OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized image of an eagle, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue as well. The logo is simple and professional, and it is easily recognizable. May 19, 2022 Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve % Mehmet Ormeci Consultant Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, 06830 Turkey Re: K211869 Trade/Device Name: OGM® 1 OGM® 1A Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB Dated: March 28, 2022 Received: April 8, 2022 Dear Mehmet Ormeci: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For: Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211869 Device Name OGM® 1 Indications for Use (Describe) OGM® 1 is a PMMA bone cement 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. Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211869 Device Name OGM® 1A Indications for Use (Describe) OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for OGM. The logo is blue and black, and it features the letters "OGM" in a stylized font. Below the letters are the words "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" in a smaller font. The logo is simple and modern, and it is likely used to represent a company or organization. # 510k Summary OGM® 1 and OGM® 1A K211869 ## 510(k) Summary | 510(k) Submitter Name | ORMED GRUP SAGLIK MEDIKAL TURIZM SAGLIK HIZMETLERI SANAYI VE TICARET LTD. STI. | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------| | 510(k) Submitter Adress | Macun Mahallesi 177 Sokak No:19 H/7b Yenimahalle, Ankara, TURKEY | | 510(k) Submitter Telephone No | +90 312 211 01 92 | | Primary Correspondent Contact Information | Mehmet Fatih Ormeci (Consultant)<br>+90-532-397-3043<br>mformeci@gmail.com<br>Fax Number: + 90 312 211 01 93 | | Summary Preparation Date | 03/28/2022 | | Trade Or Proprietary<br>Name | OGM® 1, OGM® 1A | |------------------------------|-------------------------------------------| | Common Name | PMMA Bone Cement | | Classification Name | Bone Cement | | Regulation Name | Polymethylmethacrylate (PMMA) bone cement | | Regulation Number | 21 CFR 888.3027 | | Product Code | LOD, MBB | | Regulatory Class | Class II | | Subject Device 510k No | Primary Predicate Device<br>510k No | Primary Predicate Device Manufacturer | |------------------------|-------------------------------------|--------------------------------------------------------------------------| | OGM® 1<br>K211869 | PALACOS® R<br>K202475 | Heraeus Medical GmbH<br>Philipp-Reis-Str. 8/13<br>61273 Wehrheim Germany | | OGM® 1A<br>K211869 | PALACOS® R+G<br>K202475 | Heraeus Medical GmbH<br>Philipp-Reis-Str. 8/13<br>61273 Wehrheim Germany | | Subject Device 510k No | Seconder Predicate<br>Device 510k No | Primary Predicate Device Manufacturer | |------------------------|----------------------------------------------|-------------------------------------------------------| | OGM® 1A<br>K211869 | DePuy 1 Gentamicin Bone<br>Cement<br>K023103 | DePuy, Inc.<br>700 Orthopaedic Drive Warsaw, IN 46581 | {5}------------------------------------------------ ## Device Description: A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to OGM® 1 and OGM® 1A®. This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data. ## OGM® bone cements without Gentamicin OGM® 1 is polymethylmethacrylate (PMMA) bone cement: - OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery, The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration). ## OGM® bone cements with Gentamicin OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery, The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for OGM, which is a medical company. The logo is blue and black, and it features the company's name in a stylized font. Below the logo, the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" is written in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and expertise. ### Indications For Use: OGM® 1 is a PMMA bone cement 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. OGM® 1A is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. ## Comparison of technological characteristics: ## OGM® 1 Device comparison demonstrated that the OGM® 1 is substantially equivalent to the previously cleared PALACOS® R (K202475) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same or similar technological elements: - PMMA bone cement (same), - Chemical composition (similar), - Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 (same), - Side by side mechanical testing was performed according to the ISO 5833 and ASTM D732. The mechanical characteristics are similar when it is compared with predicate device. - Mixing and application properties (same), and - Clinical use of the devices including the anatomical location of exposure (same) and intended use population (same). {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI. The logo is blue and black. The logo has the letters OGM in it. Regarding chemical composition comparison, while the predicate device contains zirconium dioxide, the subject device contains barium sulfate in the cement powder as an X ray contrast medium. Both materials are used in commercialized bone cements as an X ray contrast medium. Chemical formulas between predicate device and subject device have slight differences. The predicate device contains chlorophyll additive serves as marking of the bone cement at the site of the operation. The subject device do not contain chlorophyll, but it is still visible as off white instead of green which chlorophyll provides for predicate device. #### OGM® 1A Device comparison demonstrated that the OGM® 1A is substantially equivalent to the previously cleared PALACOS® G (K202475) and DePuy 1 Gentamicin Bone Cement (K023103) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same or similar technological elements: - PMMA bone cement (same), - Chemical composition (similar), - Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 (same), - Side by side mechanical testing was performed according to the ASTM F2118, ISO 5833 and ASTM D732. The mechanical characteristics are similar when it is compared with predicate device (K023103). - Mixing and application properties (same) and - Clinical use of the devices including the anatomical location of exposure (same), and intended use population (same). