(28 days)
Not Found
No
The description focuses on the material properties and the process of creating patient-specific implants based on CT data and surgeon specifications. There is no mention of AI or ML being used in the design or manufacturing process.
No
The device is an implant for reconstructing bony voids and defects, not a device used to treat or prevent a disease or condition for therapeutic purposes.
No
Explanation: The device, CustomizedBone Service, is described as an implant intended to replace bony voids in the skull. Its function is to reconstruct craniofacial defects, not to diagnose medical conditions or diseases. It uses CT scan data for design, but it does not perform any diagnostic interpretation of that data.
No
The device description explicitly states the device is made of porous biomimetic hydroxyapatite, which is a physical material, not software. The software component appears to be for design and planning, but the final device is a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that the CustomizedBone Service is an implant intended to replace bony voids in the cranial and craniofacial skeleton. It is a physical device that is surgically placed within the body.
- Intended Use: The intended use is to reconstruct defects, not to analyze biological samples for diagnostic purposes.
The device description and intended use clearly indicate that this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated to cranial decompression,
- · removal of tumours:
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Product codes
GXN, PJN
Device Description
Hydroxyapatite is contained in human bones in percentage close to 70% and is one of the most important elements of human bone structure. CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:
· macro-pores,
• interconnecting pores,
• micro-pores.
This material is biocompatible.
The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
cranial and/or craniofacial skeleton (frontal bone including the brow ridge)
Indicated Patient Age Range
adult and pediatric use (for children 7 years of age and above)
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
The following tests were completed to validate the effectiveness of the implantation with PEEK OPTIMA™ clamps:
· Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)
• Usability of an alternative method of fixation for CustomizedBone Service product
Based on the above testing, fixation of the CustomizedBone Service with PEEK OPTIMA™ clamps (Cranial LOOP (L) manufactured by NEOS Surgery S.L. or equivalent) has been validated and the can be considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 28, 2024
Image /page/0/Picture/1 description: The image shows 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.
Fin-ceramica faenza s.p.a. % Stephanie Perryman Fortrea 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334
Re: K240567
Trade/Device Name: CustomizedBone Service Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: February 26, 2024 Received: February 29, 2024
Dear Stephanie Perryman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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. Digitally signed by Adam D. Pierce -S Digitally signed by Pierce -S 16:45:07-04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
2
and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
CustomizedBone Service
Indications for Use (Describe)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated to cranial decompression,
- · removal of tumours:
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
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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4
Prepared on: 2024-03-27
21 CFR 807.92(a)(4)
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | Fin-ceramica faenza s.p.a. | ||
| Applicant Address | Via Ravegnana 186 Faenza RA 48018 Italy | ||
| Applicant Contact Telephone | +39 0546 607311 | ||
| Applicant Contact | Marina Monticelli | ||
| Applicant Contact Email | mmonticelli@finceramica.it | ||
| Correspondent Name | Fortrea | ||
| Correspondent Address | 5353 Wayzata Boulevard, Suite 505 Minneapolis MN 55416-1334 United States | ||
| Correspondent Contact Telephone | 612-476-4371 | ||
| Correspondent Contact | Stephanie Perryman | ||
| Correspondent Contact Email | stephanie.perryman@fortrea.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | CustomizedBone Service | ||
| Common Name | Preformed nonalterable cranioplasty plate | ||
| Classification Name | Plate, Cranioplasty, Preformed, Non-Alterable | ||
| Regulation Number | 882.5330 | ||
| Product Code(s) | GXN, PJN | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K193547 | CustomizedBone Service | GXN |
510(k) Sun
arv
Device Description Summary
Hydroxyapatite is contained in human bones in percentage close to 70% and is one of the most important elements of human bone structure. CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:
· macro-pores,
• interconnecting pores,
• micro-pores.
This material is biocompatible.
The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final
5
implant design. All the implants are accompanied by the patient's identification code.
Intended Use/Indications for Use
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
-
· trauma and vascular pathologies, either associated or non-associated to cranial decompression;
• removal of tumours; -
· reabsorption of autologous bone;
-
· rejection of other prosthetic materials;
-
· congenital malformations.
Indications for Use Comparison
The indications for use of the subject device remain the same as the predicate device.
Technological Comparison
The design and materials of the implant remain the same as the predicate device. The only change between the subject device and predicate device is the introduction of an alternative fixation method (Cranial bone fixation clamp made of biocompatible PEEK OPTIMA™ - Cranial LOOP (L) manufactured by NEOS Surgery S.L. or equivalent). The new fixation method has been validated and the subject device can be considered substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were completed to validate the effectiveness of the implantation with PEEK OPTIMA™ clamps:
· Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)
• Usability of an alternative method of fixation for CustomizedBone Service product
Based on the above testing, fixation of the CustomizedBone Service with PEEK OPTIMA™ clamps (Cranial LOOP (L) manufactured by NEOS Surgery S.L. or equivalent) has been validated and the can be considered substantially equivalent to the predicate device.
Image /page/5/Picture/17 description: The image is a blank white square. The square is uniformly white, with no discernible features or patterns. A thin gray line is present on the right edge of the square, possibly indicating a border or edge of the image.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)