(55 days)
No
The device description and performance studies focus on the physical components (plates, screws, washers) and their material properties and sterilization, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a plating system used for the stabilization of fractures and reconstruction of bones, which are structural and fixation purposes rather than directly providing a therapeutic effect.
No
The device is described as a plating system intended for the stabilization of fractures and reconstruction of small bones, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states that the system includes metallic plates, washers, and screws, which are hardware components. The submission is for offering a previously cleared non-sterile device system in sterile packaging, not for a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization of fractures, revision procedures, joint fusion, and reconstruction of small bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of metallic plates, washers, and screws intended for bone fixation. These are implants used in surgery.
- 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 are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
Product codes
HRS
Device Description
The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are pre-contoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm, and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self-tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). The system includes the necessary instrumentation to facilitate implantation. The purpose of this submission is to offer the previously cleared non-sterile device system in K141489 in sterile packaging via gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, fingers, feet, ankles and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) by qualified and trained physicians in healthcare facilities/hospitals.
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)
Biocompatibility endpoints were evaluated in accordance with ISO 10993. The results of the testing did not product unexpected findings compared to the predicate device, and therefore, adequately addresses biocompatibility for implants with a permanent duration of contact.
Testing was performed in accordance with ANSI/AAMI ST72:2011 for detection and quantification for the presence of bacterial endotoxins. The results of the testing demonstrate that the subject device in sterile conforms to the required EU/device for implants and meet pyrogen limit specifications.
No changes have been made to the mechanical properties, design, mechanism of action, intended use, or manufacturing process. Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LINOS MOH Hand Plating System (K141489)
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
KLS Martin LP Mr. Gary Moore Ouality Management and Regulatory Affairs Manager 11201 Saint Johns Industrial Pkwy S Jacksonville, Florida 32246
Re: K170124
Trade/Device Name: Level One Hand Plating 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: January 10, 2017 Received: January 13, 2017
Dear Mr. Moore:
This letter corrects our substantially equivalent letter of March 9, 2017.
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.
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Level One Hand Plating System
Indications for Use (Describe)
The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the logo for KLS Martin L.P., a medical technology company. The logo is in red and gray, with the letters "KLS" in red and "martin L.P." in gray. The image also includes the company's address, phone number, fax number, and website. The address is 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 3224.
11201 Saint Johns Industrial Pkwy S ● Jacksonville, FL 32246 www.klsmartinnorthamerica.com
Section 5
510(k) Summary 21 CFR 807.92
| Submitter: | KLS Martin LP
11201 Saint Johns Industrial Pkwy S
Jacksonville, FL 32246 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Moore
Quality Management and Regulatory Affairs Manager
Phone: 800-625-1557
Email: gmoore@klsmartin.com |
| Date Prepared: | January 10, 2017 |
| Trade Name: | Level One Hand Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances
and accessories (21 CFR 888.3030) |
| Regulatory Class: | II |
| Product Code: | HRS |
| Predicate Device: | LINOS MOH Hand Plating System (K141489) |
| Device Description: | The Level One (L1) Hand Plating System includes metallic
plates, washers, and screws intended for small bone fixation.
Plates are pre-contoured to accommodate patient anatomy,
available in various shapes and range in thickness from
0.6mm - 3.0mm, and are compatible with the standard and
multidirectional locking screws offered in the system.
Screws are self-tapping, available in a standard or
multidirectional locking configuration and range in diameter
from 1.0mm - 2.7mm with lengths from 2mm - 32mm.
Standard screws may be used alone or in conjunction with
the washers or plates for small fragment osteosynthesis.
Implants are manufactured from CP Titanium (ASTM F67)
or Ti-6Al-4V (ASTM F136). The system includes the
necessary instrumentation to facilitate implantation.
The purpose of this submission is to offer the previously
cleared non-sterile device system in K141489 in sterile
packaging via gamma irradiation. |
| Indications for Use: | The Level One Hand Plating System is used for stabilization
and fixation of fractures, revision procedures, joint fusion
and reconstruction of small bones of the hand, wrist, fingers. |
4
Image /page/4/Picture/1 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.
1201 Saint Johns Industrial Pkwy S . Jacksonville, FL 32246 904-641-7746 ● 800-625-1557 ● Fax: 904-641-7378 klsmartinnorthamerica.com
Technological Characteristics & Substantial Equivalence Discussion
Similarities to Predicate
The subject and predicate device systems are identical with respect to intended use, materials, principle of operation, design, range of sizes offered, and mechanical performance. Anatomical sites and fixation methods used for the subject and predicate devices are identical. The subject and predicate devices are for prescription use only by qualified and trained physicians in healthcare facilities/hospitals.
Differences to Predicate
The only difference between the subject and predicate device system is the method of sterilization. The predicate device system includes components that must be sterilized by the end-user. The subject device components will be provided sterile in sterile packaging via gamma irradiation.
Non-Clinical Performance Data
Biocompatibility endpoints were evaluated in accordance with ISO 10993. The results of the testing did not product unexpected findings compared to the predicate device, and therefore, adequately addresses biocompatibility for implants with a permanent duration of contact.
Testing was performed in accordance with ANSI/AAMI ST72:2011 for detection and quantification for the presence of bacterial endotoxins. The results of the testing demonstrate that the subject device in sterile conforms to the required EU/device for implants and meet pyrogen limit specifications.
The subject device encompasses the previously cleared predicate devices to offer them sterile using gamma irradiation. No changes have been made to the mechanical properties, design, mechanism of action, intended use, or manufacturing process.
Clinical Performance Data
Clinical testing was not necessary for the determination of substantial equivalence.
Conclusion
The L1 Hand Plating System has the same intended use and technological features compared to the predicate device. The L1 Hand product line will be offered in sterile packaging and have different stock numbers from the originally cleared stock numbers to identify the product as sterile. The similarities in technological characteristics do not raise new issues of safety or effectiveness and the performance data provided in the submission demonstrate the subject device is substantially equivalent to the predicate device.