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 Description

The StimuCath™ Continuous Nerve Block Device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia. The StimuCath™ is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "StimuCath Continuous Nerve Block Set." It lists performance tests, including a clinical study, that demonstrate substantial equivalence to predicate devices. However, the document does not provide detailed acceptance criteria or specific results of the clinical study beyond stating that it was performed and contributed to the conclusion of substantial equivalence.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests but does not explicitly define acceptance criteria or specific quantitative results for the StimuCath Continuous Nerve Block Set within the provided text. It concludes that the "results of the laboratory tests, calculations and the clinical study demonstrate that the device is substantially equivalent to the legally marketed predicate devices."

Acceptance Criteria	Reported Device Performance
Holding strength of Snap-Lock™ adapter to catheter	Performed, concluded substantial equivalence.
Snap force of Snap-Lock™	Performed, concluded substantial equivalence.
Leak test (positive pressure)	Performed, concluded substantial equivalence.
Flow rate	Performed, concluded substantial equivalence.
Biocompatibility tests	Performed, concluded substantial equivalence.
Power and current density calculations	Performed, concluded substantial equivalence.
Clinical study	Performed, concluded substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions a "clinical study" but does not provide any details regarding the sample size, country of origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions a "clinical study" but does not provide any details regarding experts used for ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document mentions a "clinical study" but does not provide any details regarding an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes a medical device (a catheter and needle for nerve blocks), not an AI diagnostic or assistance system. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable, and none was done in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document mentions a "clinical study" but does not specify the type of ground truth used. Given the nature of a nerve block set, it's likely related to successful nerve localization and analgesia/anesthesia outcomes, but this is not explicitly stated.

8. The sample size for the training set

The document mentions a "clinical study" for performance testing but does not mention a separate training set or its sample size. This is common for traditional medical devices where performance is evaluated through design verification, validation, and clinical studies rather than machine learning model training.

9. How the ground truth for the training set was established

As no training set is indicated, this information is not applicable.

Summary

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JUN 1 9 2002

StimuCath Continuous Nerve Block Set

510(k) Premarket Notification

121567

SECTION 3. 510K SUMMARY

Submitter:	Arrow International Inc.2400 Bernville RoadReading, PA 19605
Contact person:	William G. McLainManager, Regulatory Submissionsand Quality Systems
	Phone: 610-378-0131Fax: 610-478-3188E-mail: bill.mclain@arrowintl.com
Date summary prepared:	5/8/02
Device trade name:	StimuCath™ Continuous Nerve Block Set
Device common name:	Peripheral nerve stimulating catheter and needle
Device classificationname:	CAZ, Class II at 21 CFR 868.5140, Anesthetic Conduction Kit
Legally marketed devicesto which the device issubstantially equivalent:	K801912: Arrow TheraCath® Epidural CatheterK831715: HDC Corp NeurotracK840287: Contiplex Continuous Nerve Block Set
Description of device:	The StimuCath™ Continuous Nerve Block Device is ananesthesia conduction catheter that is electrically conductive.Using peripheral nerve stimulation, the clinician can locatespecific nerves or nerve plexuses for continuous nerve blockanesthesia or analgesia.The StimuCath™ is available sterile in a kit with the necessaryaccessories required to perform the procedure and fix thecatheter in place.
Intended use of thedevice:	The Arrow StimuCath™ Continuous Nerve Block Set permitsplacement of catheters next to nerves and nerve plexuses forcontinuous nerve block anesthesia or analgesia techniques. Itis indicated for use up to 72 hours.
Technologicalcharacteristics:	The proposed device has similar technological characteristicsto the predicate devices including design, packaging,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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).