(189 days)
The Kyphon Discyphor 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 Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of nerforming provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Discyphor" Catheter System is comprised of a Discyphor" Catheter with guidewire funnel, a Discyphor" Guidewire, a Discyphor" Introducer Needle, a Discyphor" Spinal Needle, a stopcock, syringes, catheter connectors and labels. The Discyphor Catheter is a micro-catheter with a flexible shaft and a balloon located near the distal tip. The metallic Discyphor Guidewire is .009" in diameter and is radiopaque when viewed using fluoroscopy. The stopcock retains pressure within the balloon when used in conjunction with the syringes. The catheter connectors are connected to the lumens of the Discyphor Catheter and provide access to the lumens. Labels 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 Introducer Needle is designed specifically for use with the Discyphor Catheter System. The Discyphor Introducer Needle is stainless steel with a removable stainless steel stylet. The Discyphor Catheter is delivered through the Discyphor Introducer Needle and is tracked over the Discyphor Guidewire.
The Discyphor" Spinal Needle is a standard stainless steel needle with a removable stainless steel stylet. The hubs of the needle and stylet are comprised of polymer.
Here's an analysis of the provided text regarding the Discyphor™ Catheter System, focusing on acceptance criteria and supporting studies:
It is important to note that this 510(k) submission describes a material change to one component (the guidewire) of an existing device system, rather than an entirely new device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new guidewire material is equivalent to the previous one and that the overall system remains safe and effective for its stated intended use. This is a common approach in 510(k) submissions for modifications to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Material Properties | Bending Stiffness | Evaluated | In vitro testing |
| Peak Axial Strength | Evaluated | In vitro testing | |
| Fracture Resistance | Evaluated | In vitro testing | |
| Kink Resistance | Evaluated | In vitro testing | |
| User Performance | Physician Preference | Conducted | Laboratory physician preference testing |
| Biocompatibility | Acceptability for Intended Use | Demonstrates materials are acceptable | Biocompatibility testing |
| Overall Safety & Effectiveness | Safe and Effective for Intended Use | Demonstrated by testing results | Combination of in vitro, lab, and biocompatibility testing |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for any of the individual tests. The document refers to "in vitro testing" and "laboratory physician preference testing" without providing specific numbers of samples or participants.
- Data Provenance: The studies were in vitro (laboratory-based) and "laboratory physician preference testing." There is no mention of human clinical data or animal studies in this submission for the material change. The data provenance is likely research and development labs (Kyphon Inc. or contract labs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: For the "laboratory physician preference testing," the number of physicians involved is not specified.
- Qualifications of Experts: The document refers to "physician preference testing," implying that the experts were medical doctors. However, their specific qualifications (e.g., years of experience, specialization) are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable or not specified. This type of engineering and preference testing typically doesn't involve formal adjudication methods like "2+1" or "3+1" that are common in clinical image-reading studies. Physician preference is often a direct assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging. The Discyphor Catheter System is a medical device (catheter, needles, guidewire), not an AI-powered diagnostic tool. The submission is for a material change to a guidewire, which focuses on physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- Not applicable. The Discyphor Catheter System is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. The tests described (in vitro, biocompatibility, physician preference) evaluate the device components themselves.
7. The Type of Ground Truth Used:
- Ground Truth: For the material properties (bending stiffness, axial strength, fracture, kink resistance), the "ground truth" would be established by engineering and material science standards and measurements.
- For "physician preference testing," the "ground truth" is subjective expert opinion/preference from the participating physicians.
- For biocompatibility, the "ground truth" is compliance with established biocompatibility standards and guidelines (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This submission is for a physical medical device and a material change, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI training set, there is no ground truth established for one.
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Kyphon Inc. Page 1 of 3
Special Premarket Notification, K063071, Amendment 2 Discyphor™ Catheter System Discyphor™ Introducer Needle and Discyphor™ Spinal Needle
APR 1 3 2007
Premarket Notification [510(k)] Summary
| Trade Name: | DiscyphorTM Catheter SystemDiscyphorTM Introducer NeedleDiscyphorTM Spinal 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:Title:Address:Phone: | Cindy DomecusClinical Research and Regulatory Affairs Consultant1221 Crossman AvenueSunnyvale, CA 94089(408) 548-5421 |
| PredicateDevice(s): | K061210, Functional Anaesthetic Discography (F.A.D.)Catheter System, cleared on June 27, 2006.K043500, Functional Anaesthetic Discography (F.A.D.) |
Ary 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 a atestability perspective, from any of the other devices referenced in this filing.
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Kyphon Inc. Page 2 of 3
Intended Use: The Kyphon Discyphor 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 Discyphor Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Discyphor" Catheter System is comprised of a Discyphor" Catheter with Device Description: guidewire funnel, a Discyphor" Guidewire, a Discyphor" Introducer Needle, a Discyphor" Spinal Needle, a stopcock, syringes, catheter connectors and labels. The Discyphor Catheter is a micro-catheter with a flexible shaft and a balloon located near the distal tip. The metallic Discyphor Guidewire is .009" in diameter and is radiopaque when viewed using fluoroscopy. The stopcock retains pressure within the balloon when used in conjunction with the syringes. The catheter connectors are connected to the lumens of the Discyphor Catheter and provide access to the lumens. Labels 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 Introducer Needle is designed specifically for use with the Discyphor Catheter System. The Discyphor Introducer Needle is stainless steel with a removable stainless steel stylet. The Discyphor Catheter is delivered through the Discyphor Introducer Needle and is tracked over the Discyphor Guidewire.
The Discyphor" Spinal Needle is a standard stainless steel needle with a removable stainless steel stylet. The hubs of the needle and stylet are comprised of polymer.
Substantial This 510(k) describes a material change to the Discyphor Guidewire. The Equivalence: Discyphor Guidewire is one component of the Discyphor Catheter System.
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 pateriability perspective, from any of the other devices referenced in this filing.
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Kyphon Inc. Page 3 of 3
The guidewire materials for the Discyphor Guidewire include Nitinol and Elgiloy. In vitro testing was conducted on the materials to evaluate bending stiffness, peak axial strength, fracture and kink resistance. In addition laboratory physician preference testing was conducted. Biocompatibility testing conducted on the Discyphor Catheter System and Guidewire assembly demonstrates that the materials are acceptable for the intended use. The results of testing demonstrate that the guidewire materials are safe and effective for the intended use. The changes described in this submission do not represent a change to the intended use 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 K061210.
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 The present submission and statements infringement litigation or proceeding before any Patent Office. 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
APR 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Domecus Clinical Research and Regulatory Affairs Consultant Kyphon, Incorporated 1221 Crossman Avenue Sunnyvale, California 94089
Re: K063071
Trade/Device Name: Discyphor™ Catheter System, Discyphor™ Introducer Needle, Discyphor™ Spinal Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: March 14, 2007 Received: March 15, 2007
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 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. 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); 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), 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 yours.
Qives
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
510(k) Number (if known): K063071
Device Name: Discyphor™ Catheter System Discyphor
Discyphor Discyphor
Di Introducer Needle Discyphor Spinal Needle
Indications for Use:
The Kyphon Discyphor 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 Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of nerforming provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor 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)
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| of Anesthesia / General Hospital, |
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| Infection Control, Device Services |
| 510(k) Number: | K063071 |
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§ 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).