(76 days)
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No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
This device is designed to assist in the proper placement and distribution of bone cement during hip or femoral component implantation, but it does not directly treat a disease or condition itself. It's an ancillary device for a surgical procedure.
No
Explanation: The device is a cement plug used to prevent bone cement migration and increase cement pressure during total hip or endoprosthetic femoral component insertion. Its function is mechanical and procedural, not diagnostic.
No
The device description clearly states it is a physical component made of UHMWPE and introduced with a stainless steel tool, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Prince Medical Cement Plug is a physical device inserted into the femoral canal during hip surgery. Its purpose is mechanical – to prevent cement migration and increase cement pressure. It does not analyze any biological samples.
Therefore, based on the provided information, the Prince Medical Cement Plug is a surgical implant/accessory, not an IVD.
N/A
Intended Use / Indications for Use
The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to :
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- Prevent the bone cement from distal migration during its insertion.
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- Increase the pressure of the cement during cement and femoral component insertion to facilitate bone penetration and distribution of the cement.
Product codes
JDI
Device Description
The Prince Medical Cement Plug consists of various sizes and is made from Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE). The component is produced in two outside diameters and is introduced into the medullary canal using a stainless steel inserting tool. Design crawings are typical for such components that are used in the industry. Under this premarket notification, the device is available in 18.5 and 25.0mm outside diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral canal, intramedullary canal
Indicated Patient Age Range
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Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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AUG 1 0 1998
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION IN THE PREMARKET NOTIFICATION FOR THE PRINCE MEDICAL CEMENT PLUG
Prince Medical, Inc.
Design Parameters
The Prince Medical Cement Plug consists of various sizes and is made from Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE). The component is produced in two outside diameters and is introduced into the medullary canal using a stainless steel inserting tool. Design crawings are typical for such components that are used in the Under this premarket notification, the device is available in 18.5 industry and 25.0mm outside diameter.
Material Specifications
The Prince Medical Cement Plug is manufactured from Medical Grade Ultra High Molecular Weight Polyethylene correstponding with ASTM : F648
Biocompatability
Ultra High Molecular Weight Polyethylene has a long history of use in orthopaedic applications. Its biological response has been well characterized by a history of cilnical and laboratory studies (Turner, J., Lawrence, W., and Autian, J., "Subacute Toxicity Testing of Biomaterials Using Histopathologic Evaluation of Rabbit Muscle Tissue", Journal of Biomed. Mater. Research, Vol. 7, 1973; Laing, P., "Compatibility of Biomaterials", Orthopedic Clinics of North America, Vol 4, No. 2, April 1973 . and Escalas, F., Galante, J., and Rostoker, W., "Biocompatibility of Materials for Total Joint Replacement", Journal of Biomed. Mater. Research. Vol 10, No. 2, 1976). These tests include data on human and animal performance and show that the tissue exhibits excellent biocompatibility.
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Sterilization
The Prince Medical Cement Plug is supplied double packaged in sealed, Tyvek pouches. The device is sterilized by Gamma Irradiation sterilization. The sterlify assurance level is (SAL) 104 . To substantiate this (SAL) sterility, testing will be performed on the actual device. The validation is based on the AAMI protocol.
Utilization and Implantation
Selection of the Prince Medical Cement Plug depends on the judgement of the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation by the appropriate reading of the literature, and training in the operative skill's and techniques required for the total hip arthroplasty surgery.
The femoral canal is prepared according to the surgeon's typical methodology for cemented hip arthroplasty. The proper size Prince Medical Cement Plug is chosen based on the size of the femoral canal as estimated by the surgeon.
The bone plug will be positioned in the intramedullary canal 2-3mm below the distal tip of the implant. The selected femoral component should be measured using the Cement Plug Inserter, allowing the length of the femoral cemponent, plus the height of the bone plug, plus 2-3mm.
To Insert the Prince Medical Cement Plug, it is screwed onto the Cement Plug inserter and inserted into the prepared femoral canal to the preestablished depth. Once correctly placed, the cement plug inserter is unscrewed from the plug by turning the inserter counter-clockwise, leaving the Prince Medical Cement Plug in position.
Indications
The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to:
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- Prevent the bone cement from distal migration during insertion.
2
- 2 . Increase the pressure of the cement during cement and femoral Component insertion to facilitate bone penetration and distribution of the cement
Contraindications and Adverse Effects
The Prince Medical Cement Plug should not be used in non-cemented total hip procedures or for applications other than those which are indicated.
The Indications, contrainidications, and adverse effects of the bone cement and the femoral component being used should be reviewed prior to usino the Prince Medical Cement Plug. Patient Conditions and I or predispositions noted in these inserts should be avoided.
It is possible that some patients, although infrequently, may be allergic to implant materials. These allergies should be ruled out preoperatevely.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUM V SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Mr. Mike Prince President Prince Medical, Inc. 126 S.W. 140th Terrace Newberry, Florida 32669
K981855 Re: Trade Name: Prince Medical Cement Pluq Regulatory Class: II Product Code: JDI Dated: May 22, 1998 Received: May 26, 1998
Dear Mr. Prince:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Mike Prince
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_l_of_l_
510(k) Number (if known): K981855
Device Name: PRINCE MEDICAL CEMENT Plug.
Indications For Use:
The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to :
-
- Prevent the bone cement from distal migration during its insertion.
-
- Increase the pressure of the cement during cement and femoral component insertion to facilitate bone penetration and distribution of the cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General Restorative Devices
510(k) Number K981855
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__
(Optional Format 1-2-96)