(33 days)
Not Found
No
The description focuses on patient-specific design based on CT scan data and manufacturing processes, with no mention of AI or ML for analysis, design, or other functions.
No
The device is used to correct "bony voids and/or defects of the cranium," which is a structural correction rather than a treatment for a disease or condition.
No
The device is described as an implantable prosthetic, not a device used to diagnose a condition. It is designed to correct bony voids/defects, which is a treatment, not a diagnostic function.
No
The device is a physical implant manufactured from polymethyl methacrylate materials, designed using CT scan data. It is not solely software.
Based on the provided information, the Longeviti ClearFit™ cranial Implant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "correct bony voids and/or defects of the cranium." This is a surgical implant designed to physically repair a structural issue in the body.
- Device Description: The device is a "patient specific, implantable prosthetic cranioplasty plate." It is manufactured from polymethyl methacrylate and is implanted into the patient.
- Nature of IVDs: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The Longeviti ClearFit™ cranial Implant is a Class II or Class III medical device (depending on the specific regulatory classification) that is surgically implanted.
N/A
Intended Use / Indications for Use
The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct 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 Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
cranium
Indicated Patient Age Range
adult patient
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)
No new performance testing was required to determine substantial equivalence because the manufacturing and materials are identical to those described in K191210. The only additional testing for this submission was the addition of the acoustic property testing to support the labeling change. For this submission, acoustic properties were measured using time-delay spectrometry with a swept frequency (0.25-20MHz) ultrasound transducer, a hydrophone, and test samples mounted in an acoustic test tank. Continuous quality testing, including Gas Chromatography - Mass Spectrometry, is used to manage or confirm the absence of process drift which could potentially affect acoustic properties of the cast material.
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 16, 2020
Longeviti Neuro Solutions, LLC % Elaine Duncan President Paladin Medical, Inc P.O. Box 560 Stillwater, Minnesota 55082
Re: K203349
Trade/Device Name: Longeviti ClearFit Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: November 12, 2020 Received: November 13, 2020
Dear Elaine Duncan:
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203349
Device Name Longeviti ClearFit™ cranial Implant
Indications for Use (Describe)
The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Manufacturer | Longeviti Neuro Solutions, LLC
303 International Circle Suite 150
Hunt Valley, MD 21030 |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Elaine Duncan, Paladin Medical, Inc.
regulatory consultant for Longeviti Neuro Solutions
P.O. Box 560, Stillwater, MN 55082
Phone: 715-549-6035
Email: duncan@paladinmedical.com |
| Date Prepared | December 16, 2020 |
| Device Name | Trade Name: ClearFit™ Cranial Implant
Common Name: Cranial Implant
Classification Name: Plate, Cranioplasty, Preformed, Non-alterable |
| ProCode and
Classification | Product Code: GXN, PJN
Class II , 21CFR 882.5330 |
| Predicate
Device | K191210 - Longeviti ClearFit™ Cranial implant cleared under K191210. |
| Device Description | The Longeviti ClearFit Implant is patient specific, implantable prosthetic
cranioplasty plates intended to correct and/or restore bony voids and/or defects
of the cranium. The implant is manufactured from polymethyl methacrylate
materials and are designed using the patient's CT scan data. The devices are
provided sterile and can be fixated to cranial bone using commercially available
fasteners. An identical backup implant may be supplied as a courtesy to the
surgeon, according to custom, but is not required. The typical maximum single
plate size does not exceed a total surface area of 411 cm2 and should have a
nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity.
Perfusion holes (also known as drainage holes) are available upon surgeon
request at the time of ordering. Perfusion holes are 2mm in diameter and spaced
at least 10mm apart. |
| Indication for Use | The Longeviti ClearFit implant is designed and manufactured individually for each
adult patient to correct bony voids and/or defects of the cranium. |
| Performance Testing
to Determine
Substantial
Equivalence | No new performance testing was required to determine substantial equivalence
because the manufacturing and materials are identical to those described in
K191210. The only additional testing for this submission was the addition of the
acoustic property testing to support the labeling change. For this submission,
acoustic properties were measured using time-delay spectrometry with a swept
frequency (0.25-20MHz) ultrasound transducer, a hydrophone, and test samples
mounted in an acoustic test tank. Continuous quality testing, including Gas
Chromatography - Mass Spectrometry, is used to manage or confirm the absence
of process drift which could potentially affect acoustic properties of the cast
material. |
| Summary of
Technological
Similarities and
Differences | There are no differences to the technology of the ClearFit in this submission and
the predicate device of K191210. The predicate device did not include information
or evaluation as to the acoustic properties of the ClearFit device. There are no
technological differences to the biomaterial (PMMA) and no differences to the
materials of manufacturing. There are no differences to packaging or sterilization
processes. The only difference described in this Special 510(k) is the addition of
descriptive parameters concerning the ultrasound attenuation of the ClearFit
implant material to be included in the Instructions for Use (IFU). |
| Conclusion of
Substantial
Equivalence | The additional information to the ClearFit IFU regarding ultrasound attenuation
does not change the indication for use or intended use of the ClearFit implant. The
continuous quality testing confirms the ClearFit™ Cranial implant of this submission
is substantially equivalent to the Longeviti ClearFit™ Cranial implant cleared under
K191210. |
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