(127 days)
Not Found
No
The device description focuses on mechanical components and materials for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to reconstruct the anterior cruciate ligament, which is a therapeutic intervention for a damaged or torn ACL.
No
The device is described as an implantable system for the fixation of soft tissue grafts during ACL reconstruction, not for the diagnosis of a condition.
No
The device description clearly outlines physical implants (PEEK spacer, UHMWPE graft suspension loop, titanium cortical button, PEEK screw, PEEK sheath, UHMWPE tether suture) and ancillary instruments, indicating it is a hardware-based medical device system.
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 "fixation of soft tissue grafts to bone during anterior cruciate ligament reconstruction surgeries of the knee." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device consists of implants (PEEK, UHMWPE, titanium) designed to be surgically implanted into bone.
- 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 samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The N8TVE™ ACL Abatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during antenor cruciate ligament reconstruction surgeries of the knee.
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR
Device Description
The N8TIVE ACL Reconstruction System is designed for ACL repair and consists of the N8TIVE ACL Femoral and Tibial Implants, as well as various Class I ancillary devices, all of which may be marketed or used individually or in conjunction with one another. The N8TIVE ACL System provides fixation of a soft-tissue graft within the femoral and tibial tunnels to reconstruct the anterior cruciate ligament and is designed to create femoral and tibial tunnels that are "figure-eight" or oval shaped.
The N8TIVE ACL Femoral Implant consists of a polyether etherketone (PEEK) spacer, an ultra-high molecular weight polyethylene (UHMWPE) graft suspension loop, UHMWPE suture tape, and a titanium cortical button. The suspension loop is threaded through the titanium cortical button and the PEEK spacer and forms a symmetrical graft suspension construct. The suspension loop is tightened by pulling each "tail" of the suture to remove the slack and adjust the construct to match the tunnel length. The UHMWPE suture tape is provided to secure the graft to the spacer so that it remains seated during insertion into the bone tunnel.
The N8TIVE ACL Tibial Implant consists of a PEEK screw, a PEEK sheath, and an UHMWPE tether suture pre-threaded through the screw and through an optional titanium cortical button. The Tibial Implant is available in two sizes in order to accommodate specific patient anatomy: a 29 mm length screw with a 33 mm length sheath for smaller tibial anatomy and a 36 mm screw with a 40 mm sheath for larger tibial anatomy.
Both N8TIVE ACL Implants are supplied preloaded onto an inserter handle and are provided sterile. for single patient use only.
The N8TIVE ACL Implants may be marketed and/or used in conjunction with various Class I ancillary instruments. These instruments include both sterile/reusable instrumentation for use in the ACL reconstruction procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Bench testing was conducted as follows:
- Magnetic Resonance Imaging compatibility testing.
- Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
- Insertion strength testing in a dense bone model.
- Cyclic evaluation of the interface between the UHMWPE suture tape and a graft analog.
- Design Verification testing to demonstrate conformance to design and performance specifications.
All test results confirm that the N8TIVE ACL Reconstruction System is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.
All testing demonstrates that the N8TIVE ACL Anatomic System performs as intended and has acceptable mechanical properties when used in accordance with the device labeling.
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.
K083070, K130033, K052607, K062466
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K133606 (page 1/4)
Image /page/0/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic to the left of the text "ArthroCare". The graphic is made up of several curved lines that overlap and intersect to create a sense of movement and flow. The text "ArthroCare" is written in a bold, sans-serif font, with the "A" slightly larger than the other letters.
