Ally Uterine Positioning 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 21, 2015 CooperSurgical, Inc. Roaida Johnson Associate Director, New Product Development 95 Corporate Drive Trumbull, CT 06611 Re: K153092 Trade/Device Name: Ally Uterine Positioning System™ Regulation Number: N/A Regulation Name: N/A Regulatory Class: Not Classified Product Code: LKF Dated: December 8, 2015 Received: December 9, 2015 Dear Roaida Johnson, 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 {1}------------------------------------------------ the quality systems (OS) 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 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, **Herbert P. Lerner -S** Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153092 Device Name Ally Uterine Positioning System™ # Indications for Use (Describe) Ally Uterine Positioning System™ The Ally Uterine Positioning System™ (UPS) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. #### Adapter Drape for the Ally UPS System The Advincula Delineator™ Adapter Drape for the Ally Uterine Positioning System™ UPS is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. | 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}------------------------------------------------ # (Goper Surgical # 510(k) Summary CooperSurgical Ally Uterine Positioning System™ (UPS) K153092 #### Submitter Information | Company Name: | CooperSurgical Inc. | |------------------|-----------------------------------------------------------------| | Company Address: | 95 Corporate Drive<br>Trumbull, CT 06611 | | | Telephone: 203-601-5200 | | | Fax: 203-601-9870 | | Contact Person: | Roaida Johnson<br>Associate Director of New Product Development | | | Phone: 203-601-5200 Ext: 3325 | | | Fax: 203-601-9870 | | | roaida.johnson@coopersurgical.com | | Date Prepared: | December 15, 2015 | #### Device Information: | Trade Name: | Ally Uterine Positioning System™ | |----------------------|--------------------------------------| | Common Name: | Holder, Manipulator, Positioner, Arm | | Classification: | Unclassified | | Classification Name: | Unclassified | | Product Code: | LKF | #### Predicate Device Information: The CooperSurgical Ally Uterine Positioning System™ is substantially equivalent to the predicate CooperSurgical Ally Uterine Positioning System™ (K141523) #### Device Description: The CooperSurgical Ally Uterine Positioning System™ (UPS) consists of a single, multi- segmented, articulating arm that attaches to a standard operating room bed rail, and a separate, sterile, disposable Ally UPS Adapter Drape that is used to attach a uterine manipulator to the Ally UPS. When unlocked, the articulation of the arm allows the attached manipulator to be positioned by the user. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator. The arm is then locked in the desired position by releasing a food pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The Ally UPS is not intended for patient contact. The Adapter Drape for the Ally UPS is single- use and sterilized by ethylene oxide. The Ally UPS Adapter Drape secures either the Cooper Surgical RUMI II {4}------------------------------------------------ Uterine Manipulator Handle, or the Advincula Arch Uterine Manipulator Handle, to the distal end of the Ally UPS arm. The purpose of this submission is to gain clearance to add the new Advincula Delineator™ Adapter Drape to the system, which allows the Ally UPS to be used with the CooperSurgical Advincula Delineator™ Uterine Manipulator. #### Indications for Use: ## Ally Uterine Positioning System™ (UPS) The Ally Uterine Positioning System™ (UPS) is intended to assist the surgical staff in mounting, positioning and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. ## Adapter Drape for the Ally UPS System The Advincula Delineator™ Adapter Drape for the Ally Uterine Positioning System™ UPS is intended to assist the surgical staff in mounting, and holding uterine manipulators during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment. | Attribute | Subject<br>Ally Uterine Positioning System™ | Predicate<br>Ally Uterine Positioning<br>System - K141523 | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Indications for Use: Ally<br>UPS | The Ally UPS is intended to assist the<br>surgical staff in mounting, positioning, and<br>holding uterine manipulators during<br>gynecological laparoscopic surgical<br>procedures. It is intended for use by trained<br>operating room personnel in an operating<br>room environment. | Same | | Indications for Use:<br>Adapter Drape | The Advincula Delineator™ Adapter Drape<br>for the Ally UPS System is intended to assist<br>the surgical staff in mounting, positioning,<br>and holding uterine manipulators during<br>gynecological laparoscopic surgical<br>procedures. It is intended for use by trained<br>operating room personnel and in an operating<br>room environment. | Same | | Patient Contact Type | Non-Patient Contacting | Same | | Ally UPS Material | Stainless steel, aluminum | Same | | Adapter Drape Material | Lexan, 2 mil polyethylene film | Same | | Packaging | Tyvek 1073B/polyester/polyethylene heat<br>sealed chevron pouch. The pouches are<br>packaged in SBS paperboard cartons and are<br>placed into corrugated shipping cases for<br>transport and storage. | Same | | Sterilization | The Delineator Adapter Drape is sterilized<br>by ethylene oxide to a Sterility Assurance<br>Level (SAL) of 10-6. | Same | #### Substantial Equivalence Analysis The substantial equivalence of the subject Ally UPS System with the Advincula Delineator™ Adapter Drape to the predicate is shown by similarity of intended use, indications for use, materials, design, function, sterilization, and performance. {5}------------------------------------------------ ## Non-Clinical Performance Testing The modified Ally UPS with the Advincula Delineator™ Adapter Drape was compared to the predicate for the following performance characteristics: - . Adapter Pull-off Force - Drape Pull-off Force - Handle Push Force . The Advincula Delineator™ Adapter Drape maintained its specifications for the duration of its shelf life as demonstrated by stability testing in accordance with ASTM F1980-07. Sterilization validation performed per ISO 11135-1:2007- Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, and ISO 11135-2:2008 - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 demonstrated that the Advincula Delineator™ Adapter Drape meets the appropriate ethylene oxide and ethylene chlorohydrin residual levels per the requirements of ANSVAAMI/ISO 10993-7:2008(R)2012 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. The Ally UPS is in compliance with the following standards: - IEC 60601-1 CORR 1 & 2 2007 Medical Electrical Equipment Part 1: General Requirements . for Basic Safety and Essential Performance - IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety ● #### Clinical Performance Testing Clinical testing was not required to support the conclusion of substantial equivalence. #### Conclusion Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate, the modified Ally Uterine Positioning System™ (UPS) has been shown to be substantially equivalent to the predicate device identified, and does not present any new issues of safety or effectiveness.