(69 days)
Not Found
No
The summary describes a fixed-size, off-the-shelf cranial implant made of PMMA. There are no mentions of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies.
Yes.
The device is intended to correct and/or restore bony voids and/or defects of the cranium, which provides a therapeutic benefit by addressing a medical condition.
No
The device is a cranial implant designed to correct and restore bony voids and defects. It is a prosthetic device for treatment, not for diagnosing conditions.
No
The device description explicitly states that the device is a "fixed size prosthetic cranioplasty plate" manufactured from "polymethyl methacrylate materials," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The Longeviti ClearFit™ OTS Cranial Implants are described as "fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium." This is a device that is implanted into the body to physically repair a defect.
- Intended Use: The intended use is to "correct and/or restore bony voids and/or defects of the cranium." This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgically implanted device used for structural repair, not a diagnostic test performed on a biological sample.
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 (comma separated list FDA assigned to the subject device)
GXN, PJN
Device Description
The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are 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 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)
Performance testing completed for the ClearFit™ (K202901) is applicable to the ClearFit™ OTS as Longeviti uses the manufacturing processes and materials validated for the ClearFit™ Cranial Implant to produce the ClearFit™ OTS Cranial Implant. Performance testing completed includes:
- Method: Tensile, Standard: ASTM D638-19: Standard Test Method for Tensile Properties of Plastics, Results: Pass
- Method: Flexural, Standard: ASTM D790-15: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials, Results: Pass
- Method: Impact, Standard: ASTM D4812-10: Standard Test Method for Unnotched Cantilever Beam Impact Resistance of Plastics, Results: Pass
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.
Longeviti ClearFit™ Cranial Implant K202901
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
§ 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
Image /page/0/Picture/0 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 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.
September 8, 2021
Longeviti Neuro Solutions, LLC Heather Hourihan, RAC Director of Regulatory Affairs 303 International Circle Suite 190 Hunt Valley, Maryland 21030
Re: K212058
Trade/Device Name: Longeviti ClearFit OTS Cranial Implants Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: July 21, 2021 Received: August 5, 2021
Dear Heather Hourihan:
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 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
1
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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212058
Device Name
Longeviti ClearFit OTS Cranial Implants
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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3
| LONGEVITI NEURO SOLUTIONS | |||||
|---|---|---|---|---|---|
| 510(k) Summary | |||||
| Date Prepared: | September 8, 2021 | ||||
| Applicant: | Longeviti Neuro Solutions | ||||
| 303 International Circle Suite 190 | |||||
| Cockeysville, Maryland 21030 | |||||
| (410) 527-1803 | |||||
| Contact Person: | Heather Hourihan | ||||
| hhourihan@longeviti.com | |||||
| Director of Regulatory Affairs, RAC | |||||
| Longeviti Neuro Solutions | |||||
| SUBJECT DEVICE | |||||
| Trade Name: | Longeviti ClearFit™ OTS Cranial Implants | ||||
| Common Name: | PMMA cranial implant | ||||
| Class: | 2 | ||||
| Classification: | 882.5330 | ||||
| Procode: | GXN, PJN | ||||
| Predicate Device: | Longeviti ClearFit™ Cranial Implant K202901 | ||||
| Device Description: | The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are 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 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 significant technological differences between the Longeviti | ||||
| ClearFit™ Cranial Implant (K202901) and the Longeviti ClearFit™ OTS | |||||
| Cranial Implant. Longeviti manufactures ClearFit™ OTS Cranial Implants | |||||
| using the same raw materials and applying the same manufacturing | |||||
| processes used for their ClearFit™ Cranial Implant. |
4
| Tabular Comparison of Technological Characteristics: | |||
|---|---|---|---|
| Characteristics | K212058 | ||
| Longevity ClearFit TM | |||
| OTS Cranial Implant | |||
| (Subject Device) | K202901 | ||
| Longevity ClearFit TM | |||
| Cranial Implant | |||
| (Predicate Device) | Comments | ||
| Device Classification | Class II | Class II | Same |
| Product Code | GXN, PJN | GXN, PJN | Same |
| Indications for Use | The Longeviti ClearFit TM | ||
| OTS Cranial Implants | |||
| are manufactured to | |||
| correct and/or restore | |||
| bony voids and/or | |||
| defects of the cranium. | The Longeviti ClearFit TM | ||
| Cranial Implant is | |||
| designed and | |||
| manufactured | |||
| individually for each | |||
| patient to correct bony | |||
| voids and/or defects of | |||
| the cranium. | Similar | ||
| Material | Polymethylmethacrylate | ||
| (PMMA) | Polymethylmethacrylate | ||
| (PMMA) | Same | ||
| Design | Fixed Size Implant | Patient Specific Implant | Different |
| Dimensions (cm²) | 9cm² - 37 cm² | 25cm² - 411cm² | Similar |
| Maximum thickness | 5mm | 5mm | Same |
| Radiopacity | Radiolucent | Radiolucent | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide (EO) or | |
| Vaporized Hydrogen | |||
| Peroxide (VHP) | Similar | ||
| Biocompatibility | Implant device with | ||
| permanent (>30 d) | |||
| contact with | |||
| tissue/bone | Implant device with | ||
| permanent (>30 d) | |||
| contact with | |||
| tissue/bone | Same |
5
| Evaluations and
Results to Support
Substantial
Equivalence: | Performance testing completed for the ClearFit™ (K202901) is applicable to the
ClearFit™ OTS as Longeviti uses the manufacturing processes and materials
validated for the ClearFit™ Cranial Implant to produce the ClearFit™ OTS Cranial
Implant. Performance testing completed includes: | | |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | Method | Standard | Results |
| | Tensile | ASTM D638-19: Standard Test Method for Tensile
Properties of Plastics | Pass |
| | Flexural | ASTM D790-15:
Standard Test Methods for Flexural Properties of
Unreinforced and Reinforced Plastics and Electrical
Insulating Materials | Pass |
| | Impact | ASTM D4812-10:
Standard Test Method for Unnotched Cantilever Beam
Impact Resistance of Plastics | Pass |
| Conclusion: | Based on the similarities of the intended use/indications for use, technological
and functional characteristics, and the results of the non-clinical performance
testing, the ClearFit OTS cranial implant is substantially equivalent to the legally
marked predicate device. | | |