(161 days)
No
The description focuses on image processing, segmentation, and pre-operative planning using physician input, without mentioning AI or ML algorithms. The performance studies listed are standard for medical devices and do not indicate AI/ML development or validation.
No
The device is a planning and simulation software system that produces digital and physical models for surgical preparation, not a device that directly treats or diagnoses a disease.
No
The device is a pre-operative planning system that converts medical images into models and guides for surgery. It does not provide a diagnosis of a disease or condition.
No
The device description explicitly states it is a "collection of software and associated additive manufacturing (rapid prototyping) equipment," indicating it includes hardware components beyond just software.
Based on the provided information, 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's Intended Use: The KLS Martin IPS Planning System is intended for:
- Processing medical imaging data (CT scans).
- Creating digital models and physical outputs (anatomical models, guides, splints, case reports).
- Pre-operative planning and simulation of surgical treatment options.
- Lack of Specimen Analysis: The device does not involve the analysis of biological specimens taken from the patient. Its input is imaging data, not biological samples.
The device is a software and manufacturing system used for surgical planning and creating patient-specific surgical aids based on imaging data. This falls under the category of medical devices used for surgical planning and execution, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scamer such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, splints and case reports.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based system
Anatomical Site
maxillofacial
Indicated Patient Age Range
Pediatric & Adults
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: Tensile & Bending Testing. Biocompatibility Testing. Sterilization Testing. Pyrogenicity Testing. Software Verification and Validation. 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.
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)
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.
KLS Martin Individual Patient Solutions (K163579), KLS Mini Osteosynthesis System (K943347), KLS Martin Centre-Drive Drill-Free Screws (K971297)
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
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KLS-Martin L.P. Pam Martin Regulatory Affairs Supervisor 11201 Saint Johns Industrial Parkway S Jacksonville, Florida 32246
March 11, 2019
Re: K182789
Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: February 4, 2019 Received: February 8, 2019
Dear Pam Martin:
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner - S3
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K182789
Device Name
KLS Martin Individual Patient Solutions (IPS) Planning System
Indications for Use (Describe)
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scamer such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
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) |
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Image /page/3/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 larger than the other letters in the logo.
11201 Saint Johns Industrial Pkwy S · Jacksonville, FL 32246 Phone: 904-641-7746 · 800-625-1557 · Fax: 904-641-7378 www.klsmartinnorthamerica.com
| | 510(k) Summary
21 CFR 807.92 | K182789 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 | |
| Contact Person: | Pam Martin, RAC, MSc
Regulatory Affairs Supervisor
Phone: 800-625-1557
Email: pmartin@klsmartin.com | |
| Date Prepared: | February 4, 2019 | |
| Trade Name: | KLS Martin Individual Patient Solutions (IPS) Planning
System | |
| Common Name: | System for the creation of patient specific anatomical
models, cutting/marking guides, splints, and case reports | |
| Classification Name: | Bone Cutting Instruments and Accessories (21 CFR
872.4120); System, Image Processing, Radiological (21 CFR
892.2050 | |
| Regulatory Class: | II | |
| Product Code: | DZJ, LLZ | |
| Predicate Device: | KLS Martin Individual Patient Solutions (IPS) Planning
System (K181241) - Primary | |
| Reference Devices: | KLS Martin Individual Patient Solutions (K163579)
KLS Mini Osteosynthesis System (K943347)
KLS Martin Centre-Drive Drill-Free Screws (K971297) | |
Device Description:
The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, splints and case reports.
Indications for Use:
The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, guides, splints, and case reports for use in maxillofacial surgery. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
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Image /page/4/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 smaller than the other letters/words in the logo.
Technological Characteristics/Substantial Equivalence Discussion:
The indications for use are identical for both the subject and predicate device. Further, the intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is identical to the predicate device, the KLS Martin Individual (IPS) Patient Solutions System (K181241):
The subject and primary predicate devices are intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed through the virtual planning software systems and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs. These physical outputs can be anatomical models, guides, splints, templates, and case reports. All digital data and physical devices are used to aid the surgeon during maxillofacial surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
Similarities to Predicate
The KLS Martin Individual Patient Solutions (IPS) Planning System, K181241, is identical to the subject device's technological characteristics with regard to software, material composition, biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization.
Both the subject and primary predicate devices use image data obtained from medical scanners, such as a CT scan. The subject device utilizes four (4) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the predicate device, K181241. The validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from a DICOM format to a .STL format and manipulate the images to produce a final design file. In addition, both devices require trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the trained employee/engineer during the planning session.
Both systems use additive manufacturing methods to produce physical output devices that include patient specific anatomical models, guides, and splints. In addition, the systems produce digital models and case reports for the physician to use for planning of maxillofacial surgeries or to use during surgery.
Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy) identical to what was evaluated in the predicate device, K181241. All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Validated sterilization studies were performed to ensure a sterility assurance level (SAL) of 10-9.
In addition, the subject device uses previously cleared fixation screws that are utilized for temporary guide fixation during cutting and marking of the bone. The screws range from 1.5 mm - 2.7 mm with lengths of 4 mm - 22 mm identical to what was evaluated in the predicate device, K181241.
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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 larger than the other letters in the logo. The logo is simple and modern.
Differences to Predicate
The predicate device, K181241, was cleared for the adolescent (12 to 21 years of age) and adult populations.
The purpose of this submission is to expand the patient population to include the following pediatric subpopulations:
- . Neonates (birth to 28 days)
- Infants (29 days to