(248 days)
The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction.
KLS Martin Resorb-X G is a resorbable fixation system similar to the SonicWeld-RX (Resorb-X) (K080862). The system consists of plates, meshes and pins manufactured in a variety of diameters and geometrical configurations that provide fixation and aid in the alignment and stabilization of fractures and reconstructive procedures. Resorb-X G is implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention.
The provided document, K112064, is a 510(k) summary for the KLS Martin Resorb-X G, a resorbable fixation system. The summary focuses on demonstrating substantial equivalence to predicate devices, primarily through material changes and performance verification. However, it does not present a typical "acceptance criteria" table or a full "study" report in the way one might expect for a diagnostic AI device or a comparative clinical trial.
Instead, the "acceptance criteria" can be inferred from the regulatory pathway for substantial equivalence, and the "study" is the performance testing conducted to support that equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a medical device (resorbable fixation system) and not a diagnostic algorithm or AI, typical "accuracy," "sensitivity," or "specificity" metrics are not applicable. The acceptance criteria and performance are tied to material properties and mechanical functionality, demonstrating that the new device (Resorb-X G with PLLA/PGA) is as safe and effective as the predicate devices.
| Acceptance Criteria (Inferred from regulatory pathway and predicate comparison) | Reported Device Performance (from "Performance Testing") |
|---|---|
| Biocompatibility and Material Safety (similar to predicate) | Chemical analysis to ISO 10993-12, -18 submitted |
| Mechanical Degradation Profile (comparable to predicate) | Mechanical degradation comparison testing for PDLLA vs. PLLA/PGA submitted |
| Overall Safety and Effectiveness (no new issues) | Performance testing results demonstrate that Resorb-X G (PLLA/PGA) is substantially equivalent to Resorb-X (PDLLA) and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a study involving a "test set" of patient data in the typical sense of a diagnostic or AI device. The "test set" would refer to the samples of the medical device material that underwent analytical and mechanical testing. The document does not specify the sample sizes used for the chemical analysis or mechanical degradation comparison tests (e.g., number of material samples, number of replicates).
The data provenance is not explicitly stated beyond "submitted to demonstrate product safety and effectiveness." It is assumed these tests were conducted internally or by a contracted lab. This is not patient data from a specific country, nor is it retrospective or prospective in the clinical trial sense.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable for this type of submission. There is no concept of "ground truth" established by experts for a test set of patient data, as this is a device material and mechanical property evaluation.
4. Adjudication Method
Not applicable. There is no expert adjudication for a test set of patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI assistance.
6. Standalone Performance Study
Yes, a "standalone" performance evaluation of the device's material properties was conducted. This refers to the chemical analysis and mechanical degradation testing of the Resorb-X G (PLLA/PGA) material itself, independent of human interaction or a clinical setting for initial submission purposes. The goal was to compare it directly to the predicate device's material properties.
7. Type of Ground Truth Used
The "ground truth" here is established by validated laboratory methods and engineering standards (e.g., ISO 10993-12, -18 for chemical analysis, and unspecified mechanical testing protocols). The "truth" is whether the material meets predefined specifications and performs comparably to the predicate device under these controlled conditions.
8. Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
MAR 2 3 2012
510(K) SUMMARY
Section 21CFR 807.92(a)
Section 21CFR 807.92(a)
| Submitter: | KLS-Martin, L.P.11201 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoRA/QA Director |
| Date of Summary: | October 28, 2011 |
| Device Name: | KLS Martin Resorb-X G |
| Trade Name: | Resorb-X G |
| Classification: | Class II, §872.4760- Bone Plate |
| Product Code: | JEY |
| Predicate Devices: | SonicWeld RX (Resorb-X) (K080862)Synthes (USA) Rapid Resorbable Fixation System (K062789)Biomet, Inc. Lactosorb Trauma Plating System (K992355) |
| Device Description: | KLS Martin Resorb-X G is a resorbable fixation systemsimilar to the SonicWeld-RX (Resorb-X) (K080862). Thesystem consists of plates, meshes and pins manufactured in avariety of diameters and geometrical configurations thatprovide fixation and aid in the alignment and stabilization offractures and reconstructive procedures. Resorb-X G isimplanted utilizing ultrasonic force generated by an ultrasonicunit that causes a phase transition in the pin, allowing the pinto adapt to the previously drilled pilot hole in the surgical siteand utilize the micro undercuts of the bone for retention. |
| Intended Use: | The KLS Martin Resorb-X G is intended for use in non-loadbearing fracture repair and reconstructive procedures inadolescent and adult populations. In addition, resorbablemeshes, plates and pins may be used in non-loading bearingapplications for maintaining the relative position of, and/orcontaining, bony fragments, bone grafts (autograft orallograft), or bone graft substitutes in oral and maxillofacialreconstruction. |
{1}------------------------------------------------
Contraindications:
These devices are not intended for use in load bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. Resorb-X G is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.
Technological Characteristics:
Similarities to Predicate
Resorb-X G uses the same pins, screws, and plates as SonicWeld-RX (Resorb-X) and is implanted in the same manner. The indication for use is the same as SonicWeld-RX (Resorb-X) K080862.
Differences to Predicate
Resorb-X G (PLLA/PGA) material differs in chemical composition from the SonicWeld-RX (Resorb-X) (PDLLA) material, but is the same as that in K062789 and K992355.
Performance Testing: Chemical analysis to ISO 10993-12, -18 and mechanical degradation comparison testing for PDLLA vs. PLLA/PGA were submitted to demonstrate product safety and effectiveness.
Substantial Equivalence: Performance testing results demonstrate that Resorb-X G (PLLA/PGA) is substantially equivalent to Resorb-X (PDLLA) and does not raise new issues of safety or effectiveness.
Material: Poly(L-lactide-co-glycolide) (PLLA/PGA)
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jennifer Damato Director of Quality Management & Regulatory Affairs KLS-Matrin L.P. 11201 Saint Johns Industrial Parkway South P.O. Box 16369 Jacksonville, Florida 32245-6369
MAR 2 3 2012
Re: K112064
Trade/Device Name: Resorb-X G Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 12, 2012 Received: March 13, 2012
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.
{3}------------------------------------------------
Page 2 - Ms. Damato
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
112064
SECTION 4
Indications for Use
SECTION 4
510(k) Number (if known): _
Device Name: _
Resorb-X G
Indications for Use:
The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction.
Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE' IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K112064
PAGE 1 of 1
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.