ERMIS STERILIZATION CONTAINER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for Ermis Medizintechnik. The logo consists of a stylized geometric shape on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font size. The logo is set against a dark background, with the text and geometric shape appearing in white. # K 123234 JUL 5 2013 # SECTION 05 # 510(k) Summary DATE OF APPLICATION: 2013-06-21 APPLICANT: Ermis Medizintechnik Dornierstr. 49 78532 Tuttlingen Germany Tel.: +49 7461 964857-0 Fax: +49 7461 964857-99 Establishment Registration Number: 3005071827 E-Mail: info@ermis-medizintechnik.de www.ermis-medizintechnik.de # CONTACT PERSON: Mr. Mehmet Ermis Managing Director Tel.: +49 7461 964857-0 Fax: +49 7461 964857-99 001_510K_Summary_v1.5.doc {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo for Ermis Medizintechnik. The logo consists of a stylized graphic to the left of the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font size. The logo is black and white. #### Device Name 1. Ermis Medizintechnik Sterilization Container System consisting of: - 1/1 Size, ¼ Size, ½ Size, Mini, Dental containers and Accessories - · Sterilization Container Systems Trade Names: Sterilization Container Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Classification Name: #### Classification Product Code / Subsequent Code 2. | Device | Medical<br>Specialty | Review Panel | Product Code | Device Class | Regulation Number | |------------------------------------------------------------------------------|----------------------|------------------|--------------|--------------|-------------------| | Sterilization Wrap<br>Containers, Trays,<br>Cassettes & Other<br>Accessories | Part 880 | General Hospital | KCT | 2 | 880.6850 | #### 3. Predicate Device Ermis Medizintechnik Sterilization Container Systems are substantially equivalent to the following predicate devices, most recently cleared by the FDA: | Predicate Device | 510(k) Number | 510(k) Holder | |----------------------------------------------------|---------------|-------------------| | Bahadir Sterilization Trays | K112190 | Bahadir USA Corp. | | SklarLite Rigid Sterilization Container<br>Systems | K091720 | Sklar Instruments | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Ermis Medical Technology. The logo consists of a stylized building icon on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" are the words "MEDICAL TECHNOLOGY" in a smaller font. The background of the logo is black, and the text and icon are white. #### Description of the Device 4. Ermis Medizintechnik Sterilization Container Systems are reusable devices intended to allow sterilization of enclosed medical devices and to maintain sterility of the enclosed devices until used. - Interchangeable components within the different sizes (Full size, ¼ size, ½ size, Wide Body, Den-. tal, Mini, Flat). - Containers are available with perforated and non-perforated bottom and perforated lids. . - Safety lids are available for 1/1 size, 3/4 size and 1/2 size. Safety lids protect filters during storage . and/or transportation. The Lids are not intended to be used during sterilization. - The lids are equipped with a silicone based gasket. . - All containers incorporate a filter system to be used with Ermis disposable paper filters without . chemical indicator. - To ensure effective sterilization and organization of sterilized goods, wire and screen baskets are . available. ### Available sizes: 1/1 size: 580 x 280 x 100 mm . 580 x 280 x 135 mm 580 x 280 x 150 mm 580 x 280 x 200 mm 580 x 280 x 260 mm 3/4 size: - 465 x 280 x 100 mm . 465 x 280 x 135 mm - 465 x 280 x 150 mm 1/2 size: - 285 x 280 x 100 mm . - 285 x 280 x 135 mm - 285 x 280 x 150 mm - 285 x 280 x 200 mm - 285 x 280 x 260 mm Mini Container: - 300 x 140 x 40 mm ◆ - 300 x 140 x 70 mm 300 x 140 x 100 mm . Dental Container. | | | | 300 x 190 x 40 mm | | |--|--|--|-------------------|--| | | | | | | | | | | 300 x 190 x 65 mm | | | | | | | | - 300 x 190 x 80 mm - 300 x 190 x 100 mm - 300 x 190 x 130 mm {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Ermis Medizintechnik. The logo consists of a geometric shape on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font. The logo is black and white. #### 5. Indications for Use The ERMIS Sterilization Container System is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, ¾ Size, ½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. The containers are reusable devices designed to be used with the following sterilization cycle parameters: Pre Vacuum cycle: 4 minutes 132°C (270°F) Drying Time minimum 20 minutes 3 minutes 135°C (273°F) Drying Time minimum 16 minutes Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles ### Maximum recommended loading: | | | Maximum Recommended<br>Load in kg (lbs.) incl. Container weight | | |----------------------------------|-------------|-----------------------------------------------------------------|------------| | Model | Dimension | Instruments | Textiles | | | 580x280x100 | 3.8 (8.3) | 3 (6.6) | | 1/1 (Full-)<br>Size<br>Container | 580x280x135 | 5.2 (11.4) | 4.1 (9.0) | | | 580x280x150 | 5.8 (12.7) | 4.6 (10.1) | | | 580x280x200 | 7.7 (16.9) | 6.1 (13.4) | | | 580x280x260 | 10 (22.0) | 8 (17.6) | | | 465x280x100 | 3.1 (6.8) | 2.5 (5.5) | | ¾ Size<br>Container | 465x280x135 | 4.2 (9.2) | 3.3 (7.2) | | | 465x280x150 | 4.6 (10.1) | 3.7 (8.1) | | | 285x280x100 | 1.9 (4.1) | 1.5 (3.3) | | | 285x280x135 | 2.6 (5.7) | 2 (4.4) | | ½ Size<br>Container | 285x280x150 | 2.8 (6.1) | 2.2 (4.8) | | | 285x280x200 | 3.8 (8.3) | 3 (6.6) | | | 285x280x260 | 4.9 (10.8) | 3.9 (8.5) | | Mini<br>Container | 300x140x40 | 0.4 (0.8) | 0.3 (0.6) | | | 300x140x70 | 0.7 (1.5) | 0.5 (1.1) | | | 300x140x100 | 1 (2.2) | 0.8 (1.7) | | Dental<br>Container | 310x190x40 | 0.6 (1.3) | 0.5 (1.1) | | | 310x190x65 | 0.9 (1.9) | 0.7 (1.5) | | | 310x190x80 | 1.2 (2.6) | 0.9 (1.9) | | | 310x190x100 | 1.5 (3.3) | 1.2 (2.6) | | | 310x190x130 | 1.8 (3.9) | 1.4 (3.0) | QD1 510K Summary v1 5 don Page 4 of 6 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo for "Ermis Medizintechnik". The logo consists of a geometric shape on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font. The logo is set against a black background. #### Technological Characteristics 6. The Sterilization Containers are made of anodized aluminum alloy. The containers are constructed to be used in any conventional steam sterilizer and can be stacked safely on top of one another during sterilization without slipping out of place. The ERMIS sterilization container systems allow a systematic organization of the entire instrument sterilization. Storage, transportation and disposal can be organized with the containers. The filter retainer is locked by pressing down in center of the filter. The opening of the filter retainer succeeds by pressing the plate. The performance of the subject container was validated for sterilant penetration/efficacy, maintenance of sterility, microbial barrier properties and use life. The container met acceptance criteria for all claimed tests. | | Ermis System | Bahadir System | Sklar System | |---------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------| | PROPERTIES | | | | | Indicated for use containing in-<br>struments to be sterilized in vacu-<br>um steam sterilizers | Yes | Yes | Yes | | Reusable | Yes | Yes | Yes | | Closed system | Yes | Yes | Yes | | Sealed | Yes | Yes | Yes | | DESIGN | | | | | Incorporates Filter System to per-<br>mit entry of sterilant | Yes | Yes | Yes | | Incorporates filter system to pre-<br>vent microbial migration during<br>transport | Yes | Yes | Yes | | Incorporates security lid to prevent<br>damage / contamination of filter<br>unit during transport | Yes | No | Yes | | MATERIALS | | | | | Container | Anodized Aluminium<br>Alloy, Stainless<br>Steel, Silicone | Aluminium Alloy,<br>Stainless Steel,<br>Silicone | Anodized Aluminium<br>Alloy, Stainless<br>Steel, Silicone | | PERFORMANCE | | | | | Load | Up to 22 lbs. | Up to 24.5 Ibs. | Up to 25 lbs. for all<br>container sizes | | Lumened / cannulated instruments | No | Yes | Yes | | Stainless steel medical devices | Yes | Yes | Yes | #### Characteristics compared to the Predicate Device 6.1. 001_510K_Summary_v1.5.dac {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo for "Ermis Medizintechnik". The logo consists of a stylized graphic on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font. The logo is black and white. ## 7. Testing Testing in order to proof safety and effectiveness of Ermis Medizintechnik Sterilization Container Systems has been performed according to the requirements set out in ISO 10993-1. ### 7.1. Performance Testing In order to demonstrate compliance to Safety and effectiveness requirements that apply to the device, performance testing has been conducted under consideration of the requirements for sterilization performance, reusability, maintenance of sterility and sterilization compatibility. ### 7.2. Biocompatibility The devices subject to this submission consist of the same materials as the predicate devices and do not come into direct contact with the patient. Evaluation of biological risks resulting from devices or components with indirect patient contact has been performed in accordance to the requirements set out in ISO 10993-1. #### Substantial Equivalence Summary / Conclusion 8. Based on available 510(k) information provided