APR 0 1 2014
510(k) Summary
ArthroCare® Corporation N8TIVETM ACL Anatomic Reconstruction System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Laurie Cartwright |
| Sr. Manager, Regulatory Affairs | |
| Phone: 949-585-2465 | |
| Fax: 512-895-1489 | |
| Date Prepared: | 31 March 2014 |
Device Name
| Proprietary Name: | N8TIVE™ ACL Anatomic Reconstruction System
N8TIVE™ ACL Femoral Implant
N8TIVE™ ACL Tibial Implant |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Device Class: | II |
| Product Code: | MBI |
| CFR Section: | 888.3040 |
Predicate Devices
The predicate devices for the N8TIVE ACL Anatomic Reconstruction System are:
- For the N8TIVE ACL Femoral Implant, the Biomet ToggleLoc Femoral Fixation Device cleared under K083070 and K130033.
- . For the N8TIVE ACL Tibial Implant, the Arthrex Interference Screws cleared under K052607 and K062466.
The tables on the following page provide a comparison of the technological characteristics for the N8TIVE ACL Implants and the predicate devices.
1
:
.
Image /page/1/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines that are arranged in a circular pattern. The word "ArthroCare" is written in a bold, sans-serif font.
| Comparison of Device Characteristics:
| N8TIVE ACL Femoral Implant and Biomet ToggleLoc Femoral Fixation Device | ||
|---|---|---|
| Characteristics | Biomet ToggleLoc | |
| K083070, K130033 | N8TIVE ACL Femoral Implant | |
| Proposed Device | ||
| Intended Use | Fixation of Soft Tissue to Bone | Same |
| How Supplied | Sterile | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Implant Materials | Same | |
| • Cortical Button | Titanium | |
| (TI-6AL-4V Alloy) | Same | |
| • Suspension Loop | UHMWPE/Polypropylene/Polyester | UHMWPE/Polyester |
| • Suture/Suture Tape | Not Applicable | UHMWPE |
| • Graft Spacer | Not Applicable | PEEK Optima® |
| Method of Insertion | Inserted into drilled hole/tunnel | Same |
| Design Technology | Graft Suspension Loop with Cortical Button | Graft Spacer and Suspension Loop with |
| Cortical Button | ||
| Implant Size/Dimensions | ||
| • Cortical Button | 13.2 mm x 2.0 mm x 1.8 mm | 12.1 mm x 3.9 mm x 1.8 mm |
| • Suspension Loop | Adjustable | Same |
| • Graft Spacer | Not Applicable | 23 mm x 6 mm x 6 mm |
| Comparison of Device Characteristics:
| N8TIVE ACL Tibial Implant and Arthrex Interference Screws | ||
|---|---|---|
| Characteristics | Arthrex Interference Screws | |
| K052607, K062466 | N8TIVE Tibial Implant | |
| Proposed Device | ||
| Intended Use | Fixation of Soft Tissue to Bone | Same |
| How Supplied | Sterile | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Implant Materials | ||
| • Cortical Button | Not Applicable | Titanium |
| (TI-6AL-4V Alloy) | ||
| • Screw | PEEK Optima | Same |
| • Sheath | Not Applicable | PEEK Optima |
| • Tether Sutures | Not Applicable | UHMWPE |
| Method of Insertion | Screwed into drilled hole/tunnel using | |
| reusable driver | Same, using included inserter driver | |
| Design Technology | Interference Screw | Same |
| Implant Size/Dimensions | ||
| • Cortical Button | Not Applicable | 18 mm x 11.5 mm x 6.1 mm |
| • Screw | Range of 23 to 35 mm length, | |
| 6 to 12 mm diameter | Range of 29 to 36 mm length, | |
| 8 mm diameter | ||
| • Sheath | Not Applicable | Range of 33 to 40 mm length |
:
2
Image /page/2/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left, followed by the word "ArthroCare" in a bold, sans-serif font. The wave-like design is made up of several curved lines that create a sense of motion and flow.
Description
The N8TIVE ACL Reconstruction System is designed for ACL repair and consists of the N8TIVE ACL Femoral and Tibial Implants, as well as various Class I ancillary devices, all of which may be marketed or used individually or in conjunction with one another. The N8TIVE ACL System provides fixation of a soft-tissue graft within the femoral and tibial tunnels to reconstruct the anterior cruciate ligament and is designed to create femoral and tibial tunnels that are "figure-eight" or oval shaped.
