(406 days)
The Longeviti Static Cranial Implants are designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.
The Longeviti PMMA Static Cranial Implants are patient specific, implantable 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 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. Typical maximum single plate sizes do 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.
The provided documents are a 510(k) Premarket Notification from the FDA to Longeviti Neuro Solutions, LLC for their Longeviti PMMA Static Cranial Implant. This document does not contain information about an AI/ML-driven medical device or any study proving a device meets acceptance criteria related to AI/ML performance.
The content focuses on:
- Substantial Equivalence: The FDA's determination that the Longeviti PMMA Static Cranial Implant is substantially equivalent to legally marketed predicate devices (OsteoSymbionics Patient Specific Cranial Plate K133082 and OsteoSymbionics Patient Specific Cranial Implant K072601).
- Device Description: The device is a patient-specific, implantable prosthetic cranioplasty plate manufactured from polymethyl methacrylate (PMMA) materials using patient CT scan data.
- Indications for Use: To correct bony voids and/or defects of the cranium.
- Testing Summary: Primarily focused on sterilization validation (ISO-14937) and mechanical strength tests (ASTM D638-03, D790-03, D4812-06) to demonstrate material equivalence to the predicate device.
Therefore, I cannot fulfill your request as the provided text does not contain any of the information required to describe acceptance criteria or a study related to an AI/ML device's performance. There is no mention of an algorithm, AI, machine learning, test sets, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance.
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March 23, 2018
Longeviti Neuro Solutions, LLC % Elaine Duncan President Paladin Medical, Inc. 303 International Circle Suite T128 Hunt Valley, Maryland 21030
Re: K170410
Trade/Device Name: Longeviti PMMA Static Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: February 15, 2018 Received: February 16, 2018
Dear Ms. 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170410
Device Name
Longeviti PMMA Static Cranial Implant
Indications for Use (Describe)
The Longeviti Static Cranial Implants are designed and manufactured individually for each 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 #T128Hunt Valley, MD 21030 |
|---|---|
| Contact Person | Name: Elaine Duncan, Paladin Medical, Inc.regulatory consultant for Longeviti Neuro SolutionsPhone: 715-549-6035Email: duncan@paladinmedical.com |
| Date Prepared | February 14, 2018 |
| Device Name | Trade Name: Longeviti PMMA Static Cranial ImplantCommon Name: Cranial ImplantClassification Name: Plate, Cranioplasty, Preformed, Non-alterable |
| ProCode and Classification | Product Code: GXN, PJNClass II |
| Substantially Equivalent To | The Longeviti PMMA Static Cranial Implant is substantiallyequivalent to the following legally marketed devices:Primary Predicate Device:OsteoSymbionicsPatient Specific Cranial Plate (a.k.a. ClearSheild) – K133082Secondary Predicate Device:OsteoSymbionicsPatient Specific Cranial Implant - K072601 |
| Device Description | The Longeviti PMMA Static Cranial Implants are patient specific,implantable prosthetic cranioplasty plates intended to correctand/or restore bony voids and/or defects of the cranium. Theimplants are manufactured from polymethyl methacrylatematerials and are designed using the patient's CT scan data. Thedevices are provided sterile and can be fixated to cranial boneusing commercially available fasteners. Typical maximum singleplate sizes do not exceed a total surface area of 411 cm2 andshould have a nominal thickness of 4mm, not to exceed 5mm, toensure physical integrity. |
| Indication for Use | The Longeviti Static Cranial Implants are designed andmanufactured individually for each patient to correct bony voidsand/or defects of the cranium. |
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510(k) Summary
| Summary of Testing and Basis for | The Longeviti PMMA Static Cranial Implant are provided sterile. | ||
|---|---|---|---|
| Substantial Equivalence | Sterilization validation was conducted according to the OverkillISO-14937 approach 3 (conservative process definition based oninactivation of reference microorganisms) product challengedevice method. The peracetic acid sterilization methodconducted by contract sterilizer Revox Sterilization Solutions isthe same method, cycle, and sterilizer as used by the primarypredicate device manufacturer Osteosymbionics. (K133082) | ||
| The Longeviti PMMA Static Cranial Implant are fabricated fromthe same PMMA materials using the same methods as theOsteosymbionics Patient Specific Cranial Plate.Longeviti contracted a certified and approved materials testinglaboratory to perform a series of mechanical strength tests todemonstrate that the material is physically and mechanicallysubstantially equivalent to the Osteosymbionics predicatematerial. The mechanical tests conducted were the following: | |||
| ASTM | Test Description | ||
| D638-03 | Tensile properties of Plastics | ||
| D790-03 | Flexural properties of unreinforced andreinforced plastics and electrical insulatingmaterials | ||
| D4812-06 | Unnotched cantilever beam impact | ||
| Conclusion: The Longeviti PMMA Static Cranial Implants (design,materials, properties and indication for use) are substantiallyequivalent to predicate devices by Osteosymbionics; (K072601)and (K133082) |
§ 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).