(44 days)
Use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are self-curing, polymethylmethacrylate (PMMA) bone cements containing the antibiotic gentamicin (at the rate of 1g active gentamicin in 40g of PMMA bone cement powder), for seating and securing of a metal or plastic prosthesis to living bone.
The provided text is a 510(k) premarket notification summary for medical devices, specifically bone cements. It details the device's description, intended use, and claims of substantial equivalence to previously cleared predicate devices. It does not contain information related to acceptance criteria, device performance metrics, clinical study design (sample sizes, expert qualifications, etc.), or standalone algorithm performance.
Therefore, I cannot fulfill your request for descriptions of acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or multi-reader multi-case study results based on the provided text.
The document primarily focuses on establishing substantial equivalence for regulatory clearance, not on reporting detailed performance metrics from a specific study against acceptance criteria.
{0}------------------------------------------------
JUN - 8 2006
SECTION 5: SECTION 5:
| Trade Name: | DePuy CMW 2 Gentamicin Bone CementDePuy CMW 3 Gentamicin Bone Cement |
|---|---|
| Common Name: | Antibiotic bone cement |
| Classification Name: | Bone cement, antibiotic (21 CFR 888.3027, Product Code MBB) |
| Contact Person: | Natalie S. HeckManager, Regulatory AffairsDePuy Orthopaedics Inc. |
| Tel.: (574) 267-8143Fax: (574) 371-4987 | |
| Equivalent to: | DePuy CMW 1 Gentamicin Bone Cement (K053002) |
| SmartSet GMV Endurance Gentamicin Bone Cement (K041656). | |
| SmartSet GHV Gentamicin Bone Cement (K033563). | |
| DePuy CMW 2 Bone Cement (K053003) | |
| DePuy CMW 3 Bone Cement (K053003) | |
| Device Description: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 GentamicinBone Cement are self-curing, polymethylmethacrylate (PMMA) bonecements containing the antibiotic gentamicin (at the rate of 1g activegentamicin in 40g of PMMA bone cement powder), for seating and securingof a metal or plastic prosthesis to living bone. |
| Intended Use: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 GentamicinBone Cement are both indicated for use in the second stage of a two-stagerevision for total joint arthroplasty after the initial infection has beencleared. |
| SubstantialEquivalence: | DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 GentamicinBone Cement have the same intended use as DePuy CMW 1 GentamicinBone Cement, SmartSet GHV Gentamicin Bone Cement and SmartSetGMV Endurance Gentamicin Bone Cement. |
6
{1}------------------------------------------------
DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are composed of the same materials as DePuy CMW 1 Gentamicin Bone Cement, but the ratios of the individual components have been modified to produce cements with subtly different setting characteristics to meet user needs for differing surgical situations. DePuv CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement are similar in design and performance characteristics to DePuy Gentamicin Bone Cement, SmartSet GMV Endurance CMW 1 Gentamicin Bone Cement, SmartSet GHV Gentamicin Bone Cement, DePuy CMW 2 Bone Cement and DePuy CMW 3 Bone Cement; and similar in sterilization and packaging to DePuy CMW 1 Gentamicin Bone Cement, SmartSet GMV Endurance Gentamicin Bone Cement, DePuy CMW 2 Bone Cement and DePuy CMW 3 Bone Cement. The determination of substantial equivalence of DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement to these bone cements was based on a comparison of device technological characteristics and comparative product testing data.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
DePuy Orthopaedics, Inc. c/o Ms. Natalie Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46580
Re: K061144
Trade/Device Name: DePuy CMW 2 Gentamicin Bone Cement, DePuy CMW 3 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB Dated: April 24, 2006 Received: April 25, 2006
Dear Ms. Heck:
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
{3}------------------------------------------------
Page 2 -- Ms. Natalie Heck
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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lehman mo
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
DePuy CMW 2 Gentamicin Bone Cement and DePuy CMW 3 Gentamicin Bone Cement
Indications for Use:
Use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Helent Penner wo
Division Sign-Off Division of General, Restoral ve and Neurological Devices
Co 61144 510(k) Number.
Prescription Use_ X (Per 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use (Per 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)
§ 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.”