The N8TIVE ACL Femoral Implant consists of a polyether etherketone (PEEK) spacer, an ultra-high molecular weight polyethylene (UHMWPE) graft suspension loop, UHMWPE suture tape, and a titanium cortical button. The suspension loop is threaded through the titanium cortical button and the PEEK spacer and forms a symmetrical graft suspension construct. The suspension loop is tightened by pulling each "tail" of the suture to remove the slack and adjust the construct to match the tunnel length. The UHMWPE suture tape is provided to secure the graft to the spacer so that it remains seated during insertion into the bone tunnel.
The N8TIVE ACL Tibial Implant consists of a PEEK screw, a PEEK sheath, and an UHMWPE tether suture pre-threaded through the screw and through an optional titanium cortical button. The Tibial Implant is available in two sizes in order to accommodate specific patient anatomy: a 29 mm length screw with a 33 mm length sheath for smaller tibial anatomy and a 36 mm screw with a 40 mm sheath for larger tibial anatomy.
Both N8TIVE ACL Implants are supplied preloaded onto an inserter handle and are provided sterile. for single patient use only.
The N8TIVE ACL Implants may be marketed and/or used in conjunction with various Class I ancillary instruments. These instruments include both sterile/reusable instrumentation for use in the ACL reconstruction procedure.
Indications For Use
で
The N8TIVE™ ACL Anatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during anterior cruciate ligament reconstruction surgeries of the knee.
The indications for use for the N8TIVE ACL System are comprised of a subset of the indications for use cleared for the predicate devices. While the N8TIVE ACL System is specifically designed and intended for use in anterior cruciate ligament reconstruction, the predicate devices may additionally be used for treatment in other anatomic locations. The differences between the predicate device indications for use and the N8TIVE ACL System indications for use do not affect the safety or effectiveness of the N8TIVE ACL System when used in accordance with its labeling.
Non-Clinical Data
Bench testing was conducted as follows:
- Magnetic Resonance Imaging compatibility testing.
- . Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
- Insertion strength testing in a dense bone model.
- Cyclic evaluation of the interface between the UHMWPE suture tape and a graft analog.
3
iv
Image /page/3/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left, followed by the word "ArthroCare" in a bold, italicized font. A small trademark symbol is visible to the right of the word "Care".
- 1 Design Verification testing to demonstrate conformance to design and performance specifications.
All test results confirm that the N8TIVE ACL Reconstruction System is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the N8TIVE ACL Anatomic System performs as intended and has acceptable mechanical properties when used in accordance with the device labeling.
As the intended use, operating principle, materials, and technological characteristics are comparable to the predicate devices, ArthroCare believes the N8TIVE ACL Anatomic Reconstruction System is substantially equivalent to the predicate devices. The minor differences between the ArthroCare devices and their predicate devices do not raise any new questions of safety or effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue
Document Control Center - WO66-G609 Silver Spring MD 20993-0002
Public Health Service
April 1, 2014
Arthrocare® Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Building One Austin, Texas 78735
Re: K133606
Trade/Device Name: N8TIVE™ ACL Anatomic Reconstruction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: March 19, 2014 Received: March 20, 2014
Dear Mr. Dhority:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Mitchell Dhority
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133606
Device Name
The N8TIVE™ ACL Anatomic Reconstruction System
Indications for Use (Describe)
The N8TVE™ ACL Abatomic Reconstruction System is indicated for use in the fixation of soft tissue grafts to bone during antenor cruciate ligament reconstruction surgeries of the knee.
Type of Use (Select one or both, as applicable) 図 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. PORTED TO CHARM CONTRACT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR F Concurrence of Center for Devices and Radiological Heatth (CDRH) (Signature) Page (1/1) asev I Carre Devices Division O FORM FDA 3881 (1/14) Page -1 - of 2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.