CARR RIGID CONTAINER SYSTEM

{0}------------------------------------------------ K972138 Carr Metal Products, Inc. 3735 N. Arlington Ave. ## Indianapolis, IN 46218 NOV 1 3 1997 ## Non-Coalidential Summary of Safety and Effectiveness page 1 of 4 November 7, 1997 Tel - (317) 542-0691 Fax - (317) 542-0694 | Official Contact: | Alan Booker - Operations Manager | |----------------------------|----------------------------------------------------------| | Proprietary or Trade Name: | Carr Sterilization Container System | | Common/Usual Name: | Sterilization Container - rigid | | Classification Name: | Sterilization wrap | | Device: | Carr Sterilization Container system | | Predicate Devices: | Aesculap - K792558, Medin - K833343, InstruMed - K844672 | | | and Riley - K871202 | #### Device Description: Carr Metal Products, Inc. 3735 N. Arlington Ave. Indianapolis, IN 46218 A rigid container system include a base available in several depth sizes ( 2.5", 3.0", 3.5", 4.0" and 5.0") and a lid which fits any of the bases. The lid is a standard size which fits any size (depth) of base, it also incorporates a filter retainer unit which holds a disposable filter, has a seal and incorporates a latching mechanism which latches the lid and base together. - Container system designed to contain medical and dental (excluding dental Indicated Use -hand pieces) instruments for sterilization, storage, and transportation. Suitable for Pre-vacuum steam and EO sterilization. Used and handled by healthcare personnel such as - central supply, operating room nurses, surgical nurses, dental assistants, or healthcare personnel who have responsibility for the cleaning, handling, sterilization and storage of medical and dental (excluding dental hand pieces) instruments. - Environment of Use -- Used in health care facilities hospitals, nursing homes, extended care facilities, free standing surgical centers, clinics and medical and dental offices. Within these facilities the setting may be where medical and dental (excluding dental hand pieces) instruments which are required to be sterile {1}------------------------------------------------ # Non-Confidential Summary of Safety and Effectiveness ## page 2 of 4 ## November 7, 1997 are utilized. Examples are - operating rooms - acute, sub-acute, outpatient are utilized. Examples are - operating rooms - acutes services of a hospital. are utilized. Examples are - operating rooms - a2009. surgery, physician and dental offices, wards, central services of a hospital. Summary of Performance Testing -- ce Testing -The Carr Container system was independently tested ecording to AAMI ST The Carr Container and ST 24-1192 for its performance under The Carr Container system was independently bases 33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its performance under 33, ANSI / AAMI ST 41-1992 and ST 24-1192 for its perfor 33, ANSI / AAMI ST 41-1992 and ST 24-11-2 154 -12-11-11-11 two(2) sterilization methods - Pre-vacuum steam ( (2700 - 2750 F) and two(2) sterilization methods - Pre-vacuum siealis (1275 Ethylone Oxide (EO). It passed all criteria specific to sterilization containers Ethylone Oxide (EO). It passed all c Ethylene Oxide (EO). It passed as . and maintained a shelf life sterility of at least 30 days. The staintained a shelf life sterility of at least 30 days. maintained a shell like story. | Comparison to Predicate Devices: | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------| | Attribute | Carr Container | Aesculap<br>K792558 or other<br>referenced predicates | | Use | | | | Indicated for holding instruments<br>to be sterilized and stored | Yes | Yes | | Intended to be reused | Yes | Yes | | Methods of sterilization -<br>pre-vacuum steam (2700F - 2750F)<br>for a minimum of 4 minutes<br>ethylene oxide follow sterilizer<br>manufacturer's recommendations<br>Minimum 12 hours aeration | Yes | Yes | | Design | | | | Various sizes(2.5, 3.0, 3.5, 4.0, 5.0") depth<br>of bases offered | Yes | Yes | | Incorporates a filter to permit entry<br>of steriliant agent and prevent microbial<br>migration during storage | Yes | Yes | | Utilizes latch system to hold<br>lid in place | Yes | Yes | | page 3 of 4<br>November 7, 1997<br>Carr Container | | | | Attribute | | Aesculap<br>K792558 or other<br>referenced predicates | | Design | | | | Filter retainer does not have direct align-<br>ment holes preventing accidental puncture | Yes | No | | media of filter | Yes | | | Incorporates a silicone seal within lid | Yes | Yes | | Utilizes trays to hold instruments | Yes | Yes | | in place | Yes | Yes | | Has a tamper evident device slot | Yes | | | Outside labeling slot | | | | Useful life subject to user handling<br>and routine inspection after each use | Yes | Yes | | Performance Standards / Specifications | | | | AAMI ST 33-R-11/95 Standard testing and requirements | Yes | Claimed by Aesculap<br>K792558 | | 3.2 Permits transfer of contaminated materials | Yes | Claimed by<br>Aesculap K792558 | | 3.3.1 Removable filter assembly disassembles | Yes | On Aesculap K792558 | | 3.3.4 Labeling - reusable labels | Yes | Claimed by IntsruMed<br>K844672 | | 3.4 - 3.5 Instructions provided for different cleaning<br>methods | Yes | Assumed provided | | 3.6 - 4.2 Instructions for inspections | Yes | | | 6.2.2 Sterilization - manufacturer documentation<br>available | Yes | Claimed by Medin<br>K833343, InstruMed<br>K844672 | | 6.2.3 Drying time in labeling | Yes | Assumed | | 6.2.4 EO residual removal - in labeling | Yes | Assumed | | 6.2.5 Sterility maintenance - discussed in labeling,<br>claimed in independent testing | Yes | InstruMed K844672 | {2}------------------------------------------------ # Non-Confidential Summary of Safety and Effectiveness Confidential Summary of Safety on : ・・ {3}------------------------------------------------ # Non-Confidential Summary of Safety and Effectiveness رالا ## November 7, 1997 | Attribute | Carr Container | Aesculap | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------| | | | K792558 or other | | | | referenced predicates | | The first of the first of the country of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the consisted on the | | | | Performance Standards / Specifications | | | |--------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------------------------| | 6.3 User (basic) responsibilities listed in labeling | Yes | Assumed | | 7.3.1 Routine inspection in labeling | Yes | Assumed | | Testing of container under a challenge per<br>ANSI / AAMI ST 41-1992 and ST24-1992<br>for prevacuum steam and EO sterilization | Passed | Claimed by Medin in<br>literature - K833343 | | Claim of at least 30 days sterility shelflife<br>supported by test data | Yes | InstruMed K844672 | | Validation study performed to determine<br>that contents would be sterile utilizing pre-<br>vacuum steam and ethylene oxide | Yes | Claimed by Aesculap<br>K792558, Medin<br>K833343 | | Materials | | | | Aluminum for lid and base | Yes | Yes | | Coating for lid and base | Yes | Yes | | Approved filter media | Yes | Yes | # Differences Between Other Legally Marketed Predicate Devices There are no significant differences between the intended device and the predicate - Aesculap approved under K792558, Medin - K833343, InstruMed - K844672 and Riley - K871202. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Alan Booker Operations Manager Carr Metal Products, Incorporated 3735 N. Arlington Avenue Indianapolis, Indiana 46218 NOV 1 3 1997 K972138 Re : Carr Rigid Container System Trade Name: Regulatory Class: II Product Code: FRG Dated: September 5, 1997 Received: September 8, 1997 Dear Mr. Booker: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. → {5}------------------------------------------------ Page 2 - Mr. Booker This letter will allow you to begin marketing your device as first feet wire as 0 (k) premarket notification. The FDA described in your sit (i) privalence of your device to a legally Finding or subbeancear equite in a classification for your markets produce, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcathed from the Division of Smart Manufaceardin (201) 443-6597 milli its internet address "http://www.fda/gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timothy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 11/12/199/ 12:20 31.1-335-9278 ## INDICATIONS FOR USE Page 1 of 1 510(k) Number: K972138 Carr Rigid Sterilization Container System Device Name: Container system designed to contain medical and dental Intended Use : (excluding dental hand pieces) instruments for sterilization and storage. This device is intended to be used and handled by healthcare personnel. This container system is suitable for Prevacuum steam and EO sterilization. Sterility assurance tested up to 30 days. Concurrence of CDRH, Office of Device Evaluation (ODE) Reorge L. Melle for Olin S. Zin Ph D (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K977138 510(k) Number . > Prescription Use (Per CFR 801.109) OL Over-the-counter use