - (K895771) |
| Device Description: | Anesthesia conduction needles consist of different<br>styles. All the needles consist of a plastic hub<br>connected to a stainless steel cannula. Some of the<br>needles have stylets made of the same steel whereas<br>others have stylets made of plastic. Some of the<br>needles have wings which can be attached to the<br>hub for more stability depending on user procedure.<br>The needles have been categorized as following:<br>1. Spinal Needles (Quincke) |

- 2. Pencil Point Spinal Needle (Whitacre)
- 3. Epidural Needles (Tuohy & Hustead)

. .-

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The differences between the styles of needles are the tip of the needle, which is either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke).

| Needle Style | Gage Size Range | Length Range |
|------------------------------------------|-----------------|--------------|
| Spinal Needle (Quinke) | 18g to 25g | 1 ½" to 6" |
| Pencil Point Spinal Needle<br>(Whitacre) | 18g to 25g | 1 ½" to 6" |
| Epidural Needle (Tuohy, &<br>Hustead) | 16g to 25g | 1 ½" to 6" |

These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.

Intended Use:

Specialty needles (Spinal Needle, Pencil Point Needle, and Epidural Needle) are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

### 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay

These materials have met the testing requirements and were found to be acceptable for the intended use.

Summary of tests performed to prove the substantial equivalence of the Specialty Needles with the predicate device:

- 1. Same intended use
- 2. Same material
- 3. Same flow rate
- 4. Same bonding strength

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| Technological Characteristics: | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [21 CFR 807.92(a)(6)] | The subject device has the same Technological Characteristics as a legally marketed predicate device. |
| Conclusion: | |
| [21 CFR 807.92(b)(3)] | The above statements are accurate representations of the device Busse intents to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted. |
| Manufacturer: | Busse Hospital Disposables. |
| Official Correspondent: | <img alt="Muhamed Ares (Signature)" src="signature.png"/> |

Muhamad Ansari Date: ________________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing service and protection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive P.O. Box 11067 Hauppauge, New York 11788-0920

Re: K061394

Trade/Device Name: Specialty Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: August 25, 2006 Received: August 28, 2006

Dear Mr. Ansari:

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.

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#### Page 2 - Mr. Ansari

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

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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FDA 510(k) Premarket Notification Busse Hospital Disposables - Specialty Needles

#### INDICATIONS FOR USE

510(k) Number (if known): _________

Device Name: Specialty Needles.

, t

Indication for Use: specialty needles – Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Prescription Use × (Per 21 CFR 801Subpart D) AND/OR

Over-The-Counter Use_ (Per 21 CFR 801Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Number: K061394