Uterine Manipulator

K172846 · Beijing Hangtian Kadi Technology R&D Institute · LKF · Jun 26, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K172846
• Device Name: Uterine Manipulator
• Applicant: Beijing Hangtian Kadi Technology R&D Institute
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Jun 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The HK-WQ-I and HK-WQ-II are indicated for manipulation of the uterus and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy. The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Device Story

Sterile, single-patient use uterine manipulators; four versions (HK-WQ-I/II, HK-ZQ-I/II). Input: manual operation by surgeon. Mechanism: manipulator shaft with inflatable intrauterine balloon; HK-ZQ models feature dial-actuated shaft flexion; optional cervical cups (ceramic or polyphenylene sulfite) in four sizes. Output: uterine positioning, fluid injection, and vaginal sealing to maintain pneumoperitoneum during laparoscopic surgery. Used in clinical/OR settings by gynecological surgeons. Benefits: facilitates uterine manipulation, fluid delivery, and vaginal access while maintaining pneumoperitoneum during minimally invasive procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). Mechanical performance testing included dimensional specs, tensile/burst strength, shaft deflection, movement force, inflation cycling, and sealing characteristics. Sterilization validated per ISO 11135:2017. Shelf life and package integrity testing performed.

Technological Characteristics

Manual uterine manipulator; shaft with inflatable intrauterine balloon; optional vaginal sealing balloon; cervical cups (ceramic or polyphenylene sulfite). Materials tested for biocompatibility (ISO 10993). Sterilization via ISO 11135:2017. Mechanical actuation via handle dial (HK-ZQ models).

Indications for Use

Indicated for patients undergoing laparoscopic gynecologic procedures including hysterectomy, tubal ligation, tubal occlusion, or diagnostic laparoscopy. HK-ZQ models are indicated for procedures requiring vaginal fornix delineation and colpotomy/culdotomy access.

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

• Vcare Dx (K093556)
• Clearview Total (K131781)

Submission Summary (Full Text)

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June 26, 2018

Beijing HangTian KaDi Technology R&D Institute % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K172846

> Trade/Device Name: HK-WQ-I and HK-WQ-II Uterine Manipulators HK-ZQ-I and HK-ZQ-II Uterine Manipulators Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: May 11, 2018 Received: May 24, 2018

Dear Diana Hong:

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.

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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); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael T. Bailey -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) K172846

#### K172846

Device Name HK-WQ-I and HK-WQ-II Uterine Manipulators HK-ZQ-I and HK-ZQ-II Uterine Manipulators

Indications for Use (Describe)

The HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as lapacervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.

The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary - K172846

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

Date of Preparation: June 25, 2018

#### Sponsor Identification:

Beijing HangTian KaDi Technology R&D Institute Room 301-08, 09, 10, 11, Third floor, Building No.13 No.15 Jing Sheng Nan Er Street, Tong Zhou District 101102 Beijing, PEOPLE'S REPUBLIC OF CHINA

Contact Person: Lingyi Zhang Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

#### Submission Correspondent:

Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

#### Subject Device Information:

| Trade Name: | HK-WQ-I and HK-WQ-II Uterine Manipulators HK-ZQ-I and HK-ZQ-II Uterine Manipulators |
|--------------------|--------------------------------------------------------------------------------------|
| Common Name: | Uterine Manipulator |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Regulation Number: | 21 CFR 884.4530 |
| Class: | II |
| Product Code: | LKF (cannula, manipulator/injector, uterine) |
| Review Panel: | Obstetrics and Gynecology |

#### Indications for Use Statement:

The HK-WQ-I and HK-WQ-II are indicated for manipulation of the uterus and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.

The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

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### Device Description:

There are four versions of the subject device. HK-WQ-I and HK-WO-II have a curved central guide rod, while the HK-ZQ-I and HK-ZQ-II have a central guide rod which can be rotated (or "flexed") up or down using a dial on the handle.

Each device is a sterile, disposable, single-patient use device which consists of a manipulator shaft with an inflatable intrauterine balloon at the proximal end. The intrauterine balloon is inflated by liquid via a standard syringe injected through the check valve. The internal injection tip of the manipulator shaft is open to allow direct intrauterine introduction of medicine liquid via the injector port. The device also incorporates a vaginal sealing balloon which is inflated by liquid via a standard syringe injected through the check valve to seal the vagina and maintain pneumoperitoneum. The location of the uterus can be adjusted by the handle.

Each device version can be used with a cervical cup. During use, the open-end of the cup rests on the cervix. There are two versions of the cup- a ceramic version and a polyphenylene sulfite version. For both materials, the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm.

