(177 days)
No
The document describes a physical implant made of titanium alloy for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as an "intervertebral body fusion device" intended for "treatment of degenerative disease" and to "provide support and stabilization" for spinal segments. These functions align with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device described is an implant used for intervertebral body fusion to provide support and stabilization. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device consists of "hollow tube structures made of titanium alloy," which are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "intervertebral body fusion device" used in surgery to treat degenerative disc disease. This is a therapeutic and structural function within the body.
- Device Description: The description details the physical structure of the implants (hollow tube structures made of titanium alloy) and their function as a "system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine." This describes a physical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fusion.
N/A
Intended Use / Indications for Use
The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intents who have had six months of non-operative treatment.
For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
Product codes
MAX
Device Description
The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of titanium alloy. 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 for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.
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
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)
Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression, dynamic compression, static compression shear, dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion) and the proposed implants were found to be substantially the same as predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082698, K110843, K113138, K130699, K133614, K113561, K112316, K100945, K141405
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175
Re: K150481
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 Dated: August 20, 2015 Received: August 20, 2015
Dear Ms. Giezen:
This letter corrects our substantially equivalent letter of August 20, 2015.
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
1
Page 2 - Ms. Nancy Giezen
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou 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)
K150481
Device Name Cascadia Interbody System
Indications for Use (Describe)
The CASCADIA implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondvlolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intents who have had six months of non-operative treatment.
For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.
| Company of the program and any and any and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| 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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3
510(k) SUMMARY Cascadia Interbody System K2M, Inc.
Submitter
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 571 919-2168 Date Prepared: 08/18/2015
Classification
| Trade Name: | Cascadia Interbody System |
|---|---|
| Common Name: | Intervertebral Fusion Device with Bone Graft |
| Regulatory Class: | Class II |
Classification Name(s):
Intervertebral Body Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX)
Predicate Device(s)
Primary Predicate:
-
K2M Aleutian IBF Spinal System (K082698)
Additional Predicates: -
K2M Aleutian IBF Spinal System (K110843, K113138, K130699, K133614) ●
-
Zimmer TM Ardis (K113561) ●
-
4WEB STS (K112316) ●
-
Advanced Medical Technology Fuse (K100945)
-
Signus Mobis II ST (K141405) ●
Device Description
The subject submission describes the Cascadia Interbody System. The implants consist of hollow tube structures made of titanium alloy. 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 for a line addition to the lumbar intervertebral body fusion devices previously cleared in the K2M Aleutian Intervertebral Body Fusion System, to include implants additively manufactured from titanium alloy.
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 implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one
4
level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the CASCADIA 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.
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
Performance evaluations were conducted on constructs representing the worst case components (including static torsion, static compression, dynamic compression, static compression shear, dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion) and the proposed implants were found to be substantially the same as predicate devices.
Conclusion
There are no significant differences between the Cascadia Interbody 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.