(52 days)
The SALVATION™ 3Di Plaing System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotonies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathy (Charcot).
The SALVATION™ 3Di Plating System consists of titanium alloy plates and screws used for midfoot reconstruction. The system features plates of various sizes and styles, as well as locking and non-locking screws.
The provided text is a 510(k) summary for the SALVATION™ 3Di Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with a detailed test set, ground truth, and statistical analysis as would be done for a novel AI/software device.
Therefore, many of the requested categories are not applicable (N/A) in the context of this 510(k) submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material composition equivalent to predicates | "The SALVATION™ 3Di Plating System is technologically substantially equivalent to predicate devices in material..." (Page 2) |
| Size equivalent to predicates | "The SALVATION™ 3Di Plating System is technologically substantially equivalent to predicate devices in material, size..." (Page 2) |
| Bending strength equivalent to predicates | "...and bending strength." (Page 2) |
| Acceptable static bending performance | Demonstrated through "Performance testing and analysis that demonstrated substantial equivalence includes static bending..." (Page 2) |
| Acceptable insertion performance | Demonstrated through "...insertion..." (Page 2) |
| Acceptable removal performance | Demonstrated through "...removal..." (Page 2) |
| Acceptable ultimate torque performance | Demonstrated through "...and ultimate torque..." (Page 2) |
| Acceptable pull-out rationale | Demonstrated through "...as well as a pull-out rationale." (Page 2) |
2. Sample size used for the test set and the data provenance
- N/A. The submission relies on non-clinical performance testing (in vitro/bench testing) rather than a clinical study with a 'test set' of human data. The specific sample sizes for these bench tests are not disclosed in this summary.
- Data Provenance: Not specified, but generally, such testing is performed in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As it's a non-clinical submission, there was no clinical test set requiring expert-established ground truth. Expert input would relate to the design and interpretation of the bench testing, but not in the same way as establishing ground truth for a diagnostic AI.
4. Adjudication method for the test set
- N/A. No clinical test set.
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
- N/A. This is a device for bone fixation, not an AI/software device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device (bone plate system), not an algorithm or AI.
7. The type of ground truth used
- N/A. For this non-clinical submission, "ground truth" would correspond to the engineering specifications and results of the physical performance tests (e.g., measured bending strength, torque values). These are measured directly from the device components, not established via expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device that requires a training set. The "training" in this context would be the design iterations and engineering development of the physical device prior to the final performance testing.
9. How the ground truth for the training set was established
- N/A. As above, not an AI/ML device. The "ground truth" for the device's design and manufacturing would be based on established engineering principles, material science, and predicate device characteristics.
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Image /page/0/Picture/0 description: The image shows the logo for Wright, a company that focuses on excellence. The logo features a stylized "W" symbol to the left of the company name, which is written in bold, sans-serif font. Below the company name is the tagline "Focused Excellence" in a smaller font size.
K140792 page 1 Of 2
MAY 2 2 2014
Wright Medical Technology, II
1G2 3 Cherry Road Memphis, IN 38117
901 867 997 1 wmt.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SALVATION™ Beams and Bolts System.
(a)(1). Submitted By:
Date:
Contact Person:
(a)(2). Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code, Device Panel:
(a)(3). Predicate Devices:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
March 28, 2014
Leslie Fitch, PhD Senior Regulatory Affairs Specialist Office: (901) 867-4120 Fax: (901) 867-4190
SALVATION™ 3Di Plating System
Bone Plate System
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories, Class II
HRS, Orthopedic
K061808: DARCO® RPS Plates K121651: ORTHOLOC® 3Di Recon Midfoot Plating System K090675, K110670: Smith and Nephew VLP Foot Plating, Screw System K131093: ORTHOLOC® 3Di Ankle Plating System
(a)(4). Device Description
The SALVATION™ 3Di Plating System consists of titanium alloy plates and screws used for midfoot reconstruction. The system features plates of various sizes and styles, as well as locking and non-locking screws.
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K140792 page 2 of 2
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(a)(5). INTENDED USE
The SALVATION™ 3Di Plating System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotomies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathic osteoarthropathy (Charcot).
(a)(6). Technological Characteristics Comparison
The SALVATION™ 3Di Plating System is technologically substantially equivalent to predicate devices in material, size and bending strength.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and analysis that demonstrated substantial equivalence includes static bending, insertion, removal, and ultimate torque, as well as a pull-out rationale.
(b)(2). Substantial Equivalence - Clinical Evidence N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human figures or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
Wright Medical Technology, Incorporated Leslie Fitch, Ph.D., CTBS Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K140792
Trade/Device Name: SALVATION 3Di 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: April 10, 2014 Received: April 11, 2014
Dear Dr. Fitch:
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. Ilisting 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 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
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Page 2 - Leslie Fitch, Ph.D., CTBS
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 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/McdicalDevices/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 yours.
Ronald P. Jean -S for
- Mark N. Melkerson Director
- Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140792
Device Name SALVATION 3Di Plating System
Indications for Use (Describe)
The SALVATION™ 3Di Plaing System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotonies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathy (Charcot).
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabet标检验Frank -S
Division of Orthopedic Devices
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§ 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.