(238 days)
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.
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.
The document does not describe acceptance criteria for an AI/ML powered device, but rather for a Burr Hole Cover (OssDsign Cranioplug). The sections of the document describing testing (pages 4 and 5) outline bench performance characteristics and material composition tests for the OssDsign Cranioplug and its predicates.
Therefore, many of the requested fields are not applicable (N/A) as they relate to software performance evaluation, not a physical medical device.
Here's an interpretation based on the provided document for the OssDsign Cranioplug:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compressive Strength | Comparable to predicate (Stryker Injectable Cement) | Both devices showed compressive strength of approximately 19 MPa. |
| Falling Load | Comparable to predicate (Stryker QuikFlap) withstanding loads below 30 cm drop height. (Implied: must sustain a falling load equivalent to or better than predicate) | Subject device and QuikFlap sustained falling loads below 30 cm. |
| 12 Hour Load | No plastic deformation after 12 hours under 7.5 kg load, comparable to predicate (Stryker QuikFlap). (Implied: must not deform under prolonged load) | No deformation of subject device or QuikFlap. |
| Dissolution Test | Dissolve less than 25% after 6 weeks, comparable to predicate (Stryker Injectable Cement). | Subject device and Stryker Injectable Cement dissolved less than 25% after 6 weeks. |
| Cytotoxicity | No evidence of causing cell lysis or toxicity. | No evidence of causing cell lysis or toxicity. |
| Sensitivity | Classified as a nonirritant compared to control articles. | Classified as a nonirritant as compared to the sponsor provided control article and nonirritant as compared to the negative control article. (This implies non-irritancy is the acceptance criteria). |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test. For the physical properties (compressive strength, falling load, 12-hour load), small sample sizes of devices are typical. For the biological tests (dissolution, cytotoxicity, sensitivity), multiple samples would be tested to ensure consistency.
- Data Provenance: Not explicitly stated, but these are laboratory bench and animal (rabbit) tests conducted for a medical device. It is generally understood to be prospective data generated specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A - The "ground truth" for these tests is based on objective measurements and established scientific standards (e.g., ISO standards, material properties, biological responses) rather than expert consensus on interpretive tasks. The "experts" would be the scientists and engineers conducting and analyzing these tests.
4. Adjudication Method for the Test Set
N/A - Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when discrepancies arise in expert interpretations of medical images or diagnoses, not for objective physical or biological bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A - This type of study is for evaluating the performance of diagnostic or screening devices, often involving human readers interpreting outputs (e.g., images). The OssDsign Cranioplug is a physical implantable device, not an interpretive one.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done
N/A - This concept applies to AI/ML algorithms. The OssDsign Cranioplug is a physical medical device.
7. The Type of Ground Truth Used
- Bench Performance Tests (Compressive Strength, Falling Load, 12 Hour Load): Objective physical measurements against established engineering principles and comparison to predicate device performance.
- Biological Tests (Dissolution, Cytotoxicity, Sensitivity): Objective biological responses measured against established ISO standards and comparison to control articles.
8. The Sample Size for the Training Set
N/A - "Training set" refers to data used to train AI/ML algorithms. The OssDsign Cranioplug is a physical device and does not involve AI/ML.
9. How the Ground Truth for the Training Set was Established
N/A - As above, this is not applicable to a physical medical device.
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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 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
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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 (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
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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
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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 Fax: +46 (0) 18-490 32 64 Email: info@ossdsign.com Contact: Eva Nicklasson
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- Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
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- Date prepared: October 3, 2014
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- Trade Name: OssDsign® Cranioplug
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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)
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- Class: 2
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- Predicates: K I 20352 Stryker QuikFlap Sterile Procedure Pack (Burr Hole Cover, 14 mm) K051603 Stryker Injectable Cement
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- 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.
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- 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.
| OssDsignCranioplug, (subjectdevice) | Stryker QuikFlap,predicatecomparison A,K120352 | Stryker InjectableCement, predicatecomparison B, K051603 | |
|---|---|---|---|
| Materials | Ti grade 3,proprietarycalcium phosphateformulation | Ti grade 2, screwsgrade 5 | Calcium phosphatecement |
| Titanium thickness | 0.5mm | 0.4mm | N.A. |
| Mix/cure | Mixed and cured inmanufacturer'sfacility | N.A | Mixed in the operating roomand cured in vivo |
| Sterility | Sterile | Sterile | Sterile |
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- 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 |
|---|---|---|
| Compressivestrength | Subject device and Stryker InjectableCement predicate tested withUniversal compression testingmachine with Imm/min. cross-headspeed. | Both devices showed compressivestrength of approximately 19 MPa. |
| Falling load | 530 g weight dropped on device andpredicate installed in anatomicalmodel. Drop height increased untilfailure. | Subject device and QuikFlap sustainedfalling loads below 30 cm. |
| 12 hour load | Device and predicate installed inanatomical model. Device placed onpillow and loaded with 7.5 kg weighton opposite side. Plastic deformationmeasured after 12 hours. | No deformation of subject device orQuikFlap. |
| Dissolution test | TRIS-buffered solution, pH 7.4 at37C, 120 rpm shaking table per ISO10993-14. | Subject device and Stryker InjectableCement dissolved less than 25 % after 6weeks. |
| Cytotoxicity | ISO elution method, ISO 10993-5,extracted in IX MEM at 37°C for 24hours | No evidence of causing cell lysis ortoxicity. |
| Sensitivity | ISO Subcutaneous Implantationstudies – two weeks and six weeks,ISO 10993-6. The test article,sponsor provided control article andthe negative control article weresubcutaneously implanted in therabbit. | Classified as a nonirritant as comparedto the sponsor provided control articleand nonirritant as compared to thenegative control article. |
§ 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).