(280 days)
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.
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.
This document is a 510(k) premarket notification for uterine manipulators (HK-WQ-I, HK-WQ-II, HK-ZQ-I, and HK-ZQ-II). As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information (like acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth provenance) is not present in this type of regulatory submission, as these devices are not AI/ML-based.
However, I can extract the information that is available regarding non-clinical performance tests:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical targets. Instead, it lists the types of non-clinical performance tests conducted to demonstrate that the subject devices perform similarly to their predicate devices and meet safety requirements. The "reported device performance" is implied to be successful, as the conclusion states that the devices are substantially equivalent.
Non-Clinical Performance Tests Conducted:
| Test Category | Specific Tests Performed | Outcome (Implied) |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Pass |
| Sensitization (ISO 10993-10:2010) | Pass | |
| Irritation (ISO 10993-10:2010) | Pass | |
| Acute systemic toxicity (ISO 10993-11:2006) | Pass | |
| Pyrogenicity (USP <151> and ISO 10993-11:2006) | Pass | |
| Mechanical Performance | Dimensional specifications (all versions) | Pass |
| (HK-WQ-I, -WQ-II, | Intrauterine balloon tensile and burst strength tests | Pass |
| -ZQ-I, -ZQ-II) | Uterus shaft deflection force test | Pass |
| Movement force test | Pass | |
| Intrauterine balloon inflation cycling | Pass | |
| Mechanical Performance | Vaginal sealing balloon maximum inflation volume test (HK-WQ-II, -ZQ-II only) | Pass |
| (Vaginal Balloon) | Vaginal sealing balloon tensile strength under maximum inflation volume (HK-WQ-II, -ZQ-II) | Pass |
| Vaginal sealing balloon sealing characteristics (HK-WQ-II, -ZQ-II only) | Pass | |
| Vaginal sealing balloon air leakage test (HK-WQ-II, -ZQ-II only) | Pass | |
| Mechanical Performance | Dimensional specifications (cervical cup) | Pass |
| (Cervical Cup) | Structural strength | Pass |
| Tension resistance | Pass | |
| Locking force | Pass | |
| Movement force | Pass | |
| Sterilization | Sterilization validation per ISO 11135:2017 | Pass |
| Shelf Life | Package integrity and mechanical performance testing | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical (laboratory/benchtop) and do not involve human or patient data in the sense of a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the studies are non-clinical performance and safety tests, not studies requiring expert interpretation or ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for non-clinical performance tests.
5. 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
Not applicable. This device is a manual surgical instrument, not an AI/ML-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For non-clinical tests, "ground truth" would be the measured physical properties against a standard or specification.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
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 - 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: +86-10-56407751 Fax: +86-10-56407795-803 Email: zly1110@139.com
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: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net
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.
{4}------------------------------------------------
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 1K093556 |
|---|---|---|
| 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 areindicated for manipulation of the uterusand injection of fluids duringlaparoscopic gynecologic proceduressuch as laparoscopic supracervicalhysterectomy, minilap tubal ligation,laparoscopic tubal occlusion ordiagnostic laparoscopy. | VCARE Dx uterinemanipulator/injector cannula isindicated for manipulation of theuterus, and injection of fluids duringlaparoscopic gynecologic proceduressuch as laparoscopic supracervicalhysterectomy, minilap tubal ligation,laparoscopic tubal occlusion ordiagnostic laparoscopy. |
| Curved Shaft | Yes | Yes |
| Liquid introduction | Yes | Yes |
{5}------------------------------------------------
| Balloon inflation | Yes | Yes |
|---|---|---|
| Cervical cup | Yes | Yes |
| Prevents loss ofpneumoperitoneum | Yes | Yes |
Table 2 Comparison of Technology Characteristics for HK-ZQ
| Item | Proposed Device | Predicate Device 2K131718 |
|---|---|---|
| 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 areintended for use in laparoscopicprocedures where it is desirable todelineate the vaginal fornices and thesurgeon intends to remove or accessintraperitonial tissue through thevagina by use of a colpotomy orculdotomy incision; such aslaparoscopically assisted vaginalhysterectomies, total laparoscopichysterectomies, while maintainingpneumoperitoneum by sealing thevagina while a colpotomy is performed. | The ClearView Uterine ManipulatorDevice with ColpCup and Occluderis intended for use in laparoscopicprocedures where it is desirable todelineate the vaginal fornices and thesurgeon intends to remove or accessintraperitonial tissue through thevagina by use of a colpotomy orculdotomy incision; such aslaparoscopically assisted vaginalhysterectomies, total laparoscopichysterectomies, while maintainingpneumoperitoneum by sealing thevagina while a colpotomy isperformed. |
| 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 ofpneumoperitoneum | 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
{6}------------------------------------------------
- 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.
§ 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.