The ALLY II UPS™ (Uterine Positioning System) 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 ALLY II UPS™ (Uterine Positioning System) attaches to the operating room table and enables the bed-side assistant to readily mount, hold, and position the manipulator during laparoscopic surgical procedures. The ALLY II UPS enables access and provides the ability to maneuver and maintain the manipulator in a desired position. The ALLY II UPS consists of the ALLY II UPS and a manipulator adapter with built-in sterile drape, known as the adapter drape.

The CooperSurgical ALLY II UPS is a non-patient contacting, electromechanical device that consists of a single, multi-segmented, articulated arm. The ALLY II UPS can be attached to the standard operating room bed rail, and a separate, sterile, disposable Adapter Drape that is used to attach a uterine manipulator to the ALLY II UPS. When unlocked, the flexible arm allows the attached manipulator to be positioned by the user. The arm can then be locked in the desired position by releasing a foot pedal, activating a linear actuator that applies tension to an internal cable, drawing the segments together and thus locking the arm. The segmented design of the arm allows lateral/medial movement from a single point to position the uterine manipulator.

The purpose of this submission is to gain clearance for minor modifications made to the ALL Y Uterine Positioning System to meet user needs and allow for user convenience. The overall functionality and interface of the ALLY II UPS for the user remains the same.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the ALLY II UPS™ (Uterine Positioning System). This type of document is for medical devices, not AI/ML algorithms. Therefore, the questions related to AI/ML specific aspects like training data, ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to this submission.

The acceptance criteria and performance data described in this document relate to the physical and mechanical performance of the revamped medical device compared to its predicate.

Here's an analysis based on the provided text, focusing on the device's acceptance criteria and proven performance:

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

The document doesn't provide a direct table of acceptance criteria with corresponding performance values for the ALLY II UPS™. Instead, it broadly states that "The ALLY II UPS met the pre-determined acceptance criteria for each intended output." It lists the types of tests performed.

Implied Acceptance Criteria and Performance (based on Section VII. Performance Data):

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Durability (Useful Life)	Device sustains intended function, material integrity, and performance over its expected lifespan.	"was performed" (details not provided, but implies met criteria given substantial equivalence conclusion)
Holding Force	Device can consistently and securely hold uterine manipulators in desired positions without slippage or movement beyond acceptable tolerances.	"was performed" (details not provided, but implies met criteria given substantial equivalence conclusion)
Range of Motion	Device can manipulate to designated 6 points of extension in anteverted hand position and designated 5 points of extension in retroverted hand position.	Subject device has "greater Range of Motion than the predicate" and met the specified extension points.
Link Soak	Materials of the flexible arm (17-4 stainless steel, PEEK inserts) maintain integrity and function after exposure to relevant cleaning/sterilization protocols.	"was performed" (details not provided, but implies met criteria given substantial equivalence conclusion)
Foot Pedal Cable Retention	The detachable foot pedal cable remains securely connected during use and does not pose a safety risk.	"Justification" submitted (details not provided, but implies met criteria given substantial equivalence conclusion)
Electrical Safety (IEC 60601-1)	Compliance with general requirements for basic safety and essential performance of medical electrical equipment.	Device is "compliant with the following standards: IEC 60601-1: 2005+AMD1:2012+AMD2:2020 CSV"
EMC (IEC 60601-1-2)	Compliance with requirements for electromagnetic compatibility for medical electrical equipment.	Device is "compliant with the following standards: IEC 60601-1-2: 2014"

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the sample size for any of the tests (Durability, Holding force, Range of motion, Link Soak, Foot Pedal Cable Retention).
Data Provenance: The data provenance is internal testing performed by CooperSurgical, Inc. It is a prospective test in the sense that newly designed units of the ALLY II UPS™ were manufactured and then tested to demonstrate their performance. The country of origin for the testing is not explicitly stated but is implied to be within the company's operational context (likely US, given the FDA submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is a mechanical device, not an AI/ML system that requires expert interpretation for ground truth. The "ground truth" for this device would be defined by engineering specifications and objective measurements (e.g., force in Newtons, angles in degrees, material integrity).

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

Not applicable for this type of device. Adjudication methods are typically used in clinical studies or for establishing ground truth from human interpretations (e.g., radiology reads). The performance of this device is assessed through engineering and mechanical testing against predefined specifications.

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

Not applicable. This device is a mechanical uterine positioning system, not an AI-assisted diagnostic or therapeutic tool with human readers.

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

Not applicable. This is a purely mechanical device; there is no AI algorithm to test for "standalone" performance.

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

The "ground truth" in this context is defined by engineering specifications, mechanical measurements, and compliance with recognized standards. For example:

Holding Force: Measured in units of force (e.g., Newtons or pounds) against a specified minimum.
Range of Motion: Measured in degrees or specific positions achievable, defined by design.
Durability: Performance over a specified number of cycles or operating hours.
Material Integrity: Assessed through material science tests and visual inspection post-soak/cycle.
Electrical Safety/EMC: Compliance verified against the specified IEC standards (60601-1 and 60601-1-2).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not an AI/ML device.

