MANIPULATOR; MANIPULATOR PRO

K142164 · Gynetech Pty. , Ltd. · LKF · Dec 17, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K142164
• Device Name: MANIPULATOR; MANIPULATOR PRO
• Applicant: Gynetech Pty. , Ltd.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Dec 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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). 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 Story

Sterile, single-use uterine manipulators; used in laparoscopic gynecological procedures. Device consists of rigid, anatomically curved stainless steel shaft; silicone intrauterine balloon at distal end; external handle at proximal end. Balloon inflated via 20cc syringe. ManipulatOR PRO includes vaginal cup and clamp to seal vaginal cavity, maintaining pneumoperitoneum post-colpotomy. Operated by physicians in clinical/surgical settings. Device provides uterine elevation, retraction, and tension on tissue to assist ligament dissection; improves visibility of uterus and cervix. Benefits include stable uterine positioning and maintenance of pneumoperitoneum during complex procedures like TLH.

Clinical Evidence

Bench testing only. Testing included air leak tests, balloon destructive testing, repeat inflation/deflation, tensile testing of bonds and system, tip deflection force, clamp locking forces, and accelerated aging. Biocompatibility testing per ISO 10993-1 included MEM elution cytotoxicity, mucosal (vaginal) irritation, and guinea pig maximization sensitization.

Technological Characteristics

Materials: Stainless steel shaft, silicone balloon. Design: Anatomically curved shaft, distal balloon, proximal valve/handle. ManipulatOR PRO includes cervical cup, vaginal cup, and clamp. Energy: Manual operation. Connectivity: None. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients undergoing laparoscopic gynecological procedures including laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion, and diagnostic laparoscopy requiring uterine manipulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ConMed, VCare Vaginal-Cervical Ahluwalia's Retractor-Elevator (K071907)

Submission Summary (Full Text)

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

December 17, 2014

Gynetech, PTY. LTD. % Kevin MacDonald Regulatory Consultant MacDonald Consulting 229 Marvilla Circle Pacifica, CA 94044

Re: K142164

> Trade/Device Name: ManipulatOR and ManipulatOR PRO Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: November 17, 2014 Received: November 19, 2014

Dear Kevin MacDonald,

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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

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### Indications for Use

510(k) Number (if known) K142164

Device Name Gynetech ManipulatOR PRO and ManipulatOR

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Gynetech Pty Ltd. The logo features the word "gynetech" in blue, with a stylized blue "g" made of dots to the right. The contact information includes the company's address as Unit 7, 6-8 Macquarie Drive, Thomastown VIC 3074, Australia, as well as their phone number ([phone]), fax number ([phone]), and email address ([e-mail]).

