DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR by KYPHON, INC.

The Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.

The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct ""Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System.

The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct " Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct" voner Needle is intended to be used only with the Discyphor Direct " Catheter System.

Device Description

The Discyphor Direct™ Catheter System is comprised of a Discyphor Direct™ Catheter, a Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly, an EPI-Guard Catheter Anchoring Device, Adhesive Clips, a Sheet of Labels, 1-cc Syringes and a Discyphor Direct™ Outer Needle (with stylet) and a Discyphor Direct™ Inner Needle (with stylet). The Discyphor Direct™ Catheter is a micro-catheter with a double lumen shaft and an inflatable balloon at its distal end.

The Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly are intended to be connected to the lumens of the catheter and to provide access to the lumens. The Balloon Inflation Assembly consists of an a 3-cc Syringe and a pressure relief valve. The Stopcock Assembly consists of a Stopcock, a Touhy Borst adapter and a Wing Nut. The Injection Assembly consists of a Touhy Borst adapter, a One-way valve and a Wing Nut. The EPI-Guard Catheter Anchoring Devices secures the catheter close to the needle puncture site. The Adhesive Clips are used to secure the catheter to the patient.

The 1-cc Syringes can be used for injection of contrast, antibiotic, and/or saline into the disc space.

The labels provided on the Label Sheet are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.

The Discyphor Direct " Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing.

The Discyphor Direct™ Inner Needle is manufactured from stainless steel and has a stainless steel stylet.

AI/ML Overview

The provided text describes the Kyphon Discyphor Direct™ Catheter System and its components (Outer Needle, Inner Needle). It states that the device was submitted for a 510(k) premarket notification, indicating a claim of substantial equivalence to previously cleared predicate devices. The study performed is not a clinical study in the traditional sense, but rather a series of engineering and performance tests to demonstrate that the device meets specifications and is substantially equivalent to predicates.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria Category	Reported Device Performance
Dimensional Verification	Meets specifications
Tensile Testing	Meets specifications
Bending Stiffness	Meets specifications
Corrosion Verification	Meets specifications
Fatigue Testing	Meets specifications
Functional Testing	Meets specifications
Handling	Meets specifications
Biocompatibility Testing	Completed and acceptable
Sterilization Validation	Completed and acceptable

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

The text does not specify the sample sizes used for each of the tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These are engineering and performance tests, not clinical studies involving human subjects in a traditional sense.

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)

This section is not applicable to this type of device and study. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy, where human expert interpretation is compared to an AI's output. The Kyphon Discyphor Direct™ system is a medical device for delivery of substances, and its performance is evaluated through engineering and functional tests against predefined specifications, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool would be.

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

This section is not applicable for the same reasons as in point 3. Adjudication methods are used in clinical trials or diagnostic accuracy studies to resolve discrepancies among expert readers. The tests performed for this device are objective engineering and performance tests.

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

There was no MRMC comparative effectiveness study done. This device is not an AI diagnostic tool; it is a catheter system for delivering substances. Therefore, a study comparing human readers with and without AI assistance is not relevant or applicable.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for the engineering and performance tests was based on predefined design specifications and industry standards for medical device performance, safety, and biocompatibility. For instance, dimensions must fall within specified tolerances, materials must meet certain tensile strength, and sterilization must achieve a specified sterility assurance level.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. Manufacturing processes and design iterations might involve internal testing, but this is not analogous to an AI training set.

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

This section is not applicable for the same reasons as in point 8.

Summary

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Kyphon Inc. Page 1 of 3, Tab 5

Tab 5 PREMARKET NOTIFICATION [510(k)| SU

Trade Name:	Kyphon Discyphor DirectTM Catheter SystemKyphon Discyphor DirectTM Outer NeedleKyphon Discyphor DirectTM Inner Needle
Common Name:	Anesthesia conduction catheterAnesthesia conduction needle
ClassificationName:	Class II, Anesthesia conduction needle, 21 CFR 868.5150
Device Code:	BSP
Manufacturer'sName:Address:	Kyphon Inc.1221 Crossman AvenueSunnyvale, CA 94089
CorrespondingOfficial:	Pamela Segale
Title:	Director, Regulatory Affairs
Address:	1221 Crossman AvenueSunnyvale, CA 94089
Phone:	(408) 548-5235
PredicateDevice(s):	K063071 (cleared on April 13, 2007):	DiscyphorTM Catheter SystemDiscyphorTM Introducer NeedleDiscyphorTM Spinal Needle
	K061210, (cleared on June 27, 2006) Functional AnaestheticDiscography (F.A.D.) Catheter System.
	K043500, (cleared on April 15, 2005) Functional AnaestheticDiscography (F.A.D.) Catheter System.
	The Kyphon Discyphor DirectTM Catheter System for the FunctionalAnaesthetic DiscographyTM Procedure, and its components, are intendedfor use in delivering either a single dose or continuous administration ofradiopaque contrast, local anaesthetics, and/or saline solution to theintradiscal space.

