(112 days)
No
The device description and performance studies focus on mechanical properties and clinical outcomes of a physical fixation device, with no mention of AI or ML.
Yes
The device is intended for the treatment of anterior glenoid bone loss and orthopedic reconstruction, which are therapeutic interventions.
No
The device is described as a fixation device used for the treatment of anterior glenoid bone loss and to assist in fracture fixation, which are therapeutic and reconstructive purposes, not diagnostic.
No
The device description explicitly states the device consists of three physical components: two stainless steel fixation devices and a UHMW polyethylene suture. This indicates it is a hardware device, not software-only.
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 treatment of anterior glenoid bone loss using surgical procedures (Latarjet or bone block). This is a surgical implant used in vivo (within the body) for structural support and fixation.
- Device Description: The device is described as a fixation device consisting of stainless steel and UHMW polyethylene suture, used during the healing period of osteotomies and fracture fixation. This is consistent with a surgical implant.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for use in vivo as a surgical implant.
N/A
Intended Use / Indications for Use
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
Product codes
HTN, HWC
Device Description
The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Mechanical testing demonstrates the device has met the performance specifications for the mechanical integrity of the Smith & Nephew Double ENDOBUTTON Fixation Device. The following performance testing was used as a basis for the determination of substantial equivalence.
- . Interface pressure test
- . Suture construct test with open ended suture lines
- Closed loop suture test
- Suture construct tests with closed looped suture lines .
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
A clinical literature review was completed to compare the subject devices and screws. The literature available for the Double ENDOBUTTON or screws for glenoid bone loss in the shoulder was reviewed. In the literature review, total of 299 joints in 299 patients were treated with a Double ENDOBUTTON, and 1,895 joints in 1,886 patients with various screws.
Key Metrics
The complication rate reported after use of the Double ENDOBUTTON compared favorably to screws in most complications such as revision (0% compared to 0.85-11.49% respectively), device migration(0% compared to 5.26-21.43% respectively), device breakage (0% compared to 4.68% respectively) and graft migration (4.5% compared to 3.0-14.89% respectively). No device migrations, breakages, loosening or removals were noted in the publications that reported results of patients treated with the Double ENDOBUTTON.
Clinical outcome scores such as ROWE and Walch-Duplay reported for the subject Double ENDOBUTTON device were similar to those reported by screws. In patients treated with screws, postoperative ASES scores ranged from 86.3 to 93.3 and postoperative ROWE scores ranged from 78.1 to 97.1. In patients treated with the Double ENDOBUTTON, postoperative ROWE score ranging from 81 to 95.3 and Walch-Duplay scores ranged from 80 to 96. Postoperative Walch-Duplay scores for patients treated with screws ranged from 76.7 to 91.7.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2019
Smith and Nephew, Inc. Dharaben Desai Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
Re: K183232
Trade/Device Name: Double ENDOBUTTON Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, HWC Dated: February 7, 2019 Received: February 8, 2019
Dear Ms. Desai:
We have reviewed vour 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 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
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183232
Device Name Double ENDOBUTTON Fixation Device
Indications for Use (Describe)
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
150 Minuteman Road
Andover, MA 01810 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | February 6, 2019 |
| Contact Person: | Dharaben Desai, Regulatory Affairs Specialist II
T (901) 281-8073
F (901) 566-7598 |
| Name of Device: | Smith & Nephew, Inc. Double ENDOBUTTON Fixation Device |
| Common Name: | Washer, Bolt Nut
Screw, Fixation, Bone |
| Device Classification
Name and Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HTN, HWC |
| Predicate Device: | Arthrex Low Profile Screws (3.5mm and larger, cannulated) -
K103705
Smith & Nephew Ultraslide Acromioclavicular and
Syndesmotic Repair Device - K082095 |
4
Device Description:
The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.
Indications for Use
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
Technological Characteristics
The Smith & Nephew Double ENDOBUTTON Fixation Device is substantially equivalent to the predicate screws despite the differences in technological characteristics and design. Performance data and clinical results demonstrate this equivalence and show the subject device does not raise any new issues of safety and efficacy. The technological characteristics comparison between the subject device and predicate devices is provided below.
| Technological
Characteristics | Double
ENDOBUTTON
Fixation Device-
Subject device | Arthrex Low Profile
Screws (3.5mm and
larger, cannulated)-
K103705 | Smith & Nephew
Ultraslide
Acromioclavicular
and Syndesmotic
Repair Device-
K082095 |
|----------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Components | Two
ENDOBUTTONS
and suture | Screw | Two
ENDOBUTTONS and
suture |
Table 1: Summary of Technological Characteristics
5
| Material | Stainless Steel
ENDOBUTTONS,
UHMWPE Suture | Titanium or Stainless
Steel screw | Titanium
ENDOBUTTONS,
UHMWPE Suture |
|-------------------------|--------------------------------------------------|-------------------------------------------|-------------------------------------------|
| Labeling | Sterile, single-use
only, Rx only | Non-sterile, single-
use only, Rx only | Sterile, single-use
only, Rx only |
| Sterilization
Method | Gamma or EtO | Non-sterile | EtO |
Performance Data
Mechanical testing demonstrates the device has met the performance specifications for the mechanical integrity of the Smith & Nephew Double ENDOBUTTON Fixation Device. The following performance testing was used as a basis for the determination of substantial equivalence.
- . Interface pressure test
- . Suture construct test with open ended suture lines
- Closed loop suture test
- Suture construct tests with closed looped suture lines .
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Substantial Equivalence Information
The Smith & Nephew Double ENDOBUTTON Fixation Device is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
Table 2: Predicate Devices
6
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------|---------------------------------------------------------------|----------------------|-------------------|
| Arthrex, Inc. | Low Profile Screws (3.5mm and
larger, cannulated) | K103705 | 03/18/2011 |
| Smith & Nephew | Ultraslide Acromioclavicular and
Syndesmotic Repair Device | K082095 | 10/21/2008 |
Clinical Data
A clinical literature review was completed to compare the subject devices and screws. The literature available for the Double ENDOBUTTON or screws for glenoid bone loss in the shoulder was reviewed. In the literature review, total of 299 joints in 299 patients were treated with a Double ENDOBUTTON, and 1,895 joints in 1,886 patients with various screws.
The complication rate reported after use of the Double ENDOBUTTON compared favorably to screws in most complications such as revision (0% compared to 0.85-11.49% respectively), device migration(0% compared to 5.26-21.43% respectively), device breakage (0% compared to 4.68% respectively) and graft migration (4.5% compared to 3.0-14.89% respectively). No device migrations, breakages, loosening or removals were noted in the publications that reported results of patients treated with the Double ENDOBUTTON.
Clinical outcome scores such as ROWE and Walch-Duplay reported for the subject Double ENDOBUTTON device were similar to those reported by screws. In patients treated with screws, postoperative ASES scores ranged from 86.3 to 93.3 and postoperative ROWE scores ranged from 78.1 to 97.1. In patients treated with the Double ENDOBUTTON, postoperative ROWE score ranging from 81 to 95.3 and Walch-Duplay scores ranged from 80 to 96. Postoperative Walch-Duplay scores for patients treated with screws ranged from 76.7 to 91.7.
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith & Nephew Double ENDOBUTTON Fixation Device.
7
Based on the similarities to the predicate components and a thorough review of the clinical and mechanical testing, the devices are substantially equivalent to above predicate devices.