(154 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implantable intervertebral body fusion device used in spinal surgery, which is considered a surgical or structural intervention rather than a therapeutic device in the sense of delivering therapy or affecting a biological process in a therapeutic manner.
No.
The device is an implantable fusion device used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an "implantable device manufactured from titanium alloy" and describes its physical components, indicating it is a hardware device, not software-only.
Based on the provided information, the Dyn-ALIF device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the spine in skeletally mature patients." This is a surgical implant used directly in the body for a structural purpose.
- Device Description: The description details an "implantable device manufactured from titanium alloy" with mechanical components designed for surgical implantation and stabilization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The Dyn-ALIF device is an implantable medical device used inside the body for surgical treatment.
N/A
Intended Use / Indications for Use
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.
The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I 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 to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing data was presented.
Summary of Clinical Tests (Not Applicable)
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.
K071795, P950019/S9, K983667, K010930, K024049
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.
0
Kost 6.13
Ionics Medical Corporation 248 Bird Haven Lane Ether, North Carolina 27247 lmashburn@pinehurst.net
tel. 910-428-9726 fax 910-428-1716
IONICS
MEDICAL CORPORATION
M. Laine Mashbur President and Chief Executive Officer
June 09, 2008
510(K) SUMMARY
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations 21 CFR 807.87(h) and in particular 21 CFR 807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
M. Laine Mashburn Company President and Director of Regulatory Affairs Ionics Medical Corporation 248 Bird Haven Lane P.O. Box 179 Ether, North Carolina 27247 Telephone: (910) 428-9726 Fax: (910) 428-1716 email: Imashburn@pinehurst.net
B. Device Name
Trade or Proprietary Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device Common or Usual Name: Spinal Implant or Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion DeviceWith Bone Graft, Lumbar Fixation Orthosis Device Class: Class II Classification: 21 CFR 888.3080 Product Code: MAX
C. Predicate Devices
The subject device is substantially equivalent to the NuVasive CoRoent System intervertebral body fusion device, K071795; the Surgical Dynamics Ray TFC intervertebral body fusion device, P950019/S9; the Ionics Levante Intervertebral Pillar vertebral body replacement device, K983667 and the Medtronic Sofamor Danek Verte-Span Spinal System vertebral body replacement device, K010930 and K024049.
D. Device Description
The Dyn-ALIF Anterolateral Intervertebral Body Fusion Device is an implantable device manufactured from titanium alloy which is available in the abutting plate interface
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NOV 1 4 2008
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dimension of 20mm x 30mm and a vertically expandable height ranging from 11mm anterior /9mm posterior to 15mm anterior/13mm posterior to suit the individual anatomic conditions of the patient. The assembled device consists of five components: two abutting plates with hollow threaded shafts, a central turnbuckle sleeve and two locking set screws. The components can be rigidly locked into a variety of heights, with each construct height measured for the individual case
E. Intended Use
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I 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 to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
F. Substantial Equivalence
Data was provided which demonstrate the Dyn-ALIF Anterolateral Intervertebral Body Fusion Device to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, function, material, labeling, biocompatibility, performance and standards with the named intervertebral body fusion predicate devices and upon equivalence in design (vertical expansion), material and labeling with the named vertebral body replacement predicate devices.
G. Summary of Non-Clinical Tests Mechanical testing data was presented.
H. Summary of Clinical Tests (Not Applicable)
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2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2008
NOV 14
Ionic Medical Corporation % M. Laine Mashburn President and Chicf Executive Officer 248 Bird Haven Lane Ether, North Carolina 27247
Rc: K081673
Trade/Device Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: October 29, 2008 Received: November 3, 2008
Dear M. Laine Mashburn:
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.
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Page 2 - M. Laine Mashburn
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. Mulhausen
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
510(k) Number (if known): とokllo73
Device Name: Dyn-ALIF Anterolateral Intervertebral Body Fusion Device
Indications for Use:
The Dyn-ALIF device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed for use with autogenous bone graft to facilitate fusion.
The Dyn-ALIF device is intended for use at either one level or two contiguous levels in the lumbar spine from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to grade I 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 to be used in patients who have had at least six months of non-operative treatment. The device is intended to be used with supplemental internal spinal fixation systems which are cleared by the FDA for use in the lumbar spine.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
NilapReddy. Sir mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081673
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