(20 days)
SmartSet GMV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
SmartSet GMV Gentamicin Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement, containing the antibiotic gentamicin sulfate. The bone cement is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
The provided text is a 510(k) summary for a medical device (SmartSet GMV Gentamicin Bone Cement) and an FDA clearance letter. It is not a study report or a description of a study that establishes acceptance criteria and proves a device meets them in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information, particularly items 1-9, which are relevant to the evaluation of AI/ML performance.
The document discusses:
- Device Description: SmartSet GMV Gentamicin Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement, containing the antibiotic gentamicin sulfate. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
- Intended Use/Indications For Use: It is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
- Substantial Equivalence: The primary basis for clearance is substantial equivalence to predicate devices (SmartSet GMV Endurance Gentamicin Bone Cement (K041656) and SmartSet GHV Gentamicin Bone Cement (K033563)), meaning its indications, intended use, formulation, and finished product specifications are equivalent.
This type of submission relies on demonstrating similarity to already approved devices and often involves bench testing (physical and chemical properties) and biocompatibility testing, but not the kind of clinical performance or AI/ML evaluation implied by your detailed questions.
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510(k) Summary
MAY 1 4 2008
Date Prepared:
23 April 2008
510(k) Sponsor:
Establishment Registration No:
Contact Person:
Trade Name of Device:
Common Name:
Classification Name:
Equivalent to:
Device Description:
Intended Use:
Technological Characteristics:
Special 510(k) SmartSet GMV Gentamicin Bone Cement April 2008
DePuy Orthopaedics, Inc 700 Orthopaedic Drive Warsaw, Indiana 46581 - 0988
1818910
Suzana Otaño Project Manager, Regulatory Affairs Telephone: 305-269-6386 Fax: 305-269-6441 Email: sotano@dpyus.jnj.com
SmartSet GMV Gentamicin Bone Cement
Antibiotic bone cement
Bone cement, antibiotic
(21 CFR 888.3027, Product Code MBB and LOD)
SmartSet GMV Endurance Gentamicin Bone Cement (K041656)
SmartSet GHV Gentamicin Bone Cement (K033563)
SmartSet GMV Gentamicin Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement, containing the antibiotic gentamicin sulfate. The bone cement is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
SmartSet GMV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
The technological characteristics of the SmartSet GMV Gentamicin Bone Cement are equivalent to the predicate devices.
Page 25 of 112
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Substantial Equivalence:
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The indications, intended use, formulation and finished product specifications of the SmartSet GMV Gentamicin Bone Cement are equivalent to the predicate devices.
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Page 26 of 112
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes extending from its wing, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Suzana Otano Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, IN 46581-0988
Re: K081163
Trade/Device Name: SmartSet GMV Gentamicin Bone Ccment Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB Dated: April 23, 2008 Received: April 24, 2008
Dear Ms. Otano:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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.
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Page 2 - Ms. Suzana Otano
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Device Name: SmartSet GMV Gentamicin Bone Cement
Indications For Use:
SmartSet GMV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
X Prescription Use
AND/OR
Over-the-Counter
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogle firman
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K081163
Special 510(k) SmartSet GMV Gentamicin Bone Cement April 2008
Page 24 of 112
§ 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.”