(92 days)
No
The document describes a physical implant made of porous HDPE. The manufacturing process and intended use do not involve AI/ML. The previous version used CT scans for patient-specific design, but the current submission focuses on off-the-shelf sizes. There is no mention of AI/ML in the text.
Yes
The device is intended for the restoration or augmentation of bony contour in craniofacial defects, which is a therapeutic purpose.
No
The device is an implant for restoring bony contour in craniofacial defects, not for diagnosing medical conditions.
No
The device description clearly states that StarPore™ is a range of anatomically shaped surgical implants manufactured from porous high-density polyethylene (HDPE). This is a physical, hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "restoration or augmentation of bony contour in craniofacial defects." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a surgical implant made from porous high-density polyethylene (HDPE) intended for single-use and provided sterile. It also mentions being cut by a surgeon intra-operatively.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly intended for in vivo (inside the body) use as a surgical implant.
N/A
Intended Use / Indications for Use
StarPore™ implants are intended for the restoration of bony contour in craniofacial defects.
Product codes (comma separated list FDA assigned to the subject device)
JOF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribing surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
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.(b)
Classification. Class II.
0
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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)
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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.