SINGHMED ROOLIP MANIPULATOR

K110819 · J.Singh Instruments · HEW · Oct 5, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K110819
• Device Name: SINGHMED ROOLIP MANIPULATOR
• Applicant: J.Singh Instruments
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Oct 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K110819 · Oct 5, 2011	SINGHMED ROOLIP MANIPULATOR	J.Singh Instruments	Retrospective clinical use data (Western Australia, 2002-2011)	The sponsor presented retrospective clinical performance data from 2,148 cases to support the safety and effectiveness of the Singh Colpotomizer System in laparoscopic hysterectomy procedures.	Retrospective clinical data; Clinical performance; Laparoscopic hysterectomy

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical use of the device in Western Australia; Retrospective clinical case series; Study Period: 2002-2011	Women undergoing laparoscopic hysterectomy; Sample Size: 2148	Not applicable for this study	Maintenance of pneumoperitoneum, successful completion of laparoscopic procedure, and incidence of adverse events (uterine perforation, ureteric injury, bladder injuries, vaginal vault bleeding, rectal injury).

Indications for Use

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 Story

Reusable uterine manipulator system for laparoscopic hysterectomy; consists of uterine manipulator with cervical screw, sliding inner rod, sliding/rotating funnels (35mm/40mm), and vaginal plug. Surgeon inserts uterine cannula into uterus; slides funnel onto cannula; rotates funnel manually to lift vaginal wall, identifying uterine arteries/ureters for incision. Inner rod retracts to accommodate variable uterine lengths and prevent interference during morcellation. Cervical screw secures device position. Funnel provides landmark for colpotomy and maintains pneumoperitoneum. Uterus acts as vaginal plug post-colpotomy to prevent CO2 leakage during vault suturing. Used in clinical/OR settings by surgeons to facilitate tissue access/removal and maintain pneumoperitoneum.

Clinical Evidence

Retrospective clinical data from 2,148 cases (2002-2011) presented. Primary endpoints: successful laparoscopic completion and maintenance of pneumoperitoneum. Results: 100% success rate (2,148/2,148) for both endpoints. Adverse events reported: 1 ureteric injury, 6 bladder injuries, 7 vaginal vault bleedings, 1 rectal injury; 0 cases of uterine perforation.

Technological Characteristics

Materials: stainless steel and medical grade plastics. Components: reusable uterine manipulator, cervical screw, sliding inner rod, sliding/rotating funnels (35mm/40mm), vaginal plug. Sterilization: steam sterilization (overkill method). Biocompatibility: ISO 10993-5, 10993-10, 10993-11 compliant. Connectivity: None (mechanical device).

Indications for Use

Indicated for use by surgeons during laparoscopic procedures requiring uterine manipulation and visualization of vaginal fornices for colpotomy incisions to access or remove intraperitoneal tissue.

Regulatory Classification

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.

Predicate Devices

• Koh Colpotomizer System (K954311)

Submission Summary (Full Text)

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

| Preparation Date: | September 29, 2011 | <span style="float:right">K110819<br/>OCT - 5 2011</span> |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Submission Correspondent: | Emergo Group, Inc.<br>www.emergogroup.com/ | |
| Address: | 611 West 5th Street, Third Floor<br>Austin, TX 78701 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact: | Caroline Tontini | |
| Submission Sponsor: | Surgitools Pty Ltd.<br>231 Timberlane Drive<br>Woodvale, W.Australia, 6026<br>Australia<br>Phone: [phone]<br>Fax: [phone] | |
| 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:

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.

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

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.

### 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 [phone] or [phone] 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:

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.

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