The Singh Colpotomizer System is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required. The surgeon makes the colpotomy incisions to access or remove intraperitoneal tissue.

Device Description

The Singh Colpotomizer System is comprised of a reusable uterine manipulator with cervical screw attachment, a reusable sliding uterine tip (inner rod), reusable sliding and rotating funnels with a lip acting as a colpotomizer, an O ring and screw to hold the funnel in place, and a vaginal plug. The funnels are available in two sizes: 35 and 40mm.

In Laparoscopic Hysterectomy, the Uterine Cannula is inserted into the Uterus. The Vaginal Funnel slides onto the Uterine Cannula and is rotated manually during the operation to lift the Vaginal Wall for identification and incision during Laparoscopic Hysterectomy. This identifies the uterine arteries and ureters during this procedure.

Stainless steel and medical grade plastics are used in the manufacture of the subject device.

AI/ML Overview

The provided text describes a submission for a medical device called the "Singh Colpotomizer System" for 510(k) clearance, asserting substantial equivalence to the previously cleared "Koh Colpotomizer System." The document focuses on non-clinical and clinical data to support this claim, rather than defining explicit acceptance criteria and then proving the device meets those criteria with a study.

Instead, the submission presents data from the device's clinical use and then concludes that these data, along with non-clinical testing, show the device does not raise new questions of safety and effectiveness compared to the predicate device. Therefore, the "acceptance criteria" can be inferred from the adverse events and successful outcomes reported.

Here's an attempt to structure the information based on your request, acknowledging that explicit "acceptance criteria" tables are not directly provided in the text in the way you've requested for AI device evaluations.

Inferred Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are not explicitly stated as numerical thresholds for device performance like sensitivity or specificity. Instead, they are implicitly tied to maintaining safety and effectiveness comparable to the predicate device, with a focus on acceptable rates of complications and successful procedure completion.

Acceptance Criterion (Inferred from 510(k) Goal)	Reported Device Performance (from Clinical Use)
Safety:
No uterine perforation	0 cases of uterine perforation
Low incidence of ureteric injury	1 case of ureteric injury
Low incidence of bladder injury	6 cases of bladder injuries
Low incidence of vaginal vault bleeding	7 cases of vaginal vault bleeding
Low incidence of rectal injury	1 case of rectal injury
Effectiveness:
Maintenance of pneumoperitoneum	2148 cases (100%)
Successful laparoscopic procedure completion	2148 cases (100%)

Note: The "acceptance criteria" above are inferred from the adverse events and successful outcomes reported to demonstrate that the device is safe and effective and does not raise new questions compared to its predicate. Specific numerical thresholds for "low incidence" are not defined in the provided text.

Study Information

Due to the nature of this being a 510(k) submission for a surgical instrument rather than an AI/software device, many of the requested categories (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not directly applicable or explicitly detailed in the provided text. However, I will answer what can be inferred or directly stated.

Sample size used for the test set and the data provenance:
- Sample Size: 2148 cases.
- Data Provenance: Clinical performance data from the clinical use of the device in Western Australia since 2002. This is retrospective data from real-world use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study is a retrospective review of clinical use. The "ground truth" for reported adverse events and successful completion would have been established by the operating surgeons and medical records, rather than a panel of independent experts reviewing cases for a specific "ground truth" determination in the context of an AI device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable and not mentioned. The data are from routine clinical use and records, not an adjudicated test set in the context of an AI algorithm.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a surgical instrument, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable for a surgical instrument. The device is used by a surgeon who is always "in-the-loop."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the reported outcomes (adverse events, successful procedure completion, pneumoperitoneum maintenance) is based on outcomes data from routine clinical practice and medical records, as recorded by the operating surgeons and healthcare facilities.
The sample size for the training set:
- This concept is not applicable. The device is a physical surgical instrument; there is no "training set" in the context of machine learning. The clinical performance data (2148 cases) represents real-world usage data.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning sense for this device.

Summary

{0}------------------------------------------------

Preparation Date:	September 29, 2011	K110819OCT - 5 2011
Submission Correspondent:	Emergo Group, Inc.www.emergogroup.com/
Address:	611 West 5th Street, Third FloorAustin, TX 78701
Phone:	(512) 327-9997
Fax:	(512) 327-9998
Contact:	Caroline Tontini
Submission Sponsor:	Surgitools Pty Ltd.231 Timberlane DriveWoodvale, W.Australia, 6026AustraliaPhone: +618 93093222Fax: +618 93093736
Device Trade Name:	Singh Colpotomizer System
Device Common Name:	Uterine Manipulator and Vaginal Delineator
Classification Name:	Culdoscope (and Accessories) 884.1640, HEW
Device Class:	2

Legally Marketed Devices to which Substantial Equivalence is Claimed: The Koh Colpotomizer System 510(k) Number: K954311

CooperSurgical, Inc

Intended Use:

Device Description:

{1}------------------------------------------------

Stainless steel and medical grade plastics are used in the manufacture of the subject device.

