(61 days)
Not Found
No
The description focuses on custom shaping based on CT data, which is a standard CAD/CAM process, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is intended to replace bony voids in the skeleton, which indicates a therapeutic purpose of restoring normal function or structure.
No
Explanation: The device is a custom-shaped titanium panel used to replace bony voids, making it a surgical implant rather than a diagnostic tool. Its purpose is treatment/reconstruction, not diagnosis.
No
The device is described as a custom shaped titanium panel, which is a physical hardware component, not 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 Description: The Patient Contoured Mesh (PCM) is a custom-shaped titanium panel intended to replace bony voids in the skeleton. It is a physical implant used in the body, not a device used to test samples from the body.
- Intended Use: The intended use is to replace bony voids, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Patient Contoured Mesh (PCM) is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Product codes
GXN
Device Description
Patient Contoured Mesh (PCM) is a custom shaped titanium panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh (PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based model
Anatomical Site
mandibular, maxillofacial or craniofacial 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052871, K053199, K033868, K944565, K971297
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).
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kts martin,L.P.
510(K) SUMMARY
OCT 3 1 2006
.
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| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | 18 August 2006 |
| Device Name: | Patient Contoured Mesh (PCM) |
| Trade Name: | PCM |
| Common Name: | Titanium Panel |
| Classification Name and Number: | Plate, Cranioplasty, Preformed, Non-Alterable
(CFR 882.5330) |
| Regulatory Class: | II |
| Predicate Devices: | Stryker Custom TI Implant (K052871)
Synthes Patient Specific Cranial/Craniofacial
Implant (PSCI) (K053199)
Synthes (USA) Patient Specific
Cranial/Craniofacial Implant (K033868)
KLS-Martin Micro Osteosynthesis System
(1.5 mm) (K944565)
Centre-Drive Drill Free Screws (DFS)
(K971297) |
| Intended Use: | Patient Contoured Mesh (PCM) is intended to
replace bony voids in mandibular, maxillofacial
or craniofacial skeleton. |
| Device Description: | Patient Contoured Mesh (PCM) is a custom
shaped titanium panel that is pre-shaped to fit
the anatomy of the patient using a CT based
model of the patient. Patient Contoured Mesh |
1
K662570 4/2
(PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)
Technological Characteristics:
Similarities to Predicate
Patient Contoured Mesh (PCM) and Stryker Custom TI Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are patient specific implants that are manufactured from titanium.
Patient Contoured Mesh and KLS-Martin Micro Osteosynthesis System (1.5 mm) (K944565) are identical in materials and in the intended use for reconstructive procedures of the mandibular, maxillofacial or craniofacial skeleton.
Differences to Predicate
Patient Contoured Mesh (PCM) is manufactured from CP Titanium and Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are manufactured from titanium and PEEK
Substantial Equivalence:
Patient Contoured Mesh (PCM) is substantially equivalent in materials and patient specificity to the Stryker Custom TI Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)
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Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
OCT 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KLS-Martin L.P. % Ms. Jennifer Damato Director RA/QA 11239 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K062570
Trade/Device Name: Patient Contoured Mesh Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 18, 2006 Received: August 31, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Ms. Jennifer Damato
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Kd2590
510(k) Number (if known):
Device Name: Patient Contoured Mesh (PCM)
Indications For Use:
Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Prescription Use S (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Resto and Neurological Devices | |
| Page 1 of 1 | |
| 510(k) Number | K062570 |
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