(56 days)
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.
The provided text describes a 510(k) premarket notification for surgical instruments used with total disc replacement devices. It does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML device performance, or details of a study proving such a device meets acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence of the surgical instruments to previously approved predicate devices based on indications, design, materials, function, manufacturing, and performance (which includes user testing with cadaver studies, European clinical use report, cleaning validation, and steam sterilization). It explicitly states: "All completed tests met the pre-determined acceptance criteria." However, these acceptance criteria are not specified in terms of quantitative performance metrics for a diagnostic or AI/ML device.
The document is a regulatory approval letter and summary for manual surgical instruments, not an AI/ML medical device.
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August 19, 2022
Centinel Spine LLC % Mr. Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K221848
Trade/Device Name: prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments Regulation Number: 21 CFR 888.4515 Regulation Name: Manual Instruments Designed For Use With Total Disc Replacement Devices Regulatory Class: Class II Product Code: OLO Dated: June 24, 2022 Received: June 24, 2022
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.
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
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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 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, 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
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Indications for Use
510(k) Number (if known) K221848
Device Name
prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments
Indications for Use (Describe)
The prodisc® C SK, prodisc® C Nova, and prodise® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.
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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510(K) SUMMARY K221848
| Device Trade Name: | prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments |
|---|---|
| Manufacturer: | Centinel Spine, LLC900 Airport Road, Suite 3BWest Chester, PA 19380 |
| Contact: | Jessica StaubSr. Director of Regulatory AffairsCentinel Spine, LLC900 Airport Road, Suite 3BWest Chester, PA 19380 |
| Prepared by: | Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: (202) 552-5800jeggleton@mcra.com |
| Date Prepared: | August 17, 2022 |
| Classification: | 21 CFR §888.4515; Orthopedic manual surgical instrumentation foruse with total disc replacement devices |
| Class: | II |
| Product Codes: | OLO |
Indications for Use:
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodise® C Vivo devices.
Device Description:
The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devicesto be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodise® C Nova, and prodise® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C VivoInstruments.
510k Summary K221848 Page 1 of 2
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Primary Predicate Device:
Substantial equivalence of these instruments is claimed to the Legacy prodisc C® instruments approved in P070001 prior to the down classification (Legacy prodisc C® instruments were classified in response to an Accessory Reclassification Request under Classification Order 0200722).
Technological Characteristics
The purpose of this Traditional 510(k) is to seek marketing clearance for the prodise® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments. The instrument sets include trials, keel cutters, introducers, and impactors.
Performance Testing
Testing included user testing (cadaver studies), European clinical use report, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate devices with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
Based on the information provided above, the prodisc® C SK, prodisc® C Nova, and prodise® C Vivo Instruments are substantially equivalent to the cited primary predicate.
§ 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.
(a)
Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.