(69 days)
Not Found
No
The device description and intended use focus on mechanical components and delivery of substances, with no mention of AI/ML capabilities or data processing beyond basic functional testing.
No
The device is used to deliver substances (contrast, anesthetics, saline) for diagnostic procedures (provocative discography) and to facilitate catheter placement, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Kyphon Discyphor Direct™ Inner Needle is intended to "access the nucleus of an intervertebral disc for the purpose of performing provocative discography." Provocative discography is a diagnostic procedure used to determine if a disc is a source of pain.
No
The device description explicitly lists multiple hardware components, including catheters, needles, syringes, and other physical assemblies. There is no mention of software as a component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Kyphon Discyphor Direct™ Catheter System is designed for the delivery of substances (contrast, anesthetics, saline) directly into the intradiscal space and intervertebral disc. It is a tool used during a medical procedure (Functional Anaesthetic Discography™ Procedure) performed on the patient's body.
- Lack of Sample Analysis: The device does not analyze samples taken from the body to provide diagnostic information. It facilitates the delivery of substances for a diagnostic procedure, but it is not the diagnostic test itself.
Therefore, the device falls under the category of a medical device used in a diagnostic procedure, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Kyphon Discyphor DirectTM Catheter System for the Functional Anaesthetic DiscographyTM 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 DirectTM 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 DirectTM Inner Needle and Discyphor DirectTM Catheter into the intradiscal space. The Discyphor Direct TM Outer Needle is intended to be used only with the Discyphor DirectTM Catheter System.
The Kyphon Discyphor DirectTM 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 DirectTM Catheter into the intradiscal space. The Discyphor DirectTM Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor DirectTM Inner Needle is intended to be used only with the Discyphor DirectTM Catheter System.
Product codes (comma separated list FDA assigned to the subject device)
BSP
Device Description
The Discyphor DirectTM Catheter System is comprised of a Discyphor DirectTM 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 DirectTM Outer Needle (with stylet) and a Discyphor DirectTM Inner Needle (with stylet). The Discyphor DirectTM 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 DirectTM Outer Needle is manufactured from stainless steel and has a stainless steel stylet with a beveled tip and a polycarbonate wing.
The Discyphor DirectTM Inner Needle is manufactured from stainless steel and has a stainless steel stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intradiscal space, intervertebral disc
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the Discyphor Direct (TM) Catheter System and the Discyphor Testing Direct (TM) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Kyphon Inc. Page 1 of 3, Tab 5
Tab 5 PREMARKET NOTIFICATION [510(k)| SU
| Trade Name: | Kyphon Discyphor DirectTM Catheter System
Kyphon Discyphor DirectTM Outer Needle
Kyphon Discyphor DirectTM Inner Needle | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Anesthesia conduction catheter
Anesthesia conduction needle | |
| Classification
Name: | Class II, Anesthesia conduction needle, 21 CFR 868.5150 | |
| Device Code: | BSP | |
| Manufacturer's
Name:
Address: | Kyphon Inc.
1221 Crossman Avenue
Sunnyvale, CA 94089 | |
| Corresponding
Official: | Pamela Segale | |
| Title: | Director, Regulatory Affairs | |
| Address: | 1221 Crossman Avenue
Sunnyvale, CA 94089 | |
| Phone: | (408) 548-5235 | |
| Predicate
Device(s): | K063071 (cleared on April 13, 2007): | DiscyphorTM Catheter System
DiscyphorTM Introducer Needle
DiscyphorTM Spinal Needle |
| | K061210, (cleared on June 27, 2006) Functional Anaesthetic
Discography (F.A.D.) Catheter System. | |
| | K043500, (cleared on April 15, 2005) Functional Anaesthetic
Discography (F.A.D.) Catheter System. | |
| | The Kyphon Discyphor DirectTM Catheter System for the Functional
Anaesthetic DiscographyTM 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. | |
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.
1
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 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.
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.
2
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.
3
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.
4
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
5
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™ 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.
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: