(91 days)
No
The document describes a physical intervertebral fusion device (a spinal implant) and associated instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The testing described is mechanical and sterilization testing, not performance evaluation of an AI/ML model.
Yes
The device is described as an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine, for patients with degenerative disc disease, which addresses a health condition.
No
Explanation: The device is described as an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the Cambria System is an intervertebral fusion device manufactured from PEEK and tantalum, with optional titanium coating. It also includes instruments for placement and sterilization trays. These are all physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used in spinal fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an intervertebral fusion device made of PEEK and titanium, designed to act as a disc spacer and hold bone graft. This is a physical implant, not a reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain 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 with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Product codes
ODP
Device Description
The Cambria System device is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The cervical spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers, and are generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.
The Cambria System device is offered in a variety of heights and footprints to accommodate variations in patient anatomy. The cervical spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).
The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with the Cambria System facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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
Non-Clinical Testing:
Engineering analysis verified that the device modifications did not create any new worst cases with respect to mechanical performance; conclusions from the previously performed axial compression, compression shear, and torsion testing (ASTM F2077), subsidence testing (ASTM F2267), and expulsion testing (lab protocol) remained valid.
For the Cambria NanoMetalene System implants, packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing:
An assessment of clinical literature data was completed to support the proposed indication for use of the Cambria System at 2 contiguous levels (C3-C7).
Key Metrics
Not Found
Predicate Device(s)
K082309, K162715, K142488, K151322
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
SeaSpine Orthopedics Corporation Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K171046
Trade/Device Name: SeaSpine Cambria System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 6, 2017 Received: April 7, 2017
Dear Ms. Flores:
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 Part 801); medical device reporting (reporting of medical device
1
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 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" (21 CFR 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171046
Device Name
SeaSpine Cambria NanoMetalene System
Indications for Use (Describe)
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain 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 with the device. Devices are intended to be implanted via an open, anterior approach and used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K171046
Device Name SeaSpine Cambria System
Indications for Use (Describe)
Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | (760) 216-5136 |
| Fax number: | (760) 683-6874 |
| Contact person: | Gina Flores, Sr. Regulatory Specialist |
| Email address: | gina.flores@seaspine.com |
| Date Prepared: | July 5, 2017 |
| Device Name | |
| Trade Name: | SeaSpine Cambria System |
| Common Name: | Intervertebral Fusion device with bone graft, cervical |
| Classification Name: | Intervertebral fusion device with integrated fixation, cervical |
| (21 CFR 888.3080) | |
| Class: | II |
| Product Code: | ODP |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K082309 | ODP | Cambria System | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| Additional PREDICATE Devices | |||
| K162715 | ODP | Cambria NanoMetalene Sterile | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| K142488 | ODP | Cambria NanoMetalene | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| K151322 | MAX, ODP | Zeus-C-Amendia Interbody | |
| Fusion Device | Amendia, Inc. |
5
Device Description
The Cambria System device is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The cervical spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers, and are generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.
The Cambria System device is offered in a variety of heights and footprints to accommodate variations in patient anatomy. The cervical spacers are offered in all PEEK or with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).
The Cambria NanoMetalene cervical spacers are provided in gamma sterilized packaging; the Cambria PEEK implants are provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with the Cambria System facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for use
Cambria
Cambria is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Cambria NanoMetalene
Cambria NanoMetalene is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (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 autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and supplemental fixation, such as an anterior plating system.
Summary of Technological Characteristics
The Cambria System and predicate devices have the same operating principle; they act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The Cambria System is substantially equivalent to the cited predicate devices in areas including intended use/indications
6
for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
The subject and predicate devices are based on the following similar technological elements:
- Spacer Heights
- Spacer Footprints
- Spacer Lordotic Angle ●
- Implant Materials ●
Non-Clinical Testing
Engineering analysis verified that the device modifications did not create any new worst cases with respect to mechanical performance; conclusions from the previously performed axial compression, compression shear, and torsion testing (ASTM F2077), subsidence testing (ASTM F2267), and expulsion testing (lab protocol) remained valid.
For the Cambria NanoMetalene System implants, packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10° and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing
An assessment of clinical literature data was completed to support the proposed indication for use of the Cambria System at 2 contiguous levels (C3-C7).
Conclusions
The submitted data demonstrate that the SeaSpine Cambria System are substantially equivalent to the cited legally marketed predicate. The clinical data demonstrate that the Cambria System device performs comparably to the predicate device that is currently marketed for the same intended use.