Summary

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October 28, 2022

CooperSurgical, Inc. Yin Huang Regulatory Affairs Specialist 95 Corporate Drive Trumbull, CT 06611

Re: K223064

Trade/Device Name: ALLY II UPSTM (Uterine Positioning System) Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 28, 2022 Received: September 30, 2022

Dear Yin Huang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223064

Device Name ALLY II UPSTM (Uterine Positioning System)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K223064 ALLY II UPS™ (Uterine Positioning System)

I. Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611Telephone: 203-601-5200
Contact Person:	Yin HuangRegulatory Affairs Specialist
Date Prepared:	October 27, 2022
II. Device Information:

Trade Name:	ALLY II UPS™ (Uterine Positioning System)
Common Name:	Uterine positioning system
Regulation Name:	Obstetric-gynecologic specialized manual instrument
Regulation Number:	884.4530
Regulatory Class:	II
Product Code:	LKF (Cannula, Manipulator/Injector, Uterine)

III. Predicate Device Information:

ALLY Uterine Positioning System™ (K141523), manufactured by CooperSurgical Inc. The predicate device has not been subject to a design-related recall

IV. Device Description:

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V. Indications for Use:

The ALLY II UPS™ (Uterine Positioning System) 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.

VI. Comparison of Technological Characteristics with the Predicate Device

A comparison of the intended use and technological characteristics of the subject and predicate device are included in the table below.

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Attribute	Predicate	Subject	Comparison
	ALLY Uterine	ALLY II UPSTM
	Positioning System	(Uterine Positioning
	(UPS) - K141523	System)
Principles of Operation	The ALLY II UPSTM(Uterine PositioningSystem) is intended toassist the surgical staff inmounting, positioning,and holding uterinemanipulators duringgynecologicallaparoscopic surgicalprocedures. It is intendedfor use by trainedoperating room personnelin an operating roomenvironment.	The ALLY II UPSTM(Uterine PositioningSystem) is intended toassist the surgical staff inmounting, positioning,and holding uterinemanipulators duringgynecologicallaparoscopic surgicalprocedures. It is intendedfor use by trainedoperating room personnelin an operating roomenvironment.	Identical
Sterilization	Non-sterile	Non-sterile	Identical
Range of motion	When the device isattached to the operatingtable bed rail:Anteverted hand position- The distal tip of theuterine manipulatorattached to the device canreach the:Anteverted handposition canmanipulate todesignated 6points ofextensionRetroverted hand position- Not Applicable	When the device isattached to the operatingtable bed rail:Anteverted hand position- The distal tip of theuterine manipulatorattached to the device canreach the:Anteverted handposition canmanipulate todesignated 6points ofextensionRetroverted hand position=Retroverted hand positionis able to manipulate todesignated 5 points ofextension	Different:The subject device hasgreater Range of Motionthan the predicate. TheRange of Motiondifference does not raisedifferent questions ofS&E.
Rotation angle of theElbow	None – elbow is fixed at50° toward sagittal planeof patient	Rotate 70° away from thesagittal plane of patient	Different:The subject device hasgreater Range of Motionthan the predicate. TheElbow rotation differencedoes not raise differentquestions of S&E.
Material(s) of the armLINKS	303 stainless Steel	17-4 stainless steel	Different:
			This modification allowsfor a longer useful life ofthe Flexible Arm for thesubject device than thepredicate The materialchange does not raisedifferent questions ofS&E
PEEK Inserts in theLINKS and Elbow	No protective inserts overactuator cable	Additional inserts toprovide a protectivebarrier for the cable	Different:
			This modification allowsfor a longer useful life ofthe Flexible Arm for thesubject device than thepredicate. The PEEKinsert in the LINKs doesnot raise differentquestions of S&E
Foot pedal connection todevice	Hard wired to device -undetachable	Connector can bedetachable	Different:
			The subject deviceprovides moreconvenience for usersthan the predicate byallowing ease of mobilityand packing of the devicein moving the unit aroundthe hospital. Thedetachable connectiondoes not raise differentquestions of S&E
Grounding Post	None	Attached to bottom ofdevice as a built-in featurefor grounding the device	Different:
			The Grounding Post isadded as an additionalgrounding option forhospitals when they haveconcerns over electricalgrounding within thehospital setting.The Grounding Post doesnot raise differentquestions of S&E
Handle	Flat plate with fingerholding	Whole hand handle	Different:
			This modification wasmade as an ergonomicchange to provide moreuser convenience

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The subject ALLY II UPS has the same Intended Use, fundamental scientific technology, and similar materials as the predicate device. The subject device has an identical principle of operation and similar design to the predicate device.

The minor design changes for user convenience consist of:

1. Improvement to the range of motion of the flexible arm to give users more flexibility in positioning uterine manipulators during gynecological laparoscopic surgical procedures.
1. Minor modifications to the design features of the flexible arm to aid in flexibility, durability, and cleaning of the device.
1. Addition of a detachable foot pedal connection where the predicate device was hard wired into the unit.

The changes in technological characteristics do not raise different questions of safety and effectiveness.

VII. Performance Data

The support the proposed modifications to the subject device, design control activities and a risk analysis (depicting device change, risk associated, verification method, acceptance criteria and summary of results) was performed. The ALLY II UPS was tested to identified verification and validation activities including tests comparing the subject device to the predicate ALL Y UPS -K141523.

Durability (Useful Life) testing .
. Holding force testing
Range of motion testing ●
. Link Soak testing
. Foot Pedal Cable Retention Justification

The device is compliant with the following standards:

IEC 60601-1: 2005+AMD1:2012+AMD2:2020 CSV Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

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IEC 60601-1-2: 2014 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance

The subject ALLY II UPS met the pre-determined acceptance criteria for each intended output. Therefore, design verification testing determined that the subject ALLY II UPS is substantially equivalent to the identified predicate device.

VIII. Conclusion

The results of the testing described above demonstrate that the ALLY II UPS™ (Uterine Positioning System) is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.