(163 days)
No
The device description focuses on mechanical components and their function in bone distraction. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are bench tests evaluating mechanical properties.
Yes
The device is intended for the "correction of congenital deficiencies or post traumatic defects of the cranial bones" through gradual distraction, which is a therapeutic intervention.
No
The device is described as a bone stabilizer and lengthening device used for correcting congenital deficiencies or post-traumatic defects of cranial bones through gradual distraction. It facilitates bone growth and expansion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, implantable medical device composed of footplates, activator arms, and screws, intended for surgical implantation and mechanical bone distraction. It does not describe software as the primary or sole component.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a mechanical implant used for bone stabilization and lengthening of cranial bones. It is surgically implanted and works by physically separating bone segments to induce new bone growth.
- Intended Use: The intended use is for the correction of congenital deficiencies or post-traumatic defects of the cranial bones through gradual distraction. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.
Product codes (comma separated list FDA assigned to the subject device)
PBJ
Device Description
Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bones
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)
Non-Clinical Performance Data:
Biocompatibility Testing: Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The patient-contacting materials Titanium Alloy (Ti-6Al-4V) and CP Titanium used for the Internal Distraction - Sterile devices and their components were tested for biocompatibility and are previously cleared in the predicate device. The Internal Distraction - Sterile devices and their components are comprised of the same materials, have the same chemical composition, undergo the same manufacturing processes, and have the same body contact duration as these devices; therefore, biocompatibility testing for Internal Distraction - Sterile is not needed.
Pyrogenicity Testing: Bacterial Endotoxins testing was conducted in accordance to ANSI/AAMI ST72:2011, USP , and EP 2.6.14 for detection and quantitation of bacterial endotoxins. The results of the testing demonstrate that the subject devices conform to the required endotoxin units per device for medical devices and meet pyrogen limit specifications.
Performance Testing - Bench: Axial load testing, bending torsion testing, axial-torsion testing, and transverse shear testing were performed to evaluate the mechanical properties of the subject devices. All devices passed design requirements for material properties, manufacturing tolerances, axial resistance, and torsional loading. The results of the testing demonstrate the devices are sufficiently capable of withstanding the anatomical loads placed upon them and allow for effective and safe boney movement during their intended use.
Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.
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.
Zurich Distraction System (K010139)
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.
K943347, K944561, K944565, K971297, K060177
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a symbol and text arranged in a circular format. The symbol features a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
KLS Martin LP Jennifer Damato Director of Quality MGT & Regulatory Affairs 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K163315
Trade/Device Name: Internal Distraction - Sterile Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: April 3, 2017 Received: April 4, 2017
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,
Michael J. Hoffmann -S
Carlos L. Peña. PhD, MS for 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) K163315
Device Name Internal Distraction - Sterile
Indications for Use (Describe)
Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo. The logo is simple and modern, and the use of color helps to make it stand out.
P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com
5. 510(K) SUMMARY
| Submitter: | KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director of Quality MGT and Regulatory Affairs
Phone: 1-800-625-1557
Fax: 904-641-7378 |
| Date Prepared: | May 4, 2017 |
| Trade Name: | Internal Distraction - Sterile |
| Common Name: | Preformed nonalterable cranioplasty plate |
| Classification Name: | Cranial Distraction System
Class II, 21 CFR 882.5330, Product Code PBJ |
| Predicate Devices: | Zurich Distraction System (K010139) (Primary) |
Device Description
Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.
4
Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the words "martin L.P." are in gray. The logo is simple and modern, and it is likely used to represent the company in its marketing and branding materials. The logo is horizontally oriented.
The purpose of this submission is to offer the previously cleared KLS Martin LP nonsterile predicate cranial distractors sterile via gamma irradiation and encompasses the following device:
Zurich Distraction System - K010139: The Zurich Distraction System includes devices intended as a bone stabilizer and lengthening (and or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis), mid-face, and cranial bones require gradual distraction.
Indications for Use
Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.
Technological Characteristics/Substantial Equivalence Discussion
Similarities to Predicate Devices
Internal Distraction - Sterile is similar to the Zurich Distraction System (K010139) predicate device with respect to intended use, but identical in materials, manufacturing process, principles of operation, and placement/fixation methods. The design mechanisms are similar with regard to the drive screws, distractor body, footplate shapes and sizes, distractor drive lengths, activators, and screws used to attach the footplates to the bone. The subject device performance characteristics are the same and testing performed demonstrates the devices are safe and effective for the intended use.
Differences to Predicate Devices
Internal Distraction - Sterile differs from the Zurich Distraction System (K010139) predicate device in that it will be provided in sterile packaging and will have different stock numbers from the originally cleared stock numbers to identify the product as sterile. In addition, the intended use differs only from the predicate device in that Internal Distraction - Sterile will be intended for correction of bones in the cranium, and will not include mid-face or mandible bones. The design mechanisms differ slightly in the subject devices compared to the predicate devices in that the distractors are manufactured with a ratcheting mechanism and specific activation arms are designed to be detachable based on patient need and distraction location.
Non-Clinical Performance Data
Biocompatibility Testing
Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The patient-contacting materials Titanium Alloy (Ti-6Al-4V) and CP Titanium used for the Internal Distraction - Sterile devices and their components were
5
Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.
.O. Box 16369 · Jacksonville, FL 32245-6369 04-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com
tested for biocompatibility and are previously cleared in the predicate device. The Internal Distraction - Sterile devices and their components are comprised of the same materials, have the same chemical composition, undergo the same manufacturing processes, and have the same body contact duration as these devices; therefore, biocompatibility testing for Internal Distraction - Sterile is not needed.
Pyrogenicity Testing
Bacterial Endotoxins testing was conducted in accordance to ANSI/AAMI ST72:2011, USP , and EP 2.6.14 for detection and quantitation of bacterial endotoxins. The results of the testing demonstrate that the subject devices conform to the required endotoxin units per device for medical devices and meet pyrogen limit specifications.
Performance Testing - Bench
Axial load testing, bending torsion testing, axial-torsion testing, and transverse shear testing were performed to evaluate the mechanical properties of the subject devices. All devices passed design requirements for material properties, manufacturing tolerances, axial resistance, and torsional loading. The results of the testing demonstrate the devices are sufficiently capable of withstanding the anatomical loads placed upon them and allow for effective and safe boney movement during their intended use.
Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusion
Internal Distraction - Sterile is similar in its intended use, design, function, manufacturing process, and is composed of the same materials as the predicate device. The similarities and differences in technological characteristics do not raise new questions of safety or effectiveness. Internal Distraction - Sterile will encompass the previously cleared predicate device intended for correction of cranial bones and provide them sterile. Therefore, the information presented supports substantial equivalence of Internal Distraction - Sterile to the predicate device.