PERIFIX SAFETY EPIDURAL NEEDLES

K013610 · B.Braun Medical, Inc. · BSP · Jan 25, 2002 · Anesthesiology

Device Facts

• Record ID: K013610
• Device Name: PERIFIX SAFETY EPIDURAL NEEDLES
• Applicant: B.Braun Medical, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.

Device Story

Perifix® Safety Epidural Needle is a 17G or 18G, 3.5-inch needle designed for epidural space access. Device incorporates a safety mechanism to reduce needlestick risk. Operated by physicians in clinical settings for anesthetic/therapeutic agent delivery or catheter placement. Single-dose or continuous administration. Safety mechanism adapted from previously cleared IV catheter technology.

Clinical Evidence

Bench testing only.

Technological Characteristics

17G and 18G epidural needles; 3.5-inch length; includes integrated safety mechanism for needlestick prevention.

Indications for Use

Indicated for physicians to access the epidural space for anesthetic/therapeutic agent delivery or epidural catheter placement. Suitable for single-dose or continuous administration. 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

• Perican Epidural Cannula (K813179)
• Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter (K813186)
• Introcan Safety IV Catheter (K982805)

Submission Summary (Full Text)

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JAN 2 5 2002

K013610

## Summary of Safety and Effectiveness Information [510(k) Summary]

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2375<br>Contact: Sheri L. Musgnung, RA Manager |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Perifix® Safety Epidural Needle |
| COMMON OR USUAL<br>NAME : | Safety Epidural Cannula |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 868.5150: Anesthesia conduction needle and<br>868.5140: Anesthesia Conductin Kit . |
| PREDICATE DEVICE: | B. Braun Medical Inc. Perican Epidural Cannula, K813179<br>B. Braun Medical Inc. Perifix Set for Epidural Anesthesia Tuohy<br>Needle / Catheter, K813186<br>B. Braun Medical Inc. Introcan Safety IV Catheter, K982805. |
| DESCRIPTION: | The Perifix® Safety Epidural Needle will be available in a 17 Gauge<br>and 18 Gauge size and the usable length of the needle will be<br>3 ½ inches. The device consists of a safety device mechanism to<br>reduce the risk of needlesticks. |
| INTENDED USE: | An active needle stick prevention device used by physicians to<br>access the epidural space for the purpose of delivering an<br>anesthetic and/or therapeutic agent or to facilitate placement of<br>an epidural catheter. The needle can be used for single dose<br>administration or in conjunction with the epidural catheter for<br>continuous administration. |
| SUBSTANTIAL<br>EQUIVALENCE: | The Perifix® Safety Epidural Needle is identical in materials<br>and intended use to B. Braun Medical's premarket notification,<br>Perican Epidural Cannula, K813179 and B. Braun Medical's<br>premarket notification, Perifix Set for Epidural Anesthesia<br>Tuohy Needle/Catheter, K813186. The safety mechanism that is<br>utilized in this device has also been cleared in B. Braun<br>Medical's premarket notification, Introcan Safety IV Catheter,<br>K982805. Functional testing was performed to support that<br>there are no new issues of safety or effectiveness raised by the<br>Perifix® Safety Epidural Needle. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Ms. Sheri L. Musgnung B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109

Re: K013610

Perifix® Safety Epidural Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II (two) Product Code: 73 BSP Dated: October 31, 2001 Received: November 5, 2001

Dear Ms. Musgnung:

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. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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 - Ms. Sheri L. Musgnung

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc acrised that I Dr. break that your device complies with other requirements of the Act that I DIT has made a aond regulations administered by other Federal agencies. You must of any I cacal statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by bections (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) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematics notification " 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 If you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of Compinance at (301) 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation cititived, "Niberansibilities under the Act may be obtained from the Other general information the mational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. D. Johnson, M.D.

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## BIBR

## 2.0 Indications for Use Statement

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510(k) Number (if known):

Device Name: Perifix® Safety Epidural Needle

Indications For Use:

An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ ﮯ (Per 21 CFR 801.109) OR

Over-The-Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K013610

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