(220 days)
Not Found
No
The description focuses on patient-specific design based on CT data and additive manufacturing of physical accessories. There is no mention of AI/ML algorithms for image analysis, decision support, or any other function.
No
The device is described as an accessory that supports the implantation of a cranial PSI for reconstructing cranial defects, aiding the surgeon in visualization, marking, and fit validation. It does not exert a therapeutic effect on the patient.
No
The device description indicates that the Cranial PSI Accessories are "optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device." They are designed to "support implantation" and "support accurate placement and fitting" of the cranial implant, not to diagnose a condition.
No
The device description explicitly states the devices are additively manufactured from PA2200 polyamide material and are physical accessories (Anatomical Models, Plastic Drawing Guide, Cranial Implant Trial).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that these are accessories for a Cranial PSI (Patient-Specific Implant) used for the reconstruction of cranial defects. They are physical devices used during a surgical procedure on the patient's body.
- No Specimen Examination: There is no mention of collecting or examining any specimens from the human body. The input is imaging data (CT scans), which is used for design and planning, not for diagnostic testing of a biological sample.
The device is a surgical accessory designed to aid in the implantation of a cranial implant, which is a medical device used in vivo (within the body).
N/A
Intended Use / Indications for Use
Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are 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.
Product codes (comma separated list FDA assigned to the subject device)
PJN
Device Description
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography image data set
Anatomical Site
cranial
Indicated Patient Age Range
patients in whom cranial growth is complete
Intended User / Care Setting
physician
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)
Biocompatibility of Cranial PSI Accessories:
- Cytotoxicity (ISO 10993-5): Not cytotoxic.
- Systemic (acute) toxicity (ISO 10993-11): No systemic toxicity.
- Sensitization Study (ISO 10993-10): Not a sensitizer.
- Irritation Study (ISO 10993-10): Not an irritant.
- Pyrogen Study (USP 40-NF 35): Non-pyrogenic.
- Hemolysis Study (ISO 10993-4): Non-hemolytic.
- Analytical Extractable Chemical Analysis (ISO 10993-18): Non-hazardous in all results.
Performance Testing:
- Deformation Test:
§ 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, which is 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.
OSSDSIGN AB % David Weissburg Principal Weissburg Associates 300 2nd Avenue SE. #14 St. Petersburg, Florida 33701
Re: K190523
Trade/Device Name: OSSDSIGN Cranial PSI Accessories Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: September 9, 2019 Received: September 10, 2019
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 probibitions 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
1
801); medical device reporting (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/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-devices/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 (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,
For Matthew Krueger 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
2
Indications for Use
510(k) Number (if known) K190523
Device Name OSSDSIGN Cranial PSI Accessories
Indications for Use (Describe)
Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are 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.
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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3
510(k) SUMMARY
K190523
-
- 510(k) Owner Name and Address: OSSDSIGN AB Virdings Alle 2, SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: ub@ossdsign.com Contact: Ulrik Birgersson
-
- Contact Person: David Weissburg Weissburg Associates 300 2ND Avenue SE, Suite 14 St. Petersburg, FL 33701 USA
-
- Date prepared: October 10, 2019
-
- Trade Name: OSSDSIGN Cranial PSI Accessories
-
Requlation Description: Preformed Non-alterable Cranioplasty Plate 5.
-
- Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN)
-
- Class: 2
-
- Substantially equivalent to: OSSDSIGN Cranial PSI (Parent Device, K161090)
-
- Device Description: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
- Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
- Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
- Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
- Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.
4
10. Indications for Use:
Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are 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.
| | OSSDSIGN
Cranial PSI Accessories (subject device) | OSSDSIGN
Cranial PSI (K161090) without
Cranial PSI Accessories |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | Cranial PSI Accessories are
indicated for use as accessories to
the OSSDSIGN Cranial PSI for the
reconstruction of cranial defects.
They are 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. | 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. |
| Materials | PA2200 | Ti grade 23, proprietary calcium
phosphate ceramic |
| Max size | 200 cm² | 200 cm² |
| Provided form | Formed PA2200 | Titanium and Ceramic
Ceramic mixed and cured in
manufacturer's facility |
| Sterility | Anatomical Model Original:
provided non-sterile
Anatomical Model Modified:
provided non-sterile
Plastic Drawing Guide: provided
sterile
Cranial Implant Trial: provided
sterile | Cranial PSI: provided sterile |
11. Comparison of Technological Characteristics with the Predicate Device:
5
| 12. Biocompatibility of Cranial PSI Accessories: | ||
|---|---|---|
| -- | -- | -------------------------------------------------- |
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | |
| Method:L-929 mouse fibroblast cells | Not cytotoxic. | |
| The test article extract showed no | ||
| cytotoxic potential to L-929 mouse | ||
| fibroblast cells. | ||
| Systemic (acute) | ||
| toxicity | ISO 10993-11 | |
| Method: 20 mice observed at 4, 24, | ||
| 48 and 72 hours | No systemic toxicity. | |
| There was no mortality or evidence | ||
| of systemic toxicity from the | ||
| extracts injected into mice. | ||
| Sensitization | ||
| Study | ISO 10993-10 | |
| Method: Guinea Pig Maximization | ||
| scored at 24 and 48 hours | Not a sensitizer. | |
| No evidence of delayed dermal | ||
| contact sensitization. | ||
| Irritation Study | ISO 10993-10 | |
| Method: Intracutaneous study in | ||
| rabbits scored at 24, 48 and 72 | ||
| hours | Not an irritant. | |
| No evidence of irritation. | ||
| Pyrogen Study | USP 40-NF 35 | |
| Method: IV injection in 3 rabbits | Non-pyrogenic. | |
| No rabbit showed a temperature | ||
| rise >0.5°C. | ||
| Hemolysis Study | ISO 10993-4 | |
| Method: human blood | Non-hemolytic. | |
| The mean hemolytic index for the | ||
| test article extract was of 0.1%. | ||
| Analytical | ||
| Extractable | ||
| Chemical | ||
| Analysis | ISO 10993-18 | |
| Method: extracts analyzed by FTIR, | ||
| GC-MS, UPLC-MS, ICP-MS and | ||
| GC-MS | Non-hazardous in all results. | |
| No leachables were detected in | ||
| potentially toxic concentrations | ||
| from a worst-case device | ||
| configuration. |
6
| Test Method and Relevance Summary | Results |
|---|---|
| Deformation Test: | |
| Resistance to deformation simulating a | |
| clinician pressing hard with a surgical marker | |
| against the Plastic Drawing Guide. | |
| Requirement: |