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.

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.

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).

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cooper Surgical ALLY Uterine Positioning System™ (UPS) and its Adapter Drape. It asserts that the device is substantially equivalent to a predicate device, the Intuitive Surgical "Probe Holder System, K071405. The document describes performance data and testing conducted, but it does not describe a clinical study with human patients to prove the device meets acceptance criteria in the context of clinical outcomes or diagnostic accuracy. Instead, the performance data focuses on mechanical and functional aspects relevant to substantial equivalence determination for a surgical tool's positioning system.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Holding (locking) force	Tested (in comparison to the predicate device)
Durability (cycle) testing	Tested
Handle push force	Tested
Drape pull off force	Tested
Adapter pull out force	Tested
Compliance with IEC 60601-1	The device is in compliance with IEC 60601-1 CORR 1 & 2 2007 (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)
Compliance with IEC 60601-1-2	The device is in compliance with IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety)
Adapter Drape Shelf Life	Maintained specifications for a shelf-life of one year (demonstrated by stability testing in accordance with ASTM F1980-07)
Biocompatibility (for Adapter Drape)	The Adapter portion of the Adapter Drape is provided sterile as it attaches to the uterine manipulator within the sterile field. The Drape portion maintains sterility in the event of inadvertent patient contact, as well as protects the Arm from contamination during the procedure.
Sterilization Assurance Level (SAL)	ALLY UPS Adapter Drape is sterilized to a SAL of 10⁻⁶.

Note: The document primarily outlines the types of testing performed rather than specific quantitative acceptance criteria or exact performance values. The "Determination" column in the table of "Comparison of Technological Characteristics with the Predicate Device" consistently states "Substantially Equivalent," implying that the device's performance in these areas was deemed comparable to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the mechanical and functional tests conducted (e.g., number of units tested for holding force, durability, etc.). It describes device testing, not a clinical study involving patients or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The testing described is for the mechanical and functional performance of a surgical positioning system, not for diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes device safety and performance testing, not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a mechanical surgical positioning system, not an AI-powered diagnostic or assistive tool for "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical surgical tool, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This is not applicable. The "ground truth" for the device's performance would be engineering specifications, physical measurements, and compliance with standards, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable, as there is no "training set."

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

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.

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.,75 Corporate Drive,Trumbull, CT 06611
Contact Person:	Tim M. LohnesSenior Regulatory Consultant,Orchid DesignPhone: (203) 922 0105Fax: (203) 922 0130tim.lohnes@orchid-ortho.com
Date Prepared:	November 20, 2014
Name of Device::	Cooper Surgical ALLY Uterine PositioningSystem™ (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,K071405

Device Description;

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.

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(Device Description, cont.)

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 UterinePositioning System™(UPS)	Intuitive Surgical"Probe HolderSystem, K071405	Determination
Body Contact Type	Non-Patient Contact	Non-Patient Contact	SubstantiallyEquivalent
Material(s)	Stainless steel, aluminum	Stainless steel,aluminum	SubstantiallyEquivalent
Environment	Operating room	Operating room	SubstantiallyEquivalent
Indications for Use,ALLY PositioningSystem	The ALLY UterinePositioning System™(UPS) is intended to assistthe surgical staff inmounting, positioning andholding uterinemanipulators duringgynecological laparoscopicsurgical procedures. It isintended for use by trainedoperating room personnelin an operating roomenvironment.	The Probe HolderSystem is intended toassist the surgicalstaff in mounting,positioning andholding a uterinemanipulator duringgynecologicallaparoscopic surgicalprocedures. It isintended for use bytrained operatingroom personnel in anoperating roomenvironment	SubstantiallyEquivalent

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 UterinePositioning System™(UPS)	Intuitive Surgical“Probe HolderSystem, K071405	Determination
Biocompatibility	No part of the ALLY UPSis intended for patientcontact. The Adapterportion of the AdapterDrape is provided sterile asit attaches to the uterinemanipulator within thesterile field. The Drapeportion maintains sterilityin the event of inadvertentpatient contact, as well asprotects the Arm fromcontamination during theprocedure.	Not included in the510(k) SummaryStatement.	SubstantiallyEquivalent
Packaging	The ALLY UPS AdapterDrape is heat-sealed in asingle sterile barrierDuPont Tyvek® Pouch(Uncoated 1073B Tyvek®bonded to .0005”polyester/0.0015/0.002LDPE). The pouches arelabeled and packaged inpressboard cartons.The ALLY device andnon-sterile accessories areshipped using packagingappropriate to the designand construction of theinstrument to preventdamage during shipping	The Intuitive SurgicalEndoscopicInstrument ControlSystem included aDrape, packaged in aTyvek/polymylar peelpouch and gammasterilized Reusableadapters are providedfor Cooper Surgicaluterine manipulators;specifically for theRUMI® SystemUterine ManipulatorsRUMI® UMH600 andRUMI® Arch™UMH700.	SubstantiallyEquivalent

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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;

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.

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
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.
(b)
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.