FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B by KYPHON, INC.

The Functional Anaesthetic Discography (F.A.D.) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Functional Anaesthetic Discography (F.A.D.) Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the F.A.D. Catheter and Guidewire into the intradiscal space.

Device Description

The F.A.D. Catheter is a micro-catheter with a flexible shaft. The F.A.D. Catheter has a polymer balloon located near the distal tip. Once the F.A.D. Catheter is properly positioned, the balloon is inflated with a radiopaque contrast medium and assists in maintaining proper catheter placement during the procedure. The balloon is then deflated prior to removal of the F.A.D. Catheter. Two stainless steel tubes are contained inside the polymer shaft of the F.A.D. Catheter and serve as lumena. The inflation lumen is used for inflating and deflating the balloon and the guidewire / injection lumen is used for insertion of a guidewire and injection of radiopaque contrast, local anaesthetics, and/or saline solution. The proximal portion of both lumena are connected to the Portex® Epidural Catheter Connector Adapters during the procedure. There are two radiopaque markers on the F.A.D. catheter shaft, located proximally and distally within the balloon, allowing for radiographic positioning of the balloon. There are eight markers on the proximal end of the catheter which can be utilized to monitor stable catheter placement during the course of the procedure. The F.A.D. Introducer Needle is designed specifically for use with the F.A.D. Catheter System. The F.A.D. Introducer Needle is manufactured from stainless steel and has a stainless steel stylet. The F.A.D. Introducer Needle has a square cut distal tip with rounded edges. The stylet has a bevel tip. The F.A.D. Introducer Needle provides access to the area adjacent to the intradiscal space. The F.A.D. Catheter is delivered through the F.A.D. Introducer Needle and is tracked over the guidewire. The F.A.D. Catheter System is comprised of the following: One F.A.D. Catheter, One F.A.D. Introducer Needle, One Spinal Needle, One Guidewire, One Stopcock, One 3cc syringe, Two 1cc syringes, Two Catheter Connectors (toughy-borst adapters), One package of sterile labels. The F.A.D. Introducer Needle is also offered a la carte.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle. It primarily focuses on an addition of labeling information and asserts substantial equivalence to a previously cleared device (K043500), rather than presenting a study to prove a device meets specific performance acceptance criteria through clinical or analytical testing.

Therefore, many of the requested elements (e.g., acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not explicitly present in the provided text.

Based on the provided information, here's what can be extracted:

No new study was conducted to prove the device meets acceptance criteria. The submission is focused on labeling changes for an already-cleared device. The "study" mentioned is implicitly the original submission (K043500) that established substantial equivalence for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the current document because it's a labeling update submission, not an initial clearance for a new device requiring performance studies. The original predicate device (K043500) would have contained such data.

2. Sample size used for the test set and the data provenance:

Not applicable to this submission, as no new test set or performance study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable to this submission.

4. Adjudication method for the test set:

Not applicable to this submission.

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:

No MRMC study was done. This device is a mechanical catheter system, not an AI-driven diagnostic or assistive tool, so MRMC studies and AI effect sizes are not relevant.

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

No standalone algorithm performance study was done. This is a medical device, not a software algorithm.

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

Not applicable to this submission. The "ground truth" for this 510(k) is the assertion that the updated labeling does not change the fundamental safety or effectiveness demonstrated by the predicate device.

8. The sample size for the training set:

Not applicable to this submission.

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

Not applicable to this submission.

Summary based on the document:

This 510(k) submission (K061210) for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle is a labeling update only. It explicitly states: "This 510(k) is being filed for the addition of labeling information in the Instructions for Use... The additional contraindication, warnings, and adverse events noted in this submission do not represent a change to either device's intended use or indications for use. There are also no changes to the primary design elements for either device that are the subject of this submission. Therefore, devices and the device labeling are substantially equivalent to the devices already cleared under K043500."

Because this is a labeling update and not a submission for a new device or a significant modification, the typical performance data and study details requested are not part of this specific document. The evidence of the device meeting acceptance criteria would have been established during the clearance of the predicate device, K043500.

Summary

{0}------------------------------------------------

Kyphon Inc. Page 1 of 3, Tab 4 Special Premarket Notification [510(k)] Submission Functional Anaesthetic Discography Catheter System Functional Anaesthetic Discography Introducer Needle

061210

Tab 4

JUN 2 7 2006

Premarket Notification [510(k)] Summary

Trade Name:	Functional Anaesthetic Discography (F.A.D.) Catheter SystemFunctional Anaesthetic Discography (F.A.D.) Introducer Needle
Common Name:	Anesthesia conduction catheterAnesthesia conduction needle
Classification/Name:	Class II, Anesthesia conduction needle, 21 CFR 868.5150
Device Code:	BSP
Manufacturer'sName:Address:	Kyphon Inc.1221 Crossman AvenueSunnyvale, CA 94089
CorrespondingOfficial:	Cindy Domecus
Title:Address:	Vice President, Clinical Research and Regulatory Affairs1221 Crossman AvenueSunnyvale, CA 94089
Phone:	(408) 548-5421
Predicate Device(s):	K043500, Functional Anaesthetic Discography (F.A.D.)Catheter System, cleared on April 15, 2005.
Intended Use:	The Functional Anaesthetic Discography (F.A.D.) CatheterSystem is intended for use in delivering either a single dose orcontinuous administration of a radiopaque contrast, localanaesthetics, and/or saline solution to the intradiscal space.The Functional Anaesthetic Discography (F.A.D.) IntroducerNeedle is intended for use to access the area adjacent to theintradiscal space for the purpose of facilitating placement of theF.A.D. Catheter and Guidewire into the intradiscal space.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the intented to be intention may be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of reviews in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office. The present submission and statements therein there should not be construed as aftecting or relating to the "statent and "statent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from appration, or it perspective, from any of the other devices referenced in this filing.

