(86 days)
No
The 510(k) summary describes a mechanical spinal implant system and its intended use. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to facilitate interbody fusion in patients with Degenerative Disc Disease (DDD), which is a medical condition. Its purpose is to provide support during fusion and correct spinal issues, directly impacting a patient's health and aiming to alleviate pain and improve function.
No
No
The device description explicitly states the system consists of "PEEK cages of various widths and heights, which include tantalum markers," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a spinal system designed for interbody fusion in the lumbar spine. This is a surgical implant used in vivo (within the body).
- Device Description: The description details physical implants (PEEK cages with tantalum markers) that are surgically inserted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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.
The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).
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
Mechanical Testing was conducted according to FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". For a determination of substantial equivalence, the following nonclinical mechanical tests were performed:
Tests Performed: Static Compression- Shear, Compression- Shear Fatigue
Applicable Standards: F2077 (Test Methods for Intervertebral Body Fusion Devices) ASTIM
The subject implants met the acceptance criteria. Based on the results, the subject implants demonstrated that they are as safe, as effective and perform as well as the predicate device(s).
Key Metrics
Not Found
Predicate Device(s)
K100175, K090353, K120368, K073291, K071795
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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CLYDESDALE® Spinal System 510(k) Summary December 10, 2013
DEC 1 1 2013
I. COMPANY:
II. CONTACT:
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132
Mr. Brad Sheals, MS Senior Regulatory Affairs Specialist Telephone: (901) 396-3133 Fax: (901) 346-9738
III. PROPRIETARY TRADE NAME:
CLYDESDALE® Spinal System
IV. CLASSIFICATION NAME:
COMMON NAME:
CLASS:
PRODUCT CODE:
REGULATION NUMBER:
Intervertebral Fusion with Bone Graft, Lumbar
Intervertebral Body Fusion Device
II .
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.
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.
1
The purpose of this 510(k) submission includes additional implant sizes and trials for the CLYDESDALE® Spinal System. The subject implants will be offered in 18mm, 22mm, 26mm widths, 0°, 8°, 12°, 18° of lordosis and 8mm, 10mm, 12mm, 16mm. 18mm. 20mm heights, and in the same lengths as the predicate CLYDESDALE® Spinal System, K100175 (S.E. 06/02/2010).
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 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.
VII. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
The purpose of this Traditional 510(k) submission is to seek clearance of additional implant sizes and trials into the CLYDESDALE® Spinal System family. The design, materials and fundamental technology are the same as the current CLYDESDALE® Spinal System.
VIII. IDENTIFICATION OF LEGALLY MARKETED DEVICES USED TO CLAIM SUBSTANTIAL EQUIVALENCE:
The design features and indications for use for the subject CLYDESDALE® Spinal System are substantially equivalent to the following predicates:
- CLYDESDALE® Spinal System, K100175, (S.E. 06/02/2010)
- 트 PERIMETERTM Spinal System, K090353, (S.E. 09/29/2009)
- CAPSTONE CONTROLTM Spinal System, K120368 (S.E. 04/09/2012) D
- . CAPSTONE® Spinal System K073291, (S.E. 04/24/2008)
- 발 CoRoent® System K071795. (S.E. 12/04/2007)
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IX. DISCUSSION OF NON-CLINICAL TESTING:
An assessment of the subject CLYDESDALE@ Spinal System was completed in accordance with Medtronic design control processes.
Mechanical Testing was conducted according to FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". For a determination of substantial equivalence, the following nonclinical mechanical tests were performed:
| Tests Performed Applicable Standards | |
|---|---|
| Static Compression- Shear | F2077 (Test Methods for ) |
| ASTIM | |
| Compression- Shear Fatigue | Intervertebral Body Fusion Devices) |
The subject implants met the acceptance criteria. Based on the results, the subject implants demonstrated that they are as safe, as effective and perform as well as the predicate device(s).
X. DISCUSSION OF CLINICAL TESTING:
No clinical testing was required.
XI. CONCLUSIONS DRAWN FROM THE NON-CLINICAL TESTING:
Based on the risk assessment, test results and additional supporting documentation provided in this premarket notification, Medtronic believes the subject CLYDESDALE® Spinal System demonstrates substantial equivalence to the listed predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
December 11, 2013
Medtronic Sofamor Danek USA, Incorporated Brad Sheals, MS Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K132897
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: September 13, 2013 Received: September 16, 2013
Dear Mr. Sheals:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Brad Sheals, MS
forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable. the electronic product radiation control provisions (Sections 331-542 of the Act): 21 CFR 1000-1050.
11 you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, picase note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Reportal?roblem/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.
Sincercly vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K132897
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 ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedio Devices
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