STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK

Q: Who is the manufacturer of STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK?

Arrow International, Inc. filed the 510(k) submission for STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (K030937).

Q: What is the FDA product code for STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK?

CAZ. It is classified under 21 CFR 868.5140 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK?

Arrow StimuCath™ continuous nerve block set (K021567); HDC® Corporation CLA™ regional block needle (K994059).

Q: Who can help prepare an FDA 510(k) submission like STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K030937 · Arrow International, Inc. · CAZ · Apr 23, 2003 · Anesthesiology

Device Facts

Record ID	K030937
Device Name	STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
Applicant	Arrow International, Inc.
Product Code	CAZ · Anesthesiology
Decision Date	Apr 23, 2003
Decision	SESE
Submission Type	Special
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 for periods not exceeding 72 hours.

Device Story

StimuCath™ is an electrically conductive anesthesia conduction catheter used to locate nerves or nerve plexuses via peripheral nerve stimulation. The device facilitates continuous nerve block anesthesia or analgesia. It is intended for use by clinicians in a clinical setting. The system includes a catheter and needle, utilizing electrical conductivity to assist in precise placement. The output is the successful positioning of the catheter for the delivery of anesthetic agents. Benefits include the ability to provide continuous regional anesthesia or analgesia for up to 72 hours, aiding in pain management.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included flow rate, leak testing, holding strength, snap force, biocompatibility, power and current density calculations, bond strength, dielectric tests, and peel back tests.

Technological Characteristics

Electrically conductive anesthesia conduction catheter. Includes SnapLock™ adapter. Features include flow rate, leak resistance, and bond strength. Sterilization method not specified. No software or electronic algorithm components.

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 StimuCath™ continuous nerve block set (K021567)
HDC® Corporation CLA™ regional block needle (K994059)

Related Devices

K021567 — STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 · Arrow Intl., Inc. · Jun 19, 2002
K052954 — CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET · Life-Tech, Inc. · Feb 15, 2006
K121403 — CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET · Teleflex, Inc. · Jun 20, 2012
K151072 — Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit · Solo-Dex, Inc. · Jan 22, 2016
K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 · Hdc Corp. · Sep 9, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ | 123 | |-------| | ర్యాల | | j | | | ## 510(k) Summary | Submitter: | ARROW International, Inc. 2400 Bernville Road Reading, PA 19605-9607 USA | |---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Brandon Epting, Regulatory Associate Phone: 610-378-0131, ext. 8498 Fax: 610-374-5360 Email: brandon.epting@arrowintl.com | | Date summary prepared: | 03/24/03 | | Device trade name: | StimuCath™ continuous nerve block set. | | Device common name: | Peripheral nerve stimulating catheter and needle. | | Device classification name: | CAZ, Class II, 21 CFR 868.5140, Anesthetic conduction kit. | | Legally marketed devices to which the device is substantially equivalent: | - Arrow StimuCath™ continuous nerve block set (K021567). - HDC® Corporation CLA™ regional block needle (K994059). | | Description of the device: | The StimuCath™ continuous nerve block device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the user can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia. | | Intended use of the device: | The Arrow StimuCath™ continuous nerve block set permits placement for catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia. It is indicated for use up to 72 hours. | | Technological characteristics: | The proposed device has the same technological characteristics as the predicate devices. | | Performance tests: | Tests were performed to demonstrate substantial equivalence in the following areas: - Flow rate - Leak test (positive pressure) - Holding strength of SnapLock™ adapter to catheter - Snap force of SnapLock™ - Biocompatibility tests - Power and current density calculations - Bond strength - Dielectric tests - Peel back tests | | Conclusions: | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. | {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## APR 2 3 2003 Mr. Brandon Epting Regulatory Associate ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607 Re: K030937 Trade/Device Name: StimuCath™ Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: March 24, 2003 Received: March 25, 2003 Dear Mr. Epting: 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. {2}------------------------------------------------ Page 2 - Mr. Epting 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 (OS) 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours. Suxer Runoes Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT | 510(k) Number (if known): | K030937 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | StimuCath™ continuous nerve block set | | 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) SAWutrsh (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number: K030937 مه محمد من معاهدات المحارث من محمد المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث ال