(275 days)
Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cobalt™ HV with Gentamicin Bone Cement and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the StageOne™ disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Cobalt™ HV with Gentamicin Bone Cement), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
The single-use cement spacer molds are sterile disposables made of medical grade silicone. They are designed to be filled with Cobalt™ HV with Gentamicin bone cement by injecting with a dispenser/gun into the mold. After the cement cures, the hemi-shoulder prosthesis is to be removed from the mold and placed into the joint space. The hemi-shoulder prosthesis remains in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional shoulder joint prosthesis.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Description:
The StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis are sterile, single-use molds made of medical-grade silicone. They are designed to be filled with Cobalt™ HV with Gentamicin bone cement to create a temporary hemi-shoulder prosthesis. This temporary prosthesis is used for skeletally mature patients undergoing a two-stage revision procedure due to a septic process, and it remains in place for 180 days or less.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Strength | Substantially equivalent to the predicate Tecres InterSpace® Shoulder (K112983). |
| Static Strength | Substantially equivalent to the predicate Tecres InterSpace® Shoulder (K112983). |
| Gentamicin Elution | The percentage of total gentamicin eluted from the spacer made from a StageOne™ shoulder spacer mold and Cobalt™ HV with Gentamicin bone cement was substantially equivalent to the percentage of gentamicin eluted from the predicate Tecres InterSpace® Shoulder (K112983). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the comparative mechanical (fatigue and static strength) or antibiotic elution testing.
The provenance of the data is non-clinical test data. The country of origin of the data is not specified, but it would have been generated in a laboratory setting by Biomet Manufacturing Corp. or a contracted testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's performance was evaluated through non-clinical laboratory testing (mechanical and elution studies), not by expert assessment of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation involved non-clinical laboratory testing, not human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data submitted." and "No clinical data was necessary for a determination of substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (a mold for a temporary prosthesis), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by comparison to a legally marketed predicate device (Tecres InterSpace® Shoulder, K112983) and adherence to established engineering principles for mechanical testing and analytical chemistry for elution testing. The acceptance criteria were based on achieving "substantial equivalence" to this predicate.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product, so there is no training set in the conventional sense. The design and validation of the device relied on engineering principles and comparative non-clinical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML product, there is no training set or ground truth establishment method for such a set.
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Image /page/0/Picture/0 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a thick outline. Below the logo, the words "MANUFACTURING CORP." are printed in a simple sans-serif font. The logo is black and white.
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JAN 2 2 2 2014
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| SUBMITTER INFORMATION | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46582 | |
| Phone number | (574) 371-3024 |
| Fax number | (574) 371-1027 |
| Establishment Registration Number | 1825034 |
| Name of contact person | Carmen Albany, DVM |
| Senior Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Date prepared | April 19, 2013 |
| NAME OF DEVICE | |
| Trade name | StageOne™ Disposable Cement Spacer Molds for |
| Temporary Hemi-Shoulder Prosthesis | |
| Common name | Bone Cement shoulder spacer mold; Disposable |
| Cement Spacer Molds for Temporary Hemi-Shoulder | |
| Prosthesis; StageOne™ Shoulder Spacer Mold | |
| Classification name | Regulation |
| Product Code | |
| Shoulder joint humeral (hemi-shoulder) | 21 CFR 888.3690 |
| metallic uncemented prosthesis | HSD |
| Shoulder joint metal/polymer semi-constrained | 21 CFR 888.3660 |
| cemented prosthesis | KWS |
| Polymethylmethacrylate (PMMA) bone cement | 21 CFR 888.3027 |
| MBB | |
| Classification panel | Orthopedics |
| Legally marketed device(s) to which | Comprehensive Total Shoulder Standard Stem |
| equivalence is claimed | (K060692) |
| StageOne™ Disposable Cement Spacer Mold For | |
| Temporary Hip Prosthesis with Reinforcement Stem | |
| (K052990) | |
| Tecres InterSpace® Shoulder (K112983) | |
| Reason for 510(k) submission | New device |
| Device description | The single-use cement spacer molds are sterile |
| disposables made of medical grade silicone. They are | |
| designed to be filled with Cobalt™ HV with Gentamicin | |
| bone cement by injecting with a dispenser/gun into the | |
| mold. After the cement cures, the hemi-shoulder | |
| prosthesis is to be removed from the mold and placed | |
| into the joint space. The hemi-shoulder prosthesis | |
| remains in place (180 days or less) until the second | |
| stage of the two-stage procedure is performed to | |
| implant a conventional shoulder joint prosthesis. |
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510(k) Summary StageOne™ Shoulder Spacer Mold Page 2 of 2
Page 2 of 2
| Indications for use | Disposable cement spacer molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cobalt ™ HV with Gentamicin Bone Cement and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). |
|---|---|
| The hemi-shoulder prosthesis made from the StageOne ™ disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.) | |
| Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Cobalt ™ HV with Gentamicin Bone Cement), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period. |
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATES
The StageOne™ Shoulder Spacer Molds materials, design and sizing configurations are the same whenThe StageOne" Shoulder Spacer Molds materials, design and sizing configurations are the same when compared to the named predicates. The sizing configurations of the StageOne" Shoulder Spacer Molds are oompared to the named problem Standard Stem (K060692). The StageOne" Shoulder Spacer Molds utilize the same silicone as used in the StageOne" Hip Spacer molds (K052990). The StageOne shoulder spacers are made of the same material (polymethylmethacrylate/gentamicin bone cement) as the InterSpace shoulder spacer (K112983) with the exception that the InterSpace" spacer contains a reinforcement structure made of stainless steel and the StageOne" shoulder spacers do not.
PERFORMANCE DATA
Non-Clinical Tests Conducted For Determination Of Substantial Equivalence Comparative mechanical (fatigue and static strength) was performed on the temporary shoulder prosthesis made with the StageOne" shoulder spacer molds and the predicate Tecres InterSpace Shoulder (K112983) Antibiotic (gentamicin) elution testing was performed on both the temporary shoulder prosthesis made with the StageOne" shoulder spacer molds and the predicate Tecres interSpace® Shoulder (K112983). The temporary shoulder prostheses were found to be substantially equivalent in fatigue and static strength characteristics. The percentage of total gentamicin eluted from the spacer made from a StageOne™ shoulder spacer mold and Cobalt™ HV with Gentamicin bone
cement was substantially equivalent to the percentage of gentamicin eluted from the predicate Tecres InterSpace® Shoulder (K112983). Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information
No clinical data submitted
Conclusions Drawn From Non-Clinical and Clinical Data
The results of testing No clinical data was necessary for a determination of substantial equivalence. indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines. The logo is rendered in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Biomet Manufacturing Corporation Carmen Albany, DVM Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K131135
Trade/Device Name: StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: December 5, 2013 Received: December 9, 2013
Dear Dr. Albany:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Dr. Carmen Albany
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: StageOne™ Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis _
Indications For Use:
Disposable cement spacer molds are indicated for use to mold a temporary hemishoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Cobalt" HV with Gentamicin Bone Cement and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the StageOne " disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Cobalt" HV with Gentamicin Bone Cement), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131135
Page 1 of 1
§ 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.”