(265 days)
Not Found
No
The summary describes a patient-specific implant designed from CT scans, but there is no mention of AI or ML being used in the design or manufacturing process. The focus is on the material properties and the customization based on anatomical data.
Yes
The device is intended for the "augmentation or restoration of bony contour in craniofacial defects," which directly aligns with the definition of a therapeutic device as it treats or alleviates a condition.
No
This device is a patient-specific surgical implant used for augmentation or restoration of bony contour, not for diagnosing a condition. It is designed from CT scans but does not perform diagnostic functions.
No
The device description explicitly states that the PoreStar Patient Specific Implants are manufactured from high density polyethylene (HDPE) and are physical surgical implants. While the design process utilizes software and CT scans, the final device is a physical object, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "augmentation or restoration of bony contour in craniofacial defects." This describes a surgical implant used directly on the patient's body to repair or rebuild bone structure.
- Device Description: The description details a physical implant made of HDPE, designed from CT scans, and intended for surgical implantation.
- Lack of In Vitro Testing: The description of the device and its testing focuses on material properties, mechanical integrity, sterilization, and packaging. There is no mention of testing biological samples (like blood, urine, tissue) outside of the body to diagnose a condition or provide information about a patient's health state.
- Anatomical Site: The device is used directly on the "craniofacial defects" of the patient. IVDs are used to test samples taken from the patient.
An In Vitro Diagnostic device is used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The PoreStar Patient Specific Implant is intended for the augmentation of bony contour in craniofacial defects.
Product codes (comma separated list FDA assigned to the subject device)
JOF, GWO
Device Description
The PoreStar Patient Specific Implants are a range of anatomically shaped, patient specific surgical implants manufactured from high density polyethylene (HDPE) to the reconstructive boundaries indicated by the surgeon. The interconnecting porous ("Pore-") architecture created from a star ("-Star”) shaped particle resembles trabecular bone and permits tissue ingrowth into the implant. PoreStar Patient Specific Implants are individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. The PoreStar Patient Specific Implants are provided sterile and intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D Computed Tomography (CT) scans
Anatomical Site
Craniofacial defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Testing: All non-clinical testing relating to the PoreStar Patient Specific Implant device is summarised in the table below.
Characteristic: Material Safety
Testing: Biocompatibility testing of material in accordance with ISO 10993-1 Systemic toxicity testing according to ISO 10993-11 Genotoxicity testing according to ISO 10993-3 Cytotoxicity testing according to ISO 10993-5 Implantation testing according to ISO 10993-6 Intracutaneous reactivity testing according to BS EN ISO 10993-10 Skin sensitization testing according to ISO 10993-10
Characteristic: Mechanical Integrity
Testing: Tensile testing according to ASTM D638 Flexural testing according to ASTM D790
Characteristic: Compatibility
Testing: Screw Pull-out testing in accordance to ASTM F543 Verification testing of PoreStar's mechanical compatibility with screws or other fixation methods
Characteristic: Sterilization
Testing: Sterilization validations were performed in accordance with ISO 11135-1 and 11737-1 EO residuals testing per ISO 10993-7
Characteristic: Shelf-life
Testing: Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07 consisting of: Peel testing to ASTM F88-09 Dye-testing to ASTM F1929-98 and ASTM1929-12 Mechanical characterization of aged implants consisting of: Tensile testing according to ASTM D638 Flexural testing according to ASTM D790 Screw Pull-out testing according to ASTM F543
Characteristic: Packaging
Testing: Dye testing according to ASTM F1929-15 Bubble emission testing according to ASTM F2096-11 Transport simulation test stipulated in ISTA 2A. Includes: Compression Vibration (fixed and random displacement) Shock
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
December 27, 2017
Anatomics Pty Ltd % Nicholas Connell. Consultant Brandwood Biomedical Level 8, 1 Chandos St St Leonards, NSW 2065 Australia
Re: K171037
Trade/Device Name: PoreStar Patient Specific Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: JOF, GWO Dated: November 28, 2017 Received: December 1, 2017
Dear Nicholas Connell:
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 medical devices and radiation-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,
Srinivas Nandkumar -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171037
Device Name PoreStar Patient Specific Implant
Indications for Use (Describe)
The PoreStar Patient Specific Implant is intended for the augmentation of bony contour in craniofacial defects.
