(641 days)
No
The description focuses on the mechanical design and performance of a physical implant for sacroiliac joint fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is intended for sacroiliac joint fusion, which is a therapeutic intervention to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis.
No
The device description indicates it is a fusion device designed to permit bone growth and fixate the joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium with specific dimensions and features, indicating it is a hardware device, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Camber Sacroiliac (SI) Fixation System is a physical implant designed to be surgically placed within the body to fuse the sacroiliac joint. It is a structural device, not a testing device.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure, not for analyzing biological samples.
Therefore, the Camber Sacroiliac (SI) Fixation System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Camber SI Fixation System is a fusion device consisting primarily of an open architecture 3D generated titanium body to permit bone growth (fusion) throughout the implant. All internal surfaces have a roughened texture. The upper and lower faces have specifically designed surface approximately 0.5 mm thick to provide a trabecular support structure. In addition, the device utilizes a set of two sharpened anchor plates that translate from within the device in slightly angular opposing lateral directions which provide an anchoring system to fixate the implant between ilium and sacrum. The Camber SI Fixation System device has one footprint: 23x26 mm. Implant heights range from 9 to 13mm in 2 mm increments with 8° angulation.
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)
Testing performed indicate that the Camber SI Fixation System is as mechanically sound as the cleared devices. Testing included static vertical shear, static vertical shear stiffness, dynamic vertical shear endurance, implant dislodgement and anchor collapse force. The results demonstrate that the acceptance criteria defined by predicate device performance were met. Cadaveric and usability testing was done to establish substantial equivalence.
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.
Tenon Medical Catamaran Sacroiliac Joint Fixation System (K180818)
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.
Camber Spine ENZA-A Titanium ALIF device (K173432), ENZA-A Titanium ALIF device (K173234)
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
§ 888.3040 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
September 2, 2022
Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Camber Spine Technologies, LLC Christine Scifert Official Correspondent 501 Allendale Road King of Prussia, Pennsylvania 19604
Re: K203503
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: August 24, 2022 Received: August 26, 2022
Dear Christine Scifert:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Anne D. Talley -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
for
Enclosure
2
Indications for Use
510(k) Number (if known) K203503
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 sacroiliac joint disruptions and degenerative sacroilitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over The Counter Use (21 CFR 801 Subpart C) | ☐ |
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 |
| 501 Allendale Road | |
| King of Prussia, PA 19406 | |
| Company Contact: | Noel Hetrick |
| Nhetrick@cambermedtech.com | |
| Official Correspondent: | Christine Scifert |
| Partner, MRC Global | |
| Christine.scifert@askmrcglobal.com | |
| 901-831-8053 | |
| Date Prepared: | September 2, 2022 |
| Classifications: | 21 CFR §888.3040, Smooth or Threaded Metallic Bone Fixation |
| Fastener | |
| Class: | II |
| Product Code: | OUR |
| Primary Predicate: | Tenon Medical Catamaran Sacroiliac Joint Fixation System |
| (K180818) | |
| Reference Predicate(s): | Camber Spine ENZA-A Titanium ALIF device (K173432) |
Indications For Use:
The Camber Sacroiliac (SI) Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the Camber SI Fixation System is implanted, it must be used with a SICONUS SI Joint Fixation System screw implanted across the same sacroiliac joint.
Device Description:
The Camber SI Fixation System is a fusion device consisting primarily of an open architecture 3D generated titanium body to permit bone growth (fusion) throughout the implant. All internal surfaces have a roughened texture. The upper and lower faces have specifically designed surface approximately 0.5 mm thick to provide a trabecular support structure. In addition, the device utilizes a set of two sharpened anchor plates that translate from within the device in slightly angular opposing lateral directions which provide an anchoring system to fixate the implant between ilium and sacrum. The Camber SI Fixation System device has one footprint: 23x26 mm. Implant heights
4
range from 9 to 13mm in 2 mm increments with 8° angulation.
Predicate Device:
The subject device, the Camber Sacroiliac (SI) Fixation System, is substantially equivalent to the Tenon Catamaran SI Joint Fixation System (K180818) in terms of Indications for use. The reference predicate, ENZA-A Titanium ALIF device (K173432) has an identical anchoring system as the Camber SI Fixation System.
Performance Testing Summary:
Testing performed indicate that the Camber SI Fixation System is as mechanically sound as the cleared devices. Testing included static vertical shear, static vertical shear stiffness, dynamic vertical shear endurance, implant dislodgement and anchor collapse force. The results demonstrate that the acceptance criteria defined by predicate device performance were met. Cadaveric and usability testing was done to establish substantial equivalence.
Substantial Equivalence:
The subject Camber Sacroiliac (SI) Fixation System was demonstrated to be substantially equivalent to primary predicate, Tenon Catamaran Sacroiliac Joint Fixation System (K180818) and the reference predicate, the ENZA-A Titanium ALIF device (K173234) with regards to indications for use, design inputs, materials, performance and/or manufacturing.
Conclusion:
Camber Spine Technologies has provided sufficient information to demonstrate the Camber Sacroiliac (SI) Fixation System is substantially equivalent to primary predicate, Tenon Catamaran Sacroiliac Joint Fixation System (K180818) and the reference predicate, the ENZA-A Titanium ALIF device (K173234) with regards to indications for use, design inputs, materials, performance and/or manufacturing. .