(32 days)
Not Found
No
The device description and performance studies section do not mention any AI or ML components or capabilities. The device is described as a set of surgical instruments for a specific procedure.
No
The device description states it is a set of surgical instruments used to perform posterior cervical fusion, not to treat or cure a disease itself. It's a tool for a procedure, not a therapeutic agent.
No
Explanation: The CORUS Spinal System is described as a set of surgical instruments used to perform posterior cervical fusion. Its components are tools for accessing and preparing the bone surfaces for fusion (e.g., chisels, rasps, burrs, mallets, tamps). There is no mention of the device being used to identify, detect, or monitor a disease or condition.
No
The device description explicitly lists multiple physical surgical instruments (Access Chisel, Decortication Trephine, etc.) and states they are supplied sterile and single use. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the CORUS Spinal System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform a surgical procedure (posterior cervical fusion) on a patient. This is an in-vivo procedure, meaning it is performed within the living body.
- Device Description: The device is a set of surgical instruments used to manipulate bone and tissue during surgery. It does not involve the analysis of biological samples (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to testing, analyzing, or diagnosing conditions based on biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CORUS Spinal System does not fit this definition.
N/A
Intended Use / Indications for Use
CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
Product codes
HRX
Device Description
The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior cervical spine
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)
There were no changes in the design, intended use, or risks associated with the product. Therefore, no verification or validation activities were required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DTRAX Spinal System (K180876)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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.
March 8. 2019
Providence Medical Technology, Inc. Janie Mandrusov Vice President, OA/RA/CA 3875 Hopyard Road, Suite 300 Pleasanton, California 94588
Re: K190201
Trade/Device Name: CORUS Spinal System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 1, 2019 Received: February 4, 2019
Dear Janie Mandrusov:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is for Long H. Chen -S. The date of the signature is 2019.03.08, and the time is 08:37:56 -05'00'.
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement 5
This section provides a copy of the Indications for Use Statement (Form FDA 3881).
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K190201 |
|---|---|
| Device Name | CORUS TM Spinal System |
| Indications for Use (Describe) | CORUS Spinal System is a set of instruments to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease. |
| 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
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"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
K190201 page 1 of 2
Premarket Notification [510(k)] Summary
| Classification: | Class II |
|---|---|
| Classification No.: | 21 CFR 888.1100 |
| Product Code: | HRX |
| Common Name: | Arthroscopic Accessories |
| Trade Name | CORUS™ Spinal System |
| Predicate Device | DTRAX Spinal System (K180876) |
| Submitter: | Providence Medical Technology, Inc. |
| 3875 Hopyard Road, Suite 300 | |
| Pleasanton, CA 94588, USA | |
| Tel: 415-923-9376 | |
| Fax: 415-923-9377 | |
| FDA Registration No. | 3009394448 |
| Contact Person: | Janie Mandrusov |
| Date Summary Prepared: | February 1, 2019 |
PURPOSE OF SUBMISSION
The purpose of this Special 510(k) submission is to modify the device trade name and device Instructions for Use. The intended use, indications for use, and contraindications of the modified device, as described in the Instructions for Use, have not changed as a result of this modification.
DEVICE DESCRIPTION
The CORUS™ Spinal System is a set of surgical instruments indicated for performing posterior cervical fusion. The instruments will be supplied sterile and single use only. The system consists of Access Chisel, Access Chisel Handle, Decortication Trephine, Guide Tube, Decortication Rasp, Decortication Burr, Bone Graft Tamp and a Fork Mallet. In combination, these instruments allow the user to access the posterior cervical spine to perform posterior cervical fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of autograft or allograft.
INDICATIONS FOR USE
CORUS™ Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.
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K190201 page 2 of 2
SUMMARY OF SUBSTANTIAL EQUIVALENCE
The CORUS Spinal System described and cleared in 510(k) number K180876 serves as the predicate device for this premarket notification. The CORUS™ Spinal System that is the subject of this Special 510(k) has the same technological characteristics and intended use as the device described and cleared in 510(k) number K180876. Furthermore, there have been no changes in design, intended use, indications for use statement, contraindications, operating principle, component materials, manufacturing processes, packaging, or sterilization method since FDA's clearance of K180876.
Therefore, the CORUS Spinal System remains substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.
SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES
There were no changes in the design, intended use, or risks associated with the product. Therefore, no verification or validation activities were required.
Providence Medical Technology followed its established quality system and design control requirements in accordance with the Quality System Requlation (21 CFR 820) and declares conformance to design controls and risk-based assessment procedures, including Hazard Analysis.
CONCLUSION
Based on all information in this Special 510(k), the CORUS Spinal System is substantially equivalent to the identified predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. No new issues of safety or effectiveness are raised by the modifications.