(239 days)
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Not Found
No
The document describes a physical implant (intervertebral fusion device) made of PEEK, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing.
Yes
The device is used to treat degenerative disc disease in the cervical spine.
No
The device, Cambria, is described as an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion, which is a treatment function, not a diagnostic one. Its intended use is as an adjunct to spinal fusion procedures, and it needs "degeneration of the disc confirmed by history and radiographic studies" prior to its use, indicating it is not involved in the diagnostic process itself.
No
The device description clearly states that Cambria is an intervertebral fusion device made from PEEK with radiographic markers, indicating it is a physical implant and 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Cambria's Intended Use: Cambria is an implantable device used in spinal fusion surgery. It is physically placed within the patient's body to support bone fusion.
- Lack of Specimen Analysis: The description of Cambria and its intended use does not involve the analysis of any specimens taken from the patient.
Therefore, Cambria falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
Cambria is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. Implants are made from PEEK (polyetheretherketone) with radiographic markers and are generally box-shaped with a central canal for receiving bone graft. Cambria is offered in a variety of shapes and sizes to accommodate variations in patient anatomy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cervical spine (C3-C7)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing results indicated that Cambria possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s). Clinical data was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510(k) Summary
| Company Name: | SeaSpine, Inc.
2302 La Mirada Drive
Vista, CA 92081 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Jeff Brittan
Senior Project Engineer
E-mail: jbrittan@seaspine.com
Phone: (760) 727-8399, Fax: (760) 727-8809 | APR 10 2009 |
| Date Prepared: | August 11, 2008 | |
| Trade Name: | Cambria™ | |
| Common Name:
Classification Name: | Interbody Fusion Device
Intervertebral Fusion Device with Bone Graft, Cervical
21 CFR 888.3080, Product Code ODP, Class II
Orthopedic Review Committee | |
| Device Description: | Cambria is an intervertebral fusion device intended to act as a disc spacer and
hold bone graft to promote fusion in the cervical spine. Implants are made from
PEEK (polyetheretherketone) with radiographic markers and are generally box-
shaped with a central canal for receiving bone graft. Cambria is offered in a
variety of shapes and sizes to accommodate variations in patient anatomy. | |
| Intended Use: | Cambria is intended to be used as an adjunct to spinal fusion procedures at one
level (C3-C7) in skeletally mature patients with degenerative disc disease
(defined as neck pain with discogenic origin with degeneration of the disc
confirmed by history and radiographic studies) of the cervical spine. Patients
should have received at least six weeks of non-operative treatment prior to
treatment with the device. Devices are intended to be implanted via an open,
anterior approach and used with autogenous bone and supplemental fixation,
such as an anterior plating system. | |
| Substantial
Equivalence: | Cambria was shown to be substantially equivalent to predicate device(s)
through comparison in areas including intended use, design, materials, and
function. | |
| Performance Data: | Mechanical testing results indicated that Cambria possessed appropriate
properties for its intended use and is substantially equivalent to predicate
device(s). Clinical data was not required for this device. | |
.
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
APR 1 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. % Mr. Jeff Brittan Senior Project Engineer 2302 La Mirada Drive Vista, California 92081
Re: K082309
Trade/Device Name: Cambria™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 17, 2009 Received: March 18, 2009
Dear Mr. Brittan:
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 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 (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.
2
Page 2 -- Mr. Jeff Brittan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bush
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K082309
Device Name: Cambria™
Indications for Use:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Prescription Use __ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clarbare Brennd
and Neurological Devices
Page 1 of 1
510(k) Number K082309