(406 days)
No
The description focuses on patient-specific design based on CT data and traditional manufacturing methods (PMMA). There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is designed to correct bony voids and/or defects of the cranium, which falls under the definition of a therapeutic intervention.
No
The device is described as an implantable prosthetic, designed to correct bony voids and/or defects of the cranium, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is an "implantable prosthetic cranioplasty plate" manufactured from "polymethyl methacrylate materials," which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Longeviti Static Cranial Implants are implantable prosthetic devices designed to correct bony voids and defects of the cranium. They are physically placed within the patient's body.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device is designed based on CT scan data, which is imaging data, not a biological sample.
Therefore, based on the provided information, the Longeviti Static Cranial Implants are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Longeviti Static Cranial Implants are designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.
Product codes
GXN, PJN
Device Description
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.
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
Not Found
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
Sterilization validation was conducted according to the Overkill ISO-14937 approach 3 (conservative process definition based on inactivation of reference microorganisms) product challenge device method. The peracetic acid sterilization method conducted by contract sterilizer Revox Sterilization Solutions is the same method, cycle, and sterilizer as used by the primary predicate device manufacturer Osteosymbionics. (K133082) The Longeviti PMMA Static Cranial Implant are fabricated from the same PMMA materials using the same methods as the Osteosymbionics Patient Specific Cranial Plate. Longeviti contracted a certified and approved materials testing laboratory to perform a series of mechanical strength tests to demonstrate that the material is physically and mechanically substantially equivalent to the Osteosymbionics predicate material. The mechanical tests conducted were the following: ASTM D638-03 Tensile properties of Plastics, ASTM D790-03 Flexural properties of unreinforced and reinforced plastics and electrical insulating materials, ASTM D4812-06 Unnotched cantilever beam impact. Conclusion: The Longeviti PMMA Static Cranial Implants (design, materials, properties and indication for use) are substantially equivalent to predicate devices by Osteosymbionics; (K072601) and (K133082)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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);
1
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, LLC
303 International Circle #T128
Hunt Valley, MD 21030 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Elaine Duncan, Paladin Medical, Inc.
regulatory consultant for Longeviti Neuro Solutions
Phone: 715-549-6035
Email: duncan@paladinmedical.com |
| Date Prepared | February 14, 2018 |
| Device Name | Trade Name: Longeviti PMMA Static 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 PMMA Static Cranial Implant is substantially
equivalent to the following legally marketed devices:
Primary Predicate Device:
OsteoSymbionics
Patient Specific Cranial Plate (a.k.a. ClearSheild) – K133082
Secondary Predicate Device:
OsteoSymbionics
Patient Specific Cranial Implant - K072601 |
| Device Description | 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. |
| Indication for Use | The Longeviti Static Cranial Implants are designed and
manufactured individually for each patient to correct bony voids
and/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 Overkill | ||
| ISO-14937 approach 3 (conservative process definition based on | |||
| inactivation of reference microorganisms) product challenge | |||
| device method. The peracetic acid sterilization method | |||
| conducted by contract sterilizer Revox Sterilization Solutions is | |||
| the same method, cycle, and sterilizer as used by the primary | |||
| predicate device manufacturer Osteosymbionics. (K133082) | |||
| The Longeviti PMMA Static Cranial Implant are fabricated from | |||
| the same PMMA materials using the same methods as the | |||
| Osteosymbionics Patient Specific Cranial Plate. | |||
| Longeviti contracted a certified and approved materials testing | |||
| laboratory to perform a series of mechanical strength tests to | |||
| demonstrate that the material is physically and mechanically | |||
| substantially equivalent to the Osteosymbionics predicate | |||
| material. The mechanical tests conducted were the following: | |||
| ASTM | Test Description | ||
| D638-03 | Tensile properties of Plastics | ||
| D790-03 | Flexural properties of unreinforced and | ||
| reinforced plastics and electrical insulating | |||
| materials | |||
| D4812-06 | Unnotched cantilever beam impact | ||
| Conclusion: The Longeviti PMMA Static Cranial Implants (design, | |||
| materials, properties and indication for use) are substantially | |||
| equivalent to predicate devices by Osteosymbionics; (K072601) | |||
| and (K133082) |