(197 days)
Not Found
No
The device description and performance studies focus on mechanical properties and structural integrity, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes.
The device is intended for the "reconstruction (correction) of a hallux valgus deformity," which is a therapeutic purpose. It provides for the "realignment and stabilization of an underlying skeletal deformity," which directly addresses and treats a medical condition.
No
This device is a non-resorbable system (implant) intended for the reconstruction and realignment of a hallux valgus deformity, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components (Suture Plate, UHMWPE Suture Assembly, Arrow Plate) and mentions ancillary instruments, indicating it is a hardware-based medical 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 surgical reconstruction of a hallux valgus deformity by physically correcting the angle between the 1st and 2nd metatarsals. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (suture system, plate, and suture) used to stabilize a skeletal deformity.
- 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 compatibility testing.
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
Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.
Product codes
HTN
Device Description
The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for realignment and stabilization of an underlying skeletal deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hallux valgus (foot)
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)
Substantial Equivalency:
In support of this submission, non-clinical mechanical tests and engineering evaluations were performed on the subject device and comparable predicate:
- Peak load to failure (N)
- Number of cycles completed prior to failure
- Displacement slippage per cycle interval
- Finite Element Analysis
- Clinical Evaluations
The test reports demonstrate the Arthrosurface KISSloc™ device was equivalent or outperformed the Arthrex predicate device for the non-clincial mechanical tests conducted.
No clinical data was provided in support of this substantial equivalency.
The results have demonstrated the safety and effectiveness of the KISSloc™ Suture System along with substantial equivalence to the predicate devices. Minor differences in device design and technique were determined not to be critical to the intended use of the device when used as labeled.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
JUL 0 3 2014
| Section 5 510(k) Summary | |
|---|---|
| 510(k) Owner: | Arthrosurface, Inc. |
| 28 Forge Parkway | |
| Franklin, MA 02038 | |
| Tel: 508.520.3003 | |
| Fax: 508.528.4604 | |
| Contact: | Dawn Wilson |
| VP, Quality & Regulatory | |
| Date of Preparation: | November 27, 2013 |
| Trade Name: | KISSloc™ Suture System |
| Common Name: | Plate & Suture System |
| Device: | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Classification Regulation: | |
| Device Class: | |
| Review Panel: | |
| Product Code: | Regulation Number 888.3030 |
| Class II | |
| Orthopedic | |
| HTN |
Device Intended Use
Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-2nd metatarsal (IM) angle.
Device Description
The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for realignment and stabilization of an underlying skeletal deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.
1
Substantial Equivalency:
The intended use, materials, and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:
| · Arthrex Mini TightRope | K090107 |
|---|---|
| · Arthrex Mini TightRope Repair Kit | K061925 |
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices:
- Intended for treatment of Hallux Valgus deformity. .
- . Similar device designs
- Same Titanium and UHMWPE implant materials .
In support of this submission, non-clinical mechanical tests and engineering evaluations were performed on the subject device and comparable predicate:
- . Peak load to failure (N)
- Number of cycles completed prior to failure .
- Displacement slippage per cycle interval .
- Finite Element Analysis .
- Clinical Evaluations .
The test reports demonstrate the Arthrosurface KISSloc™ device was equivalent or outperformed the Arthrex predicate device for the non-clincial mechanical tests conducted.
No clinical data was provided in support of this substantial equivalency.
The results have demonstrated the safety and effectiveness of the KISSloc™ Suture System along with substantial equivalence to the predicate devices. Minor differences in device design and technique were determined not to be critical to the intended use of the device when used as labeled.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Center - WO66-G609 Silver Spring, MI) 20993-0002
Arthrosurface. Incorporated Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin. Massachusetts 02038
Re: K133835
Trade/Device Name: KISSLocTM Suture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 30, 2014 Received: June 2, 2014
July 3, 2014
Dear Dawn Wilson:
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
3
Page 2 - Ms. Dawn Wilson
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 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" (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 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 Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement
510(k) Number (if known): K133835
Device Name: KISSloc™ Suture System
Indications for Use:
Intended for use in reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 186 metatarsal-2nd metatarsal (IM) angle.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices