(239 days)
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.
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.
This 510(k) summary describes a spinal intervertebral fusion device called Cambria. The provided text indicates that no clinical data or studies were required or performed to demonstrate substantial equivalence for this device. Instead, the substantial equivalence determination for Cambria was based on mechanical testing results. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement for a clinical study is not applicable to this submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The submission states: "Clinical data was not required for this device." The performance data relied solely on mechanical testing. While mechanical testing would have specific acceptance criteria, these are not detailed in the provided 510(k) summary. The summary only broadly states: "Mechanical testing results indicated that Cambria possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. No human clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. No human clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No human clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is a physical implant, not an AI or imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the ground truth would be defined by engineering specifications and standards for intervertebral fusion devices, which are implied by the statement "appropriate properties for its intended use."
8. The sample size for the training set
Not Applicable. No training set for a clinical study or algorithm was used.
9. How the ground truth for the training set was established
Not Applicable. No training set for a clinical study or algorithm was used.
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510(k) Summary
| Company Name: | SeaSpine, Inc.2302 La Mirada DriveVista, CA 92081 | |
|---|---|---|
| Contact Person: | Jeff BrittanSenior Project EngineerE-mail: jbrittan@seaspine.comPhone: (760) 727-8399, Fax: (760) 727-8809 | APR 10 2009 |
| Date Prepared: | August 11, 2008 | |
| Trade Name: | Cambria™ | |
| Common Name:Classification Name: | Interbody Fusion DeviceIntervertebral Fusion Device with Bone Graft, Cervical21 CFR 888.3080, Product Code ODP, Class IIOrthopedic Review Committee | |
| Device Description: | Cambria is an intervertebral fusion device intended to act as a disc spacer andhold bone graft to promote fusion in the cervical spine. Implants are made fromPEEK (polyetheretherketone) with radiographic markers and are generally box-shaped with a central canal for receiving bone graft. Cambria is offered in avariety 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 onelevel (C3-C7) in skeletally mature patients with degenerative disc disease(defined as neck pain with discogenic origin with degeneration of the discconfirmed by history and radiographic studies) of the cervical spine. Patientsshould have received at least six weeks of non-operative treatment prior totreatment 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. | |
| SubstantialEquivalence: | Cambria was shown to be substantially equivalent to predicate device(s)through comparison in areas including intended use, design, materials, andfunction. | |
| Performance Data: | Mechanical testing results indicated that Cambria possessed appropriateproperties for its intended use and is substantially equivalent to predicatedevice(s). Clinical data was not required for this device. |
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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.
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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
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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
§ 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.