(88 days)
P050010
No
The summary describes surgical instruments for implant placement and removal, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML algorithms.
No
The device, prodisc® L Instruments, is intended for the placement, positioning, and removal of prodisc® L implants, not for directly treating a disease or condition itself. It is a tool used in a therapeutic procedure.
No
The device description clearly states its purpose is for the "placement, positioning, and removal of the prodisc® L implants." This is an instrumental/surgical function, not a diagnostic one.
No
The 510(k) summary describes "Instruments" intended for the placement, positioning, and removal of implants, which are physical tools and not software.
Based on the provided information, the prodisc® L Instruments are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the instruments are for the "placement, positioning, and removal of the prodisc® L implants." This describes a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description reinforces this by stating the instruments "enable the Centinel prodisc® L disc to be implanted into the disc space." This is a description of a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the prodisc® L Instruments are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Product codes (comma separated list FDA assigned to the subject device)
QLQ
Device Description
The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.
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)
Not Found
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.
P050010
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
December 17, 2024
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Centinel Spine LLC Jessica Staub Sr. Direclor. RAQA 900 Airport Road, Suite 3B West Chester, Pennsylvania 19380
Re: K242869
Trade/Device Name: prodisc® L 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: QLQ Dated: September 20, 2024 Received: September 20, 2024
Dear Jessica Staub:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Ethan R. Naylor -S
For Ronald P. Jean, Ph.D. 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) K242869
Device Name prodisc® L Instruments
Indications for Use (Describe)
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
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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K242869 Page 1 of 2
6. 510(K) SUMMARY
| Device Trade Name: | prodisc® L Instruments |
|---|---|
| Manufacturer: | Centinel Spine, LLC |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Contact: | Jessica Staub |
| Sr. Director of Regulatory Affairs | |
| Centinel Spine, LLC | |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Prepared by: | Jessica Staub |
| Sr. Director of Regulatory Affairs | |
| Centinel Spine, LLC | |
| 900 Airport Road, Suite 3B | |
| West Chester, PA 19380 | |
| Date Prepared: | December 16, 2024 |
| Classifications: | 21 CFR §888.4515 |
| Classification Name: | Orthopedic manual surgical instrumentation for use with |
| total disc replacement devices | |
| Class: | II |
| Product Codes: | QLQ |
Indications for Use:
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Device Description:
The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.
Primary Predicate Device:
Centinel Spine believes the prodisc® L Instruments are substantially equivalent to the following primary predicate device with respect to intended use, design, and materials:
5
- prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments, . Centinel Spine LLC, K221848
Reference Device:
The subject devices were evaluated under PMA P050010, prodisc® L Implants. These devices are used for the placement, positioning and removal of prodisc® L implants.
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® L Instruments are substantially equivalent to the cited primary predicate.