(238 days)
Not Found
No
The summary describes a physical implant device made of titanium and ceramic, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant used to cover and plug holes drilled into the skull and reattach cranial bone removed during surgery. Its function is structural and restorative rather than therapeutic (i.e., treating or curing a disease or medical condition).
No
The device description and intended use clearly state that the Cranioplug is a medical implant designed to cover and plug holes drilled into the skull and reattach cranial bone after surgery. It does not perform any diagnostic functions like detecting, monitoring, or predicting medical conditions.
No
The device description explicitly states it consists of a titanium mesh plate with a biocompatible ceramic, indicating it is a physical implant, 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 removed during surgery." This is a surgical implant used directly on the patient's body.
- Device Description: The device is a physical implant made of titanium and ceramic, designed to be placed within the skull.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on the mechanical properties and biocompatibility of the implant, not on its ability to detect or measure biological markers.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (within the body) as a structural implant.
N/A
Intended Use / Indications for Use
OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reatial bone removed during surgery. It is cleared for use for non-weight bearing applications in adults and adolescents age 12 and older.
Product codes
GXR
Device Description
Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.
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
Not Found
Summary of Performance Studies
Bench performance characteristics and material composition.
Compressive strength: Both devices showed compressive strength of approximately 19 MPa.
Falling load: Subject device and QuikFlap sustained falling loads below 30 cm.
12 hour load: No deformation of subject device or QuikFlap.
Dissolution test: Subject device and Stryker Injectable Cement dissolved less than 25 % after 6 weeks.
Cytotoxicity: No evidence of causing cell lysis or toxicity.
Sensitivity: Classified as a nonirritant as compared to the sponsor provided control article and nonirritant as compared to the negative control article.
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
OssDsign AB % David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, WI 53703
Re: K140309 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 4, 2014 Received: September 5, 2014
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena - S/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140309
Device Name OssDsign Cranioplug
Indications for Use (Describe)
OssDsign Cranioplug is intended to cover and plug holes drilled into the skull during surgery and to reatial bone removed during surgery. It is cleared for use for non-weight bearing applications 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
KI40309
-
- 510(k) Owner Name and Address: OssDsign AB Virdings Allé 2 SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Fax: +46 (0) 18-490 32 64 Email: info@ossdsign.com Contact: Eva Nicklasson
-
- Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
-
- Date prepared: October 3, 2014
-
- Trade Name: OssDsign® Cranioplug
-
- Regulation Description: Burr Hole Cover
-
- Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR)
-
- Class: 2
-
- Predicates: K I 20352 Stryker QuikFlap Sterile Procedure Pack (Burr Hole Cover, 14 mm) K051603 Stryker Injectable Cement
-
- Device Description: Cranioplug consists of a titanium (Ti) mesh plate with a biocompatible ceramic. Cranioplug implants are sized to mate with standard 14 mm burr holes common in surgical procedures. Each implant includes the completely formed Ti and fully cured CaP components in one device.
-
- Indications for Use: 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.
-
- Comparison to predicates: The intended uses of the OssDsign Cranioplug and its predicates are the same. All the devices utilize either titanium mesh or calciumphosphate ceramic. Labeling and materials used are equivalent, except that the calciumphosphate ceramic component of Cranioplug is molded and cured before implantation.
| | OssDsign
Cranioplug, (subject
device) | Stryker QuikFlap,
predicate
comparison A,
K120352 | Stryker Injectable
Cement, predicate
comparison B, K051603 |
|--------------------|----------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------|
| Materials | Ti grade 3,
proprietary
calcium phosphate
formulation | Ti grade 2, screws
grade 5 | Calcium phosphate
cement |
| Titanium thickness | 0.5mm | 0.4mm | N.A. |
| Mix/cure | Mixed and cured in
manufacturer's
facility | N.A | Mixed in the operating room
and cured in vivo |
| Sterility | Sterile | Sterile | Sterile |
4
-
- Testing vs. predicates: Cranioplug and its predicates were tested for bench performance characteristics and material composition. Direct comparison of performance, safety and effectiveness of the Cranioplug and its predicates demonstrate that the Cranioplug is substantially equivalent or superior to its predicates in all characteristics. The table below provides a summary of some of the tests completed.
| Test | Test Method Summary | Results |
|---|---|---|
| Compressive | ||
| strength | Subject device and Stryker Injectable | |
| Cement predicate tested with | ||
| Universal compression testing | ||
| machine with Imm/min. cross-head | ||
| speed. | Both devices showed compressive | |
| strength of approximately 19 MPa. | ||
| Falling load | 530 g weight dropped on device and | |
| predicate installed in anatomical | ||
| model. Drop height increased until | ||
| failure. | Subject device and QuikFlap sustained | |
| falling loads below 30 cm. | ||
| 12 hour load | Device and predicate installed in | |
| anatomical model. Device placed on | ||
| pillow and loaded with 7.5 kg weight | ||
| on opposite side. Plastic deformation | ||
| measured after 12 hours. | No deformation of subject device or | |
| QuikFlap. | ||
| Dissolution test | TRIS-buffered solution, pH 7.4 at | |
| 37C, 120 rpm shaking table per ISO | ||
| 10993-14. | Subject device and Stryker Injectable | |
| Cement dissolved less than 25 % after 6 | ||
| weeks. | ||
| 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. | ||
| Sensitivity | ISO Subcutaneous Implantation | |
| studies – two weeks and six weeks, | ||
| ISO 10993-6. The test article, | ||
| sponsor provided control article and | ||
| the negative control article were | ||
| subcutaneously implanted in the | ||
| rabbit. | Classified as a nonirritant as compared | |
| to the sponsor provided control article | ||
| and nonirritant as compared to the | ||
| negative control article. |