(132 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and physical design of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is a spinal system designed for interbody fusion to treat degenerative disc disease, which involves mitigating a medical condition.
No
Explanation: The CLYDESDALE™ Spinal System is described as a system of "hollow vertebral body spacers" designed for interbody fusion in patients with degenerative disc disease. Its purpose is to facilitate fusion by holding autogenous bone graft and gripping end plates, which are therapeutic actions, not diagnostic.
No
The device description clearly states the device is comprised of physical components made of PEEK Optima 1 and Tantalum markers, and performance studies involve mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to facilitate interbody fusion in the lumbar spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of PEEK with Tantalum markers, designed to be placed within the body. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is mechanical support and fusion facilitation.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 consists of a variety of hollow vertebral body spacers featuring a convex. bullet nose design and an axial void designed to hold autogenous graft material. The subject device is comprised of medical grade PEEK Optima 1 and includes Tantalum markers for imaging purposes. This device is designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The predicate device ranges from 8mm to 16mm in height and from 45mm to 60mm in length. The purpose ofithis submission was to expand the sizes of the device to include a 40mm length device.
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)
The following mechanical tests of the subject CLYDESDALE™ Spinal System device were performed:
- static axial compression testing in accordance with ASTM 2077-03 .
- dynamic axial compression testing in accordance with ASTM 2077-03 .
- static shear compression testing in accordance with ASTM 2077-03 .
- . dynamic shear compression testing in accordance with ASTM 2077-03
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.
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K100175 page 1 of 2
CLYDESDALETM Spinal System 510(k) Summary January 2010
| I. | Company: | Medtronic Sofamor Danek
2600 Sofamor Danek Drive
Memphis, TN 38132
(901) 396-3133 | JUN - 2 2010 |
|----|----------|--------------------------------------------------------------------------------------------|--------------|
| | Contact: | Justine Viera
Regulatory Affairs Specialist | |
Proprietary Trade Name: CLYDESDALETM Spinal System II.
III. Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080)
- IV. Product Code: MAX
V. Product Description
The CLYDESDALE™ Spinal System consists of a variety of hollow vertebral body spacers featuring a convex. bullet nose design and an axial void designed to hold autogenous graft material. The subject device is comprised of medical grade PEEK Optima 1 and includes Tantalum markers for imaging purposes. This device is designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The predicate device ranges from 8mm to 16mm in height and from 45mm to 60mm in length. The purpose ofithis submission was to expand the sizes of the device to include a 40mm length device.
VI. Indications
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.
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K1001795
VII. Substantial Equivalence
Documentation, including mechanical test results, was provided which demonstrated that the subject CLYDESDALE™ Spinal System is substantially equivalent to the predicate CLYDESDALE™ device cleared in K083026, SE 12/29/08 and the CAPSTONE® device cleared in K073291, SE 04/24/08.
Brief Discussion of the Non-Clinical Tests Submitted VIII.
The following mechanical tests of the subject CLYDESDALE™ Spinal System device were performed:
- static axial compression testing in accordance with ASTM 2077-03 .
- dynamic axial compression testing in accordance with ASTM 2077-03 .
- static shear compression testing in accordance with ASTM 2077-03 .
- . dynamic shear compression testing in accordance with ASTM 2077-03
Subsidence testing was not repeated on the CLYDESDALE™ device because the predicate devices were determined to be more worst case.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue · Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 2 2010
Medtronic Sofamor Danek % Ms. Justine Viera Regulatory Affairs Specialist 2600 Sofamor Danek Drive Memphis, Tennessee 38132
Re: K100175
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: May 19, 2010 Received: May 21, 2010
Dear Ms. Viera:
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
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Page 2 - Ms. Justine Viera
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K100175 510(k) Number (if known): _
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)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100175