## Predicate Device Information:

Predicate Device 1 for the HK-WQ Curved version: 510(k) Number: K093556 Trade Name: Vcare Dx Sponsor: Conmed Corporation

Predicate Device 2 for the HK-ZQ Flexed version: 510(k) Number: K131781 Trade Name: Clearview Total Sponsor: Clinical Innovations

The predicate devices have not been subject to a design related recall.

### Substantially Equivalent (SE) Comparison:

Table 1 Comparison of Technology Characteristics for HK-WQ

| Item | Proposed Device | Predicate Device 1<br>K093556 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LKF | LKF |
| Regulation Number | 21 CFR 884.4530 | 21 CFR 884.4530 |
| Indications for Use | The HK-WQ-I and HK-WQ-II are<br>indicated for manipulation of the uterus<br>and injection of fluids during<br>laparoscopic gynecologic procedures<br>such as laparoscopic supracervical<br>hysterectomy, minilap tubal ligation,<br>laparoscopic tubal occlusion or<br>diagnostic laparoscopy. | VCARE Dx uterine<br>manipulator/injector cannula is<br>indicated for manipulation of the<br>uterus, and injection of fluids during<br>laparoscopic gynecologic procedures<br>such as laparoscopic supracervical<br>hysterectomy, minilap tubal ligation,<br>laparoscopic tubal occlusion or<br>diagnostic laparoscopy. |
| Curved Shaft | Yes | Yes |
| Liquid introduction | Yes | Yes |

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| Balloon inflation | Yes | Yes |
|--------------------------------------|-----|-----|
| Cervical cup | Yes | Yes |
| Prevents loss of<br>pneumoperitoneum | Yes | Yes |

Table 2 Comparison of Technology Characteristics for HK-ZQ

| Item | Proposed Device | Predicate Device 2<br>K131718 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LKF | LKF |
| Regulation Number | 21 CFR 884.4530 | 21 CFR 884.4530 |
| Indications for Use | The HK-ZQ-I and HK-ZQ-II are<br>intended for use in laparoscopic<br>procedures where it is desirable to<br>delineate the vaginal fornices and the<br>surgeon intends to remove or access<br>intraperitonial tissue through the<br>vagina by use of a colpotomy or<br>culdotomy incision; such as<br>laparoscopically assisted vaginal<br>hysterectomies, total laparoscopic<br>hysterectomies, while maintaining<br>pneumoperitoneum by sealing the<br>vagina while a colpotomy is performed. | The ClearView Uterine Manipulator<br>Device with ColpCup and Occluder<br>is intended for use in laparoscopic<br>procedures where it is desirable to<br>delineate the vaginal fornices and the<br>surgeon intends to remove or access<br>intraperitonial tissue through the<br>vagina by use of a colpotomy or<br>culdotomy incision; such as<br>laparoscopically assisted vaginal<br>hysterectomies, total laparoscopic<br>hysterectomies, while maintaining<br>pneumoperitoneum by sealing the<br>vagina while a colpotomy is<br>performed. |
| Bending Angle | 180 degree total range of motion | 210 degree total range of motion |
| Liquid introduction | Yes | Yes |
| Balloon inflation | Yes | Yes |
| Cervical cup | Yes | Yes |
| Prevents loss of<br>pneumoperitoneum | Yes | Yes |

Each version of the subject device has the same intended use as its respective predicate. Each subject device also has different technological characteristics (design, material composition) compared to its respective predicate device; however, the differences in technological characteristics do not raise different questions of safety or effectiveness.

## Summary of Non-Clinical Performance Tests:

The following non-clinical tests were conducted on the subject devices:

- Biocompatibility include cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010), irritation ● (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2006), and pyrogenicity (USP <151> and ISO 10993-11:2006)
- Mechanical performance testing

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- For the HK-WQ-I, HK-WQ-II, HK-ZQ-I, and HK-ZQ-II, the following tests were performed: o
- dimensional specifications ■
- ı intrauterine balloon tensile and burst strength tests
- " uterus shaft deflection force test
- movement force test
- . intrauterine balloon inflation cycling
- For the versions which include the vaginal balloon (i.e., HK-WQ-II and HK-ZQ-II) the O following additional tests were performed:
- vaginal sealing balloon maximum inflation volume test l
- vaginal sealing balloon tensile strength under maximum inflation volume l
- vaginal sealing balloon sealing characteristics
- . vaginal sealing balloon air leakage test
- For the cervical cup, the following tests were performed o
- dimensional specifications 트
- l structural strength
- .. tension resistance
- 트 locking force
- I movement force
- Sterilization validation per ISO 11135:2017 ●
- . Shelf life testing including package integrity and mechanical performance testing

#### Conclusion:

The results of performance testing demonstrate the subject devices are substantially equivalent to their respective predicate devices.