G1 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Device Description

G1 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

AI/ML Overview

The provided text describes the G1 40 Radiopaque Bone Cement, a medical device intended for use in arthroplasty procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore,
No information is available regarding acceptance criteria and a study proving a device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document details performance testing conducted to show that the G1 40 Radiopaque Bone Cement has comparable characteristics and performs similarly to its predicate devices. This type of testing is common for demonstrating substantial equivalence for Class II devices.

Here's a breakdown of the available information regarding the performance comparison, addressing the relevant parts of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" for clinical performance (e.g., a certain percentage of successful fixation). Instead, the "acceptance criteria" are implied by compliance with established international and ASTM standards for bone cement properties. The "reported device performance" is framed as "comparable" to predicate devices and "in compliance" with these standards.

Performance Characteristic	Acceptance Criteria (Implied by Standards)	Reported Device Performance
Material/Mechanical Properties
Compressive Strength	Compliance with ASTM F451-08, ISO 5833:2002	Comparable to predicate devices, in compliance with standards
Bending Modulus	Compliance with ASTM F451-08, ISO 5833:2002	Comparable to predicate devices, in compliance with standards
Cyclic Fatigue	Compliance with ASTM F2118-14	Comparable to predicate devices, in compliance with standards
Tensile Properties	Compliance with ASTM D638-14	Comparable to predicate devices, in compliance with standards
Creep	Compliance with ASTM D2990-09	Comparable to predicate devices, in compliance with standards
Fracture Toughness	Compliance with ASTM E399-12	Comparable to predicate devices, in compliance with standards
Shrinkage	Compliance with relevant standards (not explicitly listed but implied)	Comparable to predicate devices, in compliance with standards
Biocompatibility	Compliance with ISO 10993 parts -3, -5, -6, -10, -11	Complies with ISO 10993 at parts -3, -5, -6, -10, -11
Sterilization	Compliance with ISO 11135:2014, ISO 11138-1:2006, ISO 10993-7:2009, ISO 14161:2009, ISO 14937:2009, ISO 11737-1:2006, ISO 11737-2:2009, ISO 13408-1:2008, and ISO 13408-2:2003	Sterility verified according to listed ISO standards
Shelf Life	Not explicitly stated as an acceptance criterion for comparison, but evaluated.	3 years (not compared to predicate, but stated as a characteristic)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a number of samples or patients. The testing involved material samples for mechanical and material characterization, and biological samples for biocompatibility. The standards listed (e.g., ASTM F451-08, ISO 5833:2002) would dictate appropriate sample sizes for each specific test, but these are not enumerated in the document.
Data Provenance: Not specified. Given the nature of material and biological testing, it would be laboratory-generated data, likely from the manufacturer or a contracted testing facility. No information on country of origin or whether it's retrospective/prospective is provided, as these terms are more relevant to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This document describes laboratory and material testing, not human-read clinical data where expert ground truth would be established. The "ground truth" for these tests is based on objective measurements against established international and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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 device is a bone cement, not an AI-powered diagnostic or assistive technology.

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

Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's material properties and biological effects, which were indeed tested directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these material and biological performance tests is objective physical and chemical measurement against established international and industry standards. For example, compressive strength is objectively measured and compared to the acceptable range defined in ASTM F451. Biocompatibility is assessed through standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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March 19, 2020

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G21 S.r.1 % Mr. Barry Sands President and Founder ROMIS. Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K193059/S001

Trade/Device Name: G1 40 Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: February 5, 2020 Received: February 7, 2020

Dear Mr. Sands:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193059

Device Name G1 40 Radiopaque Bone Cement

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

G21 's G1 40 Radiopaque Bone Cement 510k Submission

l. SUBMITTER

G21 S.R.L. Via S. Pertini, 8 San Possidonio Modena, ITALY 41039

Phone: +39 0535 30312 Fax: 888-831-4892

Contact Person: Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: +1 (978) 255-7002

II. DEVICE

Trade/Device Name:	G1 40 Radiopaque Bone Cement
Common or Usual Name:	Bone cement
Classification Name:	Polymethylmethacrylate (PMMA) bone cement
Regulation Number:	21 CFR 888.3027
Regulatory Class:	Class II
Product codes	LOD

III. PREDICATE DEVICES

Primary Predicate Device:	Heraeus Kulzer Palacos R (K030902)
Additional Predicate:	G21 OrthoSteady G (K173494)

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IV. DEVICE DESCRIPTION

Intended Use:

Indications for Use:

V. SUBSTANTIAL EQUIVALENCE

Technological Comparison

The subject device has similar technological characteristics as the predicate devices. Both predicates and subject device provide two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The subject device and the predicate devices are all polymethylmethacrylate (PMMA) bone cements.

The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The sterilization method for the powder of the subject device is identical to the predicate device. The sterilization method for the liquid component of the subject device is identical to predicate device.

Therefore, the subject device has the same design, intended use and mode of operation as the predicate.

Performance Comparison

The following performance data are provided in support of the substantial equivalence determination.

. Biocompatibility

According to its categorization and ISO 10993-1 recommendations, biological effects that have been considered as per categorization of the predicate and then suitable for G1 40 Radiopaque Bone Cement include cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, AMES, LAL, and bone implantation toxicity and effects.

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As recommended by the FDA's Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', the subject devices and predicates comply with ISO 10993 at parts -3, -5, -6, -10, -11.

● Sterilization

The sterilization process, including both the ethylene oxide method (powder component and aseptically processed, filled glass vials) as well as the membrane filter-sterilization (liguid component), has been validated and the sterility of the subject devices has been verified according to ISO 11135:2014, ISO 11138-1:2006, ISO 10993-7:2009, ISO 14161:2009, ISO 14937:2009, ISO 11737-1:2006, ISO 11737-2:2009, ISO 13408-1:2008, and ISO 13408-2:2003.

The shelf life of the G1 40 Radiopaque Bone Cement is three years.

● Material, Mechanical and Performance Characterization

Performance testing of compressive strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage was conducted to characterize G1 40 Radiopaque Bone Cement as compared to the predicate, according to the FDA's Guide "Class II Special Controls Guidance Document: polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA". Results show comparable performances to the predicate devices, and are in compliance with ASTM F451-08, ISO 5833:2002, ASTM F2118-14, ASTM D2990-09, ASTM D638-14, and ASTM E399-12.

In all instances the device functioned as intended and all results were satisfactory and met all performance specifications.

VI. CONCLUSION

The G1 40 Radiopaque Bone Cement is as safe and effective as the primary predicate Heraeus Kulzer Palacos R (K030902) and the additional predicate G21 OrthoSteady G (K173494). The G1 40 Radiopaque Bone Cement has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the G1 40 Radiopaque Bone Cement and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the G1 40 Radiopaque Bone Cement is as safe and effective as Heraeus Kulzer Palacos R (K030902) and G21 OrthoSteady G (K173494). Thus, the G1 40 Radiopaque Bone Cement is substantially equivalent.

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.”