(27 days)
No
The document describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used to treat degenerative disc disease and provide support and stabilization for the spine, indicating a therapeutic purpose.
No
Explanation: The device is an implant for intervertebral body fusion, used for treatment, not for diagnosing a condition.
No
The device description clearly states the implants are "hollow tube structures additively manufactured from titanium alloy," indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CASCADIA implants are used in vivo (within the body) as intervertebral body fusion devices. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The device is described as an implantable structure made of titanium alloy, designed to provide support and stabilization to the spine. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the CASCADIA implants are a medical device, specifically a surgical implant, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis 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 K2M Spinal Plate Systems.
Product codes
MAX
Device Description
The implants consist of hollow tube structures additively manufactured from 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 to incorporate additional 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
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)
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, static and dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion. Engineering rationales determined that the proposed implants did not represent a new worst case for mechanical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150481, K082698, K110843, K130699
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
K2M, Incorporated Ms. Nancv Giezen Manager Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175
Re: K160547
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: February 24, 2016 Received: February 26, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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. 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)
Device Name Cascadia Interbody System
Indications for Use (Describe)
The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis 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 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)
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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: 03/23/2016
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)
Predicate Device(s)
Primary Predicate:
-
K2M Cascadia Interbody System (K150481)
Additional Predicates:
Device Description
The implants consist of hollow tube structures additively manufactured from 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 to incorporate additional 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 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 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.
4
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
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, static and dynamic compression shear (ASTM F2077), subsidence (ASTM F2267) and expulsion. Engineering rationales determined that the proposed implants did not represent a new worst case for mechanical testing.
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.