(164 days)
No
The summary describes a passive implant device made of titanium, with no mention of software, algorithms, or any features that would suggest the use of AI or ML. The focus is on the physical properties and mechanical performance of the implant.
Yes
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease or degenerative scoliosis to aid in spinal fusion, which is a therapeutic intervention.
No
Explanation: The device, CASCADIA lumbar and cervical implants, is described as an intervertebral body fusion device intended to provide support and stabilization of the spine. It is a therapy device, not a diagnostic one.
No
The device description explicitly states the implants consist of "hollow tube structures additively manufactured from titanium alloy," indicating a physical hardware device.
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 CASCADIA implants are "intervertebral body fusion devices" intended for surgical implantation in the spine to aid in bone fusion. They are physical implants, not devices used to analyze biological samples.
- Lack of IVD-related information: The text does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes.
Therefore, the CASCADIA lumbar and cervical implants are medical devices, but they fall under the category of implantable surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
Product codes
MAX, ODP
Device Description
The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L2 to S1, from C2 to T1
Indicated Patient Age Range
skeletally mature
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
The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion. Engineering rationales determined that the proposed implants did not represent a new worst case for mechanical testing.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of
§ 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
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December 14, 2017
K2M, Inc. Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K172009
Trade/Device Name: Cascadia Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: November 15, 2017 Received: November 16, 2017
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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K172009 |
| Device Name | Cascadia Interbody System |
| Indications for Use (Describe) |
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic
bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with
degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may
also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally
mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an
adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used
with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic
CASCADIA lumbar implants (i.e.,
≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar
plate).
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic
bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with
cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally
mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with
supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e.,
≥ 10°) are required to be used with an
anterior cervical plate as the form of 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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510(k) SUMMARY Cascadia Interbody System K2M, Inc.
Submitter
K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175
Contact Person: Nancy Giezen Telephone: 571 919-2168 Date Prepared: 12/13/2017
Classification
Trade Name: Cascadia Interbody System Common Name: Intervertebral Fusion Device with Bone Graft Regulatory Class: Class II
Classification Name(s):
Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX) Intervertebral Fusion Device with Bone Graft, cervical (21 CFR 888.3080, Product Code: ODP)
Predicate Device(s)
Primary Predicate:
Device Description
The implants consist of hollow tube structures additively manufactured from titanium allov. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
Indications For Use
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These
4
patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., ≥ 20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate).
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
Technological Comparison to Predicate(s)
The Cascadia Interbody System implants were compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.
Non-Clinical Performance Evaluation
The worst case implants for the Cascadia Interbody System were previously tested and performed equally to or better than the predicate devices in static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267) and expulsion. Engineering rationales determined that the proposed implants did not represent a new worst case for mechanical testing.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of