Cranial PSI

• K Number: K161090
• Device Name: Cranial PSI
• Manufacturer: OSSDSIGN AB
• Date Cleared: 2017-01-19 ( 276 days)
• Product Code: GXN PJN
• Regulation Number: 882.5330

Intended Use

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 or with or with or without duraplasty.

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 tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

Predicate Devices

K062570

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a patient-specific implant based on anatomical requirements, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as "reconstruction of cranial defects" and "replaces native bone in the cranial skeleton," which points to a therapeutic function rather than a diagnostic one. The performance studies focus on the physical integrity and protective capabilities of the implant, further supporting its role in treating a physical condition.

Diagnostic

No

Explanation: The device description and intended use clearly state that it is an implant for reconstructing cranial defects, not for diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a rigid titanium mesh covered by ceramic tiles, which are physical components, not software. The performance studies also involve physical testing of the implant's mechanical properties.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the "reconstruction of cranial defects" and "replaces native bone in the cranial skeleton." This is a surgical implant used directly in the body for structural support and repair.
• Device Description: The description details a physical implant made of titanium mesh and ceramic tiles.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The performance studies focus on mechanical properties and resistance to force, not on analyzing biological samples.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 or with or with or without duraplasty.

Product codes

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 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

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)

Dynamical Load Test:
To verify that the Cranial PSI supports the forces exerted onto the implant from sleeping during the device lifetime.
Requirement: no deformation
Method: orbital shaker, 125 rpm, 60 hours.
Relevance: test simulates changed head position every 20 minutes during 8 hours sleep for 50 years. Both the subject device and predicate passed the test.
Results: No deformation for both OSSDSIGN Cranial PSI (size: 197 cm²) and KLS Martin - PCI Titanium Mesh (size: 197 cm²).

Max Force [N]:
To establish the maximum force that can be applied to the device before failure.
Requirement: >100 N
Method: Universal testing machine at 1 mm/min
Relevance: protection from falling objects and blunt trauma. Both the subject device and predicate passed the test. The subject device provided moderately better performance than the predicate.
Results: OSSDSIGN Cranial PSI: 461 N, KLS Martin - PCI Titanium Mesh: 383 N.

Energy absorption [mJ]:
To establish the maximum energy the device can absorb before failure.
Requirement: >1000 mJ
Method: Universal testing machine at 1 mm/min
Relevance: protection from falling objects and blunt trauma. Both the subject device and blunt trauma. Both the subject device and predicate passed the test.
Results: OSSDSIGN Cranial PSI: 2260 mJ, KLS Martin - PCI Titanium Mesh: 3760 mJ.

Resistance to Deformation [mm]:
To establish device resistance to deformation before device failure.
Requirement:

Regulation Number and Section

§ 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).

Summary

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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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 19, 2017

OSSDSIGN AB % David Weissburg Principal Weissburg Associates 808 Williamson Street, Suite 402 Madison, Wisconsin 53703

Re: K161090

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: December 13, 2016 Received: December 14, 2016

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -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) K161090

Device Name OSSDSIGN Cranial PSI

Indications for Use (Describe)

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 or with or 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

K161090

• 1. 510(k) Owner Name and Address: OSSDSIGN AB Virdings Alle 2, SE 754 50, Uppsala Sweden Telephone: [phone] Email: [e-mail] Contact: Ulrik Birgersson
• 2. Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
• 3. Date prepared: January 18, 2017
• 4. Trade Name: OSSDSIGN Cranial PSI
• Regulation Description: Preformed Non-alterable Cranioplasty Plate 5.
• Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 6. 882.5330, Product code: PJN)
• 7. Class: 2
• 8. Substantially equivalent to: KLS Martin - Patient Contoured Mesh (K062570)
• Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that 9. 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 tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
• 10. Indications for Use: 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.
• 11. Comparison of Technological Characteristics with the Predicate Device :

| | OSSDSIGN
Cranial PSI (K161090, subject device) | KLS Martin
Patient Contoured Mesh
(K062570, predicate) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Indications For Use | 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. | Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton. |
| Materials | Ti grade 23, proprietary calcium phosphate ceramic | CP Titanium |

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| | OSSDSIGN
Cranial PSI (K161090, subject device) | KLS Martin
Patient Contoured Mesh (K062570, predicate) |
|-----------------------|----------------------------------------------------------------------------|-----------------------------------------------------------|
| Titanium
thickness | 0.4 – 1.6 mm | 0.6 – 1.0 mm |
| Max size | 200 cm² | 200 cm² |
| Provided form | Titanium and Ceramic
Ceramic mixed and cured in manufacturer's facility | Titanium only |
| Sterility on delivery | Sterile | Non-sterile |

• 12. Testing vs. predicate:

	Results
Test Method and Relevance Summary	OSSDSIGN Cranial
PSI	KLS Martin - PCI
Titanium Mesh
(K062570)
	Size: 197 cm²	Size: 197 cm2
Dynamical Load Test:
To verify that the Cranial PSI supports the forces
exerted onto the implant from sleeping during the
device lifetime.
Requirement: no deformation
Method: orbital shaker, 125 rpm, 60 hours.
Relevance: test simulates changed head position
every 20 minutes during 8 hours sleep for 50
years. Both the subject device and predicate
passed the test.	No deformation	No deformation
Max Force [N]
To establish the maximum force that can be
applied to the device before failure.
Requirement: >100 N
Method: Universal testing machine at 1 mm/min
Relevance: protection from falling objects and
blunt trauma. Both the subject device and
predicate passed the test. The subject device
provided moderately better performance than the
predicate.	461	383
Energy absorption [mJ]
To establish the maximum energy the device can
absorb before failure.
Requirement: >1000 mJ
Method: Universal testing machine at 1 mm/min
Relevance: protection from falling objects and
blunt trauma. Both the subject device and
blunt trauma. Both the subject device and	2260	3760

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predicate passed the test.
Resistance to Deformation [mm]
To establish device resistance to deformation
before device failure.
Requirement: