ALLY UPS

K141523 · CooperSurgical, Inc. · LKF · Nov 25, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141523
• Device Name: ALLY UPS
• Applicant: CooperSurgical, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures. It is intended for use by trained operating room personnel in an operating room environment.

Device Story

The Ally Uterine Positioning System (UPS) is a mechanical surgical support device used in operating rooms by surgical staff. It consists of a multisegmented, articulated arm that attaches to an OR bed rail and a sterile distal adapter. The device holds uterine manipulators (e.g., RUMI II or Advincula Arch) in a fixed position during gynecological laparoscopic procedures. Operation involves manually positioning the arm when unlocked, then depressing a foot pedal to activate a linear actuator; this applies tension to an internal cable, drawing segments together to lock the arm in place. A sterile adapter drape covers the arm to maintain the sterile field and prevent contamination. By providing stable, hands-free positioning of the uterine manipulator, the device assists the surgical team in maintaining optimal visualization and access during surgery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including holding (locking) force, durability (cycle) testing, handle push force, drape pull-off force, and adapter pull-out force. The device complies with IEC 60601-1 and IEC 60601-1-2 standards. Shelf-life stability was validated per ASTM F1980-07.

Technological Characteristics

Materials: stainless steel, aluminum. Sensing/Actuation: foot-pedal activated linear actuator applying tension to an internal cable for mechanical locking. Form factor: multisegmented, articulated arm for OR bed rail mounting. Sterilization: ethylene oxide for the adapter drape (SAL 10^-6). Connectivity: none (mechanical).

Indications for Use

Indicated for use by trained operating room personnel to assist in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic surgical procedures.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• Intuitive Surgical Probe Holder System (K071405)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Cooper Surgical Inc. c/o Tim M. Lohnes Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton. CT 06484

Re: K141523

Trade/Device Name: Ally Uterine Positioning System™ Adapter Drape for the Ally Uterine Positioning System™ Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Dated: October 17, 2014 Received: October 20, 2014

Dear Tim M. Lohnes:

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

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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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141523

Device Name Ally Uterine Positioning System TM

Indications for Use (Describe)

The Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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# Indications for Use

510(k) Number (if known) K141523

Device Name

Adapter Drape for the Ally Uterine Positioning System™

Indications for Use (Describe)

The Adapter Drape for the Ally Uterine Positioning System™ (Ally UPS) is intended to assist the surgical staff in mounting, positioning, and holding uterine manipulators during gynecological laparoscopic 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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# Goper Surgical

# 7. 510(K) SUMMARY:

510(k) Summary of Safety and Effectiveness, (21 CFR 807.92):

| Submitter: | Cooper Surgical Inc.,<br>75 Corporate Drive,<br>Trumbull, CT 06611 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim M. Lohnes<br>Senior Regulatory Consultant,<br>Orchid Design<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | November 20, 2014 |
| Name of Device:: | Cooper Surgical ALLY Uterine Positioning<br>System™ (UPS) |
| Common/Usual Name: | Holder, Manipulator, Positioner, Arm |
| Classification Name: | Unclassified |
| Device Class: | Class II |
| Product Code: | LKF |
| Predicate Device(s): | Intuitive Surgical "Probe Holder System,<br>K071405 |

Device Description;

The Cooper Surgical ALLY Uterine Positioning System™ (UPS) consists of a single multisegmented, articulated Arm that attaches to a standard OR bed rail and a separate, sterile distal adapter to accommodate a uterine manipulator. When unlocked, the articulation of the Arm allows the attached manipulator to be positioned by the user. The Arm is then locked in the desired position by depressing a foot pedal, activating a linear actuator which applies tension to an internal cable, drawing the segments together and locking the Arm.

The segmented design of the Arm allows lateral/medial movement from a single point, allowing the System to be attached to one side of the OR table.

The ALLY Uterine Positioning System™ (UPS) is not intended for patient contact. The Adapter Drape for the ALL Y Uterine Positioning System™ (UPS) is provided sterile (sterilized by ethylene oxide).

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### (Device Description, cont.)

The ALLY UPS Adapter Drape secures either the Cooper Surgical RUMI II Uterine Manipulator Handle or the Advincula Arch Uterine Manipulator Handle to the distal end of the ALLY Arm. After attaching the Adapter, the sterile Drape is deployed to cover the non-sterile ALLY UPS Arm, maintaining the sterile field and protecting the Arm from contamination during the procedure.

## Indications for Use:

## ALLY Positioning System;

The ALL Y 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.

