The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.

Device Description

The Disposable Endoscopic Cannula is a sterile, single patient use device composed of transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, and data cable. The patient contacting components of this device are transparent cover, suction orifice and dual function cannula that are manufactured with polycarbonate.

The transparent cover contains a LED light source and CMOS camera at the distal end for visualization of the cervical canal and uterine cavity. This device has two channels, one for transcervical aspiration of the uterine cavity and the other for transmitting the image signal through a cable connected to the Endoscopic Workstation. The images captured by the camera are transmitted to the endoscopic workstation through the cable for display. When the embryo tissues are located, the operator sucks out the embryo tissues through the suction orifice connected to a vacuum source.

The Disposable Endoscopic Cannula is provided with five sizes based on outer cannula diameter: 5mm (RL1205 model), 6mm (RL1206 model), 7mm (RL1207 model), 8mm (RL1208 model), and 9mm (RL1209 model) (outer diameter). All models have a length of 170mm.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Disposable Endoscopic Cannula". It is not a study demonstrating machine learning algorithm performance. Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance in the context of AI/ML.

The document focuses on demonstrating substantial equivalence to a predicate device (Rigid Uterine Cannulae) for the purpose of FDA clearance. This involves comparing the new device's features, intended use, technology, and safety aspects to a legally marketed predicate device.

Here's what the document does provide regarding acceptance criteria and performance, but it's for a traditional medical device, not an AI system:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct table of acceptance criteria with corresponding performance values in the way you might expect for an AI algorithm's metrics (e.g., sensitivity, specificity). Instead, it states that the device is in "compliance with requirements" for various standards.

Here's a summary of the compliance stated:

Parameter	Acceptance Criteria (Implied by Compliance)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-5 and ISO 10993-10	"demonstrated that the Disposable Endoscopic Cannula is in compliance with requirements"
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-2-18	"data demonstrates that the device is in compliance"
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	"data demonstrates that the device is in compliance"
Optical Performance	Compliance with ISO 8600-1, ISO 8600-3, ISO 8600-4, and ISO 8600-5	"demonstrated that this device is in compliance"
Mechanical Performance	Safe and Effective (evaluated for tensile strength, vacuum integrity, and vacuum performance)	"The results demonstrated that the Disposable Endoscopic Cannula is safe and effective."
Light Source Safety	Can be assessed by "accepted electrical safety, EMC, thermal safety and photobiological safety testing methods"	"The electrical safety, EMC, thermal safety and photobiological safety testing showed that the Disposable Endoscopic Cannula is safe."
Imaging Function Performance	Optical performance data including image resolution, distortion, depth of view, field of view, direction of view	"supported by optical performance data"

The remaining points (2-9) are not applicable because this document describes a hardware medical device, not an AI or machine learning system. There are no test sets, training sets, ground truth, experts for annotation, or multi-reader multi-case studies described. The "performance" referred to is about the physical and electrical integrity and functionality of the device, not the accuracy of an algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird, composed of three interconnected human profiles facing to the right.

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

March 25, 2015

Dongguan Microview Medical Technology Co. % Long Yang Company Representative Shenzhen Hlongmed Biotech Co., Ltd 15-08 East Block, Yihai Plaza, Chuangye Road North Nanshan District, Shenzhen P.R. China, 518054

Re: K140213

Trade/Device Name: Disposable Endoscopic Cannula Regulation Number: 21 CFR 884.5070 Regulation Name: Vacuum abortion system Regulatory Class: II Product Code: HGH Dated: February 10, 2015 Received: February 20, 2015

Dear Long Yang,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Benjamin R. Fisher -S

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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K140213

Device Name

Disposable Endoscopic Cannula, model: RL1205, RL1206, RL1207, RL1208, RL1209

Indications for Use (Describe)

The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.

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

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

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."

