(133 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven algorithms. The device is described as a fixed-size, off-the-shelf implant made of PMMA.
No
The device corrects and restores bony voids and defects but does not claim to directly treat a disease or condition, which is a characteristic of a therapeutic device.
No
The device description clearly states its purpose is to "correct and/or restore bony voids and/or defects of the cranium," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a physical implant made from polymethyl methacrylate (PMMA) materials, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "correct and/or restore bony voids and/or defects of the cranium." This describes a surgical implant used to physically repair a structural issue in the body.
- Device Description: The device is described as a "prosthetic cranioplasty plate" made from PMMA material, intended for surgical implantation and fixation to bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.
Product codes
GXN
Device Description
The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
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)
Longeviti ClearFit OTS Cranial Implant, K212058, Longeviti ClearFit Cranial Implant, K203349
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
November 9, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
Longeviti Neuro Solutions, LLC Brianna Myers Project Manager 303 International Circle, Suite 190 Hunt Valley, Maryland 21030
Re: K231920
Trade/Device Name: Longeviti ClearFit OTS Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 6, 2023 Received: October 13, 2023
Dear Brianna Myers:
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" (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).
1
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.
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 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,
Image /page/1/Picture/6 description: The image shows a digital signature. On the left, it says "Adam D. Pierce -S". On the right, it says "Digitally signed by Adam D. Pierce -S Date: 2023.11.09 07:58:22-05'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231920
Device Name
Longeviti ClearFit OTS Cranial Implant
Indications for Use (Describe)
The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.
| 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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4
| LONGEVITI NEURO SOLUTIONS | |
|---|---|
| 510(k) Summary | |
| Date Prepared: | Novemeber 9, 2023 |
| Applicant: | Longeviti Neuro Solutions |
| 303 International Circle Suite 150 | |
| Cockeysville, Maryland 21030 | |
| (410) 527-1803 | |
| Contact Person: | Brianna Myers |
| bmyers@longeviti.com | |
| Project Manager | |
| Longeviti Neuro Solutions | |
| SUBJECT DEVICE | |
| Trade Name: | Longeviti ClearFit OTS Cranial Implant |
| Common Name: | Cranial implant |
| Class: | 2 |
| Classification: | 882.5330 |
| Product code: | GXN |
| Primary Predicate: | Longeviti ClearFit OTS Cranial Implant, K212058 |
| Additional Predicate: | Longeviti ClearFit Cranial Implant, K203349 |
| Device Description: | The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound |
| penetrable fixed size prosthetic cranioplasty plates intended to correct | |
| and/or restore bony voids and/or defects of the cranium. The implants are | |
| manufactured from polymethyl methacrylate (PMMA) materials. The | |
| devices are provided sterile and can be fixated to cranial bone using | |
| commercially available fasteners. | |
| Indication for Use: | The Longeviti ClearFit OTS cranial implants are manufactured to correct |
| and/or restore bony voids and/or defects of the cranium. | |
| Comparison of | |
| Technological | |
| Characteristics: | There are no technological differences to the material (PMMA) and no |
| differences to the materials of manufacturing. There are no differences to | |
| the packaging or sterilization process. |
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