herein, Ermis Medizintechnik Sterilization Container Systems are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### July 5, 2013 Ermis Medizintechnik C/O Mr. Andre Weingerl Regulatory Affairs Consultant Medagent GmbH & Company KG Griesweg 47 Muehlheim Baden-Wuerttmberg GERMANY 78570 Re: K123234 Trade/Device Name: Sterilization Container System Consisting of: 1/1 Size, 1/2 Size. Mini, Dental containers and Accessories Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 6, 2013 Received: June 10, 2013 ### Dear Mr. Weingerl: 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. {7}------------------------------------------------ ## Page 2 - Mr. Weingerl Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 of medical 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportalProblem/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. Image /page/7/Picture/7 description: The image shows a signature and some text. The text reads "Sincerely yours, Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR". The signature is illegible. The text is likely part of a letter or document. Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Image /page/8/Picture/17 description: The image shows a logo for Ermis Medizintechnik. The logo features a stylized geometric shape on the left, followed by the word "Ermis" in a bold, sans-serif font. Below "Ermis" is the word "MEDIZINTECHNIK" in a smaller font. The logo appears to be in black and white. # Indications for Use Statement 510(k) Number: K 123234 Device Name: Ermis Medizintechnik Sterilization Container System consisting of: 1/1 Size, % Size, 1/2 Size, Mini, Dental containers and Accessories Indications for Use: The ERMIS Sterilization Container System Is intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, ½ Size, ½ size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. The containers are reusable devices designed to be used with the following sterilization cycle parameters: Pre Vacuum cycle: 4 minutes 132°C (270°F) Drying Time minimum 20 minutes 3 minutes 135°C (273°F) Drying Time minimum 16 minutes Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles Prescription Use (Parl 21 CFR 801 Subpart D) ···· AND/OR Over-The-Counter Use" __ X (21 SFR 801 Subparl C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sreekanth Gutala -S 2013.07.02 14:27:40 -04'00 FDA | Division Sign-Off) | |--------------------| |--------------------| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | K123234 | |----------------|---------| |----------------|---------| {9}------------------------------------------------ and the program and the comments of the comments of the comments of the comments of the comments of the first of the first of the first of the first of the first of the first Image /page/9/Picture/1 description: The image shows a logo with the text "Ermis MEDIZINTECHNIK". The logo also includes a stylized graphic to the left of the text. The text "Ermis" is in a large, bold font, while "MEDIZINTECHNIK" is in a smaller font below it. There is a registered trademark symbol to the right of the word "Ermis". Device overview Ermis Sterilization Container System ・ | | | Maximum Recommended<br>Load in kg (lbs.) incl. contain-<br>er weight | | Available configurations / Ac- | |----------------------------------|-------------|----------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | Dimension | Instruments | Textiles | cessories | | 1/1 (Full-)<br>Size<br>Container | 580x280x100 | 3.8 (8.3) | 3 (6.6) | | | | 580x280x135 | 5.2 (11.4) | 4.1 (9.0) | | | | 580x280x150 | 5.8 (12.7) | 4.6 (10.1) | | | | 580x280x200 | 7.7 (16.9) | 6.1 (13.4) | | | | 580x280x260 | 10 (22.0) | 8 (17.6) | | | ¾ Size<br>Container | 465x280x100 | 3.1 (6.8) | 2.5 (5.5) | Perforated Lid;<br>Perforated or non-perforated<br>bottom;<br>Optional safety-Lid for storage /<br>transportation;<br>Accessories: Stainless steel<br>wire- or sleeve baskets;<br>Available colours: Natural alu-<br>minium, anodized gold, red,<br>blue, green, black | | | 465x280x135 | 4.2 (9.2) | 3.3 (7.2) | | | | 465x280x150 | 4.6 (10.1) | 3.7 (8.1) | | | ½ Size<br>Container | 285x280x100 | 1.9 (4.1) | 1.5 (3.3) | | | | 285x280x135 | 2.6 (5.7) | 2 (4.4) | | | | 285x280x150 | 2.8 (6.1) | 2.2 (4.8) | | | | 285x280x200 | 3.8 (8.3) | 3 (6.6) | | | | 285x280x260 | 4.9 (10.8) | 3.9 (8.5) | | | Mini<br>Container | 300x140x40 | 0.4 (0.8) | 0.3 (0.6) | | | | 300x140x70 | 0.7 (1.5) | 0.5 (1.1) | | | | 300x140x100 | 1 (2.2) | 0.8 (1.7) | | | Dental<br>Container | 310x190x40 | 0.6 (1.3) | 0.5 (1.1) | | | | 310x190x65 | 0.9 (1.9) | 0.7 (1.5) | | | | 310x190x80 | 1.2 (2.6) | 0.9 (1.9) | | | | 310x190x100 | 1.5 (3.3) | 1.2 (2.6) | | | | 310x190x130 | 1.8 (3.9) | 1.4 (3.0) | | ·