The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.

Device Description

Not Found

AI/ML Overview

This document, K022752, is a 510(k) premarket notification for the Pandin Continuous Nerve Stimulating Catheter. It establishes substantial equivalence to predicate devices but does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

The provided text focuses on the administrative aspects of the 510(k) submission, including:

Device Name: Pandin Continuous Nerve Stimulating Catheter
Common Name: Continuous Nerve Stimulating Catheter
Classification Name: Kit, Conduction Anesthetic
Intended Use: Permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques, indicated for use up to 72 hours.
Predicate Devices: StimuCath Continuous Nerve Block Set (K021567), Neurotrac (K831715), and CLA Kit (Nerve Block Infusion) (K994059).
Substantial Equivalence Argument: The Pandin device is single patient, single use, intended to facilitate placement of a Peripherally Inserted Conductive Catheter for regional nerve block procedures, similar to its predicates. It's used procedurally the same as the StimuCath™ and contains the identical Tuhoy needle used in the CLA™ kit.
FDA Response: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (performance data, sample sizes, expert qualifications, ground truth details, MRMC studies, or training set information) from the provided text because it is not present in the document. The 510(k) summary for this device does not include details of performance testing or clinical studies for acceptance criteria.

Summary

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SEP - 9 2003

Image /page/0/Picture/1 description: The image shows a handwritten number, which appears to be 'K022752'. The numbers are written in a cursive style, with some connections between the digits. The writing is in black ink on a white background, and the image is clear and easy to read.

HDC Corporation's Pandin Continuous Nerve Stimulating Catheter 510(k) Summary

Name of Device:	Pandin Continuous Nerve Stimulating Catheter
Common or Usual Name:	Continuous Nerve Stimulating Catheter
Classification Name:	Kit, Conduction Anesthetic
CFR Section:	868.5140
Product Codes:	CAZ
Submitter:
HDC Corporation628 Gibraltar CourtMilpitas, CA 95035
Phone:	(408) 942-7340
Facsimile:	(408) 586-8680
Contact Person:	Earl Smart
Date Prepared:	08\06\02
Predicate Devices:

Intended Use:

StimuCath Continuous Nerve

Block Set

K021567

Neurotrac

(Neuro-Trace)

K831715

CLA Kit (Nerve

Block Infusion)

K994059

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Substantial Equivalence:

All predicate devices presented for comparison with the Pandin™ Continuous Nerve Stimulating Catheter are single patient, single use, intended to facilitate the placement of a Peripherally Inserted Conductive Catheter for regional nerve block procedures. Additionally the Pandin™ Continuous Nerve Stimulating Catheter is used procedurally the same as the StimuCath™ (K021567) and contains the identical Tuhoy needle used in the CLA™ kit (K994059).

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

Mr. Earl Smart Quality Assurance Manager HDC Corporation 628 Gibraltar Court Milpitas, California 95035

Re: K022752

Trade Name: Pandin Continuous Nerve Stimulating Catheter Regulation Number: 868.5140 Regulation Name: Kit, Conduction Anesthetic Regulatory Class: II Product Code: CAZ Dated: June 12, 2003 Received: June 13, 2003

Dear Mr. Smart:

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. Earl Smart

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 vour 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 yours.

Susan Punges

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

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Indications for Use Statement

510(k) Number	K022752
Device Name	Pandin Continuous Nerve Stimulating Catheter
	Indications for Use The Pandin TM Continuous Nerve Stimulating Catheter permits placement o

f catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-tne-counter Use

Q. Autoch for JXH 9/9/03

510(k) Number: K022752

000110

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).