(74 days)
Not Found
No
The summary describes a mechanical fixation system for the sacroiliac joint and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended for sacroiliac joint fusion to treat conditions like sacroliac joint disruptions and degenerative sacroiliitis, which is a therapeutic purpose.
No
The device is a sacroiliac joint fixation system used for fusion, not for diagnosing conditions. Its description focuses on implantation and stabilization, not on detecting or identifying medical conditions.
No
The device description explicitly states it is comprised of a single-use implant and reusable instruments, indicating it is a hardware-based medical device.
No, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Camber Sacroiliac (SI) Fixation System is an implantable device used to surgically fuse the sacroiliac joint. It is a physical device implanted into the body, not a device that analyzes samples taken from the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure, not for analyzing biological samples.
Therefore, based on the provided information, the Camber Sacroiliac (SI) Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The Camber SI Fixation System is comprised of a single-use implant and reusable instruments. The Camber SI Fixation System implant is intended to be implanted in the undeployed state via a posterior approach into the sacroiliac joint. Once implanted, the anchors are deployed to stabilize the sacroiliac joint. The Camber SI Fixation System implant includes multiple openings to allow surgeons to fill them with autogenous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
Not Found
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)
A battery of performance testing has been performed on the subject device to demonstrate its substantial equivalence to the predicate device, including:
- Static vertical shear and dynamic vertical shear
- Expulsion
- Pin retaining
- Anchor strength
- Cadaver testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Rialto SI Fusion System, Medtronic Sofamor Danek, K161210, Camber SI Fixation System, Camber Spine Technologies, LLC, K203503
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
February 27, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Camber Spine Technologies % Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs Mcra, LLC 803 7th Street NW, Third Floor Washington, District of Columbia 20001
Re: K233972
Trade/Device Name: Camber Sacroiliac (SI) Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: December 15, 2023 Received: December 15, 2023
Dear Justin Eggleton:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233972
Device Name
Camber Sacroiliac (SI) Fixation System
Indications for Use (Describe)
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroliac joint disruptions and degenerative sacroiliitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Device Trade Name: | Camber Sacroiliac (SI) Fixation System |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 510 Allendale Road | |
| King of Prussia, PA 19406 | |
| Phone: 484-420-4286 | |
| Contact: | Justin Eggleton |
| Vice President, Head of Musculoskeletal Regulatory Affairs | |
| MCRA, LLC | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | December 15, 2023 |
| Classifications: | 21 CFR §888.3040 |
| Class: | II |
| Product Codes: | OUR |
| Primary Predicate: | Rialto SI Fusion System, Medtronic Sofamor Danek, K16121 |
| Additional Predicate: | Camber SI Fixation System, Camber Spine Technologies, |
| LLC, K203503 |
Indications For Use:
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description:
The Camber SI Fixation System is comprised of a single-use implant and reusable instruments. The Camber SI Fixation System implant is intended to be implanted in the undeployed state via a posterior approach into the sacroiliac joint. Once implanted, the anchors are deployed to stabilize the sacroiliac joint. The Camber SI Fixation System implant includes multiple openings to allow surgeons to fill them with autogenous bone graft.
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K233972 Page 2 of 2
Performance Testing Summary:
A battery of performance testing has been performed on the subject device to demonstrate its substantial equivalence to the predicate device, including:
- Static vertical shear and dynamic vertical shear ●
- Expulsion
- Pin retaining ●
- Anchor strength ●
- Cadaver testing ●
Substantial Equivalence:
It has been determined that the Camber SI Fixation System is substantially equivalent to the following predicate and reference device for the purpose of introducing to interstate commerce.
- Primary Predicate: Rialto SI Fusion System, Medtronic Sofamor Danek, K161210
- Additional Predicate: Camber SI Fixation System, Camber Spine Technologies, LLC, ● K203503
Conclusion:
The Camber SI Fixation System is substantially equivalent to the primary and additional predicates with respect to intended use, materials, design, and function.