(85 days)
Not Found
No
The 510(k) summary describes a bone cement with an antibiotic additive and does not mention any AI or ML capabilities.
Yes
The device is used in a "two-stage revision for total joint arthroplasty after the initial infection has been cleared" and includes an antibiotic (gentamicin), which indicates it is used for treatment.
No
The device, SmartSet GHV Gentamicin Bone Cement, is described as a self-curing bone cement used for seating and securing prostheses in total joint arthroplasty. Its intended use is therapeutic (a treatment or revision for an infection that has already been cleared), not diagnostic.
No
The device description clearly states it is a "self-curing cement" and includes physical components like "bone cement powder" and "gentamicin," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for securing a prosthesis to bone during a surgical procedure (total joint arthroplasty). This is a surgical implant/device, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "self-curing cement" used for "seating and securing of a metal or plastic prosthesis to living bone." This is a physical material used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, SmartSet GHV Gentamicin Bone Cement is a surgical bone cement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage rovision for total joint arthroplasty after the initial infection has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB
Device Description
SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (active) gentamicin is included in 40 grams of bone cement powder and 0.5 gram of (active) gentamicin is included in 20 grams of bone cement powder, for allowing the seating and securing of a metal or plastic prosthesis to living 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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K03 3563
page 1 of 2
510(k) Summary SmartSet GHV Gentamicin Bone Cement
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Tiffani D. Rogers Regulatory Affairs Associate (574) 371-4927
B. Device Information:
| Proprietary Name: | SmartSet GHV Gentamicin
Bone Cement |
|----------------------------------------------|------------------------------------------------------------------------------|
| Common Name: | Methyl Methacrylate/Methyl Acrylate Copolymer
bone cement with Antibiotic |
| Regulatory Class and
Classification Name: | Class II
Bone Cement, Antibiotic |
| Product Code: | LOD |
C. Indications for Use:
SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage rovision for total joint arthroplasty after the initial infection has been cleared.
Device Description: D
SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (active) gentamicin is included in 40 grams of bone cement powder and 0.5 gram of (active) gentamicin is included in 20 grams of bone cement powder, for allowing the seating and securing of a metal or plastic prosthesis to living bone.
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page 2 of 2
E. Substantial Equivalence:
The substantial equivalence of SmartSet GHV Gentamicin Bone Cement is demonstrated by its similarity in design, materials, sterilization and packaging to SmartSet HV Bone Cement (K023012) and its similarity in indications for use to DePuy 1 Gentamicin (K023103) and Simplex P with Tobramycin (K014199) Bone Cements.
The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Ms. Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581
Rc: K033563
Trade/Device Name: SmartSet GHV Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone ccment Regulatory Class: II Product Code: LOD and MBB Dated: November 10, 2003 Reccived: November 12, 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, 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.
3
Page 2- Ms. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyourse 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) 594-4639. 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 may be obtained 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,
L. Mark A. Miller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) Cevice Name
Indications for Use
1033563
SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a twostage revision for total joint arthroplasty after the initial infection has been clared.
SmartSet GHV Gentamicin Bone Cement
Prescription Use 2 42 (l'er 21 CFR §801.109)
OR
Over-the-Counter Use _ No
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Millkern
anchi, Restorative ical Devices 33563