(129 days)
Not Found
No
The document describes a physical implant device for spinal fusion and replacement, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "intervertebral body fusion device" used for spinal fusion procedures to treat conditions like cervical disc disease and degenerative disc disease, as well as for partial replacement of a diseased vertebral body due to tumors or trauma. These applications indicate a direct therapeutic function by treating a disease or condition.
No
The Aleutian implants are spinal fusion and vertebral body replacement devices, designed to provide structural support and stabilization. They do not perform diagnosis.
No
The device description clearly states it is a system of "hollow tube or horseshoe-shaped structures" made of PEEK and Tantalum, which are physical materials, not software. The function described is providing physical support and stabilization.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Aleutian implants are physical devices (hollow tubes or horseshoe-shaped structures) intended for surgical implantation into the spine to provide support and stabilization. They are used in spinal fusion procedures and vertebral body replacement.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition based on in vitro testing. Its function is purely structural and supportive within the body.
Therefore, the Aleutian Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical 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.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of 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.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, MQP
Device Description
The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Materials: The implants are manufactured from Medical Grade PEEK per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.
The purpose of this submission is to incorporate titanium implants into the system.
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; Thoracolumbar spine, from T1 to L5
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)
Previously cleared Aleutian spacers were tested in static compression, static torsion and dynamic compression per ASTM F2077. An engineering rationale determined that the proposed spacers do not represent a new worst case for testing and are therefore considered substantially equivalent to the predicates referenced.
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.
K082698, K101302, K103169, K110843, K113138, K130699
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
510(k) Summarv Aleutian IBF System K2M, Inc.
APR 0 3 2014
This safety and effectiveness summary for the Aleutian IBF System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act
| 1. Submitter : | K2M, Inc. |
|---|---|
| 751 Miller Drive SE | |
| Leesburg, VA 20175 | |
| Contact Person : | Nancy Giezen |
| K2M, Inc. | |
| Telephone: 703-777-3155 | |
| Fax: 703-777-8136 | |
| Date Prepared: | March 13, 2014 |
| 2. Tradename: | Aleutian IBF System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, lumbar (Product Code: MAX) |
| Intervertebral Fusion Device with Bone Graft, cervical (Product Code: ODP) | |
| Spinal Vertebral Body Replacement Device (Product Code: MQP) | |
| Regulation Number: | 888.3080, 888.3060 |
| Device Class: | Class II |
3. Description of the device:
The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Materials: The implants are manufactured from Medical Grade PEEK per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.
The purpose of this submission is to incorporate titanium implants into the system.
4. Intended Use:
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical 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.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of 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.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
1
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
5. Predicate or legally marketed devices which are substantially equivalent:
Documentation was provided which demonstrated that the subject Aleutian Spinal System components are substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698, K101302, K103169, K110843, K113138, K130699).
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
Previously cleared Aleutian spacers were tested in static compression, static torsion and dynamic compression per ASTM F2077. An engineering rationale determined that the proposed spacers do not represent a new worst case for testing and are therefore considered substantially equivalent to the predicates referenced.
7. Conclusion:
There are no significant differences between the Aleutian Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE Leesburg, Virginia 20175
Re: K133614
Trade/Device Name: Aleutian IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP. MAX. MQP Dated: February 5, 2014 Received: February 6. 2014
Dear Ms. Giezen:
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. Ilsting of devices, good manufacturing practice, labcling, 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 many Federal statutes and regulations administered by other Federal agencies. You must or any i ederal statuates and regeraments, 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
3
Page 2 - Ms. Nancv Giezen
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 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/Resourcesfor You/Industry/default.htm. Also, please 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/McdicalDevices/Safetv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K133614
Device Name Aleutian IBF System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the ALEUTIAN implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical 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.
When used as a lumbar intervertebral body fusion device, the ALEUTIAN implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are 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 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.
When used as vertebral body replacement devices the ALEUTIAN implants are indicated for use in the thoracolumbar spine (T) to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or traumalfracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The ALEUTIAN implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the ALEUTIAN implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ...
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
í