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for OGM, which is a medical company. The logo is blue and black, and it features the company's name in a stylized font. Below the logo, the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" is written in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical services. - 1g Gentamicin is utilized to powder (similar for primary predicate and same for secondary predicate). - Gentamicin release profiles are compared with the secondary predicate device (K023103) and no significant difference was observed. #### Discussion of Non-Clinical Tests: For the OGM® 1 and OGM® 1A bone cements the stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of was characterized per ISO 5833. Mechanical tests were also performed according to ASTM F2118 standards. ASTM F451 requirements are met. ATCC antibacterial efficiency testing was performed to OGM 1A. Endotoxin testing was performed to OGM® 1 and OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device). EtO sterilization was validated per ISO 11135. Biocompatibility testing, including cytotoxicity, irritation, acute systemic toxicity, subacute systemic toxicity, implantation and genotoxicity was performed per ISO 10993. Because OGM® 1A can be regarded as worst case product, the results are also valid for OGM® 1. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "OGM", which is in blue and black. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI", which is in a smaller font size. The logo and text are centered in the image. ## 510k Summary OGM® 1 and OGM® 1A K211869 ## Substantially Equivalence Discussion | | Subject Device<br>K211869 | Predicate Device<br>K202475 | Comparison | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Image: COGM | Image: Heraeus | | | Device Name | OGM® 1 | Palacos® R | | | Intended Use | OGM® 1 is a PMMA bone cement intended<br>for use in arthroplastic procedures of the<br>hip, knee and other joints for the fixation<br>of polymer or metallic prosthetic implants<br>to living bone. | Palacos® R is indicated for use in<br>arthroplastic procedures of the hip, knee,<br>and other joints for the fixation of polymer or<br>metallic prosthetic implants to living bone. | same | | Components | 40g powder (polymer) and 20ml liquid<br>(monomer) is individually packed. | 40g powder (polymer) and 20ml liquid<br>(monomer) is individually packed. | same | | Sterilization | ethylene oxide and sterile filtration | ethylene oxide and sterile filtration | same | | Contact Duration | Permanent / implantable | Permanent / implantable | same | | Powder Mass | 40g | 40g | same | | Liquid Volume | 20ml | 20ml | same | | Powder Chemical<br>Composition | poly(methyl acrylate, methyl methacrylate)<br>35.6 g | poly(methyl acrylate, methyl methacrylate)<br>33.8 g | similar | | | Barium sulfate<br>4 g | zirconium dioxide<br>5.9 g | similar | | | hydrous benzoyl peroxide<br>0.4 g | hydrous benzoyl peroxide<br>0.3 g | similar | | | | chlorophyll VIII trace amount | different | | Liquid Chemical<br>Composition | methyl methacrylate<br>19.6 g | methyl methacrylate<br>18.4 g | similar | | | N,N-dimethyl-p-toluidine<br>0.4 g | N,N-dimethyl-p-toluidine<br>0.4 g | Same | | | | liquid: chlorophyll VIII in an oily solution<br>trace amount | different | | | Hydroquinone trace amount | Hydroquinone trace amount | same | Regarding chemical composition comparison, while the predicate device contains zirconium dioxide, the subject device contains barium sulfate in the cement powder as an X ray contrast medium. Both materials are used in commercialized bone cements as an X ray contrast medium. Chemical formulas between predicate device and subject device have slight differences. The predicate device contains chlorophyll additive serves as marking of the bone cement at the site of the operation. The subject device do not contain chlorophyll, but it is still visible as off white instead of green which chlorophyll {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for OGM, which is a medical group. The logo is in blue and black, with the letters "OGM" in a stylized font. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand. provides for predicate device. Subject device has been carried out the ISO 5833 performance tests and ISO 10993 biocompatibility tests. ISO 5833 requirements are fulfilled. ISO 10993 test results demonstrates biological safety. Endotoxin testing was performed to OGM® 1 according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device). {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows a logo for a company called "OCM ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI". The logo consists of the letters "OCM" in a stylized font, with a graphic to the left of the letters. The letters are in blue, with a black bar above the "M". Below the letters is the company name in smaller letters. ## Substantially Equivalence Discussion | | Subject Device<br>K211869 | Primary Predicate Device<br>K202475 | Secondary Predicate Device<br>K023103 | Primary<br>Comparison | Secondary<br>Comparison | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------------------| | Manufacturer | | Heraeus | | - | - | | Device Name | OGM® 1A | Palacos® R+G | DePuy 1 Gentamicin Bone<br>Cement | - | - | | Intended Use | OGM® 1A is indicated for use in<br>the second stage of a two-stage<br>revision for total joint<br>arthroplasty after the initial<br>infection has been cleared. | Palacos® R+G is indicated for use in<br>the second stage of a two-stage<br>revision for total joint arthroplasty<br>after the initial infection has been<br>cleared. | DePuy 1 Gentamicin is indicated for<br>use in the second stage of a two<br>stage revision for total joint<br>arthroplasty after the initial<br>infection has been cleared. | same | same | | Components | 40g powder (polymer) and 20ml<br>liquid (monomer) is individually<br>packed. | 40g powder (polymer) and 20ml<br>liquid (monomer) is individually<br>packed. | 40g powder (polymer) and 20ml<br>liquid (monomer) is individually<br>packed. | same | same | | Sterilization | ethylene oxide and sterile<br>filtration | ethylene oxide and sterile filtration | ethylene oxide and sterile filtration | same | same | | Contact Duration | Permanent / implantable | Permanent / implantable | Permanent / implantable | same | same | | Powder Mass | 40g | 40g | 40g | same | same | | Liquid Volume | 20ml | 20ml | 20ml | same | same | | Powder Chemical<br>Composition | poly(methyl acrylate, methyl<br>methacrylate)<br>35.6 g | poly(methyl acrylate, methyl<br>methacrylate)<br>33.6 g | poly(methyl acrylate, methyl<br>methacrylate)<br>84.73 (%w/w) | similar | similar | | | Barium sulfate<br>4 g | zirconium dioxide<br>6.1 g | Barium sulfate<br>9.10 (%w/w) | similar | similar | | | hydrous benzoyl peroxide<br>0.4 g | hydrous benzoyl peroxide<br>0.3 g | hydrous benzoyl peroxide<br>1.95 (%w/w) | similar | similar | | | gentamicin base (as sulphate)<br>1 g | gentamicin base (as sulphate)<br>0.5 g | gentamicin base (as sulphate)<br>1 g | different | same | | | | chlorophyll VIII trace amount | | different | same | | Liquid Chemical<br>Composition | methyl methacrylate<br>19.6 g | methyl methacrylate<br>18.4 g | methyl methacrylate<br>98.50 (%w/w) | similar | similar | | | N,N-dimethyl-p-toluidine<br>0.4 g | N,N-dimethyl-p-toluidine<br>0.4 g | N,N-dimethyl-p-toluidine<br>< 1.50 (%w/w) | same | similar | | | | liquid: chlorophyll VIII in an oily<br>solution trace amount | | different | same | | | Hydroquinone trace amount | Hydroquinone trace amount | Hydroquinone trace amount | same | same | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains a logo for OGM, which is in blue and black. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI". The text is in a smaller font size than the logo. The logo is simple and modern. Regarding chemical composition comparison, while the primary predicate device contains zirconium dioxide, the subject device contains barium sulfate in the cement powder as an X ray contrast medium. On the other hand, secondary predicate device contains barium sulfate as the subject device. Both materials are used in commercialized bone cements as an X ray contrast medium. The subject device and secondary predicate device contain 1g gentamicin sulfate, on the contrary primary predicate device contains 0.5g gentamicin sulfate. Gentamicin sulfate is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens. As per gentamicin sulfate ratio is higher than the primary predicate device antibacterial efficacy can be considered as substantially equivalent to primary predicate device. Antibacterial efficacy tests are performed to subject device. On the other hand, release ratio of Gentamicin is important both in dosage and total release duration. OGM® 1A is subjected to Gentamicin release test comparatively with the predicate device. Lastly, gentamicin has a negative effect on product mechanical and physical properties. ISO 5833 tests are applied to OGM® 1A and demonstrated compliance. Chemical formulas between predicate devices and subject device have slight differences. The primary predicate device contains chlorophyll additive serves as marking of the bone cement at the site of the operation. The subject device and secondary predicate device do not contain chlorophyll, but it is still visible as off white instead of green which chlorophyll provides for primary predicate device. Subject device has been carried out the ISO 5833 performance tests and ISO 10993 biocompatibility tests. ISO 5833 requirements are fulfilled. ISO 10993 test results demonstrates biological safety. Endotoxin testing was performed to OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device). {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI. The logo features the letters "OCM" in a stylized font, with the "O" and "C" in blue and the "M" in black. Below the letters is the company name in smaller, all-caps letters. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other branding materials. ## Conclusion The non-clinical tests comply with the requirement of ISO 5833 and ASTM F451. Biological safety has been demonstrated according to the ISO 10993-1. Side-by-side mechanical tests were also performed according to ASTM D732, ASTM F2118 standards and the results are similar when compared to predicate devices. Endotoxin testing was performed to OGM® 1 and OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device). Antibacterial efficiency testing was performed according to the AATC and it is showed that the device is efficient to the E.Coli. Gentamicin release profile is also tested side-by-side with predicate device and the results are similar when compared to predicate devices (K023103). The differences between the predicate devices and the subject device do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.