(171 days)
No reference devices were used in this submission.
No
The device description focuses on the material and manufacturing process based on a CT scan, with no mention of AI or ML for analysis or design.
Yes.
The device is intended to replace bony voids in the cranial skeleton, which directly addresses a medical condition or ailment, thereby providing therapy.
No
The device is an implant designed to replace bony voids in the cranial skeleton, which is a therapeutic function, not a diagnostic one.
No
The device is a physical implant made from PEEK material, not software. The CT-based model is used for shaping the physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace bony voids in the cranial skeleton." This is a surgical implant, not a test performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The device is a preformed implant made of PEEK material, shaped to fit the patient's anatomy based on a CT scan. It is surgically implanted and fixated to bone.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
This device falls under the category of a surgical implant or medical device used for reconstructive surgery.
N/A
Intended Use / Indications for Use
The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.
Product codes
GXN
Device Description
The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-based model
Anatomical Site
Cranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: The biocompatibility evaluation for the Patient Contoured Implant - PEEK (PCI-PEEK) was conducted in accordance with the FDA Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, 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 patient-contacting material PEEK (Polyether ether ketone) used for the Patient Contoured Implant – PEEK (PCI-PEEK) is previously cleared in K072707. The implant has identical chemical composition, undergoes identical manufacturing processes, and has the same permanent body contact duration as the predicate, K072707. LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2015
KLS Martin L.P. Ms. Jennifer Damato Director of Quality MGT & Regulatory Affairs P.O. Box 16369 Jacksonville, Florida 32245-6369
Re: K151382
Trade/Device Name: Patient Contoured Implant - PEEK (PCI-PEEK) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 7, 2015 Received: October 8, 2015
Dear Ms. Damato:
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S/A
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151382
Device Name
Patient Contoured Implant - PEEK (PCI-PEEK)
Indications for Use (Describe) The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
KIST
P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com
510(k) Summary Section 21 CFR 807.92
| Submitter: | KLS-MARTIN L.P. | |
|---|---|---|
| 11201 Saint Johns Industrial Pkwy S | ||
| Jacksonville, FL 32246 | ||
| Contact Person: | Jennifer Damato | |
| Director of Quality MGT & Regulatory Affairs | ||
| Phone: 800-625-1557 | ||
| Fax: 904-641-7378 | ||
| Date Prepared: | November 4, 2015 | |
| Trade Name: | Patient Contoured Implant - PEEK (PCI-PEEK) | |
| Common Name: | Preformed Plate | |
| Classification: | Plate, Cranioplasty, Preformed, Non-alterable | |
| Class II, 21 CFR 882.5330, Product Code GXN | ||
| Predicate Devices: | Patient Contoured Mesh – PEEK (PCM-P) [K072707] | |
| No reference devices were used in this submission. |
Device Description:
The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
The purpose of this premarket notification is to offer the implants sterile.
Indications for Use:
The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.
4
KLS martın LP.
Technological Characteristics / Substantial Equivalence:
| | Patient Contoured Implant – PEEK (PCI-PEEK)
(Subject Device) | Patient Contoured Mesh – PEEK (PCM-P)
(Predicate: K072707) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton. | Patient Contoured Mesh – PEEK (PCM-P) is intended to replace bony voids in the crania and/or craniofacial skeleton. |
| Anatomical Sites | Cranial | Craniomaxillofacial |
| Material | PEEK | PEEK |
| Style | Solid or solid with holes | Solid or solid with holes |
| Sterilization | Provided Sterile (Gamma) | Provided Non-sterile (Steam) |
| Method of Fixation | Titanium Screws and Titanium Plates | Titanium Screws and Titanium Plates |
| Where used (hospital, home, ambulance, etc) | Health Care Facilities / Hospitals | Health Care Facilities / Hospitals |
5
Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.
Performance Data:
Biocompatibility Testing
The biocompatibility evaluation for the Patient Contoured Implant - PEEK (PCI-PEEK) was conducted in accordance with the FDA Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, 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 patient-contacting material PEEK (Polyether ether ketone) used for the Patient Contoured Implant – PEEK (PCI-PEEK) is previously cleared in K072707. The implant has identical chemical composition, undergoes identical manufacturing processes, and has the same permanent body contact duration as the predicate, K072707.
LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required