(127 days)
Not Found
No
The description focuses on custom fabrication based on CT data and does not mention any AI/ML algorithms for design or analysis.
No
The device is a custom skull implant used to replace bony voids in the cranial skeleton, which is a structural repair and not a therapeutic function.
No
Explanation: The device is an implant for replacing bony voids in the cranial skeleton, not for diagnosing conditions. It is a prosthetic device fabricated using patient CT imaging data but does not perform diagnostic functions.
No
The device description explicitly states the device is an "implantable prosthetic cranioplasty plate" composed of PEEK-OPTIMA, which is a physical material, not software.
No, 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, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided description clearly states that this device is a patient-specific cranial implant intended for the replacement of bony voids in the cranial skeleton. It is a physical implantable device, not something used to test or analyze bodily specimens.
- Intended Use: The intended use is to fill defects in the cranial skeleton, which is a surgical procedure, not an in vitro diagnostic test.
The device uses patient CT imaging data to create a custom implant, but this is for the design and fabrication of a physical device, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Kelyniam Custom Skull Patient Specific Cranial implant is intended to replace bony voids in the cranial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
GXN
Device Description
The Kelyniam Custom Skull Implant (CSI) is designed individually for each patient to correct defects in cranial bone. The Kelyniam Custom Skull Implant (CSI) is individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial skeleton. The implants are composed of PEEK-OPTIMA, and are fabricated using the patient's CT imaging data. The implants are provided with .125" diameter pressure relief holes, equally spaced over the contour of the implant with .625″ centerline spacing and a minimum of .500″ edge margin. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners. This product is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging data
Anatomical Site
Cranial bone / cranial skeleton
Indicated Patient Age Range
Not Found
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)
A series of Limulus Amebocyte Lysate (LAL) test were performed. In these test, the Kelyniam Custom Skull Implants detected endotoxin levels were lower than the minimum requirements for medical devices in contact with cerebrospinal fluid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a black and white drawing of a globe. The globe is tilted slightly to the left, and the continents of North and South America are visible. The globe is surrounded by lines of latitude and longitude. The drawing is simple and stylized.
200 Myrtle Street, 2nd Floor, New Britain, CT 06053, 1-800-280-8192, FAX 501-641-2000
510(k) Summary Kelyniam Custom Skull Implant
APR 1 4 2011
- 510(k) Submitter Kelyniam Global, Inc. 200 Myrtle Street, 2nd Floor New Britain, CT 06053 (800) 280-8192
- Contact Person: James Ketner President/CEO (800) 280-8192 (860) 832-9331, Ext 223 (501) 641-2000, Fax
Date of Summary: 25 October 2010
Proprietary Name: Kelyniam Custom Skull Implant (CSI) Device Name: Common Name: Patient-specific cranial implant Classification Name: "plate, cranioplasty, preformed, nonalterable,' a class II device in accordance with 21 CRF §882.5330
Panel: Neurology
Product Code: GXN
Device Description:
The Kelyniam Custom Skull Implant (CSI) is designed individually for each patient to correct defects in cranial bone. The Kelyniam Custom Skull Implant (CSI) is individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial skeleton. The implants are composed of PEEK-OPTIMA, and are fabricated using the patient's CT imaging data. The implants are provided with .125" diameter pressure relief holes, equally spaced over the contour of the implant with .625″ centerline spacing and a minimum of .500″ edge margin. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners. This product is a single use device.
Indications for use:
The Kelyniam Custom Skull Patient Specific Cranial implant is intended to replace bony voids in the cranial skeleton.
1
Toxicity
A series of Limulus Amebocyte Lysate (LAL) test were performed. In these test, the Kelyniam Custom Skull Implants detected endotoxin levels were lower than the minimum requirements for medical devices in contact with cerebrospinal fluid.
Substantial Equivalence:
The Kelyniam Custom Skull Implants (CSI) are substantially equivalent to the Synthes Patient Specific Cranial Implant (PSCI) (K053199), OsteoSymbionics Patient-Specific Cranial Implant (K072601) and KLS Martin Patient Contoured Mesh (K072707). Like these other devices, the Kelyniam Custom Skull Implant (CSI) is manufactured from PEEK or equivalent polymers, sold non-sterile and is customized to each patient.
| | Kelyniam
Custom Skull
Implant (CSI) | Synthes Patient
Specific
Cranial/Craniofacial
Implant (PSCI)
(K053199) | OsteoSymbionics
Patient-Specific
Cranial Implant
(K072601) | KLS Martin
Patient
Contoured
Mesh
(K072707) |
|-----------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended Use | Correction of
defects in
cranial bone | Replace bony voids
in the
cranial/craniofacial
skeleton | Correct defects
in craniofacial
bone | Replace
bony voids
in the cranial
and/or
craniofacial
skeleton |
| Material | PEEK-OPTIMA
LT1 | PEEK Optima-LT1 | Polymethyl
Methacrylate
(PMMA) | PEEK (PCM-
P) |
| Technical
Specifications | Plate - Custom
sized to each
patient using
CT data | Custom sized to
each patient | Plate - Custom
sized to each
patient | Mesh -
Custom
sized to each
patient |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
Substantial Equivalence Chart
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. James Ketner President/CEO/Chairman Kelyniam Global. Inc. 200 Myrtle Street, 2nd Floor New Britain. CT 06053
APR 1 4 2011
Re: K103582
Trade Name: Kelyniam Custom Skull Implant (CSI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: GXN Dated: October 25, 2010 Received: January 25, 2011
Dear Mr. Ketner:
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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
for
Sincerely yours,
Sincerely yours,
Keoia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Kelyniam Custom Skull Implant (CSI)
Indications for Use: Patient Specific Cranial implants are intended for the replacement of bony voids in the cranial skeleton.
| Prescription Use Yes
(Part 21 CFR 801 Subpart D) | Over-The-Counter Use No
(21 CFR 801 Subpart C) |
|-----------------------------------------------------|---------------------------------------------------|
| AND/OR | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rusanau
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103582