(288 days)
Not Found
No
The summary describes a physical implant device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an "intervertebral body fusion device" used for "spinal fusion procedures" to treat degenerative disc disease and improve spinal stability, which directly indicates a therapeutic function.
No
The description states that it is an "intervertebral body fusion device" used to improve stability of the spine and support fusion. There is no mention of it being used for diagnosis, only treatment.
No
The device description clearly states it is an "intervertebral body fusion device that is implanted into the vertebral body space," and is manufactured from PEEK, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. This involves physically placing a device within the patient's body to treat a condition.
- Device Description: The device is described as an "intervertebral body fusion device that is implanted into the vertebral body space." This is a physical implant.
- 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 samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.
When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
Product codes
MAX, ODP
Device Description
Ackermann Intervertebral Body Fusion Device c|spine and t|spine 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 implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C2 to T1; lumbar spine, from L2 to 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)
The Ackermann Intervertebral Body Fusion Device c|spine implants were tested for static axial compression, dynamic axial compression, static torsion, and dynamic torsion in accordance with ASTM 2077 and for load induced subsidence in accordance with ASTM 2267. The t|spine implants were tested for static axial compression and dynamic axial compression in accordance with ASTM 2077 and for load induced subsidence in accordance with ASTM 2267.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Ackermann Instrumente GmbH % Mr. Frank Ferguson Chief Executive Officer Ferguson Medical International Device Consultants, LLC 332 Laskin Road, Suite 437 Virginia Beach, Virginia 23451
Re: K143450
Trade/Device Name: Ackermann Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 14, 2015 Received: August 17, 2015
Dear Mr. Ferguson:
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
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Page 2 - Mr. Frank Ferguson
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143450
Device Name
Ackermann Intervertebral Body Fusion Device
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device cispine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the clspine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.
When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device tispine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The tlspine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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finest surgical technology
Ackermann®
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Ackermann Medical Intervertebral Body Fusion Device c|spine and t|spine implants.
DATE PREPARED: 13 August 2015
APPLICANTS NAME AND ADDRESS:
Ackermann Instrumente GmbH Attn: Rolf Ackermann, CEO Eisenbahnstrasse 65-67 78604 Rietheim-Weilheim Germanv Phone: +49 7461 966170; FAX: +49 7461 9661770 RA@Ackermanninstrumente.de
APPLICANTS CONTACT PERSON IN THE USA:
Ferguson Medical International Device Consultants LLC Attn: Frank Ferguson, CEO 332 Laskin Road Suite 437 Virginia Beach, VA 23451 Phone: 757.286.4383; FAX: 801.749.0451 frankf@fergusonmedical-idc.com
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DEVICE NAME:
Trade Name: Ackermann Intervertebral Body Fusion Device Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion Device, 21 CFR 888.3080 Product Code: MAX, ODP
LEGALLY MARKETED DEVICES TO WHICH ACKERMANN IS CLAIMING SUBSTANTIAL EQUIVALENCE:
Primary Predicate Device: Amedica Valeo II Interbody Fusion Device (K142347) Additional Predicate Devices: Aesculap CeSpace PEEK Spinal Implant System (K083311) and Aesculap PEEK Spinal Implant System (K071983)
DEVICE DESCRIPTION:
Ackermann Intervertebral Body Fusion Device c|spine and t|spine 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 implant grade PEEK (polyetheretherketone, VESTAKEEP® i4 R bv Evonik).
INTENDED USE:
When used as a cervical intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device c|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Cervical interbody fusion implants are intended for use at one level in the cervical spine, from C2 to T1, for treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. Additionally, the c|spine implants are to be used with autogenous bone graft and supplemental fixation via an open, anterior approach.
When used as a lumbar intervertebral body fusion device, the Ackermann Intervertebral Body Fusion Device t|spine implants are indicated for spinal fusion procedures in skeletally mature patients. Lumbar interbody fusion implants are intended for use at either one level or two contiquous levels in the lumbar spine, from L2 to S1, for treatment of lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of
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the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. The t|spine implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may be implanted via a transforaminal approach. These implants are to be used with autogenous bone graft and supplemental fixation.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:
The components of the Ackermann Intervertebral Body Fusion Device c|spine and t|spine implants are offered in the same general range of sizes and shapes of the predicate devices. The material used for the Ackermann device is the same as that used to manufacture the reference predicate.
PERFORMANCE DATA:
The Ackermann Intervertebral Body Fusion Device c|spine implants were tested for static axial compression, dynamic axial compression, static torsion, and dynamic torsion in accordance with ASTM 2077 and for load induced subsidence in accordance with ASTM 2267. The t|spine implants were tested for static axial compression and dynamic axial compression in accordance with ASTM 2077 and for load induced subsidence in accordance with ASTM 2267.
CONCLUSIONS:
Based upon the testing and comparison to the predicate device, the Ackermann Intervertebral Body Fusion Device c|spine and t|spine implants have the same intended use and similar technological characteristics. Therefore, the device is substantially equivalent to other legally marketed devices.