(92 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for spinal fusion procedures to treat cervical disc disease, which is a medical condition, making it a therapeutic device.
No
Explanation: This device is a medical implant used for spinal fusion procedures, providing support and stabilization. Its function is therapeutic rather than diagnostic.
No
The device description clearly states it consists of physical implants and screws made of titanium, which are hardware components.
Based on the provided information, 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 Function: The Chesapeake Spinal System is a surgical implant designed to be placed within the body to provide structural support and stabilization for spinal fusion. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
- Device Description: The description focuses on the physical structure, materials, and function as an implantable device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information.
Therefore, the Chesapeake Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.
When used as a cervical intervertebral body fusion device, the Chesapeake 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.
Product codes
OVE
Device Description
- The Chesapeake Spinal System consists of interbody implants and titanium bone screws intended for fusion, without the need for supplementary fixation. The implants are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.
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
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)
The Chesapeake cervical implants were mechanically tested and compared to predicate devices. The The Chesapeake Spinal System performed equally to or better than these systems in station Clicsapcake Spinal Pystem periornied equasion in accordance with ASTM F2077 and F2267. torslon, dyname compression, after components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092211, K051454, K082698, K072415, K083389, K100698
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
K11143.9
AUG 2 4 2011
510(k) Summary Chesapeake Spinal System K2M, Inc.
This 510(k) summary for the Chesapeake Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
- Submitter :
K2M. Inc. 751 Miller Drive SE, Suite Fi Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155
Date Prepared: 08/23/11
| 2. Tradename: | Chesapeake Spinal System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, cervical |
| Device Product Code: | OVE |
| Regulation Number: | 888.3080 |
| Regulatory Class: | Class II |
3. Predicate or legally marketed devices which are substantially equivalent :
- K2M Chesapeake (K092211) .
- . K2M Aleutian (K051454, K082698)
- Surgicraft Stalif C (K072415) .
- Globus Coalition (K083389) .
- . Cardinal Spine STCC (K100698)
4. Description of the device:
- The Chesapeake Spinal System consists of interbody implants and titanium bone screws intended for fusion, without the need for supplementary fixation. The implants are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The cervical interbody implants are made of CP titanium and the screws are fabricated from Ti6Al4V titanium, in accordance with ASTM F67 and F1472
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical segments of the spine.
5. Intended Use:
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.
When used as a cervical intervertebral body fusion device, the Chesapeake 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.
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- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Chesapeake cervical implants were mechanically tested and compared to predicate devices. The The Chesapeake Spinal System performed equally to or better than these systems in station Clicsapcake Spinal Pystem periornied equasion in accordance with ASTM F2077 and F2267. torslon, dyname compression, after components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems.
There are no significant differences between the K2M implants and other wires currently being marketed I his are no significant affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Chesapeake cervical implants were mechanically tested and compared to predicate devices. The The Chesapeake Spinal System performed equally to or better than these systems in station Clicsapcake Spinal Pystem periornied equasion in accordance with ASTM F2077 and F2267. torslon, dyname compression, after components were also compared and the Chesapeake Spinal System was found to be substantially the same as these systems.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive SE, Suite Fl Leesburg, Virginia 20175
AUG 24 2011
Re: K111439
Trade/Device Name: Chesapeake Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 05, 2011 Received: August 08, 2011
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
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Page 2 - Ms. Nancy Giezen
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 (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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Chesapeake Spinal System Device Name :
Indications For Use :
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation.
When used as a cervical intervertebral body fusion device, the Chesapeake 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.
Prescription use______________________________________________________________________________________________________________________________________________________________
OR
Over-the-counter use ( PER 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation ( ODE )
Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII1439 510(k) Number_