Who is the manufacturer of Hysteroscope System?

Shanghai AnQing Medical Instrument Co., Ltd. filed the 510(k) submission for Hysteroscope System (K181545).

What is the FDA product code for Hysteroscope System?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Hysteroscope System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Hysteroscope System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Hysteroscope System

K181545 · Shanghai AnQing Medical Instrument Co., Ltd. · HIH · May 10, 2019 · Obstetrics/Gynecology

Device Facts

Record ID	K181545
Device Name	Hysteroscope System
Applicant	Shanghai AnQing Medical Instrument Co., Ltd.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	May 10, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: - Abnormal bleeding - · Infertility and pregnancy wastage - · Evaluation of abnormal hysterosalpingogram - · Intrauterine foreign body - · Amenorrhea - · Pelvic pain Generally recognized indications for operative hysteroscopy include: - · Directed endometrial biopsy - · Polypectomy - Submucous myomectomy - · Transection of intrauterine adhesions - · Transection of intrauterine septa - · Endometrial ablation

Device Story

Hysteroscope System consists of sterile, single-use rigid hysteroscope and video processor. CMOS chip at distal end of scope collects anatomical images; transmitted via processor to external monitor for physician viewing. Used in clinical settings by physicians to visualize cervical canal and uterine cavity during diagnostic and surgical procedures. Provides real-time visual guidance for interventions like biopsy, polypectomy, and myomectomy. Benefits include direct visualization of intrauterine pathology, facilitating minimally invasive gynecological procedures.

Clinical Evidence

Bench testing only. Biocompatibility (ISO 10993-5, -10), sterilization validation (ISO 11135), electrical safety/EMC (IEC 60601-1, -2-18, -1-2), optical performance (ISO 8600 series), and mechanical performance (leaking, bending, irrigation) met predefined acceptance criteria.

Technological Characteristics

Rigid hysteroscope with CMOS sensor; LED illumination. Models: GSA01-B (straight, no operative channel), GSB04-B (straight, operative channel), GSB14-B (curved tip, operative channel). Working length 260mm. Power: 5V. Sterilization: Ethylene Oxide (EO). Software: Moderate level of concern.

Indications for Use

Indicated for diagnostic and surgical procedures of the cervical canal and uterine cavity. Patient population includes those with abnormal bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign bodies, amenorrhea, or pelvic pain. Also indicated for directed endometrial biopsy, polypectomy, submucous myomectomy, transection of intrauterine adhesions/septa, and endometrial ablation.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

