(59 days)
Not Found
No
The summary describes a patient-specific implant based on anatomical requirements and material properties, with no mention of AI or ML in the design or function.
No
The device is an implant for reconstructing cranial defects, not for therapy or treatment of a disease.
No
The device is described as an implant for the reconstruction of cranial defects, replacing native bone in the cranial skeleton, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium mesh and ceramic tiles, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implant intended for the reconstruction of cranial defects." This describes a device that is surgically placed within the body to repair or replace tissue.
- Device Description: The description details a physical implant made of titanium mesh and ceramic tiles, designed to replace bone in the cranial skeleton.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, OSSDSIGN Cranial PSI is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
Product codes (comma separated list FDA assigned to the subject device)
PJN
Device Description
OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that 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 component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial skeleton
Indicated Patient Age Range
patients in whom cranial growth is complete
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2021
OssDsign AB % David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, Florida 32043-3443
Re: K212414
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: July 30, 2021 Received: August 3, 2021
Dear David 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212414
Device Name OSSDSIGN Cranial PSI
Indications for Use (Describe)
OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
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
K212414
-
- 510(k) Owner Name and Address: OSSDSIGN AB Rapsgatan 23A SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: ia@ossdsign.com Contact: Jonas Åberg
-
- Contact Person: David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, FL 32043-3443 USA
-
- Date prepared: October 1, 2021
-
- Trade Name: OSSDSIGN Cranial PSI
-
- Regulation Description: Preformed Non-alterable Cranioplasty Plate
-
- Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN)
-
- Class: 2
-
- Predicate Device: OSSDSIGN Cranial PSI (K161090)
-
- Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that 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 component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
-
- Indications for Use: OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
-
- Comparison of Technological Characteristics with the Predicate Device: The subject device is identical to cleared predicate device OssDsign Cranial PSI K161090 in every way except the proposed labeling change.
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| | OSSDSIGN
Cranial PSI (K212414, subject
device) | OSSDSIGN
Cranial PSI (K161090, predicate) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | OSSDSIGN Cranial PSI is an
implant intended for the
reconstruction of cranial defects.
These osseous defects are
surgically created or the result of
traumatic injury to the bone and
are not intrinsic to the stability of
the bony structure. The ceramic
component of Cranial PSI resorbs
and is replaced with bone during
the healing process. Cranial PSI is
indicated for use in patients in
whom cranial growth is complete
and for use with an intact dura,
with or without duraplasty. | 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. |
| | the healing process. Cranial PSI is
indicated for use in patients in
whom cranial growth is complete
and for use with an intact dura,
with or without duraplasty. | |
| Materials | Ti grade 23, proprietary calcium
phosphate ceramic | Ti grade 23, proprietary calcium
phosphate ceramic |
| Titanium
thickness | 0.4 – 1.6 mm | 0.4 – 1.6 mm |
| Max size | 200 cm² | 200 cm² |
| Provided form | Titanium and Ceramic
Ceramic mixed and cured in
manufacturer's facility | Titanium and Ceramic
Ceramic mixed and cured in
manufacturer's facility |
| Sterility on
delivery | Sterile | Sterile |
12. Performance Testing:
| Test | Test Method Summary | Results |
|---|---|---|
| in vivo | ||
| implantation | 52-week sheep implantation study, | |
| ISO 10993-6 | in vivo studies show | |
| biocompatibility, adequate | ||
| resorption rate and | ||
| osteoconduction. |
13. Conclusion:
Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device.