STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000

K021567 · Arrow Intl., Inc. · CAZ · Jun 19, 2002 · Anesthesiology

Device Facts

• Record ID: K021567
• Device Name: STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
• Applicant: Arrow Intl., Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow StimuCath™ Continuous Nerve Block Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.

Device Story

StimuCath is an electrically conductive anesthesia conduction catheter; used by clinicians to locate specific nerves or nerve plexuses via peripheral nerve stimulation. The device facilitates continuous nerve block anesthesia or analgesia. It is supplied in a sterile kit with accessories for catheter placement and fixation. The conductive nature of the catheter allows for nerve localization; the catheter remains in place for up to 72 hours to provide continuous anesthetic delivery. This assists clinicians in regional anesthesia procedures, potentially improving patient comfort and pain management.

Clinical Evidence

Clinical study performed to demonstrate substantial equivalence. No specific metrics or sample sizes provided in the summary document.

Technological Characteristics

Electrically conductive catheter for peripheral nerve stimulation. Kit includes accessories for catheter fixation. Sterilized device. Design and materials are consistent with predicate anesthesia conduction kits.

Indications for Use

Indicated for patients requiring continuous nerve block anesthesia or analgesia via catheter placement near nerves or nerve plexuses for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Arrow TheraCath® Epidural Catheter (K801912)
• HDC Corp Neurotrac (K831715)
• Contiplex Continuous Nerve Block Set (K840287)

Submission Summary (Full Text)

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JUN 1 9 2002

StimuCath Continuous Nerve Block Set

### 510(k) Premarket Notification

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121567

## SECTION 3. 510K SUMMARY

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| Submitter: | Arrow International Inc.<br>2400 Bernville Road<br>Reading, PA 19605 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | William G. McLain<br>Manager, Regulatory Submissions<br>and Quality Systems |
| | Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date summary prepared: | 5/8/02 |
| Device trade name: | StimuCath™ Continuous Nerve Block Set |
| Device common name: | Peripheral nerve stimulating catheter and needle |
| Device classification<br>name: | CAZ, Class II at 21 CFR 868.5140, Anesthetic Conduction Kit |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | K801912: Arrow TheraCath® Epidural Catheter<br>K831715: HDC Corp Neurotrac<br>K840287: Contiplex Continuous Nerve Block Set |
| Description of device: | The StimuCath™ Continuous Nerve Block Device is an<br>anesthesia conduction catheter that is electrically conductive.<br>Using peripheral nerve stimulation, the clinician can locate<br>specific nerves or nerve plexuses for continuous nerve block<br>anesthesia or analgesia.<br>The StimuCath™ is available sterile in a kit with the necessary<br>accessories required to perform the procedure and fix the<br>catheter in place. |
| Intended use of the<br>device: | The Arrow StimuCath™ Continuous Nerve Block Set permits<br>placement of catheters next to nerves and nerve plexuses for<br>continuous nerve block anesthesia or analgesia techniques. It<br>is indicated for use up to 72 hours. |
| Technological<br>characteristics: | The proposed device has similar technological characteristics<br>to the predicate devices including design, packaging,<br>sterilization and labeling. |

Comments of the country of the comments of

· · · · · · ·

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Performance tests:

The following tests were performed to demonstrate substantial equivalence:

- Holding strength of Snap-Lock™ adapter to catheter .
- Snap force of Snap-Lock TM .
- Leak test (positive pressure) .
- Flow rate
- Biocompatibility tests
- Power and current density calculations .
- Clinical study .

Conclusions:

The results of the laboratory tests, calculations and the clinical study demonstrate that the device is substantially equivalent to the legally marketed predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 . Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Arrow International Inc c/o Mr. William G. McLain Manager, Regulatory Submissions and Quality Systems 2400 Bernville Road Reading, PA 19605

Re: K021567

StimuCath™ Continuous Nerve Block Set Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II (two) Product Code: 73 CAZ Dated: May 8, 2002 Received: May 13, 2002

Dear Mr. McLain:

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. William G. McLain

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 and additionally 21 CFR Part 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Deaht Ten

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

# SECTION 13. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Ko21567

Device Name:

StimuCath™ Continuous Nerve Block device (SCNB).

Indications for Use:

The Arrow StimuCath™ Continuous Nerve Block Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021567