LiNA OperaScope (K171113)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". May 10, 2019 Shanghai AnQing Medical Instrument CO., Ltd. Lina Fei Quality Manager 150 Cailun Road, Zhangjiang High-Tech Park Shanghai, 201210 China Re: K181545 > Trade/Device Name: Hysteroscope System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: April 3, 2019 Received: April 10, 2019 Dear Lina Fei: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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, Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181545 Device Name Hysteroscope System Indications for Use (Describe) The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: - Abnormal bleeding - · Infertility and pregnancy wastage - · Evaluation of abnormal hysterosalpingogram - · Intrauterine foreign body - · Amenorrhea - · Pelvic pain Generally recognized indications for operative hysteroscopy include: - · Directed endometrial biopsy - · Polypectomy - Submucous myomectomy - · Transection of intrauterine adhesions - · Transection of intrauterine septa - · Endometrial ablation Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> 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 – K181545 # I. Submitter Device submitter: Shanghai AnQing Medical Instrument CO., Ltd. Room 202, 2nd Floor, No.7 Building & Room 202, 2nd Floor No.4 Building, 150 Cailun Road, Zhangjiang High-Tech Park, 201210, Shanghai, China Contact person: Wen Shi Quality Manager Phone: +86 135 8580 5802 Fax: +86 21 5019 1132 – 8004 Email: wenshi@innovexmed.com.cn Date prepared: May 9, 2019 ### II. Device Trade Name of Device: Hysteroscope System Common Name: Hysteroscope (And Accessories) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Product Code Name: Hysteroscope and Accessories #### III. Predicate Devices | Trade name: | LiNA OperaScope | |-------------------------|----------------------------------------------| | Common name: | Hysteroscope | | Classification: | 21 CFR 884.1690 Hysteroscope and Accessories | | Product Code: | HIH, Hysteroscope and Accessories | | Premarket Notification: | K171113 | The predicate device has not been subject to a design-related recall. # IV. Device description The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid {4}------------------------------------------------ shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The specifications for the three models are as follows: | Model | Shape | Scope diameter | Working length | Minimum insertion channel diameter | Injection channel Diameter | Tip Curve | Curved Tip length | |---------|----------------------|-----------------------|----------------|---------------------------------------------|----------------------------------|------------|----------------------| | GSA01-B | Straight | Φ4.0mm +0.0/-0.3mm | 260mm±8mm | N/A | 0.8mm +0.2/-0.0mm | N/A | N/A | | GSB04-B | Straight | Φ6.4mm +0.0/-0.3mm | 260mm±8mm | 2.3mm +0.2/-0.0mm | 1.1mm +0.2/-0.0mm | N/A | N/A | | GSB14-B | Curved distal tip | Φ6.4mm +0.0/-0.3mm | 260mm±8mm | 2.3mm +0.2/-0.0mm | 1.1mm +0.2/-0.0mm | 22° ±5° | 25mm ±1.3mm | The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor. #### V. Indications for use The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: - Abnormal bleeding - Infertility and pregnancy wastage - Evaluation of abnormal hysterosalpingogram - Intrauterine foreign body - Amenorrhea - Pelvic pain {5}------------------------------------------------ Generally recognized indications for operative hysteroscopy include: - · Directed endometrial biopsy - · Polypectomy - · Submucous myomectomy - Transection of intrauterine adhesions - · Transection of intrauterine septa - Endometrial ablation #### VI. Comparison of technological characteristics with the predicate devices The Hysteroscope System has the same intended use as the predicate device. The Hysteroscope System and the predicate device are designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the cervical canal and uterus. As summarized in the table below, there are differences in technological characteristics between the subject and predicate device. The technological differences between the Hysteroscope System and predicate device do not raise different questions of safety or effectiveness. | Device Feature | Hysteroscope System (subject device) | LiNA OperaScope K171113 | Discussion | |-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: • Abnormal bleeding | The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the OperaScope could offer visualization include: • Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram; • Assessment of Infertility and pregnancy wastage; • Confirmation of the presence of intrauterine foreign body; • Assist in locating submucosal fibroids and polyps targeted for | Similar; the difference in wording of the indications does not alter the intended use. | | | | | | | | • Infertility and pregnancy wastage • Evaluation of abnormal hysterosalpingogram • Intrauterine foreign body • Amenorrhea • Pelvic pain Generally recognized indications for operative hysteroscopy include: • Directed endometrial biopsy • Polypectomy • Submucous myomectomy • Transection of intrauterine adhesions • Transection of intrauterine septa • Endometrial ablation | removal; • Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa. | | | System Components | The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. | Sterile/Single-use Handpiece (Hysteroscope) with CMOS camera, LED illumination, LCD display unit, channel for infusion of irrigating fluid, channel for fluid outflow, microelectronics, firmware and single use batteries for powering the device. Non-Sterile/Reusable Recording Module with software, microelectronics and controls for recording pictures/video, HDMI ports (2) for connection to | Similar; the basic system composition is identical (single use scope with video processor). | | | | | | | | | | | | Optical Image | CMOS | handpiece (hysteroscope) and external monitor and input port for external 9V DC power supply. | Identical | | Image Resolution | 100,000 pixels | Digital CMOS Technology CMOS camera consists of approximately 160,000 pixels | Different; the difference does not raise different questions of safety or effectiveness. | | Illumination Light Source | LED | LED at tip of cannula | Identical | | Inflow and outflow channel for saline instillation | Inflow and outflow channels separately | Inflow: Inflow channel and working channel combined in one channel above the camera. Outflow: One outflow channel with two entrances placed on top and bottom of distal tip. | Different; The difference does not raise different questions of safety or effectiveness. | | Cannula tip design | Angled shaft proximal to tip: Straight: 0° Curved tip:22° | Rounded polymer tip. Angled shaft proximal to tip (~ 20°C). Steerable by rotation knob. | Different; the predicate device is steerable by rotation knob. The difference does not raise different questions of safety or effectiveness. | | Image Transmission | Transmits images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the image showing on a monitor. | Transmits images from CMOS video camera to local LCD display unit on the handpiece and remote monitor. | Identical | | Maximum | 4.0 to 6.4mm | 4.3 mm | Different; the | | | | | | | Insertion Diameter (Tip) | depending on model | | difference in diameter does not raise different questions of safety or effectiveness. | | Shaft/Cannula Length | 260mm | 240mm (24cm) | Different; the difference in length does not raise different questions of safety and effectiveness. | | Energy Source | Hysteroscope: 5V Video Processor: 5V 2A | Handpiece: 3V (2 AA batteries) Recording Module: 9V DC external power adapter | Similar; Different output formats do not raise different safety or effectiveness. | | Sterilization | The Rigid Hysteroscope is provided sterilized by EO. No re-sterilization is permitted. Video Processor: Non-Sterile | Handpiece (Hysteroscope): Ethylene Oxide (EO) Handpiece Batteries: Radiation (Gamma) Recording Module: Non-Sterile | Identical | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ K181545 Page 6 of 7 # VII. Performance data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing Biocompatibility of the Hysteroscope System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed: Cytotoxicity per ISO 10993-5:2009, Irritation and Sensitization per ISO 10993-10:2010. The device was demonstrated to be non-cytotoxic, non-sensitizing and non-irritating. # Sterilization and shelf life testing The ethylene oxide sterilization method has been validated to ISO 11135:2014. The shelf life of the Rigid Hysteroscope was demonstrated through a stability study which included {9}------------------------------------------------ testing of aged devices to ensure devices maintained specifications and that device packaging maintained sterility. #### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the Hysteroscope System. The system complies with the IEC 60601-1:2005/(R)2012, IEC60601-2-18 Edition 3, and IEC 60601-1-2:2014. #### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a "moderate" level of concern. #### Optical performance testing Optical performance testing was conducted on the Hysteroscope System. The optical performance of the system complies with ISO 8600 series. The system was demonstrated to meet predefined acceptance criteria. #### Mechanical performance testing Mechanical characteristics including leaking, bending, articulating and irrigation tests were performed. Devices were demonstrated to meet predefined acceptance criteria. #### VIII. Conclusion The subject device has the same intended use as the predicate, and differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness. The non-clinical testing demonstrates that the subject device is as safe and as effective as the legally marketed predicate device. Therefore, the subject device is substantially equivalent to the predicate.

Hysteroscope System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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