(25 days)
Not Found
No
The 510(k) summary describes a spinal implant system made of PEEK with tantalum markers, intended for interbody fusion. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance study described is a cadaveric surgeon validation, which is typical for a mechanical implant.
No
The device, CLYDESDALE® Spinal System, is intended to facilitate interbody fusion in patients with Degenerative Disc Disease, providing structural support and correction during lumbar interbody fusion surgeries. While it addresses a medical condition, its primary function is structural support and fusion, not direct treatment or alleviation of a disease or its symptoms in the way a therapeutic device typically does (e.g., drug delivery, energy delivery, or active therapy). It acts as an aid to the fusion process rather than a direct therapeutic agent.
No
The CLYDESDALE® Spinal System is an implantable device designed to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description explicitly states the system consists of "PEEK cages of various widths and heights, which include tantalum markers." These are physical implants, not software.
Based on the provided information, the CLYDESDALE® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to facilitate interbody fusion in the lumbar spine using autogenous bone graft. This is a surgical implant used directly within the body.
- Device Description: The description details a system of PEEK cages with tantalum markers, designed to provide support during spinal fusion surgery. This is a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The CLYDESDALE® Spinal System does not perform this function.
Therefore, the CLYDESDALE® Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
Product codes
MAX
Device Description
The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation.
The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2 to S1
Indicated Patient Age Range
skeletally mature
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)
This modified labeling has been validated for the subject device by a cadaveric surgeon validation. Data from this validation supports the labeling modification. The intended use has not changed as the result of this labeling modification. This device is substantially equivalent to the predicate device.
A validation and risk analysis was completed for the labeling change. Based on the validation, risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject system demonstrates substantial equivalence to listed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K122591 Page 1 of 2
CLYDESDALE® Spinal System 510(k) Summary August 2012
SEP 18 2012
I. COMPANY:
II. CONTACT:
.
Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, Tennessee 38132
Becky Ronner Regulatory Affairs Specialist Telephone: (901) 399-2757 Fax: (901) 346-9738
III. PROPRIETARY TRADE NAME:
IV. CLASSIFICATION NAMES:
COMMON NAME:
Intervertebral Body Fusion Device
CLYDESDALE® Spinal System
Intervertebral Fusion with Bone Graft, Lumbar
CLASS:
PRODUCT CODE:
MAX (21 CFR 888.3080)
V. PRODUCT DESCRIPTION:
The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation.
II
The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allow them to be packed with autogenous bone graft.
VI. INDICATIONS FOR USE:
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental
1
fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to $1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
VII. Summary of the Technological Characteristics:
The subject system has the same indications, intended use and fundamental scientific technology as the previously FDA cleared predicate; CLYDESDALE® Spinal System K113528 (S.E. 12/20/2011). There has been no design, material, indication, sterilization changes to the previously cleared CLYDESDALE® Spinal System K113528 (S.E. 12/20/2011), the only change in the application is a modification to the labeling.
VIII. Identification of Legally Marketed Devices:
The fundamental scientific technology, design features and indications for use for the subject CLYDESDALE® Spinal System are identical to the predicate CL YDESDALE® Spinal System K113528 (S.E. 12/20/2011).
IX. Discussion of Non-Clinical Testing:
This modified labeling has been validated for the subject device by a cadaveric surgeon validation. Data from this validation supports the labeling modification. The intended use has not changed as the result of this labeling modification. This device is substantially equivalent to the predicate device.
X. Conclusion:
A validation and risk analysis was completed for the labeling change. Based on the validation, risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject system demonstrates substantial equivalence to listed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K122591
Trade/Device Name: Clydesdale® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 23, 2012 Received: August 24, 2012
Dear Ms. Ronner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical
SEP 18 2012
3
Page 2 - Ms. Becky Ronner
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K122591
Device Name: CLYDESDALE® Spinal System
Indications for Use:
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Dission of Surgical, Orthopedic, and Restorative Devices
K122591 510(k) Number_