NP Cements Genta / NP Cement System Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

The NP Cements Genta and NP Cements System Genta are PMMA, radiopaque bone cements, containing gentamicin and 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 Genta 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 Genta 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 Tyyek lid, and then placed in an aluminum bag.
The devices are sold disposable and sterile. The NP Cements Genta are available in a low and high viscosity version. The NP Cements System Genta are also available in a low and high viscosity version.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense. Therefore, many of the requested elements for a detailed study description are not explicitly present.

However, based on the available information, I can construct a response that addresses what is provided and what can be inferred.

Here's the breakdown of the acceptance criteria and the study (or, in this case, performance data submitted to demonstrate substantial equivalence) for the "NP Cements Genta / NP Cement System Genta":

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a formal table with pass/fail values. Instead, it states that "Performance testing was performed to characterize the bone cements in accordance with special controls guidance document" and that "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."

The "acceptance criteria" are thus implicitly defined by the properties and performance of the predicate device (Tecres Cemex Genta HV) and the requirements outlined in the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. The reported device performance is that it met these implicit criteria and demonstrated substantial equivalence.

Summary of Performance Goals (Implicit Acceptance Criteria based on Guidance and Predicate):

Characteristic / Test	Implicit Acceptance Criteria / Goal	Reported Device Performance
Sterilization	Meet international standards for sterilization validation.	Sterilization cycles validated (std. methods).
Shelf Life	Established through stability studies. (Predicate: 5 years)	Established in ongoing stability studies. (Claimed: 2 years, noted as 'Different' from predicate)
Biocompatibility	Safe, biocompatible, suitable for intended use (per ISO 10993 and FDA Draft Guidance)	Biocompatibility testing performed, materials shown safe.
Mixing and Application Characteristics	Comparable to predicate, meet guidance (e.g., dough time, setting time)	Characterized through testing.
Chemical Composition	Comparable to predicate, meet guidance (e.g., residuals, molecular weight, polymer structure, glass transition temperature)	Characterized through testing.
Thermal Properties	Comparable to predicate, meet guidance (e.g., polymerization temperature)	Characterized through testing.
Mechanical Properties	Comparable to predicate, meet guidance (e.g., modulus, flexural properties, static compression & bending, fatigue testing, fracture toughness, viscoelasticity)	Characterized through testing.
Substantial Equivalence to Predicate Device	Demonstrate equivalence in materials, mechanical, and chemical-physical performances to Tecres Cemex Genta HV.	Demonstrated (as per the conclusion of the 510(k)).
Compliance with Special Controls Guidance Document	Meet all requirements of the FDA Class II Special Controls Guidance Document (July 17, 2002).	Met requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for each performance test. The data provenance is also not explicitly stated in terms of country of origin, but the submission is from "Cossington Ltd, United Kingdom," suggesting the testing could have been conducted there or by affiliated entities. The data is retrospective in the sense that it supports a premarket notification for a device that has been developed and tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to a submission for a bone cement device. The "ground truth" here is objective physical and chemical properties measured in laboratory settings, not subjective interpretations by human experts.

4. Adjudication Method for the Test Set

Not applicable for objective physical and mechanical property testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-driven diagnostic device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical bone cement device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this type of device and submission is based on:

Established material science and engineering principles: Properties like mechanical strength, chemical composition, thermal behavior, etc., are measured using validated scientific methods.
International standards: Adherence to ISO standards (e.g., ISO 10993 for biocompatibility).
FDA guidance documents: Compliance with specific guidance for PMMA bone cement.
Predicate device's established performance: The predicate device (Tecres Cemex Genta HV) effectively serves as a benchmark for "ground truth" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.

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: K143100

Trade/Device Name: NP Cements Genta / NP Cement System Genta Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB Dated: January 23, 2015 Received: January 23, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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

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4.0 Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143100

Device Name NP Cements Genta / NP Cement System Genta

Indications for Use (Describe)

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)

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FORM FDA 3881 (1/14)

PSC" Pablishing Survices (301) 447-6740 EJ

Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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 Genta - Low and High Viscosity NP Cements System Genta- Low and High Viscosity

1.4 Date of Preparation

October 16, 2014

NAME OF THE DEVICE AND CLASSIFICATION INFORMATION 2

This traditional 510(k) has been submitted for the following devices.

NP Cements Genta - Low and High Viscosity
NP Cements System Genta 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.

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2.2 Common/Usual Name

PMMA bone cement with antibiotic for orthopedics PMMA bone cement with antibiotic 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
Product Code:	LOD – Bone CementMBB – Bone Cement, Antibiotics
Panel:	Orthopedic

PREDICATE DEVICE 3

The predicate device is as follows:

Tecres Cemex Genta HV, which was cleared originally through 510(k) application . K033596 and then subsequently through 510(k) application K092773.

DEVICE DESCRIPTION ব

1. NP Cements Genta 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.
1. NP Cements System Genta 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 Tyyek lid, and then placed in an aluminum bag.

The devices are sold disposable and sterile. The NP Cements Genta are available in a low and high viscosity version. The NP Cements System Genta are also available in a low and high viscosity version.

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5 INDICATIONS FOR USE

Below is the indication for use for each bone cement.

NP Cements Genta/NP Cements System Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE く

The NP Cements Genta and the NP Cements System Genta 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
CossingtonNP Cement Genta /NP Cement System Genta	NP Cements Genta/NP Cements System Genta are intended for the fixation ofprosthesis to living bone in the second stage of a two-stage revision for total jointarthroplasty after the initial infection has been cleared.
Tecres Cemex Genta HV(K033596 and K092773)	Cemex Genta HV is intended for the fixation of prosthesis to living bone in thesecond stage of a two-stage revision for total joint arthroplasty after the initialinfection has been cleared.

		Table 1: Comparison of the Indication Statement with the Predicate Device

7 COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The NP Cements Genta and NP Cements System Genta share many of the same technological characteristics compared to the predicate Cemex Genta HV, 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	CossingtonNP Cements GentaNP Cements System Genta	TecresCemex Genta HVK033596 and K092773	Comparison
Main Components	Polymethylmethacrylate(PMMA)Methylmethacrylate (MMA)Gentamicin SulphateBarium Sulphate	Polymethylmethacrylate(PMMA)Methylmethacrylate (MMA)Gentamicin SulphateBarium Sulphate	Same
Other Components	Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone	Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone	Same
Coloring Agents	Pigments	None	Different

Table 2: Comparison of the Technological Characteristics with the Predicate Device

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Characteristics	CossingtonNP Cements GentaNP Cements System Genta	TecresCemex Genta HVK033596 and K092773	Comparison
Mixing/Application	ManualSyringe-like device (Systemversion)	Manual	Same for manual:different forsystem
Powder SterilizationMethod	Gamma-ray irradiation (manual)Ethylene oxide (system)	Ethylene Oxide	Same for manual:different forsystem
Sterility AssuranceLevel (SAL) -Powder	10-6	10-6	Same
Liquid SterilizationMethod	Filtration	Filtration	Same
SAL - Liquid	10-3	10-3	Same
Shelf Life	2 years	5 years	Different

8 PERFORMANCE DATA

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 Genta and NP Cements System Genta 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)

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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.

Regulation Number and Section

§ 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.”