(74 days)
Not Found
Not Found
No
The summary describes a surgical instrument for inserting a cervical artificial disc and focuses on usability improvements and mechanical testing, with no mention of AI or ML.
No
The device is described as a surgical instrument for placing an artificial disc, not the disc itself or a device that provides therapy.
No
The device is described as a surgical instrument intended for the "placement and positioning" of a cervical artificial disc, not for diagnosing any condition.
No
The device description explicitly states it is an "instrument set" including "surgical instruments" designed to facilitate implantation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "placement and positioning of the Simplify Cervical Artificial Disc." This describes a surgical instrument used during a surgical procedure on a patient.
- Device Description: The description clearly states it's a set of "surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation." This further reinforces its role as a surgical tool.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The Simplify Disc Inserter FP is a surgical instrument used in a surgical procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.
Product codes (comma separated list FDA assigned to the subject device)
QLQ
Device Description
The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.
The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria.
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". To the left of the FDA logo is the Department of Health & Human Services logo, which features a stylized human figure.
August 20, 2021
NuVasive, Inc. % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K211757
Trade/Device Name: Simplify Disc Inserter FP Regulation Number: 21 CFR 888.4515 Regulation Name: Orthopedic Manual Surgical Instrumentation For Use With Total Disc Replacement Devices Regulatory Class: Class II Product Code: QLQ Dated: June 4, 2021 Received: June 7, 2021
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/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.
1
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 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.
Brent Showalter -S
Brent L. Showalter, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K211757
Device Name Simplify Disc Inserter FP
Indications for Use (Describe)
The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.
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)
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
510(k) SUMMARY
| Device Trade Name: | Simplify Disc Inserter FP |
|---|---|
| Manufacturer: | NuVasive, Inc. |
| 7475 Lusk Blvd. | |
| San Diego, CA 92121 USA | |
| Phone: (858) 909-1800 | |
| Contact: | Mark Alvis |
| NuVasive, Inc. | |
| Phone: (831) 600-6859 | |
| malvis@nuvasive.com | |
| Prepared by: | Mr. Justin Eggleton |
| Vice President, Spine Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Office: (202) 552-5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | July 20, 2021 |
| Classifications: | 21 CFR §888.4515 |
| Classification Name: | Orthopedic Manual Surgical Instrumentation For Use With Total |
| Disc Replacement Devices | |
| Class: | II |
| Product Codes: | OLO |
Indications for Use:
The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.
Device Description:
The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.
The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.
4
Primary Predicate Device:
The Simplify Disc Inserters were downclassified in response to an Accessory Classification Request under Classification Order Q200722. This 510(k) put forth a discussion to claim substantial equivalence to the Simplify Disc Inserters that were originally PMA Approved (P200022) prior to the downclassification.
Technological Characteristics:
The purpose of this Traditional 510(k) is to seek marketing clearance for modifications to the Simplify Disc Inserter to Simplify Disc Inserter FP utilized to insert the Simplify® Cervical Artificial Disc. The modifications include the following:
- Ejector subfeature addition ●
- Enlarged thumb nut ●
- . Wider jaws
Performance Testing:
Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria.
Conclusion:
The indications for use and intended use are consistent with FDA classification per Q200722. Comparisons of technological characteristics and results of performance testing demonstrate the modifications to the design do not introduce any new questions of safety or effectiveness. Therefore, the Simplify Disc Inserter FP is substantially equivalent to the cited primary predicate.