(125 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of bone cement, with no mention of AI or ML technologies.
No.
The device is a bone cement used for fixation of artificial joint prostheses within the body, which is a supportive rather than a therapeutic function.
No
Explanation: The device, NP Cements / NP Cements System, is a bone cement intended for the fixation of artificial joint prostheses, which is a therapeutic and structural function, not a diagnostic one.
No
The device description clearly outlines physical components (PMMA bone cement, vials, sachets, syringes, vacuum tubes, cannulas, blister packaging) and performance testing related to material properties and mechanical characteristics, indicating it is a physical medical device, not software-only.
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 "fixation of artificial joint prostheses to the host bone." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used to physically bond a prosthesis to bone. It is applied during surgery.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve testing samples (like blood, urine, tissue) outside of the body to diagnose a condition or monitor a patient's health.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
Product codes
LOD
Device Description
The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:
-
- NP Cements are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use.
-
- NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements are available in a low and high viscosity version. The NP Cements System are also available in a low and high viscosity version.
- NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
host bone, artificial joint prostheses
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)
This 510(k) submission provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. The following is a summary of the performance data.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established in ongoing stability studies.
Biocompatibility: Biocompatibility testing of the NP Cements and NP Cements System has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing (Chemical, Material and Mechanical): Performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and application characteristics (e.g., dough time, setting time)
- Chemical composition (e.g., residuals, molecular weight and polymer structure, glass transition temperature)
- Thermal properties (e.g., polymerization temperature)
- Mechanical properties (e.g., modulus and flexural properties, static compression and ● bending, fatigue testing, fracture toughness and viscoelasticity)
The performance data demonstrate that the new devices are substantially equivalent to the predicate device, and meet the requirements of the Special Controls Guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Cossington Limited % Diane Mandell Horwitz, Ph.D. Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, Virginia 22031
Re: K143134
Trade/Device Name: NP Cements / NP Cements System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: January 22, 2015 Received: January 22, 2015
Dear Dr. Horwitz:
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 - Diane Mandell Horwitz, Ph.D.
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143134
Device Name NP Cements / NP Cements System
Indications for Use (Describe)
NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1
Submitter and Owner of the 510(k) 1.1
Cossington Ltd 1 Princeton Mews Kingston Upon Thames Surrey KT2 6PT United Kingdom
Official Correspondent 1.2
Diane Mandell Horwitz, PhD, RAC Regulatory Affairs Consultants Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, Virginia 20031
Telephone: (703) 307-2921 Fax: (703) 242-1117 E-mail: dmh@mandellhorwitzconsulting.com
1.3 Devices Subject of this 510(k)
NP Cements - Low and High Viscosity NP Cements System - Low and High Viscosity
1.4 Date of Preparation
October 28, 2014
NAME OF THE DEVICE AND CLASSIFICATION INFORMATION 2
This traditional 510(k) has been submitted for the following devices.
- NP Cements - Low and High Viscosity
- NP Cements System Low and High Viscosity ●
2.1 Trade/Proprietary Name
As of the date of this application, the Sponsor has not yet developed a trade name for the new bone cements.
4
2.2 Common/Usual Name
PMMA bone cement for orthopedics PMMA bone cement for orthopedics within a syringe-like device system
2.3 Classification Information
Classification Name: Polymethylmethacrylate (PMMA) Bone Cement
Classification Regulation: 21 CFR § 888.3027
Regulatory Class: Class II
LOD – Bone Cement Product Code:
Panel: Orthopedic
PREDICATE DEVICE 3
The predicate device is as follows:
- Tecres Cemex Isoplastic, which was cleared through 510(k) application K021715.
DEVICE DESCRIPTION ব
The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:
-
- NP Cements are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use.
-
- NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements are available in a low and high viscosity version. The NP Cements System are also available in a low and high viscosity version.
5
5 INDICATIONS FOR USE
Below is the indication for use.
NP Cements /NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.
6 COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The NP Cements and the NP Cements System have the same indication for use statements (other than the identification of the trade name) as the predicate device, and thus have the same intended use, as shown in Table 1.
| Device | Indication for Use |
|---|---|
| Cossington | |
| NP Cement / | |
| NP Cement System | NP Cements /NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone. |
| Tecres Cemex Isoplastic | |
| (K021715) | Cemex bone cement is intended to be used for the fixation of artificial joint prostheses to the host bone. |
| Table 1: Comparison of the Indication Statement with the Predicate Device | |
|---|---|
| --------------------------------------------------------------------------- | -- |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The NP Cements and NP Cements System share many of the same technological characteristics compared to the predicate Cemex Isoplastic, including important considerations such as the same materials, and mechanical and chemical-physical performances. There are, however, some differences in the shelf life, method of sterilization of the powder component, the presence of colored pigments and how the device is supplied to the surgeon for the system version. These comparisons are summarized in Table 2.
| Characteristics | Cossington
NP Cement HV/LV
NP Cement HV/LV System | Tecres
Cemex Isoplastic
K021715 | Comparison |
|--------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------|
| Main Components | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Same |
| Other Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Color Additives | Pigments (FD&C Blue No.1 and
FD&C Yellow No.5 ) | None | Different |
| Mixing/Application | Manual
Syringe-like device (System
version) | Manual | Same for Manual:
Different for
system |
Table 2: Comparison of the Technological Characteristics with the Predicate Device
6
| Characteristics | Cossington
NP Cement HV/LV
NP Cement HV/LV System | Tecres
Cemex Isoplastic
K021715 | Comparison |
|------------------------------------------------|-----------------------------------------------------------|---------------------------------------|---------------------------------------------|
| Powder Sterilization
Method | Gamma-ray irradiation (manual)
Ethylene Oxide (system) | Ethylene Oxide | Same for manual;
different for
system |
| Sterility Assurance
Level (SAL) -
Powder | 10-6 | 10-6 | Same |
| Liquid Sterilization
Method | Filtration | Filtration | Same |
| SAL – Liquid | 10-3 | 10-3 | Same |
| Shelf Life | 2 years | 5 years | Different |
PERFORMANCE DATA 8
This 510(k) submission provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. The following is a summary of the performance data.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established in ongoing stability studies.
Biocompatibility: Biocompatibility testing of the NP Cements and NP Cements System has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing (Chemical, Material and Mechanical): Performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and application characteristics (e.g., dough time, setting time) ●
- Chemical composition (e.g., residuals, molecular weight and polymer structure, glass transition temperature)
- Thermal properties (e.g., polymerization temperature)
- Mechanical properties (e.g., modulus and flexural properties, static compression and ● bending, fatigue testing, fracture toughness and viscoelasticity)
The performance data demonstrate that the new devices are substantially equivalent to the predicate device, and meet the requirements of the Special Controls Guidance document.