(117 days)
Not Found
No
The document describes a physical spinal implant system made of PEEK and titanium, intended for vertebral body replacement and intervertebral body fusion. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the physical device.
Yes
The device is described as a "Vertebral Body Replacement Device" and an "Intervertebral Body Fusion System," indicating its use in treating medical conditions like collapsed/damaged vertebrae due to tumor/trauma and degenerative disc disease to restore function and support fusion, which are therapeutic actions.
No
The device is an implantable medical device used for spinal fusion and replacement, not for diagnosing medical conditions.
No
The device description explicitly states it is an implant manufactured from PEEK with a titanium layer and coating, and includes tantalum markers. This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a spinal implant system designed for surgical implantation into the spine to replace vertebral bodies or facilitate spinal fusion. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Aesculap PEEK Spinal Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5), cervical intervertebral (C3-C7)
Indicated Patient Age Range
skeletally mature patients
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)
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS SIBD XP Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077.
- Static and dynamic axial compression per ASTM F2077.
- Shear resistance evaluation.
- Subsidence per ASTM F2267
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing in addition to in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:
- Microstructure of the coating per ASTM F1854.
- Static Tensile Strength per ASTM F1147.
- Static Shear Strength per ASTM F1044.
- Shear Fatigue Test per ASTM F1160.
- Abrasion Resistance per ASTM F1978
The results of these tests showed that the CeSpace XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
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
§ 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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APR 1 5 2013
CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)
Page 1 of 3
510(k) SUMMARY (as required by 21 CFR 807.92) B.
Aesculap® Implant Systems(AIS) - CeSpace XP Intervertebral Body Fusion System
December 18, 2012
| COMPANY: | Aesculap® Implant Systems (AIS), LLC.
3773 Corporate Parkway |
|----------|--------------------------------------------------------------------------|
| | Center Valley, PA 18034
Establishment Registration Number: 300567331- |
Lisa M. Boyle, Sr. Regulatory Affairs Specialist CONTACT: 610-984-9274 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com
| TRADE NAME: | AIS CeSpace XP Intervertebral Body Fusion System |
|---|---|
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | ODP |
| REVIEW PANEL: | Orthopedics |
INDICATIONS FOR USE
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebrail body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion erodial in Shape Min Hattoned elessed telefally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System is also intended for use with autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
1
CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated) K123909
Page 2 of ತಿ
DEVICE DESCRIPTION
The Aesculap CeSpace XP Intervertebral Body Fusion System is a cervical intervertebral I no fusiondevice that is implanted into the vertebral body space to improve stability of bour fusional hile supporting fusion. Components are offered in a variety of sizes to meet the requirements of the individual patient anatomy. Components are manufactured from the requirements of the Inalifical P026) with a titanium layer and a vacuum plasma spray coating (Plasmapore® - per ISO 5832-3). The device will have Tantalum markers per ASTM F-560.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the CeSpace XP Intervertebral Body Fusion System are offered in the same range of shapes and sizes as the predicate device. The material used for the the same Tango of Systems device is the same as that used to manufacture the predicate devices. The only difference between the predicate device and the subject produce is the titanium layer and a vacuum plasma spray coating (Plasmapore®).
PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the AIS SIBD XP Spinal System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic torsion per ASTM F2077 .
- Static and dynamic axial compression per ASTM F2077 .
- Shear resistance evaluation .
- . Subsidence per ASTM F2267
In addition to FDA's Spine Guidance, Aesculap has also completed non-clinical testing in addition to in the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The following tests were performed:
- Microstructure of the coating per ASTM F1854 .
- Static Tensile Strength per ASTM F1147 .
- Static Shear Strength per ASTM F1044 .
- Shear Fatigue Test per ASTM F1160 .
- · Abrasion Resistance per ASTM F1978
The results of these tests showed that the CeSpace XP Spinal Implant System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
SUBSTANTIAL EQUIVALENCE
AIS believes that the Cespace XP Intervertebral Body Fusion System is substantially All believes that the Ocepace Al " in the Aesculap CeSpace PÉEK VBR and Intervertebral Body
2
K123909 Page 3 of 3
Fusion Systems (K083311). The Plasmapore® coating has been used and cloared in a number of legally marketed product lines manufactured by Aesculap (hip, knee, and spinal implants) for many years.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2013
Aesculap Implant Systems, Incorporated % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K123909
Trade/Device Name: Aesculap® Implant Systems (AIS) - CeSpace XP Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 13, 2013 Received: March 14, 2013
Dear Ms. Boyle:
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
4
Page 2 - Ms. Lisa Boyle
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The first name, "Erin," is written in a standard, bold typeface. The middle initial, "I.," and the last name, "Keith," are rendered in a more decorative, outlined font, giving the overall name a unique and visually distinct appearance. The design suggests a logo or personal branding element.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CeSpace PEEK Intervertebral Body Fusion System (Plasmapore® Coated)
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number:_ K123909
Device Name: Aesculap® Implant Systems (AIS) – CeSpace XP Intervertebral Body Fusion System
Indications for Use:
When used as a Vertebral Body Replacement Device:
The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral or the upinal one and the Intent System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK Spinal Implant System implants can be used individually or in pairs. The Aesculap PEEK Spinal Implant System is also intended for use with bone graft.
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of CeSpace PEEK Implants that are circular in shape with flattened sides. The CeSpace implants are indicated for spinal fusion orrocedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 The Aesculap PEEK Spinal Implant System is also intended for use with System. autogenous bone graft.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Aesculap device.
Prescription Use
(per 21 CFR 801.109)
(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 Orthopedic Devices