(421 days)
Not Found
No
The description focuses on basic visualization and aspiration, with no mention of image analysis, pattern recognition, or automated decision-making that would typically involve AI/ML. The image signal is simply transmitted for display.
Yes
The device is indicated for "rapid transcervical aspiration of the first trimester of pregnancy", which is a medical procedure to terminate a pregnancy. This falls under the definition of a therapeutic device as it is used to treat a condition (pregnancy) or alter a body process.
No.
The device's intended use is for rapid transcervical aspiration, which is a therapeutic procedure, not a diagnostic one. While it has a visualization feature, this is for guidance during the aspiration and not for making a diagnosis.
No
The device description clearly outlines multiple hardware components, including a transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, data cable, LED light source, and CMOS camera. It is a physical device with a visualization feature, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is used directly within the human body (cervical canal and uterine cavity) for a procedural purpose (aspiration of pregnancy tissue). While it has a visualization feature, the primary function is a surgical/interventional procedure, not the analysis of a specimen in vitro.
The device description and intended use clearly indicate it's a tool for a medical procedure performed in vivo, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.
Product codes (comma separated list FDA assigned to the subject device)
HGH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity
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)
Biocompatibility: The biocompatibility data from cytotoxicity, irritation and 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.
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
§ 884.5070 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).
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
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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 |
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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
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.
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, with | |
| additional feature of visualization | For rapid transcervical aspiration of | |
| the uterine cavity during the first | ||
| trimester of pregnancy | ||
| Design | Curved in shape two channels | |
| One channel for aspiration | ||
| The other channel for data | ||
| transmission via cable | Straight or curved in shape | |
| One 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
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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.