Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. OSSDSIGN AB % David Weissburg Principal Weissburg Associates 300 2nd Avenue SE. #14 St. Petersburg, Florida 33701 Re: K190523 Trade/Device Name: OSSDSIGN Cranial PSI Accessories Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: September 9, 2019 Received: September 10, 2019 Dear David Weissburg: 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 probibitions 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 (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-devices/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 Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190523 Device Name OSSDSIGN Cranial PSI Accessories #### Indications for Use (Describe) Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty. 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 #### K190523 - 1. 510(k) Owner Name and Address: OSSDSIGN AB Virdings Alle 2, SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: ub@ossdsign.com Contact: Ulrik Birgersson - 2. Contact Person: David Weissburg Weissburg Associates 300 2ND Avenue SE, Suite 14 St. Petersburg, FL 33701 USA - 3. Date prepared: October 10, 2019 - 4. Trade Name: OSSDSIGN Cranial PSI Accessories - Requlation Description: Preformed Non-alterable Cranioplasty Plate 5. - 6. Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN) - 7. Class: 2 - 8. Substantially equivalent to: OSSDSIGN Cranial PSI (Parent Device, K161090) - 9. Device Description: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. - Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. - Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial. - Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile. - Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile. {4}------------------------------------------------ # 10. Indications for Use: Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty. | | OSSDSIGN<br>Cranial PSI Accessories (subject device) | OSSDSIGN<br>Cranial PSI (K161090) without<br>Cranial PSI Accessories | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>For Use | Cranial PSI Accessories are<br>indicated for use as accessories to<br>the OSSDSIGN Cranial PSI for the<br>reconstruction of cranial defects.<br>They are indicated for non-load<br>bearing applications for patients in<br>whom cranial growth is complete<br>and for use with an intact dura,<br>with or without duraplasty. | OSSDSIGN Cranial PSI is<br>intended for the reconstruction of<br>cranial defects. It is indicated for<br>non-load bearing applications for<br>patients in whom cranial growth is<br>complete and for use with an intact<br>dura, with or without duraplasty. | | Materials | PA2200 | Ti grade 23, proprietary calcium<br>phosphate ceramic | | Max size | 200 cm² | 200 cm² | | Provided form | Formed PA2200 | Titanium and Ceramic<br>Ceramic mixed and cured in<br>manufacturer's facility | | Sterility | Anatomical Model Original:<br>provided non-sterile<br>Anatomical Model Modified:<br>provided non-sterile<br>Plastic Drawing Guide: provided<br>sterile<br>Cranial Implant Trial: provided<br>sterile | Cranial PSI: provided sterile | # 11. Comparison of Technological Characteristics with the Predicate Device: {5}------------------------------------------------ | | | 12. Biocompatibility of Cranial PSI Accessories: | |--|--|--------------------------------------------------| |--|--|--------------------------------------------------| | Test | Test Method Summary | Results | |---------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | ISO 10993-5<br>Method:L-929 mouse fibroblast cells | Not cytotoxic.<br>The test article extract showed no<br>cytotoxic potential to L-929 mouse<br>fibroblast cells. | | Systemic (acute)<br>toxicity | ISO 10993-11<br>Method: 20 mice observed at 4, 24,<br>48 and 72 hours | No systemic toxicity.<br>There was no mortality or evidence<br>of systemic toxicity from the<br>extracts injected into mice. | | Sensitization<br>Study | ISO 10993-10<br>Method: Guinea Pig Maximization<br>scored at 24 and 48 hours | Not a sensitizer.<br>No evidence of delayed dermal<br>contact sensitization. | | Irritation Study | ISO 10993-10<br>Method: Intracutaneous study in<br>rabbits scored at 24, 48 and 72<br>hours | Not an irritant.<br>No evidence of irritation. | | Pyrogen Study | USP 40-NF 35<br>Method: IV injection in 3 rabbits | Non-pyrogenic.<br>No rabbit showed a temperature<br>rise >0.5°C. | | Hemolysis Study | ISO 10993-4<br>Method: human blood | Non-hemolytic.<br>The mean hemolytic index for the<br>test article extract was of 0.1%. | | Analytical<br>Extractable<br>Chemical<br>Analysis | ISO 10993-18<br>Method: extracts analyzed by FTIR,<br>GC-MS, UPLC-MS, ICP-MS and<br>GC-MS | Non-hazardous in all results.<br>No leachables were detected in<br>potentially toxic concentrations<br>from a worst-case device<br>configuration. | {6}------------------------------------------------ | Test Method and Relevance Summary | Results | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Deformation Test:<br>Resistance to deformation simulating a<br>clinician pressing hard with a surgical marker<br>against the Plastic Drawing Guide.<br>Requirement: <1mm deviation<br>Method: test article supporting 200g weight | <1mm deformation<br>in all cases | | Simulated Clinical Use Study:<br>Plastic Drawing Guide (PDG) evaluated for worst<br>case friction and generation of particles.<br>Requirement: no visible particles generated during<br>the test or clinically acceptable particles.<br>Method: 10X 360° screw rotations and 2 cm drop<br>test, 10X magnification and visual inspection<br>Relevance: there is slight friction associated with<br>placement and removal of PDG into its<br>corresponding anatomical location. This study<br>simulates normal placement with a 5X worst-case<br>bias. | No visible particles<br>generated during the<br>test. | | Dimensional Integrity Test:<br>Verification of dimensional integrity and fit.<br>Requirement: no dimensional changes to any<br>devices.<br>Method: qualitative evaluation of fit after transport.<br>Relevance: conforming manufacturing controls<br>and packaging and shipping system. | No dimensional<br>changes to any<br>devices. | ### 13. Performance Testing: 14. Conclusions: Nonclinical tests demonstrate that the Cranial PSI Accessories which are intended to be used with the Cranial PSI are substantially equivalent to the Cranial PSI. - Cranial PSI Accessories demonstrate biocompatibility consistent with current ● consensus standards. - Plastic Drawing Guide demonstrates resistance to deformation in excess of loading . applied in clinical use.