Comparison to the Predicate Device:

਼?

יינ

The Singh Colpotomizer System has the same intended use as the Koh Colpotomizer System. The two devices use slightly different design features to achieve the same results; i.e. anterversion and retroversion of uterus, providing a landmark for vaginal vault incision, and maintenance of pneumoperitoneum during colpotomy and vaginal vault closure.

Both devices have 35mm and 40mm colpotomizers.

Both devices are provided non sterile and contain reusable components. All components of the Singh Colpotomizer System are reusable. The predicate device's silicon parts and balloons must be discarded after one use.

The subject device's inner rod can be retracted to fit variable uterine lengths. The predicate device's uterine tips are not retractable and require a range of uterine to fit various uterine lengths.

The Singh Colpotomizer System has a cervical screw on manipulator screws into the endocervical canal and maintains the device in position; while the predicate device features a balloon in the uterine tip which is inflated to hold the device within the uterus.

The Singh funnel is solid and selecting the correct sized non-fenestrated funnel, to provide a snug fit at the vaginal vault to prevent leakage of CO2. The Koh Colpo-Pneumo Occluder balloon is inflated prior to making colpotomy incisions to prevent CO2 leakage.

During uterine morcellation with the subject device, the stainless steel inner rod of the subject device can be retracted so that it does not interfere with the morcellator. Whereas in the predicate device, the plastic uterine tip and balloon cannot be retracted during uterine morcellation.

Similar to the predicate device, the uterus is pulled into the vagina after the colpotomy incisions are completed and acts as a vaginal plug to prevent CO2 leakage while the vaginal vault is sutured. Alternatively, the Singh Colpotomizer utilizes two other methods to maintain pneumoperitoneum if the uterus has been morcellated before delivery.

{2}------------------------------------------------

Summary of Non-Clinical Data Submitted:

The following testing has been performed to support substantial equivalence: Automated and Manual Cleaning Evaluation Reports according to AAMI TIR30:2003, Steam Sterilization Validation Report using the biological indicator (Bl) overkill method, ISO Guinea Pig Maximization Sensitization Test, ISO Mucosal (Vaginal) Irritation Test to ISO 10993-10:2002, ISO Acute Systemic Injection Test to ISO 10993-11:2006, MEM Elution Test to ISO 10993-5:2009, and Mediated Pyrogen Test to ISO 10993-11:2006.

Discussion of Clinical Tests Performed:

Clinical performance data from the clinical use of the device in Western Australia since 2002 was presented.

Number of cases:	2148
Number of women included in the study:	2148
Summary of adverse events:	No cases of uterine perforation
	1 case of ureteric injury
	6 cases of bladder injuries
	7 cases of vaginal vault bleeding
	1 case of rectal injury
Number of cases in which pneumoperitoneum was maintained:	2148
Number of cases successfully completed laparoscopically:	2148

Conclusion:

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

lt has been shown in this 510(k) submission that the differences between the Singh Colpotomizer System and the predicate device do not raise any questions regarding its safety and effectiveness. The Singh Colpotomizer System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a circular logo with a stylized depiction of the U.S. Department of Health and Human Services (HHS) symbol in the center. The HHS symbol consists of three wavy lines that resemble a stylized human figure. The text "U.S. Department of Health and Human Services" is arranged around the perimeter of the circle.

Food and Drug Administration 10003 New Flampshire Avenne Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Surgitools Pry Ltd. % Ms. Caroline Tontini Project Manager Emergo Group 611 West 310 Street, Third Floor AUSTIN TX 78701

0CT -- 5 201

Re: K110819

Trade/Device Name: Singh Colpotomizer System Regulation Number: 21 CFR$ 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: II Product Code: HEW, LKF Dated: August 30, 2011 Received: September 1. 2011

Dear Ms. Tontini:

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. Wc 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 of medical device-related

{4}------------------------------------------------

Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Hubert Lewer MD

Herbert P. Lemer, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): ______________ K110819

Singh Colpotomizer System Device Name:

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helent Kunn

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110819

Page 1 of 1

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. 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.