(287 days)
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No
The summary describes a passive implantable device made of PEEK for spinal fusion and vertebral body replacement. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a spinal implant system used for vertebral body replacement and intervertebral body fusion to treat conditions like tumors, trauma, and degenerative disc disease, which are therapeutic interventions.
No
The device is described as an implant system for vertebral body replacement and intervertebral body fusion, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it is an "intervertebral body fusion device that is implanted into the vertebral body space" and is manufactured from PEEK material. This indicates a physical implant, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Aesculap PEEK Spinal Implant System is an "intervertebral body fusion device that is implanted into the vertebral body space." Its intended use is for surgical procedures to replace or fuse vertebral bodies in the spine.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. It is a physical implant used for structural support and fusion.
Therefore, this device falls under the category of 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 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 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 A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) 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. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. 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) months of non-operative treatment prior to being treated with the Aesculap device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5), L2-S1
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and dynamic testing of the Aesculap PEEK Spinal Implant System was performed in accordance with ASTM F2077 and/or F1717 as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.
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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Aesculap PEEK Spinal Implant System
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
MAY - 1 2008
Aesculap PEEK Spinal Implant System 3 March 2008
| COMPANY: | Aesculap®Implant Systems, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull
800-258-1946 (phone)
610-791-6882 (fax) |
| TRADE NAME: | Aesculap PEEK Spinal Implant System |
| COMMON NAME: | Intervertebral Body Fusion Device |
| CLASSIFICATION NAME: | Orthosis, Spinal Intervertebral Fusion |
| REGULATION NUMBER: | 888.3080 |
| PRODUCT CODE: | MAX |
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems, Inc. believes that the Aesculap PEEK Spinal Implant System is substantially equivalent to the Aesculao PEEK VBR System (K060762), the Spinal Elements Lucent and Lucent Magnum Interbody Fusion devices (K071724 & K073348).
DEVICE DESCRIPTION
The Aesculap PEEK Spinal Implant System is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK - Optima (per ASTM F2026).
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 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.
1
Aesculap PEEK Spinal Implant System
Page 2 of 2
When used as an Intervertebral Body Fusion System:
The Aesculap PEEK Spinal Implant System consists of A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) 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. DDD patients may also have up to Grade 1 Spondy/olisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. 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) months of non-operative treatment prior to being treated with the Aesculap device.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The components of the Aesculap PEEK Spinal Implant System are offered in the same range of shapes and sizes as the predicate devices. The material used for the Aesculap device is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
Static and dynamic testing of the Aesculap PEEK Spinal Implant System was performed in accordance with ASTM F2077 and/or F1717 as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2008
Aesculap Implant Systems, Incorporated % Mr. Matthew Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, PA 18034
Re: K071983
Trade/Device Name: Aesculap PEEK Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2008 Received: April 16, 2008
Dear Mr. Hull:
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.
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.
3
Page 2 - Mr. Matthew Hull
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT A.
510(k) Number: K071983
Device Name: Aesculap PEEK Spinal Implant 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 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 A-Space (semi-circular), ProSpace (bullet), and T-Space (curved) components. These implants are indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) 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. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at involved levels. These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The Aesculap PEEK Spinal Implant System is intended for use with supplemental spinal fixation systems that have been cleared for use in the lumbrosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The Aesculap PEEK Spinal Implants can be used individually or in pairs. 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) months of non-operative treatment prior to being treated with the Aesculap device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(ber 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)
Neil RPOgL for nx
Division of General, Restorative, and Neurological Devices
510(k) Number_Ko71983