(270 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of metallic implants and instruments, with no mention of AI or ML.
Yes
The device is described as an implantable system used in surgical procedures to repair a medical condition (pectus excavatum), which directly falls under the definition of a therapeutic device.
No
The device description clearly states it consists of "metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum." This indicates a therapeutic or support function, not a diagnostic one.
No
The device description explicitly states it consists of metallic implants (pectus bars and connector bars) and instruments to facilitate their placement, which are hardware components.
Based on the provided information, the KLS Martin Pure Pectus System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical repair of pectus excavatum, which is a structural issue of the chest wall. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of metallic implants and instruments used in surgery. These are physical devices used to support and repair the thoracic cavity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVD devices typically involve analyzing biological samples.
Therefore, the KLS Martin Pure Pectus System is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
Product codes
HRS
Device Description
The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum The implants are provided non-sterile in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic cavity
Indicated Patient Age Range
adult and pediatric (children and adolescents) populations
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
Non-Clinical Performance Data: Comparative head-to-head bench testing was conducted to determine substantial equivalence to the primary predicate device in static and dynamic 4-point bending. The testing met all predetermined acceptance criteria and the results demonstrate that the subject device's performance is substantially equivalent to the primary predicate device. Biological safety isk 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 28, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
KLS Martin L.P. Liza Gordillo Regulatory Affairs Project Manager 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K221938
Trade/Device Name: KLS Martin Pure Pectus 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 21, 2023 Received: February 21, 2023
Dear Liza Gordillo:
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,
Shumaya Ali-S
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
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Indications for Use
Submission Number (if known)
Device Name
KLS Martin Pure Pectus System
Indications for Use (Describe)
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
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) #: K221938 | 510(k) Summary | Prepared on: 2023-03-24 |
| 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. Liza Gordillo | |
| Correspondent Contact Email | liza.gordillo@klsmartin.com |
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | KLS Martin Pure Pectus 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 | |
| K972420 | Lorenz Pectus Support Bar | HRS | |
| K153482 | KLS Martin Thoracic Plating System | HRS |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
|---|---|---|---|
| The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum The implants are provided non-sterile in multiple |
that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.
Intended Use/Indications for Use
4
The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.
Indications for Use Comparison
The intended use of the subject device is identical to the primary predicate device, Lorenz Pectus Support Bar (K972420). The potential impact on substantial equivalence of each technological difference was addressed through risk analysis as well as verification and validation testing.
Technological Comparison
Similarities to Predicates
The subject and predicate devices have fundamental technologies in that they are all designed for use in surgical procedures of the thoracic and sternal region and are manufactured in a variety of sizes and configurations to provide the prous sizing options to repair pectus excavatum.
Differences from Predicate
The subject device is manufactured from CP titanium (ASTM F67:2017) and Ti-6Al-4V (ASTM F136:2013) and the predicate device is manufactured from stainless steel. Performance testing demonstrated that the differences in material does not affect the safety and effectiveness of the subject devices and can be determined substantially equivalent.
Conclusion
Based on the questions above as well as conformance to FDA-recognized standards, along with the performance data compared with the predicate, K972420, safety and effectiveness has been demonstrated.
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 substantial equivalence to the primary predicate device in static and dynamic 4-point bending. The testing met all predetermined acceptance criteria and the results demonstrate that the subject device's performance is substantially equivalent to the primary predicate device. Biological safety isk 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 Pure Pectus System has the same intended use and similar technological characteristics as the predicate device. Technological differences have been addressed through performance data from the predicate and reference devices, in addition to analysis of peer-reviewed clinical studies. All information provided show the subject device for the intended patient population.
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.