Jewel Precision Reusable Rigid Sterilization Container System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 9, 2016 Jewel Precision Sheet Metal and Machine, Inc. c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313 Re: K162600 Trade/Device Name: Jewel Precision Reusable Rigid Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: December 2, 2016 Received: December 5, 2016 Dear Mr. Job: 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Image /page/1/Picture/7 description: The image shows the name "Michael J. Ryan -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the name is presented in a straightforward manner. for Tina Kiang, Ph.D. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162600 Device Name Jewel Precision Reusable Rigid Sterilization Container System Indications for Use (Describe) The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days. Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270°F (132°C) for 4 minutes with a drying time of 30 minutes. Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container. Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X 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}------------------------------------------------ # K162600 510(k) ## Summary per 21 CFR 807.92 | Submitter Information | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Jewel Precision Sheet Metal and Machine, Inc. | | Address | 200 Commerce Road<br>Cedar Grove, NJ 07009 | | Phone Number | 973-857-5545 | | Fax Number | 973-857-5548 | | Establishment Registration<br>Number | 3004112448 | | Name of Contact Person | Gary Schneberger, Manager Quality Assurance & Regulatory Affairs | | Date Prepared | 9-December-2016 | | Device Information | | | Trade or Proprietary Name | Jewel Precision Reusable Rigid Sterilization Container System | | Common or Usual Name | Sterilization Container | | Classification Name | Sterilization Wrap, Containers, Trays, Cassettes, and Other Accessories | | Classification Panel | 80 | | Regulation | Class II per 21CFR 880.6850 | | Product Code(s) | KCT | | Legally Marketed Device to<br>which equivalence is claimed | Genesis Reusable Rigid Sterilization Container System<br>K142529 | | Reason for 510(k) submission | To obtain clearance to market for a new medical device | | Device Description | The Jewel Precision Reusable Rigid Sterilization Container System is a device<br>intended to be used to enclose another medical device that is to be sterilized by<br>a healthcare provider. It allows sterilization of the enclosed medical device and<br>maintains sterility of the enclosed device until used, for a maximum of 30 days.<br><br>The containers are suitable for dynamic air removal (pre-vacuum) steam<br>sterilization when used as described in the instructions for use.<br><br>Reusable trays and accessory items such as brackets of various configuration,<br>dividers, caddies, and silicone nipple mats are intended to organize and secure<br>the enclosed medical devices during sterilization and storage of the container.<br><br>The Jewel Precision Reusable Rigid Sterilization Container System comprises a<br>sealed sterilization container consisting of a base, cover, filter retainers, single<br>use replaceable paper filters, and accessories consisting of inner trays, and<br>support brackets. Support brackets are configured to securely support container<br>contents, and are secured to inner trays with stainless steel screws and cap<br>nuts. The container is designed to allow efficient exposure of the tray's contents<br>to sterilant gas during the sterilization process, and to contain and protect<br>reusable surgical instruments during sterilization, transport, and storage. The<br>cover incorporates a sealing gasket, and is secured to the base with latches<br>which lock in place. The latching mechanism places a load on the gasket, which<br>is held in compression against the top surface of the container base, maintaining<br>sterile integrity and preventing unwanted separation. The cover also<br>incorporates an alignment flange along its perimeter, which ensures correct<br>alignment of the cover with the container bottom. Provisions are made on the<br>external container surfaces for the use of user provided Sterilizer Load Data<br>Cards and user provided Tamper Evident Locks, through the incorporation of<br>stainless steel Load Data Card Holders and stainless steel basp and pin stude | | are designed to fit standard autoclaves, and are manufactured of materials<br>capable of withstanding repeated steam sterilization cycles. The containers and<br>accessories are manufactured from materials which are suitable for use with<br>Pulsed Pre-Vacuum Steam Sterilization methods. | | | Filter media is Ahlstrom Reliance 335 WL11359D paper, FDA cleared under<br>K800123, which allows ingress and egress of sterilant gas while providing a<br>microbial barrier. The Filter media is single use only. | | | The Jewel Precision Reusable Rigid Sterilization Container System is used to<br>organize, protect, and transport surgical instruments during steam sterilization<br>and subsequent storage. The Jewel Precision Reusable Rigid Sterilization<br>Container System maintains sterility of enclosed instruments, having been<br>validated for a period of 30 days post sterilization, using containers previously<br>subjected to more than 100 sterilization usage cycles. The Jewel Precision<br>Reusable Rigid Sterilization Container System is intended for sterilization of non-<br>porous and porous items, e.g. scissors, hooks, probes, extractors, suction<br>instruments, drivers, rasps, obturators, etc. The container does not come into<br>direct patient contact while in use. | | {4}------------------------------------------------ The containers, insert trays, covers, brackets, and filters are manufactured from the following materials: | Material | Specification | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aluminum Sheet Metal | Alloy 5052 H32 | | Aluminum Bar Stock | Alloy 6061 | | Stainless Steel Sheet Metal | SAE 304 | | Stainless Steel Rod Stock | AISI 303 | | Nylon Powder Coating | USP Class VI Polyamide 11 | | Silicone Elastomer | USP Class VI Vinyl Methyl Siloxane,<br>Platinum Cured | | Filter Paper | Ahlstrom Reliance 335 WL11395D, a Wet<br>Laid Non-Woven Fabric comprised of Natural<br>Wood Pulp Fibers bonded with a Synthetic<br>Resin Binder, having a Basis Weight of 52.2<br>g/m². Cleared by FDA for use as a<br>Sterilization Barrier System under 510(k)<br>Number K800123. | ### Indications For Use The Jewel Precision Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used, for a maximum of 30 days. Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270 °F (132 °C) for 4 minutes with a drying time of 30 minutes. Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddles, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container. Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is single use only. {5}------------------------------------------------ | Summary of the Technological Characteristics of the Device Compared to the Predicate Device | | | | |--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Characteristic | Predicate Device - K142529…