(72 days)
Not Found
No
The document describes a physical implantable device (spinal fusion system) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is indicated for spinal fusion procedures for the treatment of cervical and degenerative disc disease, which are therapeutic interventions.
No
The device is described as an intervertebral body fusion device and implants, which are used for surgical procedures to treat spinal conditions, not for diagnosing them. It is referred to as a "treatment" for cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and degenerative disc disease.
No
The device description explicitly states it consists of "PEEK spacers and titanium bone screws," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Chesapeake Spinal System is a physical implant (spacers and screws) designed to be surgically placed within the spine to facilitate bone fusion. Its purpose is structural support and stabilization, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens. The input imaging modality (radiographic studies) is used for assessing the patient's condition and the placement of the implant, not for in vitro diagnostic testing.
Therefore, the Chesapeake Spinal System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I 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 (DD) 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.
The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. The bone contacting surfaces of the implants have machined teeth which are designed to engage with the vertebral body endplates. Tantalum markers are embedded within the spacers identify the location and orientation of the implants to radiographically. Implants with footprints ranging from 24x30mm-28x36mm are available to accommodate anatomical variations. The purpose of this submission is to add 30x40mm footprints to the system.
Materials:
PEEK-OPTIMA LT1 F2026
TANTALUM F560
TITANIUM ALLOY F1472
CP TITANIUM F67
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
Cervical spine, from C2 to T1; Lumbar spine, 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)
Not Found
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.
K051454, K082698, K073109, K062083, K072253, K083475, K081501
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
12003
MAR 1 6 2012
510(k) Summary Chesapeake Spinal System K2M, Inc.
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 Suite F 1 Leesburg, VA 20175
Contact Person : Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite FI Leesburg, VA 20175 Telephone: 703-777-3155
| Date Prepared: | July 16, 2009 |
|---|---|
| ---------------- | --------------- |
| 2. Tradename: | Chesapeake Spinal System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | OVD |
| Regulation Number: | 888.3080 |
3. Description of the device:
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. The bone contacting surfaces of the implants have machined teeth which are designed to engage with the vertebral body endplates. Tantalum markers are embedded within the spacers identify the location and orientation of the implants to radiographically. Implants with footprints ranging from 24x30mm-28x36mm are available to accommodate anatomical variations. The purpose of this submission is to add 30x40mm footprints to the system.
Materials:
| PEEK-OPTIMA LT1 | F2026 |
|---|---|
| TANTALUM | F560. |
| TITANIUM ALLOY | F1472 |
| CP TITANIUM | F67 |
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
4. Intended Use:
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.
When used as a lumbar intervertebral body fusion device, the Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I 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 (DD) 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.
sheet 1 of 2
1
The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
5. Predicate or legally marketed devices which are substantially equivalent:
Documentation was provided which demonstrated that the subject Chesapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501).
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Chesapeake 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.
sheet 2. of 2
2
Image /page/2/Picture/0 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 symbol resembling an eagle or bird with three wing-like shapes extending upwards and to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175
Re: K120031
Trade/Device Name: Chesapeake Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 16, 2012 Received: February 17, 2012
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
3
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH/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 N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
Device Name : Chesapeake Spinal System
Indications For Use :
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 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 Chesapeake implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar I 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.
The Chesapeake spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device the Chesapeake spacers are intended to be used with the bone screws provided. When using a 2 screw implant, 2 screws must be used. When using a 3 screw implant 3 screws must be used.
Prescription use X
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 )
Aout th to. RPJ
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K12003 ﺎ