## 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92(c).

| Submitted by: | Gynetech Pty Ltd<br>Unit 7, 6-8 Macquarie Drive, Thomastown 3074, Australia<br>Phone: [phone] |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact email: [e-mail]<br>Fax: [phone] |
| Contact Person | Kevin MacDonald<br>Clinical/Regulatory Consultant<br>229 Marvilla Circle<br>Pacifica, CA 94044<br>Phone: [phone] |
| Date Prepared: | Email: [e-mail]<br>December 15, 2014 |
| | |
| Proprietary Name: | ManipulatOR, ManipulatOR PRO |
| Common Name: | Uterine elevator; uterine manipulator |
| Classification: | LKF, Unclassified, Pre-Amendment<br>Cannula, Manipulator/Injector, Uterine |
| Predicate Devices: | Primary Predicate Device: ConMed, VCare Vaginal-Cervical<br>Ahluwalia's Retractor-Elevator, K071907 |
| Device Description: | The ManipulatOR and ManipulatOR PRO are sterile, single-use<br>uterine manipulators indicated for uterine manipulation and<br>preventing loss of pneumoperitoneum during laparoscopic<br>gynecology procedures. The ManipulatOR and ManipulatOR PRO are<br>silicone insulated and anatomically designed stainless steel<br>manipulators with a silicone intrauterine balloon at one end and an<br>external handle at the other end. The balloon is inflated with air<br>using a 20cc syringe that is supplied with the device.<br>The ManipulatOR and ManipulatOR PRO are designed to improve<br>physician visibility of the uterus and cervix during various medical<br>examinations and procedures. Like many uterine elevators currently |
| | |
| | in the market place, the ManipulatOR and ManipulatOR PRO are<br>designed for use in surgical procedures requiring cervical uterine<br>motions with elevation and retraction of the vaginal fornices. The<br>ManipulatOR and ManipulatOR PRO can help to create the tension<br>on the tissue to assist in ligament dissection. In the most commonly<br>used procedure, the total laparoscopic hysterectomy, the uterine<br>elevator must expose the fornix and seal the vagina following<br>removal of the uterus. |
| Indications for Use: | The ManipulatOR is indicated for manipulation of the uterus during<br>laparoscopic procedures including laparoscopic assisted vaginal<br>hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic<br>laparoscopy. The ManipulatOR, when used together with the<br>McCartney Tube, is indicated for manipulation of the uterus during<br>laparoscopic procedures requiring maintenance of<br>pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).<br>The ManipulatOR PRO is indicated for manipulation of the uterus<br>during laparoscopic procedures such as laparoscopic assisted vaginal<br>hysterectomy (LAVH), total laparoscopic hysterectomy (TLH),<br>laparoscopic tubal occlusion and diagnostic laparoscopy. The<br>ManipulatOR PRO maintains pneumoperitoneum by sealing the<br>vagina once colpotomy is performed. |
| Summary of<br>Performance Data | The following product performance testing was successfully<br>completed to confirm the subject device met the user requirements<br>for the proposed intended use:<br>Air Leak Test – inflation of the balloon to confirm the system and balloon integrity would be maintained during "worst"<br>case conditions. Balloon destructive testing - Balloon integrity when exposed to maximum inflation volume. Repeat inflation/deflation of balloon Correlation of balloon inflated diameter and infused balloon volume Tensile Testing of all critical bonds Tensile Testing of entire system Compatibility of ManipulatOR PRO with McCartney Tube Force required for tip deflection Locking forces of clamp on ManipulatOR PRO Ease of movement of ManipulatOR PRO when clamp is unlocked. Accelerated age testing Packaging validation testing |
| Summary of Safety<br>Data/Biocompatibility<br>Testing | Per ISO 10993-1, the following biocompatibility tests were<br>conducted and confirmed all direct body materials used in the<br>subject device are biocompatible for the proposed intended use:<br>• MEM Elution Cytoxicity<br>• Mucosal (vaginal) Irritation<br>• Guinea Pig Maximization Sensitization |
| Substantial Equivalence<br>Discussion: | The subject and predicate devices do not have the same<br>indication statement but have the same intended use<br>(manipulations of the uterus during laparoscopic procedures).<br>The differences do not raise any concerns, because the subject<br>devices have narrowed indications compared to the predicate<br>device. |
| | The ManipulatOR PRO and predicate device have the same<br>fundamental technological characteristics, including the<br>following:<br>• A rigid, anatomically curved manipulator shaft<br>• A balloon at distal end of the shaft<br>• A valve and handle at proximal end of the shaft<br>• A cervical cup<br>• A vaginal cup<br>• A clamp to secure the vaginal cup<br>• The vaginal cup seals the vaginal cavity from within to<br>maintain pneumoperitoneum and prevent abdominal<br>deflation.<br>The ManipulatOR and predicate device have the following<br>same fundamental technological characteristics:<br>• A rigid, anatomically curved manipulator shaft<br>• A balloon at distal end of the shaft<br>• A valve and handle at proximal end of the shaft |
| | The ManipulatOR does not have the cervical cup and vaginal cup<br>compared to the predicate device. However, the differences do not<br>raise safety and effectiveness concerns, because ManipulatOR may<br>be used with the access tube if maintenance of pneumoperitoneum<br>is needed. |
| | The subject devices are different from the predicate device<br>in that they are not designed for injection of fluids or gases<br>into the uterus. The difference does not raise safety and<br>effectiveness concerns, because the subject devices are not<br>indicated for injection of fluids or gases into the uterus. |
| | The subject and predicate devices use different materials in the<br>balloon and other patient contact components. The different<br>materials raise concerns on biocompatibility and mechanical<br>performance of the subject devices. However, these concerns<br>do not represent new types of safety and effectiveness<br>questions. Accepted scientific methods exist for assessment of<br>the difference (e.g., biocompatibility testing for safety and<br>bench testing for mechanical performance). The<br>biocompatibility and bench testing demonstrated that the<br>subject devices are safe and effective. |
| Conclusion: | The ManipulatOR and ManipulatOR PRO share most technological<br>and design features and functions with the predicate device. The<br>performance testing show the safety and functionality of the<br>Gynetech devices. In summary, the Gynetech ManipulatOR and<br>ManipulatOR PRO are substantially equivalent to the predicate<br>devices, ConMed VCare Vaginal-Cervical Ahluwalia's Retractor-<br>Elevator. |

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Image /page/5/Picture/0 description: The image shows the logo for Gynetech. The word "gynetech" is written in lowercase letters, with "gyne" in blue and "tech" in gray. To the right of the word is a blue circle made of dots, with a stylized "g" in the center.

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Image /page/6/Picture/0 description: The image shows the logo for Gynetech. The word "gynetech" is written in lowercase letters, with "gyne" in blue and "tech" in gray. To the right of the word is a blue circle made of dots, with a white "g" in the center.