(33 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.
I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving device performance for an AI/CADe device. The document is a 510(k) premarket notification letter and summary for a cranial implant (Longeviti ClearFit Cranial Implant), which is a physical medical device, not an AI or CADe product.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance (for an AI/CADe).
- Sample sizes or data provenance for a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Information about MRMC comparative effectiveness studies or effect sizes for human readers.
- Stand-alone performance data for an algorithm.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "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." This indicates that the device's performance was not evaluated through the types of studies typically conducted for AI/CADe systems.
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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, LLC303 International Circle Suite 150Hunt Valley, MD 21030 |
|---|---|
| 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 16, 2020 |
| Device Name | Trade Name: ClearFit™ Cranial ImplantCommon Name: Cranial ImplantClassification Name: Plate, Cranioplasty, Preformed, Non-alterable |
| ProCode andClassification | Product Code: GXN, PJNClass II , 21CFR 882.5330 |
| PredicateDevice | K191210 - Longeviti ClearFit™ Cranial implant cleared under K191210. |
| 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 implant is designed and manufactured individually for eachadult patient to correct bony voids and/or defects of the cranium. |
| Performance Testingto DetermineSubstantialEquivalence | No new performance testing was required to determine substantial equivalencebecause the manufacturing and materials are identical to those described inK191210. The only additional testing for this submission was the addition of theacoustic property testing to support the labeling change. For this submission,acoustic properties were measured using time-delay spectrometry with a sweptfrequency (0.25-20MHz) ultrasound transducer, a hydrophone, and test samplesmounted in an acoustic test tank. Continuous quality testing, including GasChromatography - Mass Spectrometry, is used to manage or confirm the absenceof process drift which could potentially affect acoustic properties of the castmaterial. |
| Summary ofTechnologicalSimilarities andDifferences | There are no differences to the technology of the ClearFit in this submission andthe predicate device of K191210. The predicate device did not include informationor evaluation as to the acoustic properties of the ClearFit device. There are notechnological differences to the biomaterial (PMMA) and no differences to thematerials of manufacturing. There are no differences to packaging or sterilizationprocesses. The only difference described in this Special 510(k) is the addition ofdescriptive parameters concerning the ultrasound attenuation of the ClearFitimplant material to be included in the Instructions for Use (IFU). |
| Conclusion ofSubstantialEquivalence | The additional information to the ClearFit IFU regarding ultrasound attenuationdoes not change the indication for use or intended use of the ClearFit implant. Thecontinuous quality testing confirms the ClearFit™ Cranial implant of this submissionis substantially equivalent to the Longeviti ClearFit™ Cranial implant cleared underK191210. |
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§ 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).