(144 days)
Not Found
No
The summary describes a mechanical sternal fixation system made of plates and cerclage, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for "stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures," which directly addresses and treats a medical condition.
No
The device is described as a "Sternal Fixation System" intended for "stabilization and fixation of fractures of the anterior chest wall". This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it consists of plates, accessories, and a cerclage-based device made of titanium or stainless steel, which are physical hardware components.
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 "stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures." This describes a surgical implant used to physically support and stabilize bone, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The device consists of "plates and accessories as well as a cerclage-based device" made of titanium or stainless steel. These are physical components designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KTT, IDO, HWC
Device Description
The ACUTE Innovations® Sternal Fixation System consists of plates and accessories as well as a cerclage-based device to provide fixation for sternotomies and sternal fractures. The plate designs for the Sternal Fixation System match the general anatomy of the sternum. The components of the ACUTE Innovations® Sternal Fixation System are made of commercially pure titanium, titanium alloy or stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternum
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
Non-clinical tests performed by the company included: an analysis of bending strength of the ACUTE Innovations® sternum plate and tensile testing of the cerclage-based device. Based on comparability to the predicate screws, no additional testing was performed on the stainless steel screws.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the performed tests demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices.
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.
Acumed Cerclage Crimp Sleeve (K931246), KLS-Martin Sternal Plating System (K032413), Lorenz Sternal Closure System with Modular Screw (K011076), Synthes Sternal Reconstruction System (K052683, K031508)
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
510(k) Summary
| Manufacturer: | ACUTE Innovations, LLC
21421 NW Jacobson Road, Suite 700
Hillsboro OR, 20005
503.686.7200 | SEP 17 2010 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Trade Name: | ACUTE Innovations Sternal Fixation System | |
| Contact: | Ms. Mariah Knight
Regulatory Representative | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 | |
| Classifications: | 21 CFR 888.3030, Single/multiple component metallic
bone fixation appliances and accessories
and
21 CFR 888.3010, Bone fixation cerclage | |
| Class: | II | |
| Product Codes: | KTT, IDO, and HWC | |
Indications For Use:
The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Device Description:
The ACUTE Innovations® Sternal Fixation System consists of plates and accessories as well as a cerclage-based device to provide fixation for sternotomies and sternal fractures. The plate designs for the Sternal Fixation System match the general anatomy of the sternum. The components of the ACUTE Innovations® Sternal Fixation System are made of commercially pure titanium, titanium alloy or stainless steel.
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the ACUTE® Innovations Sternal Fixation System with respect to its indications for use, design, materials, and function.
1
This 510(k) demonstrates the substantial equivalence of the ACUTE Innovations® Sternal Fixation System to the following predicate devices: Acumed Cerclage Crimp Sleeve (K931246); KLS-Martin Sternal Plating System (K032413); Lorenz Sternal Closure System with Modular Screw (K011076); Synthes Sternal Reconstruction System (K052683, K031508).
The geometry of the subject plates matches that of the sternum and predicate sternal plates. The cerclage-based device has the same crimping mechanism as one of the predicate devices. The ACUTE Innovations® Sternal Fixation System and the predicate sternal fixation systems are made of the same materials. The methods of fixation for the subject device are the same as for the predicate devices. The non-clinical tests performed by the company included: an analysis of bending strength of the ACUTE Innovations® sternum plate and tensile testing of the cerclage-based device. Based on comparability to the predicate screws, no additional testing was performed on the stainless steel screws. The results of the performed tests demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ACUTE Innovations, LLC % Ms. Mariah Knight Regulatory Representative 21421 NW Jacobson Road, Suite 700 Hillsboro, Oregon 20005
SEP 1 7 2010
Re: K101170
Trade/Device Name: ACUTE Innovations® Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JDQ, HWC Dated: August 2, 2010
Received: August 4, 2010
Dear Ms. Knight:
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
3
Page 2 - Ms. Mariah Knight
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Mikkelson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use
SEP 1 7 2010
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACUTE Innovations® Sternal Fixation System
The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following starnony and sternal reconstructive surgical procedures.
Prescription Use V (Part 29 CFR 801 Subpart D)
. |
AND/OR
Over-The-Counter Use (29 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)
Jutta for mxm
(Division Sign)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101170