{4}------------------------------------------------

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(K) number is: Date of Preparation: March 24, 2015

1. Submitter information

Manufacturer Name: DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD. Address: Galaxy Industrial Area, Qingxi, Dongguan, Guangdong, China Tel: +86-769-87738870-862 Fax: +86-769-87895932

2. Contact person

Long Yang (COO.) Shenzhen Hlongmed Biotech Co., Ltd. R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P. R. China Tel: +86-755-86664986 Fax: +86-755-86664933 E-mail: yanglong@hlongmed.com

3. Device Information

Trade Name: Disposable Endoscopic Cannula Model: RL1205, RL1206, RL1207, RL1208, RL1209 Common Name: Uterine Cannulae Regulatory Class: II

Classification Name	Product Codes	Regulation Number
Vacuum Abortion System	HGH	21 CFR 884.5070

{5}------------------------------------------------

4. Predicative Device

Item	Predicate Device
Device Name	Rigid Uterine Cannulae
Common Name	Uterine Cannulae
Manufacturer	Doranne Frano
Classification regulation	21CFR 884.5070
Classification and	Class II
Product code	HGH
510(k) number	K093508

5. Indications for Use

The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.

6. Device Description

7. Summary of non-clinical data

Biocompatibility: The biocompatibility data from cytotoxicity, irritation and

{6}------------------------------------------------

sensitization testing demonstrated that the Disposable Endoscopic Cannula is in compliance with requirements in ISO 10993-5 and ISO 10993-10.

Electrical Safety and Electromagnetic Compatibility: Electrical Safety and Electromagnetic Compatibility data demonstrates that the device is in compliance with IEC 60601-1, IEC 60601-2-18 and IEC 60601-1-2.

Bench testing: Optical performance testing has demonstrated that this device is in compliance with ISO 8600-1, ISO 8600-3, ISO 8600-4, and ISO 8600-5. In addition, this device has been evaluated for tensile strength, vacuum integrity, and vacuum performance

Parameter	Subject device (K140213)	Predicate device (K093508)
Device name	Disposable Endoscopic Cannula	Rigid Uterine Cannulae
Intended use	Same as the predicate, withadditional feature of visualization	For rapid transcervical aspiration ofthe uterine cavity during the firsttrimester of pregnancy
Design	Curved in shape two channelsOne channel for aspirationThe other channel for datatransmission via cable	Straight or curved in shapeOne channel for aspiration
Working length	Maximal 170 mm	Maximal 190 mm
Outer diameter	5-9 mm	6-12 mm
Material	Polycarbonate	Plastic (Styrenic copolymer resin)
Built in camera	Yes	No
Light source	Yes	No

8. Comparison to Predicate Device

Substantial equivalent discussion:

The Disposable Endoscopic Cannula and the predicate device have the same . intended use - uterine aspiration.
The Disposable Endoscopic Cannula and the predicate device have the same . fundamental technological designs (shape, suction channel, etc.) and comparable dimensions.
The Disposable Endoscopic Cannula is different from the predicate device in that . it has a light source, raising a safety concern. The difference does not raise new

{7}------------------------------------------------

types question because light source is common in other uterine devices (e.g., hysteroscopes). The difference can be assessed by accepted electrical safety, EMC, thermal safety and photoviological safety testing methods. The electrical safety, EMC, thermal safety and photobiological safety testing showed that the Disposable Endoscopic Cannula is safe.

. Unlike the predicate device, the Disposable Endoscopic Cannula has a camera that can capture the image of uterine cavity. The imaging function of this device is supported by optical performance data including image resolution, distortion, depth of view, field of view, direction of view, etc.
The Disposable Endoscopic Cannula uses different material, raising safety . concerns. There is no new type of question, because biocompatibility is a common question for patient-contacting medical devices. The biocompatibility testing showed that the Disposable Endoscopic Cannula is safe.
To ensure mechanical performance, the Disposable Endoscopic Cannula was . evaluated for tensile strength, suction integrity, and suction performance. The results demonstrated that the Disposable Endoscopic Cannula is safe and effective.

In conclusion, the Disposable Endoscopic Cannula is substantially equivalent to the predicate device in terms of safety and effectiveness.

Regulation Number and Section

§ 884.5070 Vacuum abortion system.

(a)
Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.(b)
Classification. Class II (performance standards).