(123 days)
Not Found
No
The summary describes a physical implant device made of ceramic and titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical and biological properties.
No
The device is described as an implant used to cover and plug holes in the skull and reattach cranial bone after surgery. It does not actively treat a disease or condition, but rather restores an anatomical structure.
No
This device is an implant designed to cover and plug holes in the skull during surgery, and to reattach cranial bone. It is explicitly described as an osteoconductive implant and is used for structural repair, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical implant made of ceramic and titanium mesh, intended to be surgically placed in the skull. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover and plug holes drilled into the skull during surgery and to reattach cranial bone. This is a surgical implant used directly on the patient's body.
- Device Description: The device is a physical implant made of ceramic and titanium, designed to be placed within the skull.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. The OSSDIGN Cranioplug is a therapeutic device used during surgery.
No
A Predetermined Change Control Plan (PCCP) is a relatively new program (established in 2023) that allows manufacturers to make certain modifications to their devices within the scope of an approved plan without requiring a new 510(k) submission. This clearance letter does not mention any authorization under a PCCP, nor does it list any details related to a PCCP. Moreover, the predicate device K140309 was cleared in 2014, long before the PCCP program was established.
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 Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.
Product codes
GXR
Device Description
OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull
Indicated Patient Age Range
adults and adolescents age 12 and older.
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Bench performance characteristics and biologic performance testing were performed.
Test: Energy absorption, flap reattachment; Test Method Summary: Device and predicate installed in anatomical model. Tested in Universal Testing Machine to 2mm displacement to determine deformation energy.; Results: Subject device and predicate sustained deformation energy of 0.06 J.
Test: Flap Fixation Dynamic Load; Test Method Summary: Flap fixated with 3 Cranioplugs installed in anatomic model. 8.5 kg head weight tested to simulate 50 years of sleep with hourly repositioning.; Results: No flap deformation. All Cranioplug models tested.
Test: Cytotoxicity; Test Method Summary: ISO elution method, ISO 10993-5, extracted in IX MEM at 37°C for 24 hours; Results: No evidence of causing cell lysis or toxicity.
Test: in vivo implantation; Test Method Summary: 52-week sheep implantation study, ISO 10993-6; Results: in vivo studies show biocompatibility, adequate resorption rate and osteoconduction.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5250 Burr hole cover.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows 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 consists of 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| ☑ 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
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- 510(k) Owner Name and Address: OssDsign AB Virdings Allé 2 SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: info@ossdsign.com Contact: Ulrik Birgersson
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- Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
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ന് Date prepared: October 10, 2018
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Trade Name: OSSDSIGN® Cranioplug 4.
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- Regulation Description: Burr Hole Cover
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Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR) 6.
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- Class: 2
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- Predicate: K140309, Cranioplug, OssDsign
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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.
-
- 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
(subject device) | OSSDSIGN Cranioplug001
(Predicate, K140309) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | OSSDSIGN Cranioplug is
intended to cover and plug
holes drilled into the skull
during surgery and to reattach
cranial bone removed during
surgery. It is cleared for use for
non-weight bearing
applications in adults and
adolescents age 12 and older. |
| Materials | Ti grade 2,
proprietary calcium phosphate
formulation (same as
predicate) | Ti grade 3,
proprietary calcium phosphate
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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- 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 | ||
| absorption, flap | ||
| reattachment | Device and predicate installed in | |
| anatomical model. Tested in | ||
| Universal Testing Machine to 2mm | ||
| displacement to determine | ||
| deformation energy. | Subject device and predicate sustained | |
| deformation energy of 0.06 J. | ||
| Flap Fixation | ||
| Dynamic Load | Flap fixated with 3 Cranioplugs | |
| installed in anatomic model. 8.5 kg | ||
| head weight tested to simulate 50 | ||
| years of sleep with hourly | ||
| repositioning. | No flap deformation. All Cranioplug | |
| models tested. | ||
| Cytotoxicity | ISO elution method, ISO 10993-5, | |
| extracted in IX MEM at 37°C for 24 | ||
| hours | No evidence of causing cell lysis or | |
| toxicity. | ||
| in vivo | ||
| implantation | 52-week sheep implantation study, | |
| ISO 10993-6 | in vivo studies show biocompatibility, | |
| adequate resorption rate and | ||
| osteoconduction. |
-
- Conclusions: Nonclinical tests demonstrate that Cranioplug003 is as safe and effective as its legally marketed predicate device.