(70 days)
K211757, Q200722
Not Found
No
The device description focuses solely on mechanical surgical instruments for implanting a cervical disc, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are also focused on the physical properties and sterilization of the instruments.
No.
The device described is a set of surgical instruments used for the placement and positioning of an artificial cervical disc, not the therapeutic disc itself. These instruments aid in the surgical procedure, but do not provide therapy directly.
No
The device description indicates that the instruments are used for the placement and positioning of an artificial cervical disc, including tools to determine size, create tracks, and insert the disc. These are surgical tools for intervention, not for diagnosing a condition.
No
The device description explicitly details physical surgical instruments made of surgical stainless steel, aluminum, and Radel materials. It also mentions an instrument tray. There is no mention of software as a component of this device.
Based on the provided information, 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 M6-C Artificial Cervical Disc." This is a surgical procedure involving the implantation of a medical device, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details surgical instruments used during surgery (templates, trials, cutters, inserters, etc.) to facilitate the implantation of an artificial disc. These are tools for a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the M6-C Artificial Cervical Disc Surgical Instruments are tools used in a surgical procedure to implant a medical device. They do not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The M6-C Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-C Artificial Cervical Disc.
Product codes
QLQ
Device Description
The surgical implantation of the M6-C Artificial Cervical Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments are provided nonsterile and are intended to be reusable.
The instruments provided in the kit include Footprint Templates. Trials, Inserters, Fin Cutters, a Tamp, Removal Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer Pins and Locking Nuts.
The M6-C Instrument Tray is multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur in a steam autoclave.
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
M6-C Artificial Cervical Disc Instrument G7 version has been evaluated via the following performance testing:
- Impact testing .
- . Bend/Functional testing
- Transit testing ●
- Sterilization validation .
The results demonstrated the performance of M6-C Artificial Cervical Disc Instrument G7 is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K211757, Q200722
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.
June 2, 2022
Spinal Kinetics LLC Joyce Zhong Regulatory Affairs Manager 501 Mercury Drive Sunnyvale, California 94085
Re: K220861
Trade/Device Name: M6-C Artificial Cervical Disc Instruments AS Regulation Number: 21 CFR 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: March 23, 2022 Received: March 24, 2022
Dear Joyce Zhong:
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 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.
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220861
Device Name
M6-C Artificial Cervical Disc Instruments AS
Indications for Use (Describe)
The M6-C Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-C Artificial Cervical 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)
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510(k) Summary
| Device Trade Name: | M6-C Artificial Cervical Disc Instruments AS |
|---|---|
| Manufacturer: | Spinal Kinetics LLC |
| 501 Mercury Drive | |
| Sunnyvale, CA 94085 | |
| USA | |
| Contact Person: | Joyce Zhong |
| Manager, Regulatory Affairs | |
| Orthofix/Spinal Kinetics | |
| 501 Mercury Drive | |
| Sunnyvale, CA 94085 | |
| Phone: (408) 636-2524 | |
| JoyceZhong@orthofix.com | |
| Date Prepared: | May 27, 2022 |
| Registration Number: | 3004987282 |
| Product Code: | QLQ |
| Classifications: | Class II - 21 CFR §888.4515 |
| Classification Name: | Orthopedic manual surgical instrumentation for use with total disc |
| replacement devices | |
| Primary Predicate: | K211757 Simplify Disc Inserter FP |
| M6-C Artificial Cervical Disc Instrument (G6 version) Approved | |
| via PMA P170036 and reclassified in Q200722 |
Reason for the 510(k) Submission: Design Changes to Fin cutters, Inserters and Instrument tray assembly.
Device Description:
The surgical implantation of the M6-C Artificial Cervical Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments are provided nonsterile and are intended to be reusable.
4
The instruments provided in the kit include Footprint Templates. Trials, Inserters, Fin Cutters, a Tamp, Removal Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer Pins and Locking Nuts.
The M6-C Instrument Tray is multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur in a steam autoclave.
Indications for Use:
The M6-C™ Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-CTM Artificial Cervical Disc.
Performance Testing Summary:
M6-C Artificial Cervical Disc Instrument G7 version has been evaluated via the following performance testing:
- Impact testing .
- . Bend/Functional testing
- Transit testing ●
- Sterilization validation .
The results demonstrated the performance of M6-C Artificial Cervical Disc Instrument G7 is substantially equivalent to the predicate devices.
Substantial Equivalence:
The subject device is substantially equivalent to the M6-C Artificial Cervical Disc Instrument G6 predicate devices with respect to indication, design, materials, function, and performance.
Conclusion:
M6-C Artificial Cervical Disc Instrument G7 has the same intended use, indications for use, technological characteristics as the predicate device M6-C Artificial Cervical Disc Instrument G6 version per Q200722 and K211757, and the results of performance testing demonstrate the subject device do not introduce any new question of safety or effectiveness. Therefore, the M6-C Artificial Cervical Disc Instrument G7 is substantially equivalent to the cited primary predicate.