(59 days)
Not Found
No
The summary describes a passive, molded implant with no mention of software, image processing, or AI/ML terms.
No.
The device is used for restoration and augmentation of the craniofacial skeleton, which is a structural or reconstructive purpose rather than a therapeutic one. It does not treat a disease or condition.
No
Explanation: The device description states it is an implant for augmentation and restoration of contour, and the performance studies mention biocompatibility and mechanical evaluations. There is no indication of diagnosis.
No
The device description explicitly states that the Longeviti PorousFit implants are made of high density polyethylene (HDPE) and are molded into various dimensions and shapes. This indicates a physical, hardware-based medical device, not a software-only 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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Longeviti PorousFit implants are described as anatomical shapes made of high-density polyethylene intended for permanent implantation within the craniofacial skeleton. They are used to restore contour.
- Intended Use: The intended use is for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton. This is a surgical procedure involving implantation, not the analysis of bodily specimens.
The description clearly indicates a surgically implanted device used for structural restoration, which is fundamentally different from the function of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.
Product codes
KKY
Device Description
Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton
Indicated Patient Age Range
Not Found
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
Testing completed by Matrix Surgical USA for their OmniPore implants are applicable to the Longeviti PorousFit implants. This includes biocompatibility evaluations (Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study), mechanical evaluations, impact testing, purity testing per USP, and porosity testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 15, 2021
Longeviti Neuro Solutions, LLC Heather Hourihan Program Manager 303 International Circle Suite 190 Hunt Valley, Maryland 21030
Re: K211514
Trade/Device Name: Longeviti PorousFit implant Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with Carbon Fibers Composite Implant Material Regulatory Class: Class II Product Code: KKY Dated: May 14, 2021 Received: May 17, 2021
Dear Heather Hourihan:
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 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
1
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 (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,
for Cindy Chowdhury, Ph.D., MBA Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Longeviti PorousFit implant
Indications for Use (Describe)
Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.
| 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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K211514 Page 1 of 2
ongeviti
Longeviti Neuro Solutions Traditional 510k Submission- PorousFit Implants
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92
Submitted By: Longeviti Neuro Solutions 303 International Circle Suite 190 Cockeysville, Maryland 21030 (410) 527-1803
- Contact Person: Heather Hourihan hhourihan@longeviti.com Director of Regulatory Affairs, RAC Longeviti Neuro Solutions
Date Submitted: July 13, 2021
Device Name and Classification:
| Trade/Proprietary Name: | PorousFit implants |
|---|---|
| Common Name: | Porous HD Polyethylene (HDPE) implants |
| Classification Name: | Material, porous polymer, for maxillofacial reconstruction |
| Class: | II |
| Regulation: | 21 CFR 878.3500 |
| Procode: | KKY |
Legally Marketed Predicate Devices :
Substantial Equivalent: OmniPore Surgical Implants (K123908)
Device Description:
Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).
Indication for Use:
Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.
4
longeviti
Longeviti Neuro Solutions Traditional 510k Submission- PorousFit Implants
Similarities and Difference to the Predicate Device:
Similarities
Longeviti has contracted Matrix Surgical USA, owner of the OmniPore predicate device, to manufacture the PorousFit implants. The same raw materials, manufacturing processes, packaging materials, performance standards, and the same indication for use are used in the PorousFit implants and the predicate device.
Differences
There are no technological differences between the OmniPore Surgical Implants and the PorousFit implants.
Summary of Testing:
Testing completed by Matrix Surgical USA for their OmniPore implants are applicable to the Longeviti PorousFit implants. This includes biocompatibility evaluations (Cytotoxicity, ISO Systemic Toxicity, ISO Intracutaneous Study, USP Pyrogen Study, and ISO Muscle Implantation Study), mechanical evaluations, impact testing, purity testing per USP, and porosity testing.
Substantial Equivalence Conclusion:
Longeviti PorousFit implants will be manufactured by Matrix Surgical USA, owner, and manufacturer of OmniPore Surgical implants. There are no technological differences between PorousFit and OmniPore and Matrix will apply the same processes and materials used in manufacturing of OmniPore for the manufacturing of PorousFit. The processes and materials used for the manufacturing of the PorousFit implants are identical to the processes and materials used for the manufacturing of the OmniPore implants. For these reasons, the Longeviti PorousFit implants are substantially equivalent to the Matrix Surgical USA OmniPore surgical implants.