Cranial PSI

K161090 · Ossdsign AB · GXN · Jan 19, 2017 · Neurology

Device Facts

• Record ID: K161090
• Device Name: Cranial PSI
• Applicant: Ossdsign AB
• Product Code: GXN · Neurology
• Decision Date: Jan 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is 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.

Device Story

OSSDSIGN Cranial PSI is a patient-specific implant (PSI) designed to replace native bone in the cranial skeleton. The device consists of a rigid titanium mesh (Grade 23) covered by a mosaic pattern of biocompatible calcium phosphate ceramic tiles. The spacing between tiles allows for fluid circulation. The device is manufactured to match a patient's unique anatomical requirements. It is intended for surgical implantation by a physician to reconstruct cranial defects. The implant provides structural support and protection for the brain; it is tested to withstand forces associated with daily activities and blunt trauma. The device is delivered sterile.

Clinical Evidence

No clinical data. Evidence consists of bench testing only. Mechanical performance evaluated via dynamical load testing (125 rpm, 60 hours), max force testing (>100 N requirement), energy absorption (>1000 mJ requirement), and resistance to deformation. Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, mutagenicity, implantation, extractable chemical analysis, hemolysis, and pyrogenicity. All tests met acceptance criteria.

Technological Characteristics

Materials: Titanium Grade 23 and proprietary calcium phosphate ceramic. Form: Patient-specific rigid mesh with ceramic tile mosaic. Dimensions: 0.4–1.6 mm titanium thickness, max size 200 cm². Sterilization: Sterile delivery. Energy source: None (passive implant).

Indications for Use

Indicated for reconstruction of cranial defects in patients with complete cranial growth; non-load bearing applications; use with intact dura, with or without duraplasty.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• KLS Martin - Patient Contoured Mesh (K062570)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

OSSDSIGN AB % David Weissburg Principal Weissburg Associates 808 Williamson Street, Suite 402 Madison, Wisconsin 53703

Re: K161090

Trade/Device Name: OSSDSIGN Cranial PSI Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: December 13, 2016 Received: December 14, 2016

Dear Mr. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161090

Device Name OSSDSIGN Cranial PSI

Indications for Use (Describe)

OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with or with or with or without duraplasty.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------|----------------------------------------------------------|
| <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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### 510(k) SUMMARY

#### K161090

- 1. 510(k) Owner Name and Address: OSSDSIGN AB Virdings Alle 2, SE 754 50, Uppsala Sweden Telephone: [phone] Email: [e-mail] Contact: Ulrik Birgersson
- 2. Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
- 3. Date prepared: January 18, 2017
- 4. Trade Name: OSSDSIGN Cranial PSI
- Regulation Description: Preformed Non-alterable Cranioplasty Plate 5.
- Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 6. 882.5330, Product code: PJN)
- 7. Class: 2
- 8. Substantially equivalent to: KLS Martin - Patient Contoured Mesh (K062570)
- Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that 9. replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
- 10. Indications for Use: OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is 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.
- 11. Comparison of Technological Characteristics with the Predicate Device :

| | OSSDSIGN<br>Cranial PSI (K161090, subject device) | KLS Martin<br>Patient Contoured Mesh<br>(K062570, predicate) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Indications For Use | OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is 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. | Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton. |
| Materials | Ti grade 23, proprietary calcium phosphate ceramic | CP Titanium |

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| | OSSDSIGN<br>Cranial PSI (K161090, subject device) | KLS Martin<br>Patient Contoured Mesh (K062570, predicate) |
|-----------------------|----------------------------------------------------------------------------|-----------------------------------------------------------|
| Titanium<br>thickness | 0.4 – 1.6 mm | 0.6 – 1.0 mm |
| Max size | 200 cm² | 200 cm² |
| Provided form | Titanium and Ceramic<br>Ceramic mixed and cured in manufacturer's facility | Titanium only |
| Sterility on delivery | Sterile | Non-sterile |

