(128 days)
Not Found
No
The 510(k) summary describes a system of bone plates, nails, screws, and instruments for fracture fixation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are non-clinical mechanical tests.
Yes
Explanation: The device is designed to provide fixation for fractures, fusions, and osteotomies of the humerus while they heal, which constitutes a therapeutic intervention.
No
The device is a system of plates, nails, screws, and accessories designed for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes plates, nails, screws, accessories, and instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to address fractures, fusions, and osteotomies of the humerus. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details bone plates, intramedullary nails, screws, and instruments for fixation during healing. These are implants and surgical tools, not reagents, kits, or instruments used to analyze biological samples for diagnostic purposes.
- 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. This device is a surgical implant and instrument system used for mechanical fixation of bone.
N/A
Intended Use / Indications for Use
The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.
Product codes (comma separated list FDA assigned to the subject device)
LXT, HRS, HSB
Device Description
The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. The Polarus® Connect System also includes instruments to facilitate placement of implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 Acumed Polarus® Connect System was tested according to the following standards: ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates; ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws; ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices. The information discussed above demonstrates that the Acumed Polarus® Connect System devices are effective and perform as well as or better than the predicate devices. Based upon the similarities of the Polarus® Connect System and the predicate devices studies, the safety and the effectiveness of the Polarus® Connect System is substantially equivalent to the predicate devices referenced.
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.
K051735, K091425, K012655, K951740
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:
Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124
Date:
Submitted by:
Company Contact
5885 NW Cornelius Pass Road
Hillsboro, OR 97124
June 1, 2013
Orgenix LLC
111 Hill Road
+1-646-460-2984
Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124
Brittany Cunningham Regulatory Specialist 2 Phone: (503) 207-1467 Fax: (503) 520-9618
Mr. Donald W. Guthner
Douglassville, PA 19518
+1-484-363-5879 (FAX)
component, metal composite
Acumed Polarus® Connect System
F382, ASTM F543 and ASTM F1264
OCT 1 0 2013
Secondary Contact:
Classification Name:
Common/Usual Name:
Proprietary Name:
Performance standards:
Classification no .:
21 CFR 888.3030 LXT, HRS, HSB - Humerus Intramedullary Nail and Plate System Class II
The Acumed Polarus Connect System components and constructs were mechanically tested to the following standards - ASTM
Appliance, fixation, nail/blade/plate combination, multiple
Humerus Intramedullary Nail and Plate Fixation System
Substantial Equivalence:
Substantial equivalence for the Acumed Polarus Connect System is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions:
- . K051735 Smith & Nephew PERI-LOC Locking Bone Plates and Locking Bone Screws for the upper extremity
- K091425 NMB Medical Applications. Ltd Quantum IM . Composite Nailing System
। 09
1
K131636
| K012655 Acumed Congruent Bone Plate System K951740 Acumed Intramedullary Fixation Rod | |
|---|---|
| Predicate Devices: | The subject device is substantially equivalent to previously cleared devices listed above. |
| Device Description: | The Acumed Polarus® Connect System of bone plates, intramedullary nails, screws and accessories are designed to provide fixation for fractures of the humerus while they heal. |
| The Polarus® Connect System also includes instruments to facilitate placement of implants. | |
| Intended Use: | The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus. |
| Summary of | |
| Technological | |
| Characteristics | The Acumed Polarus® Connect System is manufactured from Titanium alloy complying with ASTM F136 and PEEK complying with ASTM F2026. The devices provide stabilization of humerus fractures. |
| Non-Clinical Testing | The Acumed Polarus® Connect System was tested according to the following standards: |
| ASTM F382 - Standard Specification and Test Method for Metallic Bone Plates | |
| ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws | |
| ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices | |
| The results demonstrated that the Polarus Connect System is substantially equivalent to the predicate devices. | |
| Conclusion | The information discussed above demonstrates that the Acumed Polarus® Connect System devices are effective and perform as well as or better than the predicate devices. Based upon the similarities of the Polarus® Connect System and the predicate devices studies, the safety and the effectiveness of the Polarus® Connect System is substantially equivalent to the predicate devices referenced. |
・
.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2013
Acumed. LLC Ms. Brittany Cunningham Regulatory Specialist 2 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
Re: K131636
Trade/Device Name: Polarus * Connect Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT. HRS. HSB Dated: September 26, 2013 Received: September 30, 2013
Dear Ms. Cunningham:
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
Image /page/2/Picture/11 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter appears to be the name of a government organization, possibly related to health or human services. The symbol in the center consists of three curved lines that resemble a stylized representation of a person or a flame. The logo is in black and white and has a simple, clean design.
3
Page 2 - Ms. Brittany Cunningham
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 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/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/MedicalDcvices/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.
Erin | Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K131636
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page
510(k) Number (if known) K131636
Device Name Polarus® Connect
Indications for Use (Describe)
The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.
Type of Use (Select one or both, as applicable)
区 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)