(44 days)
No
The device description and intended use are purely mechanical, describing a screw and its function in conjunction with a rod. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No.
The device's intended use is to secure a screw in a humeral rod and prevent bone ingrowth, which is a mechanical function to maintain the implant's position and integrity, not directly treat a disease or condition.
No
The provided text describes a surgical implant (Polarus Cap Screw) used to fix a bone rod, not a device used for diagnosis.
No
The device description clearly states it is a physical implantable device made of titanium alloy and polyethylene, provided sterile. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the Polarus Cap Screw is a mechanical device intended to be used in conjunction with a humeral rod (a bone implant). Its purpose is to prevent screw back-out and bone ingrowth. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity related to diagnosing a medical condition.
Therefore, based on the provided information, the Polarus Cap Screw is a surgical implant/accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Polarus Cap Screw is intended to be used in conjunction with the Polarus Humeral Rod. It engages the 5.0 mm proximal screw in the rod to prohibit / minimize the screw from backing out and to prohibit the in growth of bone into the 1/4-20 hole.
Product codes
HSB
Device Description
The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod 10 prohibit/minize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole. The Polarus Cap Screw is manufactured from two different materials. The cap is manufactured from a titanium alloy per ASTM F 136 and the tip portion is manufactured from medical grade polyethylene per ASTM F 648.
The Polarus Cap Screw is provided sterile and is packaged in inner and outer PETG blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed using the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 104.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the set screw for the Howmedica Vitallium IM Device, the Ace Medical AIM Titanium Humeral Nail System's end cap, the Alta IM Rod's cap screw, and the SynthesTitanium Solid Humeral Nail System's end cap
Reference Device(s)
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
DEC 1 9 2001
K013616
page 1 of 1
Appendix V - 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
Classification Name: Intramedullary Fixation Rod Common Name: Humeral Rod Proprietary Name: Polarus Cap Screw Proposed Regulatory Class: II Device Product Code: HSB Manufacturing Facility: Acumed, Inc. 10950 SW 5th Street, Suite 170 Beaverton, OR 97005 U.S.A.
Establishment Registration No.: 3025141 Contact: Shari Jeffers Labeling/Promotional Materials: See Appendix III Substantial Equivalence: This product is similar in design to the set screw for the Howmedica Vitallium IM Device, the Ace Medical AIM Titanium Humeral Nail System's end cap, the Alta IM Rod's cap screw, and the SynthesTitanium Solid Humeral Nail System's end cap. Literature on these predicate devices is included in Appendix IV.
The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod 10 prohibit/minize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole. The Polarus Cap Screw is manufactured from two different materials. The cap is manufactured from a titanium alloy per ASTM F 136 and the tip portion is manufactured from medical grade polyethylene per ASTM F 648.
The Polarus Cap Screw is provided sterile and is packaged in inner and outer PETG blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed using the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 104.
Predicate devices that are substantially equivalent to Acumed's Polanus Cap Screw are the set screw for the Howmedica Vitallium IM Device, the Ace Medical AIM Titanium Humeral Nail System's end cap, the Alta IM Rod's cap screw, and the SynthesTitanium Solid Humeral Nail System's end cap. These devices are similar in indication, intended use, material (titanium) design, and size to Acumed's Polarus Cap Screw.
Based on the similarities between the Acumed Polarus Cap Screw and its predicate devices, the safety and effectiveness of the Acumed Polarus Cap Screw is expected to be similar to the predicate devices mentioned above.
10950 SW 5th Street, Suite 170, Beaverton, OR 97005 U.S.A. + (503) 627-9957 + Fax: (503) 520-જુર 18
Page 10 @ 2001, Acumed, Inc.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2013
Acumed Incorporated % Ms. Shari Jeffers Regulatory Affairs 10950 SW 5th Street. Suite 170 Beaverton, Oregon 97005
Re: K013616
Trade/Device Name: Polarus Cap Screw Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: November 4, 2001 Received: November 5, 2001
Dear Ms. Jeffers:
This letter corrects our substantially equivalent letter of December 19, 2001. 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 (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.
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
2
Page 2 - Ms. Shari Jeffers
forth in the quality systems (OS) 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.html 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/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 I. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): - K013616
Device Name: Polarus Cap Screw
Indications For Use:
The Polarus Cap Screw is intended to be used in conjunction with the Polarus Humeral Rod.
It engages the 5.0 mm proximal screw in the rod to prohibit / minimize the screw from backing out and to prohibit the in growth of bone into the 1/4-20 hole.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Signature
(Division Sign-Off) Division of General, Rest and Neurological Devic
510(k) Number: K013616
Over-The-Counter Use
Prescription Use X (Per 21 CFR 801.109)
(Optional Format 1-2-96)