(233 days)
No
The summary describes a mechanical fixation system (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for stabilization and rigid fixation of rib fractures, which is a therapeutic intervention.
No
The device is a rib fixation system composed of plates and screws intended for the stabilization and rigid fixation of rib fractures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is comprised of PEEK plates and titanium locking screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "stabilization and rigid fixation of rib fractures in the chest wall". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of "PEEK plates and titanium locking screws" which are implants used to physically fix bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the KLS Martin Level One Rib Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KLS Martin Level One Rib Fixation System is in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM F136) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ribs, chest wall
Indicated Patient Age Range
18 years of age or older
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)
Comparative head-to-head bench testing was conducted to determine whether the subject device performs equivalent to or better than the primary predicate device in pull-out system testing was compared to the reference device, Synthes MatrixRlB Fixation System (K081623). The testing met all predetermined acceptance criteria and the results demonstrate that the subject device's performance is substantially equivalent to both the primary predicate device and the reference device. Biological safety risk assessments in compliance with ISO 10993-1 :2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 29, 2023
KLS-Martin L.P. Pam Martin Regulatory Affairs Project Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246
Re: K222397
Trade/Device Name: KLS Martin Level One Rib Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: February 24, 2023 Received: March 1, 2023
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
KLS Martin Level One Rib Fixation System
Indications for Use (Describe)
The KLS Martin Level One Rib Fixation System is indicated for use in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.
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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Page 1 of 2
| 510(k) #: K222397 | 510(k) Summary | Prepared on: 2023-03-28 | |||
|---|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | KLS-Martin L.P. | ||||
| Applicant Address | 11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States | ||||
| Applicant Contact Telephone | 800-625-1557 | ||||
| Applicant Contact | Ms. Melissa Bachorski | ||||
| Applicant Contact Email | rapm_na@klsmartin.com | ||||
| Correspondent Name | KLS-Martin L.P. | ||||
| Correspondent Address | 11201 Saint Johns Industrial Pkwy S Jacksonville FL 32246 United States | ||||
| Correspondent Contact Telephone | 800-625-1557 | ||||
| Correspondent Contact | Ms. Pam Martin | ||||
| Correspondent Contact Email | pmartin@klsmartin.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | KLS Martin Level One Rib Fixation System | ||||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||||
| Classification Name | Plate, Fixation, Bone | ||||
| Regulation Number | 888.3030 | ||||
| Product Code | HRS | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K153482 | KLS Martin Thoracic Plating System | HRS | |||
| K151983 | KLS Martin Longitudinal Sternal Stabilization (LSS) System | JDQ | |||
| K081623 | Synthes MatrixRIB Fixation System | HRS | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The KLS Martin Level One Rib Fixation System is comprised of PEEK plates and titanium locking screws intended to provide rigid fixation of bone in the thoracic anatomy. The PEEK plates are pre-contoured to accommodate patient anatomy and are offered in plate thicknesses of 2 mm - 3 mm. The PEEK plates are compatible with the Ti-6Al-4V (ASTM F136) 2.3 mm x 7 mm multidirectional locking screws offered in the system. The plates are manufactured from PEEK (ASTM F2026). The system includes the necessary instrumentation
4
Intended Use/Indications for Use
The KLS Martin Level One Rib Fixation System is in the stabilization and rigid fixation of rib fractures in the chest wall including reconstructive procedures, trauma, or planned osteotomies in patients 18 years of age or older.
Indications for Use Comparison
The subject device differs from the primary predicate, KLS Martin Thoracic Plating System (K153482), in indications for use. The addition of the Transitional Adolescent B patient population to the subject device indications does not constitute a new intended use because no special considerations are being qiven, or required, for the Category B adolescents compared to adults. The anatomical area of use for the subject device is exclusive to the ribs, whereas the primary predicate device is cleared for the chest wall including sternum.
Technological Comparison
Similarities to Predicate:
Both the subject and primary predicate devices are intended for stabilization of bone in the thoracic anatomy. The design / shape of the PEEK rib plates is similar to the rib plates evaluated in the subject and primary predicate devices are fixated with titanium screws.
Differences from Predicate:
The subject device plates are made from PEEK whereas the plates are made from CP Titanium. The subject device is limited for use in the rib, whereas the primary predicate device was cleared for use in the chest wall, including sternum.
Reference Devices:
The KLS Martin LSS Plating System (K151983) has been included as a reference docompatibility data for the subject device. The KLS Martin Level One Rib Fixation System includes implants manufactured from the same materials as the reference device, PEEK The PEEK plates and titanium screws are identical composition, undergo identical manufacturing processes, and have the same permanent body contact duration as those cleared in K151983 - KLS Martin LSS Plating System.
The Synthes MatrixRIB Fixation System (K081623) has been included as a reference device to compare mechanical performance against the subject device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Performance Data:
Comparative head-to-head bench testing was conducted to determine whether the subject device performs equivalent to or better than the primary predicate device in pull-out system testing was compared to the reference device, Synthes MatrixRlB Fixation System (K081623). The testing met all predetermined acceptance criteria and the results demonstrate that the subject device's performance is substantially equivalent to both the primary predicate device and the reference device. Biological safety risk assessments in compliance with ISO 10993-1 :2018 were completed on the subject devices and concluded the devices are biocompatible and appropriate for their intended use.
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusions:
The KLS Martin Level One Rib Fixation System has the same intended use and similar technological characteristics as the primary predicate device. Technological differences have been addressed through performance data from the predicate and reference devices. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.