(105 days)
No
The summary describes a bone cement and does not mention any AI or ML capabilities.
Yes
The device, a gentamicin bone cement, is indicated for use in a two-stage revision for total joint arthroplasty after an infection has been cleared. This suggests it plays a role in treating a medical condition (infection and joint replacement), thus fitting the definition of a therapeutic device.
No
Explanation: The provided text describes a bone cement used for securing prostheses in total joint arthroplasty, not for diagnosing medical conditions.
No
The device description clearly states it is a "self-curing cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a bone cement for securing a prosthesis to bone during joint replacement surgery. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description confirms it's a self-curing cement for seating and securing a prosthesis to living bone. This is also an in vivo application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
SmartSet GMV Endurance 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 clearcd.
Product codes
LOD
Device Description
SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K023103, K014199, P960001/S003
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
(033382
FEB - 5 2004
510(k) Summary SmartSet GMV Endurance Gentamicin Bone Cement
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Tiffani D. Rogers Regulatory Affairs Associatc (574) 371-4927
Device Information:
| Proprietary Name: | SmartSet GMV Endurance Gentamicin |
|---|---|
| Bone Cement | |
| Common Name: | Polymethylmethacrylate (PMMA) and styrene co-polymer bone cement with Antibiotic |
| Regulatory Class and | |
| Classification Name: | Class II; 21 CFR 888.3027 |
| Product Code: | LOD |
C. Indications for Use:
SmartSet GMV Endurance 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 clearcd.
D. Device Description:
SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone. -
E. Substantial Equivalence:
The substantial equivalence of the SmartSet GMV Endurance Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Gentamicin Bone Cement (K023103), Simplex P with Tobramycin Bone Ccment (K014199), St and Endurance Bone Cement (P960001/S003). Endurance Bone Cement (KU14199)
to Class II by the EDA official (P960001/S003). Endurance Bone Cement was down classified to Class II by the FDA effective August 16, 2002.
The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Ms. Tiffani D. Rogers Regulatory Affairs Associate Depuy Orthopacdics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581
Rc: K033382
Trade/Devicc Name: Smartset GMV Endurance Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Il Product Code: I.OD Dated: December 29, 2003 Received: December 30, 2003
Dear Ms. Rogers:
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, Insting 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 he 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 docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Ms. Tiffani D. Rogers
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K033382_________________________________________________________________________________________________________________________________________
. . . . .
Device Name: ___SmartSet GMV Endurance Gentamicin Bone Cement Indications for Use:
Smartset GMV Endurance 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.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Craive
for Mark A. Milliken
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