← Product Code [JOF](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JOF) · K200532 # StarPore (K200532) _Anatomics Pty, Ltd. · JOF · Jun 2, 2020 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JOF/K200532 ## Device Facts - **Applicant:** Anatomics Pty, Ltd. - **Product Code:** [JOF](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JOF.md) - **Decision Date:** Jun 2, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3620 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects. ## Device Story StarPore™ is a range of preformed, porous high-density polyethylene (HDPE) implants; designed to restore or augment bony contour in craniofacial defects. Unlike the predicate device (PoreStar, K171037), which is patient-specific based on 3D CT scans, StarPore™ is offered as off-the-shelf implants in various sizes and shapes. Surgeons select an appropriate size and cut the implant intra-operatively to achieve an anatomically matched fit. The porous architecture, created by star-shaped particles, mimics trabecular bone. The device is non-conductive, non-magnetic, and MRI-compatible. It is provided sterile via ethylene oxide gas for single-use in a clinical setting. ## Clinical Evidence No clinical data. Substantial equivalence is supported by bench testing and design validation/verification activities previously performed for the PoreStar (now StarPore) product line, including material properties, sterilization, biocompatibility, and shelf-life/stability testing. ## Technological Characteristics Material: Medical grade high-density polyethylene (HDPE). Architecture: Interconnecting porous structure resembling trabecular bone. Dimensions: Lengths 27-80mm, widths 27-110mm, thicknesses 1-8mm. Energy: None (passive implant). Connectivity: None. Sterilization: Ethylene Oxide gas. MRI compatibility: Non-conductive and non-magnetic. ## Regulatory Identification Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene. ## Predicate Devices - Anatomics Pty Ltd. PoreStar Patient Specific Implant - [K171037](/device/K171037.md) ## Reference Devices - Porex MEDPOR Surg Implant Material: Prefor Cran/Fac Impla - [K922489](/device/K922489.md) - Porex MEDPOR Plus Surgical Biomaterial - [K012350](/device/K012350.md) - Porex MEDPOR Pterional Surgical Implant - [K002586](/device/K002586.md) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. June 2, 2020 Anatomics Pty, Ltd. % Christine Scifert Partner MRC Global 9085 East Mineral Circle, Suite 110 Centennial, CO 80112 Re: K200532 Trade/Device Name: StarPore™ Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: JOF Dated: March 3, 2020 Received: March 4, 2020 ## Dear Christine Scifert: 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 mediation-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, for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200532 Device Name StarPore™ Indications for Use (Describe) StarPore™ implants are intended for the restoration of bony contour in craniofacial defects. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary StarPore™ June 1, 2020 | Company: | Anatomics Pty Ltd
Warehouse 1, 246 East Boundary Road,
Bentleigh East, VIC 3165, Australia
Telephone: +0011 61 3 9529 8088
Fax: +0011 61 3 9529 8099 | |--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact: | Christine Scifert
Phone: (901) 831-8053 | | Company Contact: | Robert Thompson
VP Product Innovation
E-Mail: Robert.thompson@anatomics.com | | Trade Name: | StarPore™ | | Common Name: | Polymer, Ent Synthetic, Porous Polyethylene
Plate, Cranioplasty, Preformed, Alterable | | Classification: | Class II | | Regulation Number: | 21 CFR 874.3620 (Ear, Nose, and Throat Synthetic Polymer Material) | | Panel: | Ear, Nose, and Throat | | Product Code: | JOF | ## Predicate Device: - . Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037 #### Reference Devices: - Porex MEDPOR Surg Implant Material: Prefor Cran/Fac Impla - K922489 - Porex MEDPOR Plus Surgical Biomaterial - K012350 - Porex MEDPOR Pterional Surgical Implant - K002586 K922489 and K012350 provide reference devices that have previously been cleared with preformed shapes for craniofacial defects. The geometries of the subject implants are similar to the reference devices previously cleared under K922489 and K002586 for craniofacial defects. #### Device Description: StarPore™ (previously cleared as PoreStar™ Patient Specific Implants) is a range of anatomically shaped surgical implants manufactured from porous high-density polyethylene (HDPE). The star ("Star-") shaped particles create an interconnecting porous ("-Pore") architecture resembling trabecular bone. The implants are provided sterile and intended for single-use. StarPore™ is manufactured from medical grade HDPE (an electrically nonconductive and nonmagnetic polymer) and is suitable for use during Magnetic Resonance Imaging (MRI). The purpose of this Traditional 510(k) submission is to add "off-the-shelt" implant options to the StarPore™ product line. These off-the-shelf implants would provide surgeons the options of various sizes of implants which, unlike the predicate, would not be individually designed from 3D Computed {4}------------------------------------------------ Tomography (CT) scans provided to Anatomics by the referring surgeon. Instead, the subject implants would be offered in various off-the-shelf sizes and shapes which could then be cut by the prescribing surgeon intra-operatively to create an anatomically matched patient specific design. StarPore™ is intended for single use only and is provided sterile, using ethylene oxide gas. #### Indications for Use: StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects. ## Technological Characteristics Summary: The subject device is substantially equivalent to the following predicate: Anatomics Pty Ltd. PoreStar Patient Specific Implant - K171037 (S.E. 12/27/2017) The subject and predicate devices are similar in Intended Use, Technological Characteristics, Performance Specifications, and Material. See the table below for details on comparison between the subject and predicate devices: | Characteristic | StarPore™ (New Device) | PoreStar Patient Specific Implant (K171037) | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | StarPore™ implants are intended for the
restoration or augmentation of bony
contour in craniofacial defects. | The PoreStar Patient Specific Implant is
intended for the augmentation or restoration of
bony contour in craniofacial defects. | | Material | Medical grade, HDPE (high density
polyethylene) | Medical grade, HDPE (high density
polyethylene) | | Dimensions | Various shapes consisting of lengths
27mm - 80mm, widths 27mm - 110mm,
and thicknesses/heights 1mm - 8mm to be
further cut by prescribing surgeons
intraoperatively to achieve best fit. | Patient specific implants created based on
patient CT scans and approved by prescribing
physician | | Packaging | Double steri-pouch and put in shelf box | Double peel pouched and put in a shelf box | | Sterility | Sterile, by Ethylene Oxide gas | Sterile, by Ethylene Oxide gas | ## Performance Testing Summary: Previous design validation and verification activities were performed for the PoreStar™ (renamed StarPore™) implants. A new risk analysis assessment for the subject products and design specifications has been performed and show no new worst case has been introduced. Therefore, all previous testing including validation of specifications related to material properties, sterilization, biocompatibility, shelflife, stability, and material properties are applicable to the subject device. Thus, it has been determined that no further performance testing is needed. #### Substantial Equivalence Conclusions: In conclusion, the subject StarPore™ device is similar to the predicate device in intended use, technological characteristics, material, and performance. No new questions of safety and effectiveness have been raised. Therefore, the subject device can be considered substantially equivalent. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JOF/K200532](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/JOF/K200532) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com