(92 days)
Not Found
No
The summary describes a combination of existing mechanical devices and instruments for surgical procedures, with no mention of AI or ML capabilities.
No
The device is described as an ACL fixation system, which is a surgical tool used to secure soft tissue grafts during ligament reconstruction, rather than a device that delivers therapy.
No
The device is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states that the device is a system combining two cleared hardware devices (EndoButton CL Ultra and GTS Tapered Screw) into disposable kits with disposable instruments. The performance studies also focus on mechanical testing of the hardware components.
Based on the provided information, the Smith & Nephew ACL SMART System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of soft tissue grafts during cruciate ligament reconstruction." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is described as combining surgical implants (EndoButton and screw) and disposable instruments for a surgical procedure. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ACL SMART System is a surgical device used for reconstruction, not diagnosis.
N/A
Intended Use / Indications for Use
The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The subject device combines two cleared devices (i.e., EndoButton CL Ultra and GTS Tapered Screw) into disposable kits along with the necessary disposable instruments to perform cruciate ligament reconstruction procedures. Both the EndoButton CL Ultra and GTS Tapered Screw provided in the ACL SMART System are identical in design to the previously cleared predicate devices. However, the GTS Tapered Screw was originally cleared for use with the GTS Sleeve and the GTS Tapered Screw in the ACL SMART System is intended to be used independent of the sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cruciate ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the GTS Tapered Screw without the GTS sleeve. Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device listed in Table 1. The specific types of non-clinical testing conducted are listed below:
- Fixation strength
- Insertion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980155, K081098, K040542, K992396, K032224
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2015
Smith & Nephew, Inc. Mr. Samir Ibrahim Senior Regulatory Affairs Specialist 150 Minuteman Rd. Andover, Massachusetts 01810
Re: K143172 Trade/Device Name: ACL Smart System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 3, 2014 Received: November 4, 2014
Dear Mr. Ibrahim,
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 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
1
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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known): __K143172 __________________________________________________________________________________________________________________________________________
Device Name: ACL SMART System
Indications for Use:
The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Prescription Use X__ AND/OR (Part 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Orthopedic Devices 510(k) Number: K142933
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510(k) Summary Smith & Nephew, Inc. ACL SMART System
| Submitted by: | Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810 | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------|--|
| Date of Summary: | January 23, 2015 | |
| Contact Person and Address: | Samir Ibrahim, PhD, MBA, RAC
Senior Regulatory Affairs Specialist
T (901) 399-6139
F (901) 721-2421 | |
| Name of Device(s): | Smith & Nephew, Inc. ACL SMART System | |
| Common Names: | Fastener, Fixation, Biodegradable, Soft Tissue
Fastener, Fixation, Nondegradable, Soft Tissue | |
| Device Classification Names | | |
| and References: | 21 CFR 888.3030 Single/multiple component metallic bone fixation
and accessories. | |
| Device Class: | Class II | |
| Panel Code: | Orthopedics | |
| Product Codes: | MAI (primary)
MBI (secondary) | |
Device Description
The subject device combines two cleared devices (i.e., EndoButton CL Ultra and GTS Tapered Screw) into disposable kits along with the necessary disposable instruments to perform cruciate ligament reconstruction procedures. Both the EndoButton CL Ultra and GTS Tapered Screw provided in the ACL SMART System are identical in design to the previously cleared predicate devices. However, the GTS Tapered Screw was originally cleared for use with the GTS Sleeve and the GTS Tapered Screw in the ACL SMART System is intended to be used independent of the sleeve.
Indications for Use
The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
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The indications for the subject device are identical to the GTS Tapered Screw and similar to the EndoButton CL Ultra and BioRCI Screw. The indications of the EndoButton CL Ultra and BioRCI Screw also include fixation of soft tissue grafts during cruciate ligament reconstruction, therefore the indications of the subject device are equivalent to the predicate devices.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the proposed implants in the ACL SMART System are substantially equivalent to the legally marketed predicate devices (listed below in Table 1) with regard to indications for use and performance characteristics. The primary technological differences that exist between the subject and predicate implant devices are the following:
- Use of the GTS Tapered Screw without the GTS Sleeve.
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | EndoButton CL Ultra | K980155, K081098 | 04/01/1998 |
| Smith & Nephew, Inc. | GTS Sleeve and GTS Tapered Screw | K040542 | 03/25/2011 |
| Smith & Nephew, Inc. | BioRCI Screw | K992396, K032224 | 10/07/2004 |
Table 1: Substantially Equivalent Predicates to the implants in the ACL SMART System
Summary of Preclinical Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the GTS Tapered Screw without the GTS sleeve. Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device listed in Table 1. The specific types of non-clinical testing conducted are listed below:
- Fixation strength
- Insertion
Conclusion
Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the predicate devices listed in Table 1.