## ALLY Adapter Drape:

The 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.

| Attribute | ALLY Uterine<br>Positioning System™<br>(UPS) | Intuitive Surgical<br>"Probe Holder<br>System, K071405 | Determination |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Body Contact Type | Non-Patient Contact | Non-Patient Contact | Substantially<br>Equivalent |
| Material(s) | Stainless steel, aluminum | Stainless steel,<br>aluminum | Substantially<br>Equivalent |
| Environment | Operating room | Operating room | Substantially<br>Equivalent |
| Indications for Use,<br>ALLY Positioning<br>System | The ALLY Uterine<br>Positioning System™<br>(UPS) is intended to assist<br>the surgical staff in<br>mounting, positioning and<br>holding uterine<br>manipulators during<br>gynecological laparoscopic<br>surgical procedures. It is<br>intended for use by trained<br>operating room personnel<br>in an operating room<br>environment. | The Probe Holder<br>System is intended to<br>assist the surgical<br>staff in mounting,<br>positioning and<br>holding a uterine<br>manipulator during<br>gynecological<br>laparoscopic surgical<br>procedures. It is<br>intended for use by<br>trained operating<br>room personnel in an<br>operating room<br>environment | Substantially<br>Equivalent |

Comparison of Technological Characteristics with the Predicate Device:

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| Indications for Use, | The Adapter Drape for the | (Substantially |
|----------------------|-----------------------------|----------------|
| ALLY Adapter Drape | ALLY Uterine Positioning | Equivalent) |
| | 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. | |
| | | |
| | | |

| Attribute | ALLY Uterine<br>Positioning System™<br>(UPS) | Intuitive Surgical<br>“Probe Holder<br>System, K071405 | Determination |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Biocompatibility | No part of the ALLY UPS<br>is intended for patient<br>contact. The Adapter<br>portion of the Adapter<br>Drape is provided sterile as<br>it attaches to the uterine<br>manipulator within the<br>sterile field. The Drape<br>portion maintains sterility<br>in the event of inadvertent<br>patient contact, as well as<br>protects the Arm from<br>contamination during the<br>procedure. | Not included in the<br>510(k) Summary<br>Statement. | Substantially<br>Equivalent |
| Packaging | The ALLY UPS Adapter<br>Drape is heat-sealed in a<br>single sterile barrier<br>DuPont Tyvek® Pouch<br>(Uncoated 1073B Tyvek®<br>bonded to .0005”<br>polyester/0.0015/0.002<br>LDPE). The pouches are<br>labeled and packaged in<br>pressboard cartons.<br>The ALLY device and<br>non-sterile accessories are<br>shipped using packaging<br>appropriate to the design<br>and construction of the<br>instrument to prevent<br>damage during shipping | The Intuitive Surgical<br>Endoscopic<br>Instrument Control<br>System included a<br>Drape, packaged in a<br>Tyvek/polymylar peel<br>pouch and gamma<br>sterilized Reusable<br>adapters are provided<br>for Cooper Surgical<br>uterine manipulators;<br>specifically for the<br>RUMI® System<br>Uterine Manipulators<br>RUMI® UMH600 and<br>RUMI® Arch™<br>UMH700. | Substantially<br>Equivalent |

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| (Packaging) | This may include foam | The Adapters are | (Substantially |
|----------------------|------------------------------|-------------------------|----------------|
| | cushioned corrugated | supplied non-sterile. | Equivalent) |
| | cardboard shippers, PETG, | | |
| | vinyl, or acrylic tubes with | | |
| | end caps, and 2 or 4 mil | | |
| | polybags for small/light | | |
| | weight components. | | |
| Stability/Shelf Life | The ALLY UPS Adapter | Sterilized by end user. | Substantially |
| | Drape is sterilized by | | Equivalent |
| | Assurance Level (SAL) of | | |
| | 10°, with an initial shelf | | |
| | life of one year. | | |

The basis of substantial equivalence of the ALL Y Uterine Positioning System™ (UPS) is the similarities in materials, design, function, performance, sterilization, and indications for use in comparison to the predicate device.

## Performance Data:

The ALL Y Uterine Positioning System™ (UPS) was tested in comparison to the predicate Intuitive Surgical "Probe Holder System, K071405 for;

1) Holding (locking) force

Testing also included; 1) Durability (cycle) testing 2) Handle push force 3) Drape pull off force 4) Adapter pull out force

The device 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

The Adapter Drape maintained its specifications for the shelf-life as demonstrated by stability testing in accordance with ASTM F1980-07.

Clinical testing was not required to support the conclusion of substantial equivalence.

## Conclusion:

The substantial equivalence of the Cooper Surgical ALLY Uterine Positioning System (UPS) has been established by the similarities in design, materials, function, and Intended Use to the previously cleared Intuitive Surgical "Probe Holder System", K071405.