(625 days)
VersaBond® AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
VersaBond® AB Bone Cement consists of two separate components: polymer powder and moratists, who The two components are packaged together and are pre-measured, sterlitzed components which, when nixed, form a radiopaque, rapidly setting bone cement.
The provided text is a 510(k) summary for the VersaBond® AB Bone Cement, a Polymethylmethacrylate (PMMA) bone cement loaded with an antibiotic (Gentamicin). This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of device performance metrics like sensitivity, specificity, or image analysis.
The document states that "VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex." The "Performance Characteristics" section merely says that "denomination and testing has indicated that VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex."
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance metrics. It relies on a qualitative statement of "substantial equivalence."
- Sample sizes used for the test set and the data provenance: No information on test sets or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring expert ground truth is described for performance evaluation.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this summary.
- Standalone (algorithm-only) performance: Not applicable as this is a physical medical device (bone cement), not an AI algorithm.
- Type of ground truth used: Not applicable as it's not an AI/diagnostic device. The "ground truth" for a bone cement would involve material properties and clinical outcomes, which are not detailed in this summary.
- Sample size for the training set: Not applicable as it's not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of what can be gleaned from the document regarding "acceptance criteria" and "study":
The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to legally marketed predicate devices. The "study" mentioned is a general "denomination and testing" to establish this substantial equivalence.
Key points from the document regarding substantial equivalence:
- Predicate Devices:
- VersaBond® Bone Cement, K001160 and K033509 (without antibiotic) by Smith & Nephew, Inc.
- K012193 (for use of gentamicin antibiotic) by Smith & Nephew, Inc. (likely a prior 510(k) for the antibiotic component)
- Surgical Simplex P®, PMA N17004 (without antibiotic) by Howmedica Osteonics, Inc.
- Palacos® G Bone Cement w/Gentamicin, K030086 by Biomet, Inc. (identified as using the "identical, but common antibiotic")
- Palacos® R Bone Cement, PMA P810020 by EM Industries, Inc.
- Basis for Substantial Equivalence:
- Technological Characteristics: VersaBond® AB Bone Cement is "to VersaBond Bone Cement (i.e. non-antibiotic)." Similarities include the base bone cement formulation, with the addition of an antibiotic. It shares "similar indications for use and technological characteristics."
- Antibiotic: The antibiotic used (Gentamicin) is identical to that in Palacos® G Bone Cement with Gentamicin (K030086), which is a predicate device.
- Performance: "denomination and testing has indicated that VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex."
In conclusion, this 510(k) summary focuses on regulatory substantial equivalence based on material composition and intended use, rather than presenting a detailed clinical or performance study with quantitative acceptance criteria typically associated with diagnostic or AI-driven devices.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENE
APR 2 9 2004
VersaBond® AB Bone Cement
| Submitter:Submitter's address: | Smith & Nephew, Inc.1450 Brooks RoadMemphis, TN 38116 |
|---|---|
| Submitter's phone number:Contact person:Date summary prepared:Trade or proprietary name:Common or usual name: | 901-399-6487David HenleyApril 27, 2004VersaBond® AB Bone CementPolymethylmethacrylate (PMMA) Bone Cement(antibiotic loaded) |
| Classification name and reference: | 21 CFR 888.3027, polymethylmethacrylate (PMMA) bonecement - Class II |
1)evice product code and panel code: Orthopedics / 87 / LOD
I Device Description
r levice Description
' lersaBond' AB Bone Cement consists of two separate components: polymer powder and moratists, who The two components are packaged together and are pre-measured, sterlitzed components which, when nixed, form a radiopaque, rapidly setting bone cement.
Device Intended Use
VersaBond" AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for velsion the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Technological Characteristics
Techninogical Characteriler to VersaBond Bone Cement (i.e. non-antibiotic). Similarities include vel subono "Ab bone Canifor the bone cement, except that an antibiotic has been added to In e lefthical chemical considents to the Cement also shares similar indications for use and technological characteristics. With regard to the antibiotic, Palacos® G Bone Cement with Gentamicin (K030086), marketed by Biomet, Inc., is a predicate device that uses the identical, but common antibiotic.
Substantially Equivalent Device
- VersaBond® Bone Cement, K001160 and K033509 (without antibiotic) Smith & Nephew, Inc. �
- vel. Society Domanic Rooms of R12193 (for use of gentamicin antibiotic) Smith & Nephew, Inc. �
- Surgical Simplex P®, PMA N17004 (without antibiotic) Howmedica Osteonics, Inc. .
- Palacos® G Bone Cement w/Gentamicin, K030086 Biomet, Inc. *
- Palacos® R Bone Cement, PMA P810020 EM Industries, Inc. �
Performance Characteristics
r enomination and testing has indicated that VersaBond" AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex.
VBABSumS&E
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Orthopedics Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K022688
K022088
Trade/Device Name: VersaBond™ AB Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: I.OD and MBB Dated: January 30, 2004 Received: February 5, 2004
Dear Mr. Henley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalling in the device is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the enorsale) to togally the enactment date of the Medical Device Amendments, or to comments prior to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug, uevices mat nave been require approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not require appear al controls provisions of the Act. The r ou may, mercerere, manel 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 cither class II (Special Controls) or class III (PMA), it If your device is elassinou von ontrols. Existing major regulations affecting your device can they be subject to been as a segulations, Title 21, Parts 800 to 898. In addition, I'DA 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 r reaso be aarmade a determination that your device complies with other requirements of the Act that 1177 has intates and regulations administered by other Federal agencies. You must or any I 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 sct OFF . and 0977 . actime (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 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in yourse FDA finding of substantial equivalence of your device to a legally premaince nedicate 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 If you acan's specific as noliance 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,
Mark N Milken
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
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K 022688
INDICATIONS for USE STATEMENT
VersaBond® AB Bone Cement
Indications for Use:
VersaBond® AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number KO 22688 Page 1 of
§ 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.”