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.

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.

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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the CooperSurgical Ally Uterine Positioning System™ (UPS), specifically an update to include the Advincula Delineator™ Adapter Drape. This is a medical device, and the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance or AI effectiveness.

Therefore, many of the requested categories for AI-related studies (like MRMC, human-in-the-loop, training set details) are not applicable here. The document details non-clinical performance testing for a physical device.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristic)	Reported Device Performance
Adapter Pull-off Force	Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds).
Drape Pull-off Force	Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds).
Handle Push Force	Maintained specifications (specific values not provided in this summary, but implies it met predetermined thresholds).
Sterilization Validation	Advincula Delineator™ Adapter Drape meets appropriate ethylene oxide and ethylene chlorohydrin residual levels per ANSVAAMI/ISO 10993-7:2008(R)2012, and achieved a Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1:2007 and ISO 11135-2:2008.
Shelf Life (Stability Testing)	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.
Electrical Safety & Performance	Ally UPS is in compliance with IEC 60601-1 CORR 1 & 2 2007 and IEC 60601-1-2.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for each specific test (e.g., number of adapters tested for pull-off force). This is common for this type of summary, where the focus is on the type of test and the outcome rather than the granular details of the test execution (which would be in a full test report).

The data provenance is from non-clinical performance testing conducted by CooperSurgical, Inc. The document does not specify country of origin for the data; it's assumed to be part of the manufacturer's internal testing process. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device before market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. This is a physical medical device, not an AI or diagnostic tool where human experts establish ground truth. The "ground truth" here is determined by engineering specifications, safety standards, and performance metrics measured in laboratory settings.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of human-interpreted data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of this device submission. The document explicitly states: "Clinical testing was not required to support the conclusion of substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

Engineering Specifications and Performance Metrics: Pre-defined thresholds for forces (pull-off, push), material properties, and functionality.
International Standards: Compliance with standards like ISO 11135, ISO 10993, ASTM F1980, and IEC 60601 for sterilization, shelf life, and electrical safety. These standards themselves are established through expert consensus and scientific validation.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K153092

Device Name Ally Uterine Positioning System™

Indications for Use (Describe)

Ally Uterine Positioning System™

Adapter Drape for the Ally UPS System

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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(Goper Surgical

510(k) Summary CooperSurgical Ally Uterine Positioning System™ (UPS) K153092

Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611
	Telephone: 203-601-5200
	Fax: 203-601-9870
Contact Person:	Roaida JohnsonAssociate 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:

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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)

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	SubjectAlly Uterine Positioning System™	PredicateAlly Uterine PositioningSystem - K141523
Indications for Use: AllyUPS	The Ally UPS is intended to assist thesurgical staff in mounting, positioning, andholding uterine manipulators duringgynecological laparoscopic surgicalprocedures. It is intended for use by trainedoperating room personnel in an operatingroom environment.	Same
Indications for Use:Adapter Drape	The Advincula Delineator™ Adapter Drapefor the Ally UPS System is intended to assistthe surgical staff in mounting, positioning,and holding uterine manipulators duringgynecological laparoscopic surgicalprocedures. It is intended for use by trainedoperating room personnel and in an operatingroom 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 heatsealed chevron pouch. The pouches arepackaged in SBS paperboard cartons and areplaced into corrugated shipping cases fortransport and storage.	Same
Sterilization	The Delineator Adapter Drape is sterilizedby ethylene oxide to a Sterility AssuranceLevel (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.

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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.

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.