(248 days)
The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.
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.
The Longeviti ClearFit Cranial Implant is designed to correct bony voids and/or defects of the cranium. The provided document, a 510(k) Premarket Notification, primarily focuses on demonstrating substantial equivalence to a predicate device (Longeviti PMMA Static Cranial Implant, K170410) rather than a comprehensive study proving novel acceptance criteria.
Based on the information provided, the "acceptance criteria" are implied through various ISO and ASTM standard tests and the "study" is the battery of tests performed to fulfill these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard & Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | All assessments were found acceptable. |
| - ISO 10993-1 (2018): Biological evaluation (risk management) | Satisfied |
| - ISO 10993-5 (2009): In vitro cytotoxicity | Satisfied |
| - USP, General Chapter <151> & ISO 10993-11 (2017): Material mediated pyrogenicity (rabbit) | Satisfied |
| - ISO 10993-10 (2010): Irritation & skin sensitization (Guinea Pig Maximization Sensitization Test & Intracutaneous Study in Rabbits) | Satisfied |
| Sterility & Endotoxin: | All assessments were found acceptable. |
| - AAMI 11737-1: Bioburden | Satisfied |
| - ANSI ST72:2011/(R)2016: Endotoxin pyrogenicity | Satisfied |
| Material Properties (Polymethyl Methacrylate - PMMA): | All assessments were found acceptable. |
| - ASTM D7028: Glass Transition (Tg) | Satisfied |
| - ASTM D638-14: Tensile strength | Satisfied |
| - ASTM D790-15: Flexural strength | Satisfied |
| - ASTM D4812-11: Impact strength | Satisfied |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the listed tests (e.g., number of animals for biocompatibility tests, number of material samples for mechanical tests). It generally indicates that "These tests and their results contributed to the determination of Substantial Equivalence."
The data provenance is not specified. It is likely from laboratory testing conducted as part of the device development and regulatory submission process, rather than patient data. Therefore, it is prospective in the sense that the tests were conducted specifically for this submission. The country of origin for the data is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the provided document. The acceptance criteria and the "ground truth" (i.e., whether the device meets the standards) are established by the internationally recognized standards (ISO, ASTM, USP, AAMI, ANSI) themselves and assessed by qualified testing laboratories, not by a panel of clinical experts for a "test set" in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple experts to establish a consensus ground truth. The tests described here are laboratory and material characterization tests where the results are objectively measured against predefined standard specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through material properties, biocompatibility, and manufacturing process similarities to a predicate device, not on assessing the diagnostic or clinical effectiveness with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable here. The device is a physical cranial implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is the defined specifications and requirements within the referenced ISO, ASTM, USP, AAMI, and ANSI standards. For instance, for cytotoxicity, the ground truth is the cellular response deemed acceptable by ISO 10993-5. For tensile strength, the ground truth is the specified range or minimum value per ASTM D638-14 to ensure safety and performance.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The Longeviti ClearFit Cranial Implant is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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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
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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,
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
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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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510(K) SUMMARY
| Manufacturer | Longeviti Neuro Solutions, LLC303 International Circle Suite 150Hunt Valley, MD 21030Phone: (410) 527-1803 |
|---|---|
| Contact Person | Name: Elaine Duncan, Paladin Medical, Inc.regulatory consultant for Longeviti Neuro SolutionsP.O. Box 560, Stillwater, MN 55082Phone: 715-549-6035Email: duncan@paladinmedical.com |
| Date Prepared | December 30, 2019 |
| Device Name | Trade Name: ClearFit™ Cranial ImplantCommon Name: Cranial ImplantClassification Name: Plate, Cranioplasty, Preformed, Non-alterable |
| ProCode andClassification | Product Code: GXN, PJNClass II |
| SubstantiallyEquivalent To: | The Longeviti ClearFit™ Cranial implant is substantially equivalent to thefollowing legally marketed devices:Longeviti PMMA Static Cranial Implant,Longeviti Neuro Solutions K170410 |
| Device Description | The Longeviti ClearFit Implant is patient specific, implantable prostheticcranioplasty plates intended to correct and/or restore bony voids and/or defectsof the cranium. The implant is manufactured from polymethyl methacrylatematerials and are designed using the patient's CT scan data. The devices areprovided sterile and can be fixated to cranial bone using commercially availablefasteners. An identical backup implant may be supplied as a courtesy to thesurgeon, according to custom, but is not required. The typical maximum singleplate size does not exceed a total surface area of 411 cm² and should have anominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity.Perfusion holes (also known as drainage holes) are available upon surgeonrequest at the time of ordering. Perfusion holes are 2mm in diameter and spacedat least 10mm apart. |
| Indication for Use | The Longeviti ClearFit Cranial implant is designed and manufacturedindividually for each adult patient to correct bony voids and/or defects of thecranium. |
| Comparison ofTechnologicalCharacteristics | The changes compared to the Longeviti Cranial Implant covered in thissubmission are: 1) Trade name change and plural to singular description(previously updated via registration), 2) Recognition of option for perfusionholes and 3) description of process changes. There are no technologicalchanges to the biomaterial (PMMA) and no change to the materials ofmanufacturing There are no changes to packaging or sterilization processes. |
| Continued next page |
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| These tests and their results contributed to the determination of SubstantialEquivalence | RESULTS-All assessmentswere foundacceptable |
|---|---|
| (ISO) 10993-1, (2018) Biological evaluation of medical devices -Part 1: Evaluation and testingwithin a risk management process (2018).ISO 10993-5 (2009), Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity.Material mediated pyrogenicity in the rabbit. conducted based on USP, General Chapter <151 >,Pyrogen Test. The procedure is recommended in ISO 10993-11, Biological evaluation of medicaldevices - 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 andskin sensitization. --- ISO Guinea Pig Maximization Sensitization Test and ISO IntracutaneousStudy in Rabbits. | |
| Bioburden: AAMI 11737-1 methodsEndotoxin pyrogenicity: ANSI ST72:2011/(R)2016Glass Transition (Tg): ASTM D7028Tensile strength: ASTM D638-14Flexural strength: ASTM D790-15Impact strength: ASTM D4812-11 | |
| Conclusion: | The Longeviti ClearFit™ Cranial Implant is equivalent to the predicate, PMMAStatic Cranial Implants, cleared under K170410, as shown by testing andqualification evaluations listed above. |
§ 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).