(139 days)
G3 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.
G3 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.
The provided text describes the 510(k) summary for the G3 40 Radiopaque Bone Cement, which is a polymethylmethacrylate (PMMA) bone cement. It details the substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria for an AI/ML device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and how training set ground truth was established) are not applicable as this document pertains to a traditional medical device (bone cement) and not an AI/ML powered device.
However, I can extract the information relevant to the performance of the bone cement for the applicable categories.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Biocompatibility (ISO 10993) | Complies with ISO 10993 parts -3, -5, -6, -10, -11 for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, AMES, LAL, and bone implantation toxicity and effects. |
| Sterility (Multiple ISO Standards) | Validated 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. |
| Compressive Strength (ASTM F451-08, ISO 5833:2002) | Comparable to predicate devices and in compliance with specified standards. |
| Bending Modulus (ASTM F451-08, ISO 5833:2002) | Comparable to predicate devices and in compliance with specified standards. |
| Cyclic Fatigue (ASTM F2118-14) | Comparable to predicate devices and in compliance with specified standards. |
| Tensile Properties (ASTM D638-14) | Comparable to predicate devices and in compliance with specified standards. |
| Creep (ASTM D2990-09) | Comparable to predicate devices and in compliance with specified standards. |
| Fracture Toughness (ASTM E399-12) | Comparable to predicate devices and in compliance with specified standards. |
| Shrinkage (ASTM F451-08, ISO 5833:2002) | Comparable to predicate devices and in compliance with specified standards. |
| Shelf Life | Three years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device (bone cement), and the testing described is primarily in-vitro and mechanical characterization, not a clinical study with patients or data requiring test sets in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for an AI/ML algorithm is not relevant for this traditional medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are not relevant for the performance testing of this physical medical device.
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/ML device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical bone cement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physical Properties/Standardized Tests: The "ground truth" for this device's performance is established by adherence to recognized international and ASTM standards (e.g., ISO 10993 for biocompatibility, ISO/ASTM standards for mechanical properties like compressive strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage). The results of these tests define its performance against established benchmarks for PMMA bone cements.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
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March 19, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
G21 S.r.l % Mr. Barry Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K193061/S001
Trade/Device Name: G3 40 Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: October 28, 2019 Received: November 1, 2019
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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) K193061
Device Name G3 40 Radiopaque Bone Cement
Indications for Use (Describe)
G3 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.
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 G3 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: | G3 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:
G3 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.
Indications for Use:
G3 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.
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 G3 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 G3 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 G3 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 G3 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 G3 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 G3 40 Radiopaque Bone Cement and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the G3 40 Radiopaque Bone Cement is as safe and effective as Heraeus Kulzer Palacos R (K030902) and G21 OrthoSteady G (K173494). Thus, the G3 40 Radiopaque Bone Cement is substantially equivalent.
§ 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.”