SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES

K983858 · Sims Portex, Inc. · MIA · Jan 29, 1999 · Anesthesiology

Device Facts

• Record ID: K983858
• Device Name: SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
• Applicant: Sims Portex, Inc.
• Product Code: MIA · Anesthesiology
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

Device Story

Spinal anesthesia needles and introducer needles; used for regional anesthesia delivery. Device consists of luer hub, stainless steel cannula, and stainless steel stylet. Available in Lancet (Quincke), Pencil (Whitacre), and European (Sprotte) styles. Introducer needles (18g or 20g) facilitate initial skin puncture. Sterile, single-use, disposable. Operated by clinicians in clinical settings. Design features increased inside diameter, reduced outside diameter/wall thickness, and improved cannula strength compared to predicates. Provides faster flashback and reduced penetration force. Output is delivery of anesthetic agent to patient; aids in regional anesthesia procedures.

Clinical Evidence

Bench testing only. Comparison of flow rates, flashback speed, and penetration force between subject needles and predicate devices. Results showed increased inside diameter, reduced penetration force (up to 32.8% for Whitacre style), and improved or similar flashback performance compared to predicates.

Technological Characteristics

Materials: Stainless steel cannula and stylet, luer hub. Design: Lancet, Pencil, and European styles. Dimensions: 18g-25g gauge, 2.0"-6.0" length. Introducer needles: 18g or 20g. Sterile, single-use, disposable. No software or electronic components.

Indications for Use

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

Regulatory Classification

Identification

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

Predicate Devices

• Becton-Dickinson spinal needles
• Pajunk Medizintechnologie Sprotte spinal needles (K911221, K911202)
• Preferred Medical Products spinal needles (K885277)
• Sherwood Medical introducer needle
• American Medical Instruments, Inc. introducer needles

Submission Summary (Full Text)

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JAN 29 1999

K983858

#### SIMS Portex Inc.

l 0 Bowman Drive PO Box 0724

Keene NH 03431 USA ji. Telephone: [phone] Fax: [phone]

# H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

# 510(K) SUMMARY:

# COMPANY INFORMATION:

SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 [phone] Contact: Timothy J. Talcott Manager, Regulatory Affairs

#### PREPARATION DATE OF SUMMARY:

October 30, 1998

## TRADE NAME:

Spinal Anesthesia Needles

#### COMMON NAME:

Spinal Anesthesia Needles

# PRODUCT CLASS/CLASSIFICATION:

Class II, 80 MIA, 21 CFR 862.5150

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#### PREDICATE DEVICE(S):

Becton-Dickinson spinal needles, marketed as preamendment devices.

- Pajunk Medizintechnologie, Germany, Sprotte spinal needles, marketed under 510(k) K911221 and K911202.
- Preferred Medical Products ( a division of Ballard Medical Products), spinal needles purchased from Unisis Corp., Tokyo, Japan, marketed under K885277.

Sherwood Medical, introducer needle, marketed as preamendment device.

American Medical Instruments, Inc., New Bedford, MA, introducer needles, marketed as preamendment devices.

## DESCRIPTION:

A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte) (refer to drawings, attachment IX). The needles range in size as indicated in the following table:

| Needle Style | Gage Size Range | Length Range |
|----------------|-----------------|--------------|
| Lancet Point | 18g to 25g | 2.0" to 6.0" |
| Pencil Point | 22g to 25g | 2.0" to 6.0" |
| European Style | 24g to 25g | 2.0" to 6.0" |

The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.

## INDICATIONS FOR USE:

Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

# TECHNICAL CHARACTERISTICS:

The device has the same technical characteristics as the predicate device marketed by Preferred Medical Products, Becton-Dickinson, Pajunk, Sherwood, and AMI.

# NON-CLINICAL DATA:

To summarize, comparison testing between the proposed device and the predicate devices from Becton Dickinson, Pajunk, Sherwood, and AMI, the proposed devices compared well against the predicate devices. For the spinal needles, overall, an increased inside diameter

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was achieved with a reduced outside diameter and wall thickness, while still achieving increased strength of the cannula.

The greater inside diameter allowed for an increased flow rate for all of the Unisis needles tested. The flashback in the European Style (Sprotte) needles was generally quicker for the proposed device. The results of the Quincke (K-3 Lancet) type needles showed similar results for the 18, 20, and 22-gage cannula. The 25-gage cannula showed an improved rate of flashback. The Whitacre (Pencil Point) type needles also showed similar results between the predicate and proposed devices. When the stylete is retracted, the rate of flashback will be further increased.

Finally, the penetration force for all proposed needles was reduced by as much as 32.8% for the Whitacre (Pencil Point) type needle, except for the 22g and 25g Ouincke (K-3 Lancet) type needle, 1.9% and 13.3% respectively.

There are three proposed introducer needles. These compare favorably to the Sherwood and AMI needles for all criteria.

In summary, the differences in these needles are not significant and substantiate that the needles are safe and effective. This testing, and the marketing of the same spinal needles by Preferred Medical Products, substantiates this claim.

# CONCLUSION:

The testing performed and comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices.

Very truly yours.

SIMS PORTEX INC.

Timothy J. Fallon

Timothy J. Talcott Manager, Regulatory Affairs

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three overlapping heads, representing the department's focus on health, human services, and the well-being of the nation. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431

K983858 Re: Spinal Anesthesia Needles and Introducer Needles Regulatory Class: II (two) Product Code: MIA Dated: October 30, 1998 Received: November 2, 1998

Dear Mr. Talcott:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# B: INTENDED USE OF DEVICE

# PROPOSED INDICATIONS FOR USE:

Page 1 of 1

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510(k) Number (if known): Unknown

Device Name: Spinal Anesthesia Needles

Indications For Use:

Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use

Mark Kramer