| 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
| Date Prepared: | 25 December 2017 |
|---|---|
| 510(k) Owner: | Anatomics Pty |
| 23-27 Wellington Street, | |
| St Kilda, VIC 3182 | |
| Australia | |
| Tel: +61 (0) 3 9529 8088 | |
| Application Contact | Nicholas Connell |
| Level 8, 1 Chandos St | |
| St Leonards NSW 2065 | |
| Australia | |
| Tel: +61(0) 299062984 | |
| Fax: +61(0) 285804613 | |
| Trade Name: | PoreStar Patient Specific Implant |
| Common Name: | Porous Polyethylene Implants |
| Classification Name: | 21 CFR 874.3620 |
| Product Code: | JOF, GWO |
| Predicate Device: | MEDPOR Customized Surgical Implant (K083621) |
| Indications for Use: | The PoreStar Patient Specific Implant is intended for the |
| augmentation or restoration of bony contour in craniofacial defects. | |
| Device Description: | The PoreStar Patient Specific Implants are a range of anatomically |
| shaped, patient specific surgical implants manufactured from high | |
| density polyethylene (HDPE) to the reconstructive boundaries | |
| indicated by the surgeon. The interconnecting porous ("Pore-") | |
| architecture created from a star ("-Star”) shaped particle resembles | |
| trabecular bone and permits tissue ingrowth into the implant. | |
| PoreStar Patient Specific Implants are individually designed from 3D | |
| Computed Tomography (CT) scans provided to Anatomics by the | |
| referring surgeon. The PoreStar Patient Specific Implants are | |
| provided sterile and intended for single-use. | |
| Non-Clinical Testing: All non-clinical testing relating to the PoreStar Patient Specific | |
| Implant device is summarised in the table below | |
| Characteristic | Testing |
| Material Safety | Biocompatibility testing of material in accordance with ISO 10993-1 Systemic toxicity testing according to ISO 10993-11 Genotoxicity testing according to ISO 10993-3 Cytotoxicity testing according to ISO 10993-5 Implantation testing according to ISO 10993-6 Intracutaneous reactivity testing according to BS EN ISO 10993-10 Skin sensitization testing according to ISO 10993-10 |
| Mechanical Integrity | Tensile testing according to ASTM D638 |
| Flexural testing according to ASTM D790 | |
| Compatibility | Screw Pull-out testing in accordance to ASTM F543 |
| Verification testing of PoreStar's mechanical compatibility with screws or | |
| other fixation methods | |
| Sterilization | Sterilization validations were performed in accordance with ISO 11135-1 |
| and 11737-1 | |
| EO residuals testing per ISO 10993-7 | |
| Shelf-life | Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07 consisting of: |
| Peel testing to ASTM F88-09 Dye-testing to ASTM F1929-98 and ASTM1929-12 | |
| Mechanical characterization of aged implants consisting of: | |
| Tensile testing according to ASTM D638 Flexural testing according to ASTM D790 Screw Pull-out testing according to ASTM F543 | |
| Packaging | |
| Dye testing according to ASTM F1929-15 | |
| Bubble emission testing according to ASTM F2096-11 | |
| Transport simulation test stipulated in ISTA 2A. Includes: | |
| Compression Vibration (fixed and random displacement) Shock |
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Summary of Equivalence:
| Characteristic | MEDPOR Customized | PoreStar Patient | Comment |
|---|---|---|---|
| Surgical Implant | Specific Implant | ||
| Intended Use | The MEDPOR | ||
| Customized Surgical | |||
| Implant is intended for | |||
| the augmentation or | |||
| restoration of bony | |||
| contour in craniofacial | |||
| defects. | The PoreStar Patient | ||
| Specific Implant is | |||
| intended for the | |||
| augmentation or | |||
| restoration of bony | |||
| contour in craniofacial | |||
| defects. | Same | ||
| Prescription/ | |||
| ОТС | Prescription - sale by or | ||
| on the order of a | |||
| physician | Prescription - sale by or | ||
| on the order of a | |||
| physician | Same | ||
| Materials | Porous, high density | ||
| polyethylene | Porous, high density | ||
| polyethylene with | |||
| stabilizing additives | Equivalent - the presence of | ||
| additives in the material's | |||
| formulation has no impact on | |||
| the safety or efficacy of the | |||
| device. The biocompatibility of | |||
| the PoreStar Patient Specific | |||
| Implant has been fully | |||
| assessed according to the | |||
| requirements of ISO 10993-1 | |||
| (Section 16) and its mechanical | |||
| characteristics have been | |||
| assessed to be equivalent to | |||
| the predicate (Section 19). | |||
| Size Range/ | |||
| Specifications | Patient specific implants | ||
| created based on patient | |||
| CT scans and approved | |||
| by prescribing physician | Patient specific implants | ||
| created based on patient | |||
| CT scans and approved | |||
| by prescribing physician | Same | ||
| Packaging | Double-peel pouched | ||
| and put in a clamshell or | |||
| shelf box | Double peel pouched and | ||
| put in a shelf box | Same | ||
| Sterile/Non- | |||
| Sterile | Sterile | Sterile | Same |
| Sterilization | |||
| Method | EO Gas | EO Gas | Same |
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| Shelf-Life | 10 Years | 2 Years | Equivalent - no safety or efficacy impact as this mode of use is stipulated in the product labeling |
|---|---|---|---|
| ------------ | ---------- | --------- | ----------------------------------------------------------------------------------------------------- |
Conclusion: The predicate and proposed devices share the same indications for use, usage environments and general principle of operation. Both devices are single patient, single-use devices which are supplied sterile. The technical characteristics are equivalent between the Anatomics PoreStar Patient Specific Implants and the Predicate device and include:
- Both devices are manufactured from high density porous polyethylene ●
- Both devices have the same design method whereby the implants are ● manufactured to the specifications set by the surgeon via submission of CT scan
- Both devices utilise plates and screws as the method of fixation
- Both devices have the same sterilization method ●
The primary differences between the devices are:
- . The addition of small quantities of proprietary additives in the formulation of the PoreStar Patient Specific Implant's HDPE
- . A validated shelf-life of 2 vears for the proposed device, compared with 10 years for the predicate device.
These differences raise no issues regarding the safety or effectiveness of the proposed device and have been documented and validated in this submission.
On the basis of these similarities in design and performance, it can be established the proposed device is substantially equivalent to the predicate.