(303 days)
No
The description focuses on patient-specific design based on CT data and fabrication using PEEK material. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device replaces bone and corrects defects, which is a structural rather than a therapeutic function.
No
Explanation: The device is an implant designed to replace bony voids; it does not diagnose medical conditions. It uses CT imaging data for fabrication, not for diagnostic interpretation.
No
The device is a physical implant made of PEEK material, designed and fabricated based on patient imaging data, and requires sterilization before use. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device 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.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's condition. Its purpose is structural replacement.
The information provided about the device's intended use, description, and performance studies all point to it being a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.
Product codes
GXN
Device Description
The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc.
The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging data
Anatomical Site
cranial and/or craniofacial skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Facilities / Hospitals
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 biocompatibility evaluation for the PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) was conducted in accordance with the 2020 FDA quidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA.
The evaluation tests of the PSCI contain:
- In Vitro Cytotoxicity Test
- Skin Sensitization Test
- Intracutaneous Reactivity Test
- Acute Systemic Test
- Material-mediated Pyrogens
- Bone Implantation Test
- Extractable Assessment
The LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required ≤20 EU/device.
The Particle testing has been conducted in accordance with USP.
Based on the intended use of the subject device, the performance evaluation for PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) was conducted in compression, fitting, and fixation.
No clinical tests were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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October 28, 2022
Kontour(Xi'an) Medical Technology Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518100, China
Re: K214109
Trade/Device Name: PEEK Patient Specific Craniofacial Implant(PSCI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: September 28, 2022 Received: September 29, 2022
Dear Joyce Yang:
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
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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 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 (OS) 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 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. 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) K214109
Device Name
PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)
Indications for Use (Describe)
The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date of Summary prepared: October 28, 2022
1. Submission Sponsor
| Applicant Name | Kontour(Xi'an) Medical Technology Co., Ltd. |
|---|---|
| Address | No.6, Qinling Avenue, Caotang Technology |
| Industries Base, Xi'an High-tech Zone, 710304 | |
| Xi'an, China | |
| Contact person | Rongrong Cong |
| Phone | 086-29-63364685 |
| cong rongrong@kontmed.com |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times |
| Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) |
| Model: | No specific model (Custom device) |
| Classification name: | Plate, Cranioplasty, Perfoemed, Non-alterable |
| Review Panel: | Neurology |
| Product Code: | GXN |
| Device Class: | II |
| Regulation Number: | 21 CFR § 882.5330 |
4. Legally Marketed Predicate Device
| Trade Name | Patient Contoured Implant - PEEK (PCI-PEEK) |
|---|---|
| Regulation number | 21 CFR § 882.5330 |
| Regulation class | II |
| Regulation name | Preformed nonalterable cranioplasty plate |
| 510(k) Number | K151382 |
| Product Code | GXN |
| Manufacturer | KLS-MARTIN L.P. |
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5. Device Description
The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc.
The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.
6. Intended Use/ Indications for Use
The PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is intended to replace bony voids in the cranial and /or craniofacial skeleton, excluding maxillofacial and /or oral regions.
7. Technological characteristics Comparison
| .Compariso
n item | Subject Device:
PEEK Patient Specific
Cranial/Craniofacial Implant | Predicate Device:
Patient Contoured Implant-PEEK
(K151382) | Comments |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication for
Use | The PEEK Patient Specific
Cranial/Craniofacial
Implant(PSCI) is intended to
replace bony voids in the
cranial and /or craniofacial
skeleton, excluding
maxillofacial and /or oral
regions. | The Patient Contoured Implant -
PEEK (PCI-PEEK) is intended to
replace bony voids in the cranial
skeleton. | Same |
| Anatomical
Sites | Cranial or Craniofacial | Cranial | Similar
(Issue 1) |
| Material | PEEK | PEEK | Same |
| Style | Solid with holes | Solid or solid with holes | Same |
| Sterilization | Provided non-sterile (The PSCI
is provided non-sterile and must
be sterilized before use) | Provided Sterile (Gamma) | Different
(Issue 2) |
| Design and
manufacture | Customized device, designed
and manufactured in accordance | Customized device, designed
and manufactured in accordance | Same |
Table 1: General Comparison
5
| .Compariso
n item | Subject Device:
PEEK Patient Specific
Cranial/Craniofacial Implant | Predicate Device:
Patient Contoured Implant-PEEK
(K151382) | Comment
s |
|----------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------|--------------|
| | with patient's CT-scan data | with patient's CT-scan data | |
| Method of
Fixation | Titanium Screws and Titanium
Plates | Titanium Screws and Titanium
Plates | Same |
| Where used
(hospital,
home,
ambulance,e
tc.) | Health Care Facilities / Hospitals | Health Care Facilities / Hospitals | Same |
lssue 1: The difference between a implant used to replace Cranial bone and a implant used to replace craniofacial bone is that the shape of the implant. The implant and its contact with the human body are the same. So this difference would not raise new issue of safety or effectiveness.
lssue 2: The subject device is provided in non-sterilized before use in Health Care Facility. The sterilization has been validated. And many similar devices are also provided in this way, such as Patient Contoured Mesh - PEEK (K072707).
8. Summary of Non-clinical Testing
The biocompatibility evaluation for the PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) was conducted in accordance with the 2020 FDA quidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA.
The evaluation tests of the PSCI contain:
- In Vitro Cytotoxicity Test
- Skin Sensitization Test
- Intracutaneous Reactivity Test
- Acute Systemic Test
- Material-mediated Pyrogens
- Bone Implantation Test
6
● Extractable Assessment
The LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required ≤20 EU/device.
The Particle testing has been conducted in accordance with USP.
Based on the intended use of the subject device, the performance evaluation for PEEK Patient Specific Cranial/Craniofacial Implant (PSCI) was conducted in compression, fitting, and fixation.
9. Brief discussion of clinical tests
No clinical tests were performed.
10.Conclusions
The subject device, PEEK Patient Specific Cranial/Craniofacial Implant has the same intended use, design, function, and is composed of the same material as the predicate device, Patient Contoured Implant-PEEK. The subject device differs from the predicate device in that it will be provided in non-sterile and must be sterilized before use in Health Care Facility. This difference does not raise new issues of safety or effectiveness. Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.