The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).

The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

Device Description

The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.

The ManipulatOR and ManipulatOR PRO are designed to improve physician visibility of the uterus and cervix during various medical examinations and procedures. Like many uterine elevators currently in the market place, the ManipulatOR and ManipulatOR PRO are designed for use in surgical procedures requiring cervical uterine motions with elevation and retraction of the vaginal fornices. The ManipulatOR and ManipulatOR PRO can help to create the tension on the tissue to assist in ligament dissection. In the most commonly used procedure, the total laparoscopic hysterectomy, the uterine elevator must expose the fornix and seal the vagina following removal of the uterus.

AI/ML Overview

The provided document is a 510(k) summary for the Gynetech ManipulatOR and ManipulatOR PRO devices. It describes the devices, their intended use, and claims substantial equivalence to previously cleared predicate devices.

However, the document does not contain information about acceptance criteria, detailed study designs, specific device performance metrics, sample sizes for test or training sets, ground truth establishment, or expert involvement for a performance study.

Instead, the document primarily focuses on:

Indications for Use: What the device is cleared to do.
Technological Characteristics: How the device is similar to and different from its predicate, largely related to material changes (addition of colorants).
Performance (mention only): A general statement that the devices were subjected to safety and performance testing for the initial 510(k) review and passed biocompatibility testing. It states this testing "demonstrated the functionality and safety of the device for its intended use."

Therefore, based solely on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study proving device performance in detail.

The document states: "The ManipulatOR and ManipulatOR PRO were subjected to safety and performance testing by the manufacturer for the initial 510(k) review." and "The performance testing undertaken for the initial 510(k) review demonstrated the functionality and safety of the device for its intended use." This is a summary statement, not a detailed report of a performance study. No specific metrics like sensitivity, specificity, accuracy, or other quantitative performance measures are given.

In the context of 510(k) submissions, "performance testing" often refers to engineering and bench testing to ensure the device meets its design specifications and safety requirements, rather than a clinical study evaluating diagnostic accuracy or reader improvement. The described changes (colorants) are material changes, and the associated performance testing would likely be focused on biocompatibility and mechanical property verification, not a clinical study of efficacy.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2015

Gynetech PTY. LTD. % Christopher Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852

Re: K150519

Trade/Device Name: ManipulatOR PRO, ManipulatOR Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: July 23, 2015 Received: July 24, 2015

Dear Christopher Sloan,

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 device

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

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/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,

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

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

Indications for Use

510(k) Number (if known) K150519

Device Name ManipulatOR and ManipulatOR PRO

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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

510(K) SUMMARY FOR K150519

ManipulatOR and ManipulatOR PRO

510(k) Owner

Brett Telford Managing Director Gynetech Pty Ltd 122-124 Balmain Street Richmond VIC 3121, Australia Phone: +61 3 9413 5588 Fax: +61 3 9413 5556 Email: btelford@gynetech.com.au

Official Correspondent

Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Phone: (301) 272-3114 Facsimile: (301) 272-0004 Email: chris.sloan@quintiles.com

Date Prepared: 18 August 2015

Device Tradename: ManipulatOR and ManipulatOR PRO

Device Common or Usual Name: ManipulatOR and ManipulatOR PRO (Cannula, Manipulator / Injector, Uterine)

Classification Name and Regulation Number, Class, Panel, and Product Code

Classification Name andRegulation Number	Class	Product Code(Device Name)	Panel
None	Unclassified	LKF(Cannula, Manipulator /Injector, Uterine)	Obstetrics/Gynecology

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

Predicate Device: ManipulatOR and ManipulatOR PRO (K142164)

Device Description: The ManipulatOR and ManipulatOR PRO are sterile, single-use uterine manipulators indicated for uterine manipulation and preventing loss of pneumoperitoneum during laparoscopic gynecology procedures. The ManipulatOR and ManipulatOR PRO are silicone insulated and anatomically designed stainless steel manipulators with a silicone intrauterine balloon at one end and an external handle at the other end. The balloon is inflated with air using a 20cc syringe that is supplied with the device.

Intended Use / Indications for Use: The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).

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

ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

Technological Characteristics: The following characteristics are shared by both device systems (Original Gynetech ManipulatOR and the modified Gynetech ManipulatOR):

Are provided sterile by means of EO sterilization and are single use .
. Are designed for use in the uterus and vagina
. Have a plastic handle that remains outside the patient for gripping and positioning by the surgeon
Incorporate an anatomically curved stainless steel shaft ●
Use an inflatable intrauterine balloon at the end of the shaft ●
. Packaged in single peel Tyvek pouch
Use identical materials for the shaft; balloon
. Use biocompatible materials

The following characteristics are shared by both device systems (Original Gynetech ManipulatOR PRO and the modified Gynetech ManipulatOR PRO):

Are provided sterile by means of EO sterilization and are single use .
Are designed for use in the uterus and vagina .
Have a plastic handle that remains outside the patient for gripping and positioning by the surgeon
Incorporate an anatomically curved stainless steel shaft ●
Incorporate a cervical cup and a vaginal cup
Use an inflatable intrauterine balloon at the end of the shaft .
. Are available with a variety of sizes of cervical cup
Packaged in single peel Tyvek pouch
. Use identical materials for the shaft; vaginal cup; cervical cup; valve
. Use biocompatible materials

The following characteristics differ between the Original Gynetech ManipulatOR and the modified Gynetech ManipulatOR:

{6}------------------------------------------------

The original ManipulatOR did not incorporate colorants within the silicone shaft overmould and balloon material, whereas, the modified ManipulatOR incorporates a blue colorant
The following characteristics differ between the Original Gynetech ManipulatOR PRO and the modified Gynetech ManipulatOR PRO:
The original ManipulatOR PRO did not incorporate colorants within the silicone ● material, vaginal cup or cervical cup, whereas, the modified ManipulatOR PRO incorporates a blue colorant within the silicone shaft overmould and balloon, a blue colorant in the vaginal cup and a green colorant in the various sizes of cervical cups
The technological similarities between the Gynetech Original Gynetech ManipulatOR / ManipulatOR PRO and the modified Gynetech ManipulatOR / ManipulatOR PRO devices show that the devices are substantially equivalent in intended use and operation, design, anatomical site of usage, most materials, sterilization, and biocompatibility.

Performance: The ManipulatOR and ManipulatOR PRO were subjected to safety and performance testing by the manufacturer for the initial 510(k) review. The materials used in the original and modified ManipulatOR and ManipulatOR PRO devices are wellcharacterized, commonly-used materials that have passed all biocompatibility testing, including cytotoxicity, vaginal irritation, guinea pig maximization sensitization, and an assessment of the toxicological risks of colorants. The performance testing undertaken for the initial 510(k) review demonstrated the functionality and safety of the device for its intended use.

Conclusion

The information and data provided in this 510(k) establish that the modified ManipulatOR and ManipulatOR PRO are substantially equivalent to the aforementioned predicate devices.

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.