(285 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant, with no mention of AI or ML.
Yes
The device is a PHS™ System, which is an implantable device used for the fixation of proximal humerus fractures, directly treating a medical condition.
No
The device is described as an intramedullary implant for fracture fixation, not for diagnosing conditions. Its intended use and description focus on treatment, not diagnosis. The performance studies also relate to mechanical and material properties of the implant.
No
The device description clearly states it is an "intramedullary device" and an "implant" made from titanium alloy and Nitinol, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Conventus PHS™ System is an implantable medical device designed to fix bone fractures within the body. It is surgically inserted into the proximal humerus.
- Intended Use: The intended use is for the fixation of proximal humerus fractures, which is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HRS, JDS
Device Description
The Conventus PHST™ is an intramedullary device intended to treat proximal humerus fractures. The PHST™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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)
The following pre-clinical tests have been performed:
- Static and cyclic axial/bend testing
- Static and cyclical torsional testing
- Screw pullout testing
- Corrosion testing
- Wear testing
- Nickel ion release testing
- Surface analysis testing
- Nitinol phase composition
- Nitinol transition temperature (Af)
- Biocompatibility testing
- Animal testing
The results demonstrate that the PHS™ System is substantially equivalent to the 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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, one behind the other. The faces are oriented to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
April 8, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conventus Orthopaedics, Incorporated Mr. Kent Lind Vice President Quality, Regulatory, Clinical 10200 73td Avenue North, Suite 122 Maple Grove, Minnesota 55369
Re: K141737
Trade/Device Name: Conventus PHS™ System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HRS Dated: March 17, 2015 Received: March 17, 2015
Dear Mr. Lind:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Kent Lind
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/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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K141737
Device Name: Conventus PHS™ System
The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
V Prescription Use (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)
3
510(k) Summary 5.
| Company: | Conventus Orthopaedics, Inc.
10200 73rd Avenue North, Suite 122
Maple Grove, MN 55369 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Conventus PHST™ System |
| Device Common Name: | Proximal humerus fracture fixation system |
| Contact: | Kent R. Lind
Vice President, Quality, Regulatory, Clinical
Phone: (763) 515-5003
Fax: (763) 315-4980 |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 |
| Date Prepared: | April 3rd, 2015 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3020: Intramedullary fixation rod |
| Class: | II |
| Product Codes: | JDS and HRS |
| Indications for Use: | The Conventus Orthopaedics PHST™ System is indicated for the
fixation of proximal humerus fractures except when there are too
many fracture fragments to repair the articular surface. |
| Device Description: | The Conventus PHST™ is an intramedullary device intended to treat
proximal humerus fractures. The PHST™ System is a self-
expanding implant which is deployed into the medullary canal and
provides a scaffold to which bone fragments are attached using
fragment screws. The implant is made from titanium alloy (Ti-6Al-
4V ELI) and Nitinol. |
| Substantial Equivalence: | Conventus Orthopaedics has demonstrated that, for purposes of
FDA's regulation of medical devices, the Conventus PHST™ System |
4
is substantially equivalent to the following devices that have been previously cleared by the FDA:
- · DePuy ACE TiMAX Meta Plate (K983853)
- · Synthes Titanium Cannulated Humeral Nail System (K033071)
- · Conventus Orthopaedics, Inc. DRS™ System (K102689)
This finding is supported by the following pre-clinical tests that have been performed:
- Static and cyclic axial/bend testing
- Static and cyclical torsional testing
- · Screw pullout testing
- · Corrosion testing
- · Wear testing
- Nickel ion release testing
- Surface analysis testing
- Nitinol phase composition
- · Nitinol transition temperature (Af)
- · Biocompatibility testing
- · Animal testing
The results demonstrate that the PHS™ System is substantially equivalent to the legally marketed predicate devices.