(248 days)
Not Found
No
The description focuses on patient-specific design based on CT data and material properties, with no mention of AI or ML for analysis, design, or manufacturing processes.
Yes
The device is described as an implantable prosthetic to correct and restore bony voids and defects of the cranium, which directly addresses a medical condition to improve patient health, fitting the definition of a therapeutic device.
No
The device is described as an "implantable prosthetic cranioplasty plate" designed to correct and/or restore bony voids and defects in the cranium. Its function is to replace or repair tissue, not to diagnose a condition.
No
The device is a physical implant manufactured from polymethyl methacrylate materials, designed using CT scan data. While software is used in the design process, the final product is a tangible medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Longeviti ClearFit™ Cranial Implant is a physical implant designed to correct bony defects in the skull. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to "correct bony voids and/or defects of the cranium," which is a surgical procedure, not an in vitro diagnostic test.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It is a physical prosthetic.
Therefore, based on the provided information, the Longeviti ClearFit™ Cranial Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Longeviti ClearFir™ 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
Intended User / Care Setting
Prescription Use
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)
Tests performed:
- (ISO) 10993-1, (2018) Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process (2018).
- ISO 10993-5 (2009), Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- Material mediated pyrogenicity in the rabbit. conducted based on USP, General Chapter , Pyrogen Test. The procedure is recommended in ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. Annex G: Information on material-mediated pyrogens (2017).
- ISO 10993-10, (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. --- ISO Guinea Pig Maximization Sensitization Test and ISO Intracutaneous Study in Rabbits.
- Bioburden: AAMI 11737-1 methods
- Endotoxin pyrogenicity: ANSI ST72:2011/(R)2016
- Glass Transition (Tg): ASTM D7028
- Tensile strength: ASTM D638-14
- Flexural strength: ASTM D790-15
- Impact strength: ASTM D4812-11
Key Results: All assessments were found acceptable.
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
January 9, 2020
Longeviti Neuro Solutions, LLC % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K191210
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: December 9, 2019 Received: December 10, 2019
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
1
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,
Matthew Krueger, M.S.E. 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) K191210
Device Name Longeviti ClearFit™ Cranial Implant
Indications for Use (Describe)
The Longeviti ClearFir™ 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) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Manufacturer | Longeviti Neuro Solutions, LLC
303 International Circle Suite 150
Hunt Valley, MD 21030
Phone: (410) 527-1803 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 30, 2019 |
| 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 |
| Substantially
Equivalent To: | The Longeviti ClearFit™ Cranial implant is substantially equivalent to the
following legally marketed devices:
Longeviti PMMA Static Cranial Implant,
Longeviti Neuro Solutions K170410 |
| 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 Cranial implant is designed and manufactured
individually for each adult patient to correct bony voids and/or defects of the
cranium. |
| Comparison of
Technological
Characteristics | The changes compared to the Longeviti Cranial Implant covered in this
submission are: 1) Trade name change and plural to singular description
(previously updated via registration), 2) Recognition of option for perfusion
holes and 3) description of process changes. There are no technological
changes to the biomaterial (PMMA) and no change to the materials of
manufacturing There are no changes to packaging or sterilization processes. |
| | Continued next page |
4
| These tests and their results contributed to the determination of Substantial
Equivalence | RESULTS-
All assessments
were found
acceptable |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (ISO) 10993-1, (2018) Biological evaluation of medical devices -Part 1: Evaluation and testing
within a risk management process (2018).
ISO 10993-5 (2009), Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity.
Material mediated pyrogenicity in the rabbit. conducted based on USP, General Chapter ,
Pyrogen Test. The procedure is recommended in ISO 10993-11, Biological evaluation of medical
devices - Part 11: Tests for systemic toxicity. Annex G: Information on material-mediated pyrogens
(2017).
ISO 10993-10, (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization. --- ISO Guinea Pig Maximization Sensitization Test and ISO Intracutaneous
Study in Rabbits. | |
| Bioburden: AAMI 11737-1 methods
Endotoxin pyrogenicity: ANSI ST72:2011/(R)2016
Glass Transition (Tg): ASTM D7028
Tensile strength: ASTM D638-14
Flexural strength: ASTM D790-15
Impact strength: ASTM D4812-11 | |
| Conclusion: | The Longeviti ClearFit™ Cranial Implant is equivalent to the predicate, PMMA
Static Cranial Implants, cleared under K170410, as shown by testing and
qualification evaluations listed above. |