OSSDSIGN Cranioplug

K181539 · Ossdsign AB · GXR · Oct 12, 2018 · Neurology

Device Facts

• Record ID: K181539
• Device Name: OSSDSIGN Cranioplug
• Applicant: Ossdsign AB
• Product Code: GXR · Neurology
• Decision Date: Oct 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

Device Story

OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate. It is designed to fill and cover burr holes created during cranial surgery and to assist in reattaching removed cranial bone. The device is available in 11mm and 14mm diameters to match standard perforators. During the healing process, the ceramic component resorbs and is replaced by natural bone. The device is intended for use by surgeons in a clinical setting. It provides mechanical stability for the burr hole site; the titanium reinforcement ensures structural integrity while the ceramic promotes osteoconduction. The device is supplied sterile and is for single use only.

Clinical Evidence

Bench testing and in vivo studies were performed. Bench tests included energy absorption (0.06 J) and dynamic load flap fixation (simulating 50 years of sleep) showing no deformation. Biocompatibility was confirmed via ISO 10993-5 cytotoxicity testing. A 52-week in vivo sheep implantation study (ISO 10993-6) demonstrated biocompatibility, adequate resorption rates, and osteoconduction.

Technological Characteristics

Materials: Titanium Grade 2 and proprietary calcium phosphate ceramic. Form factor: 11mm and 14mm diameter plugs with 0.4mm thick titanium mesh. Sterilization: Supplied sterile, single-use. Mechanical principle: Osteoconductive ceramic plug with titanium reinforcement for mechanical fixation of cranial bone flaps.

Indications for Use

Indicated for adults and adolescents age 12 and older requiring coverage and plugging of surgically created burr holes in the skull and reattachment of cranial bone.

Regulatory Classification

Identification

A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

Predicate Devices

• Cranioplug (K140309)

Submission Summary (Full Text)

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October 12, 2018

OssDsign AB % David Weissburg Prinicpal Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin 53703

Re: K181539

Trade/Device Name: OSSDSIGN Cranioplug Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: September 10, 2018 Received: September 11, 2018

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. 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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Matthew C. Krueger -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) K181539

Device Name OSSDSIGN Cranioplug

#### Indications for Use (Describe)

OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) SUMMARY

## K181539

- 1. 510(k) Owner Name and Address: OssDsign AB Virdings Allé 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

- ന് Date prepared: October 10, 2018
- Trade Name: OSSDSIGN® Cranioplug 4.
- 5. Regulation Description: Burr Hole Cover
- Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR) 6.
- 7. Class: 2
- 8. Predicate: K140309, Cranioplug, OssDsign
- Device Description: OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate 9. ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.
- 10. Intended Use / Indications For Use: OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Craniopluq resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

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| | | 11. Comparison of Technological Characteristics with the Predicate Device: |
|--|--|----------------------------------------------------------------------------|
| | | |

| | OSSDSIGN Cranioplug003<br>(subject device) | OSSDSIGN Cranioplug001<br>(Predicate, K140309) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | OSSDSIGN Cranioplug is<br>an implant intended to cover<br>and plug holes drilled into<br>the skull during surgery and<br>to reattach cranial bone<br>removed during surgery.<br>These osseous defects are<br>surgically created and are<br>not intrinsic to the stability<br>of the bony structure. The<br>ceramic component of<br>Cranioplug resorbs and is<br>replaced with bone during<br>the healing process.<br>Cranioplug is indicated for<br>use in adults and<br>adolescents age 12 and<br>older. | OSSDSIGN Cranioplug is<br>intended to cover and plug<br>holes drilled into the skull<br>during surgery and to reattach<br>cranial bone removed during<br>surgery. It is cleared for use for<br>non-weight bearing<br>applications in adults and<br>adolescents age 12 and older. |
| Materials | Ti grade 2,<br>proprietary calcium phosphate<br>formulation (same as<br>predicate) | Ti grade 3,<br>proprietary calcium phosphate<br>formulation |
| Re-sterilizable | No | No |
| Titanium thickness | 0.4mm | 0.5mm |
| Sizes (diameter) | 11mm and 14mm | 14mm |
| Ceramic hardening | Cured in manufacturer's facility | Cured in manufacturer's facility |
| Sterility on delivery | Sterile | Sterile |
| Shelf life | 24 months | 18 months |

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- 12. Testing vs. predicate: Cranioplug003 and its predicate were tested for bench performance characteristics and biologic performance. Direct comparison of performance, safety and effectiveness of Cranioplug003 and its predicate demonstrates that Cranioplug003 is substantially equivalent to its predicate in all characteristics. The table below provides a summary of some of the tests completed.

| Test | Test Method Summary | Results |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Energy<br>absorption, flap<br>reattachment | Device and predicate installed in<br>anatomical model. Tested in<br>Universal Testing Machine to 2mm<br>displacement to determine<br>deformation energy. | Subject device and predicate sustained<br>deformation energy of 0.06 J. |
| Flap Fixation<br>Dynamic Load | Flap fixated with 3 Cranioplugs<br>installed in anatomic model. 8.5 kg<br>head weight tested to simulate 50<br>years of sleep with hourly<br>repositioning. | No flap deformation. All Cranioplug<br>models tested. |
| Cytotoxicity | ISO elution method, ISO 10993-5,<br>extracted in IX MEM at 37°C for 24<br>hours | No evidence of causing cell lysis or<br>toxicity. |
| in vivo<br>implantation | 52-week sheep implantation study,<br>ISO 10993-6 | in vivo studies show biocompatibility,<br>adequate resorption rate and<br>osteoconduction. |

- 13. Conclusions: Nonclinical tests demonstrate that Cranioplug003 is as safe and effective as its legally marketed predicate device.