(43 days)
Not Found
No
The summary describes a mechanical implant system and a sterilization tray. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The focus of the Special 510(k) is on modifications to the sterilization tray.
Yes
The document states, "The actual therapeutic effect is achieved by the CoFix implants." and further describes the device's role in promoting fusion for patients with degenerative disc disease.
No
The CoFix System is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving stabilization to promote fusion." It is an implant system used in lumbar interbody fusion surgery. Its purpose is therapeutic stabilization, not diagnosis. The text also states, "The actual therapeutic effect is achieved by the CoFix implants."
No
The device description explicitly states it is an implant system made of titanium alloy and a sterilization tray made of stainless steel. It also mentions screws and sleeves. These are all physical hardware components, not software. The submission is specifically for a modification to the sterilization tray.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CoFix System is a "posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine." This describes a surgical implant used to stabilize the spine.
- Device Description: The device description details an "implant system for interlaminar/interspinous fixation" made of titanium alloy. This is consistent with a surgical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The CoFix System does not perform this function.
- Performance Studies: The performance studies focus on the sterilization tray and the sterilization process, which are relevant to a reusable surgical implant, not an IVD.
The CoFix System is a surgical implant intended for use in the body to promote fusion, not a device used to test samples from the body.
N/A
Intended Use / Indications for Use
The CoFix System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The CoFix System is an implant system for interlaminar/interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.
The purpose of this Special 510(k) is to modify the CoFix Sterilization Tray , which is manufactured from stainless steel. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The CoFix sterilization tray is intended to hold and protect the system's instruments during transport, storage, and steam sterilization.
The actual therapeutic effect is achieved by the CoFix implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L1-S1)
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)
Functional testing was conducted to validate the sterilization tray's critical functions per EN ISO 17664. Adoptions into an existing steam sterilization were performed to ensure clean instrumentation and a sterility assurance level (SAL) of 106 in accordance with the following:
- AAMI TIR12:2010. Designing, testing, and labeling reusable medical devices for . reprocessing in health care facilities: A guide for medical device manufacturers.
- AAMI TIR30:2011/(R2016). A Compendium of Processes, Materials, Test Methods, and acceptance Criteria for Cleaning Reusable Medical Devices.
- ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012. Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- ISO 17664:2017 Sterilization of Medical Devices – Information to be provided by the manufacturer for the processing of Resterilizable Medical Devices.
- 그 ANSI/AAMI ST81:2004/(R2016). Sterilization of Medical Devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices.
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.
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.
Not Found
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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, 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.
Paradigm Spine GmbH % Justin Eggleton Vice President Spine Regulatory Affairs MCRA, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K201704
Trade/Device Name: CoFix System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: June 15, 2020 Received: June 22, 2020
Dear Mr. 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 (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/cfpmp/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
August 4, 2020
1
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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name CoFix System
Indications for Use (Describe)
The CoFix System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.
| 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) |
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510(k) Summary
| Device Trade Name: | CoFix System |
|---|---|
| Manufacturer: | Paradigm Spine GmbH |
| 375 River Park Circle | |
| Marquette, MI 49855 | |
| (906) 226-9909 | |
| Phone: (800) 557-9909 | |
| Contact: | Mr. Justin Eggleton |
| Vice President, Spine Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5804 | |
| jeggleton@mcra.com | |
| Prepared By: | MCRA, LLC |
| 1050 K Street, NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5800 | |
| Date Prepared: | June 15, 2020 |
| Classifications: | 21 CFR §888.3050, Spinal interlaminal fixation orthosis |
| Class: | Class II |
| Product Code: | PEK |
| Primary Predicate Device: | K153302 - coflex-IF System |
| The modified coflex-IF System (CoFix System) is | |
| substantially equivalent to the predicate coflex-IF System | |
| (K153302), with respect to indications, design, function, | |
| and materials. |
Indications for Use:
The CoFix System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease -
4
defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies – with up to Grade 1 spondylolisthesis.
Device Description:
The CoFix System is an implant system for interlaminar/interspinous fixation within lumbar interbody fusion surgery. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.
The purpose of this Special 510(k) is to modify the CoFix Sterilization Tray , which is manufactured from stainless steel. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The CoFix sterilization tray is intended to hold and protect the system's instruments during transport, storage, and steam sterilization.
The actual therapeutic effect is achieved by the CoFix implants.
Performance Testing Summary:
Functional testing was conducted to validate the sterilization tray's critical functions per EN ISO 17664. Adoptions into an existing steam sterilization were performed to ensure clean instrumentation and a sterility assurance level (SAL) of 106 in accordance with the following:
- AAMI TIR12:2010. Designing, testing, and labeling reusable medical devices for . reprocessing in health care facilities: A guide for medical device manufacturers.
- AAMI TIR30:2011/(R2016). A Compendium of Processes, Materials, Test Methods, and acceptance Criteria for Cleaning Reusable Medical Devices.
- ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012. Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- ISO 17664:2017 Sterilization of Medical Devices – Information to be provided by the manufacturer for the processing of Resterilizable Medical Devices.
- 그 ANSI/AAMI ST81:2004/(R2016). Sterilization of Medical Devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices.
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Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate cited above with respect to indications, design, function, and performance.
Conclusion:
The CoFix System is substantially equivalent to the previously cleared device with respect to its indications for use, design, function, and performance.