- 12. Testing vs. predicate:

| | Results | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------------------------|
| Test Method and Relevance Summary | OSSDSIGN Cranial<br>PSI | KLS Martin - PCI<br>Titanium Mesh<br>(K062570) |
| | Size: 197 cm² | Size: 197 cm2 |
| Dynamical Load Test:<br>To verify that the Cranial PSI supports the forces<br>exerted onto the implant from sleeping during the<br>device lifetime.<br>Requirement: no deformation<br>Method: orbital shaker, 125 rpm, 60 hours.<br>Relevance: test simulates changed head position<br>every 20 minutes during 8 hours sleep for 50<br>years. Both the subject device and predicate<br>passed the test. | No deformation | No deformation |
| Max Force [N]<br>To establish the maximum force that can be<br>applied to the device before failure.<br>Requirement: >100 N<br>Method: Universal testing machine at 1 mm/min<br>Relevance: protection from falling objects and<br>blunt trauma. Both the subject device and<br>predicate passed the test. The subject device<br>provided moderately better performance than the<br>predicate. | 461 | 383 |
| Energy absorption [mJ]<br>To establish the maximum energy the device can<br>absorb before failure.<br>Requirement: >1000 mJ<br>Method: Universal testing machine at 1 mm/min<br>Relevance: protection from falling objects and<br>blunt trauma. Both the subject device and<br>blunt trauma. Both the subject device and | 2260 | 3760 |

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| predicate passed the test. | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|
| Resistance to Deformation [mm]<br>To establish device resistance to deformation<br>before device failure.<br>Requirement: <6 mm<br>Method: Universal testing machine at 1 mm/min to<br>100 N applied force<br>Relevance: Both the subject device and predicate<br>passed the test. | 0.5 mm | 1.1 mm |

## 13. Biocompatibility:

| Test | Test Method Summary | Results |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5<br>Method:L-929 mouse fibroblast cells | Not cytotoxic<br>No evidence of causing cell lysis or<br>toxicity |
| Sensitization | ISO 10993-10<br>Method: guinea pig maximization<br>test | Non-sensitizer<br>All test article extracts showed no<br>evidence of causing delayed<br>dermal contact sensitization in the<br>guinea pig. |
| Sensitivity,<br>Irritation | ISO 10993-6<br>Method: polar and non-polar test<br>article extracts intracutaneously<br>injected into five separate sites on<br>the right side of the back of three<br>rabbits. Observations for erythema<br>and edema were conducted at 24,<br>48, and 72 hours. | Non-irritant<br>Difference between the test and<br>the control mean scores <1.0,<br>confirming the device is a non-<br>irritant |
| Systemic (acute)<br>toxicity | ISO 10993-11<br>Method: 20 mice observed at 4, 24,<br>48 and 72 hours. | Non-toxic<br>No mortality or evidence of<br>systemic toxicity |
| Genotoxicity | ISO 10993-3<br>Method: mouse lymphoma forward<br>gene mutation assay. | Not mutagenic<br><2-fold increase in mean mutant<br>frequency of the L5178Y/TK cell<br>line. |
| Mutagenicity | ISO-10993-3<br>Method: bacterial reverse mutation<br>study | Non-mutagenic<br><2-fold increase in mutagenic<br>frequency. |
| Implantation | ISO 10993-6<br>Test for local effects after<br>implantation, 2- and 6-week<br>subcutaneous implantations in<br>rabbits. | Non-irritant<br>Non-irritant compared to control. |
| Analytical<br>Extractable<br>Chemical<br>Analysis | ISO 10993-12<br>Analysis by GC-MS, ICP-MS, LC-MS<br>and HPLC-ELSD | Non-hazardous in all results,<br>including extractions in polar, non-<br>polar and mid-polar solvents.<br>No hazardous materials detected. |
| Indirect<br>Hemolysis | ISO 10993-4<br>Biological evaluation of medical<br>devices - Part 4: Selection of tests<br>for interactions with blood | The hemolytic index for the test<br>article extract was 3.8% and the<br>test article extract was slightly<br>hemolytic.<br>All samples passed the<br>acceptance criteria. |
| Material Mediated<br>Pyrogenicity | ISO 10993-11<br>Biological evaluation of medical<br>devices - Part 11: Tests for systemic<br>toxicity, Pyrogen Test | The total rise of temperatures<br>during the 3 hour observation<br>period was within acceptable<br>limits.<br>The test article was judged as<br>nonpyrogenic.<br>All samples passed the<br>acceptance criteria |

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#### 14. Conclusions:

Nonclinical tests demonstrate that Cranial PSI is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified in this summary.

- Cranial PSI mechanical performance in a battery of life-style emulating test scenarios . shows substantial equivalence in mechanical effectiveness compared to the predicate device
- . Cranial PSI demonstrated biocompatibility per current consensus standards