{1}------------------------------------------------

Kyphon Inc. Page 2 of 3, Tab 4

Special Premarket Notification [510(k)] Submission Functional Anaesthetic Discography Catheter System Functional Anaesthetic Discography Introducer Needle

Device Description: The F.A.D. Catheter is a micro-catheter with a flexible shaft. The F.A.D. Catheter has a polymer balloon located near the distal tip. Once the F.A.D. Catheter is properly positioned, the balloon is inflated with a radiopaque contrast medium and assists in maintaining proper catheter placement during the procedure. The balloon is then deflated prior to removal of the F.A.D. Catheter. Two stainless steel tubes are contained inside the polymer shaft of the F.A.D. Catheter and serve as lumena. The inflation lumen is used for inflating and deflating the balloon and the guidewire / injection lumen is used for insertion of a guidewire and injection of radiopaque contrast, local anaesthetics, and/or saline solution. The proximal portion of both lumena are connected to the Portex® Epidural Catheter Connector Adapters during the procedure. There are two radiopaque markers on the F.A.D. catheter shaft, located proximally and distally within the balloon, allowing for radiographic positioning of the balloon. There are eight markers on the proximal end of the catheter which can be utilized to monitor stable catheter placement during the course of the procedure.
The F.A.D. Introducer Needle is designed specifically for use with the F.A.D. Catheter System. The F.A.D. Introducer Needle is manufactured from stainless steel and has a stainless steel stylet. The F.A.D. Introducer Needle has a square cut distal tip with rounded edges. The stylet has a bevel tip. The F.A.D. Introducer Needle provides access to the area adjacent to the intradiscal space. The F.A.D. Catheter is delivered through the F.A.D. Introducer Needle and is tracked over the guidewire.

The F.A.D. Catheter System is comprised of the following:

. One F.A.D. Catheter
. One F.A.D. Introducer Needle
. One Spinal Needle
One Guidewire
. One Stopcock
. One 3cc syringe
. Two 1cc syringes
Two Catheter Connectors (toughy-borst adapters) .
. One package of sterile labels

The F.A.D. Introducer Needle is also offered a la carte.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclares to " whether the intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent opplication, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a a ateritability perspective, from any of the other devices referenced in this filing.

{2}------------------------------------------------

Kyphon Inc. Page 3 of 3, Tab 4 Special Premarket Notification [510(k)] Submission Functional Anaesthetic Discography Catheter System Functional Anaesthetic Discography Introducer Needle

Substantial Equivalence:

This 510(k) is being filed for the addition of labeling information in the Instructions for Use of Kyphon's Functional Anaesthetic Discography (F.A.D.) Catheter System and Functional Anaesthetic Discography (F.A.D.) Introducer Needle. Both devices are already cleared for use under 510(k) #K043500. The additional contraindication, warnings, and adverse events noted in this submission do not represent a change to either device's intended use or indications for use. There are also no changes to the primary design elements for either device that are the subject of this submission. Therefore, devices and the device labeling are substantially equivalent to the devices already cleared under K043500.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the intended to has intensed in this submission may be lawfully market approval or reclared to "when it not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including parti infringement litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, or o whether the product addressed in this submission, or its use, may be considered indistinct, from a a atentability perspective, from any of the other devices referenced in this filing.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, conveying a sense of strength and protection. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2006

Ms. Cindy Domecus Vice President Kyphon, Incorporated Clinical Research and Regulatory Affairs 1221 Crossman Avenue Sunnyvale, California 94089

Re: K061210

Trade/Device Name: Functional Anaesthetic Discography (FAD) Catheter Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: June 5, 2006 Received: June 6, 2006

Dear Ms. Domecus:

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 m 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 premarker 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 cither class II (Special Controls) or class HI (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.

{4}------------------------------------------------

Page 2 - Ms. Domecus

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); .ji) 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 secure 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 P ), , , please contact the Office of Compliance at (240) 276-0120. 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 11-Division of Small Manufacturers. International and Consumer Assistance at its with and number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K061210

Device Name: Functional Anaesthetic Discography (FAD) Catheter System &

Functional Anaesthetic Discography (FAD) Introducer Needle

Indications for Use:

The Functional Anaesthetic Discography (FAD) Catheter System is interi for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.

The Functional Anaesthetic Discography (FAD) Introducer ! . . intended for use to access the area adjacent to the intradiscal space wo he purpose of facilitating placement of the FAD Catheter and Guidewire into. Inv intradiscal space.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Unite (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

tuis Smilcom

Page 1 of

n of Anas Leafology, General Hospits. Jon Control, Dental Devices

K061210

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).