(270 days)
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.
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.
The KLS Martin Pure Pectus System is a metallic implant system designed for surgical repair of pectus excavatum in both adult and pediatric populations. The submission K221938 received FDA clearance. Given the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and not a standalone algorithm, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML device. Instead, the acceptance criteria are related to mechanical and biological performance designed to demonstrate substantial equivalence to an existing predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Report) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Performance (Static Load) | Equivalent or superior static 4-point bending performance compared to the primary predicate device (Lorenz Pectus Support Bar K972420). Detailed thresholds for deflection, failure load, or stiffness would have been defined in test protocols, but are not explicitly reported in this summary document. | "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." |
| Mechanical Performance (Dynamic/Fatigue Load) | Equivalent or superior dynamic (fatigue) 4-point bending performance compared to the primary predicate device. Detailed thresholds for fatigue life or fracture mechanics would have been defined. | Same as above. |
| Biocompatibility | Biocompatible for its intended use, complying with ISO 10993-1:2018 standards for medical devices with prolonged tissue contact. No unacceptable cytotoxic, genotoxic, sensitization, irritation, or systemic toxicity effects. | "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." |
| Material Properties | Acceptable material composition (CP Titanium and Ti-6Al-4V) that does not adversely affect safety and effectiveness compared to the predicate's stainless steel. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" because this was bench testing on physical devices, not a clinical trial or algorithm evaluation with data. The sample size would refer to the number of bars tested for each mechanical test (static and dynamic bending). While not specified, these types of tests typically involve a statistically significant number of samples per variant (e.g., 5-10 samples per size/configuration for fatigue, 3-5 for static).
- Data Provenance: The data provenance is from non-clinical "bench testing" conducted by the manufacturer, KLS Martin L.P. This is not patient data; it's laboratory test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of submission (mechanical and biocompatibility testing for a medical device), "ground truth" is not established by human experts in the way it would be for an AI diagnostic algorithm. Ground truth is established by validated laboratory testing procedures and international standards.
4. Adjudication Method for the Test Set
Not applicable. This was not an expert review/adjudication of clinical images or patient cases. The "adjudication" in this context is the comparison of test results against pre-defined acceptance criteria per established test protocols and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The KLS Martin Pure Pectus System is a metallic implant; its evaluation focused on its physical and biological performance, not its interpretive capabilities.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation was not done. This is also not relevant for an implantable medical device. Standalone performance is assessed for algorithms that provide diagnostic or prognostic outputs without human oversight.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" is the measured physical properties and performance of the subject device compared against the measured physical properties and performance of the predicate device, with both tested under standardized conditions. The benchmark for "ground truth" for biocompatibility is conformance to ISO 10993-1:2018 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm that requires a "training set" or ground truth for training.
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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
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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
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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.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
§ 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.