(280 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
Yes
The device is used to manipulate the uterus, inject fluids, and maintain pneumoperitoneum during gynecologic procedures, all of which are actions taken to treat or assist in the treatment of a medical condition.
No
The device is described as an instrument for manipulating the uterus and injecting fluids during laparoscopic gynecologic procedures, not for identifying a disease or condition. While "diagnostic laparoscopy" is mentioned as a procedure it can be used in, the device itself performs mechanical functions (manipulation, injection, sealing), not diagnostic analysis.
No
The device description clearly outlines physical components such as a manipulator shaft, inflatable balloons, a central guide rod, a handle, and optional cervical cups made of ceramic or polyphenylene sulfite. The performance studies also focus on mechanical and material properties, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a surgical tool for manipulating the uterus, injecting fluids, and sealing the vagina during laparoscopic gynecologic procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of the device (shaft, balloons, handle, cervical cup) and how they are used for physical manipulation and sealing. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is a surgical instrument used during a procedure, not a tool for diagnosing a condition based on in vitro analysis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LKF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, vaginal fornices
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and ISO 10993-11:2006)
- Mechanical performance testing
- For the HK-WQ-I, HK-WQ-II, HK-ZQ-I, and HK-ZQ-II, the following tests were performed:
- dimensional specifications
- 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 following additional tests were performed:
- vaginal sealing balloon maximum inflation volume test
- vaginal sealing balloon tensile strength under maximum inflation volume
- vaginal sealing balloon sealing characteristics
- vaginal sealing balloon air leakage test
- For the cervical cup, the following tests were performed:
- dimensional specifications
- structural strength
- tension resistance
- locking force
- movement force
- Sterilization validation per ISO 11135:2017
- Shelf life testing including package integrity and mechanical performance testing
The results of performance testing demonstrate the subject devices are substantially equivalent to their respective predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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 1
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
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. | VCARE Dx uterine
manipulator/injector cannula is
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. |
| Curved Shaft | Yes | Yes |
| Liquid introduction | Yes | Yes |
5
| Balloon inflation | Yes | Yes |
|---|---|---|
| Cervical cup | Yes | Yes |
| Prevents loss of | ||
| pneumoperitoneum | Yes | Yes |
Table 2 Comparison of Technology Characteristics for HK-ZQ
| Item | Proposed Device | Predicate Device 2
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
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. | The ClearView Uterine Manipulator
Device with ColpCup and Occluder
is 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. |
| 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
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 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.