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 reclassification, and is not 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 application, or to whether the froduct addressed in this submission, or its use, may be considered indistinct, from a patentiality perspective, from any of the other devices referenced in this filing.

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The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct " Inner Needle and Discyphor Direct " Catheter into the intradiscal space. The Discyphor Direct ""Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System.

The Kyphon Discyphor Direct" Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct™ Inner Needle is intended to be used only with the Discyphor Direct " Catheter System.

The Discyphor Direct™ Catheter System is comprised of a Discyphor Device Description: Direct" Catheter, a Balloon Inflation Assembly, a Stopcock Assembly, an Injection Assembly, an EPI-Guard Catheter Anchoring Device, Adhesive Clips, a Sheet of Labels, 1-cc Syringes and a Discyphor Direct™ Outer Needle (with stylet) and a Discyphor Direct™ Inner Needle (with stylet). The Discyphor Direct™ Catheter is a micro-catheter with a double lumen

shaft and an inflatable balloon at its distal end.

The 1-cc Syringes can be used for injection of contrast, antibiotic, and/or saline into the disc space.

The labels provided on the Label Sheet are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not 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 application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

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The Discyphor Direct " Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing.

The Discyphor Direct™ Inner Needle is manufactured from stainless steel and has a stainless steel stylet.

Testing of the Discyphor Direct™ Catheter System and the Discyphor Testing Direct™ Needles was completed to demonstrate that the devices meet the specifications and performance characteristics, and were substantially equivalent to the predicate devices. This included dimensional verification, tensile testing, bending stiffnes, corrosion verification, fatigue testing, functional testing and testing of the handling. In addition, biocompatibility testing and sterilization validation were completed.

The Discyphor Direct™ Catheter System and the Discyphor Direct™ Sterilization Outer and Inner Needles will be provided sterile and are intended for single use only.
The Discyphor Direct"" Catheter System is packaged in a Tyvek® sealed Packaging and PETG tray and a cardboard box. The 1-cc syringes are packaged Labeling separately in Tyvek® pouches and are provided with the Discyphor Direct™ Catheter System package. The Discyphor Direct™ Outer and Inner Needles are packaged separately in Tyvek® pouches and are provided in a cardboard box.

The information submitted in this pre-market notification supports a Substantial determination that the Discyphor Direct™ Catheter System and Equivalence: Discyphor Direct" Outer and Inner Needles are substantially equivalent to the predicate devices cleared under K063071. The results of testing demonstrate that the Discyphor Direct™ Catheter System and Discyphor Direct " Outer and Inner Needles are safe and effective for their intended uses. The changes described in this submission do not represent a change to the intended usees and they do not represent a change in the fundamental scientific technology of the device. Therefore, the devices included in this submission are substantially equivalent to the predicate devices already cleared under K063071.

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 reclassification, and is not 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 application, or fo whether the product addressed in this submission, or its use, may be considered indistinct, from a pateriability perspective, from any of the other devices referenced in this filing.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three strokes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a sans-serif font.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela Segale Director, Regulatory Affairs Kyphon, Incorporated 1221 Crossman Avenue Sunnyvale, California 94089

Re: K073516

Trade/Device Name: Kyphon Discyphor™ Catheter System Kyphon Discyphor™ Outer Needle Kyphon Discyphor™ Inner Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: December 13, 2007 Received: December 14, 2007

Dear Ms. Segale:

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 - Ms. Segale

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 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 (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 the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Owes

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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K073516

Device Name: -

Kyphon Discyphor Direct™ Catheter System Kyphon Discyphor Direct™ Outer Needle Kyphon Discyphor Direct™ Inner Needle

Indications for Use:

The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Outer Needle is intended to be used only with the Discyphor Direct " Catheter System.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K073616 510(k) Number:

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).