(266 days)
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.
This document does not contain an acceptance criteria table or a detailed study of device performance to meet such criteria. It is a 510(k) summary for a Hysteroscopy System. While it lists various performance tests conducted, it does not provide quantitative acceptance criteria or the specific results demonstrating compliance.
Here's a breakdown of what is available based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document lists performance tests but does not define acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific image resolution targets) nor does it present the numerical results from these tests against any defined criteria. It only states, "The protocol and results of all performance testing were acceptable."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document mentions various performance tests (e.g., biocompatibility, electrical safety, mechanical performance, image quality) but does not provide details on:
* The sample sizes used for any of these tests.
* The provenance of the data (e.g., country of origin, retrospective or prospective nature). These tests appear to be bench testing or material-level assessments, not clinical trials on human subjects.
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)
Missing. This type of information would typically be relevant for studies involving diagnostic accuracy or clinical interpretation. The performance tests described are largely engineering and safety evaluations (e.g., tensile strength, vacuum integrity, electrical safety, biocompatibility, image quality parameters like field of view, resolution). There's no indication of any expert-based ground truth establishment in the context usually meant by this question (e.g., for image interpretation or diagnosis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. Adjudication methods are typically used in clinical studies where multiple observers or methods are used to establish a definitive diagnosis or outcome. The performance tests listed are technical validations, not clinical outcome adjudications.
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
Missing. An MRMC study is not mentioned. The device is a "Hysteroscopy System" used for visualization and vacuum aspiration. There is no mention of AI or human-in-the-loop performance improvement in this document, as it describes a medical device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing. Not applicable, as this document describes a physical medical device (Hysteroscopy System), not an algorithm or AI software requiring standalone performance testing in that context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. As noted above, the performance tests described are largely technical/engineering validations. For example, for "image quality testing," the ground truth would be objectively measured parameters such as actual field of view, photometric measurements for illumination, and resolution targets. For "mechanical performance testing," ground truth would be defined by engineering specifications (e.g., expected tensile strength, vacuum pressure). There's no mention of clinical "ground truth" derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Missing. This is not an AI device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Missing. Not applicable, as there is no training set for an AI algorithm.
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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: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 9, 2018
Chongqing Jinshan Science & Technology (Group) Co., Ltd. Qing Xu Regulatory Manager Yubei District No. 18 Ningshang Avenue Jinshan International Industrial City Chongqing, 400000 China
Re: K172151 Trade/Device Name: Hysteroscopy System Regulation Number: 21 CFR§ 884.5070 Regulation Name: Vacuum Abortion System Regulatory Class: II Product Code: HGH Dated: March 6, 2018 Received: March 9, 2018
Dear Oing Xu:
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.
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be on a white background. The letters are clearly legible and well-defined. The overall impression is clean and professional.
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) K172151
Device Name Hysteroscopy System
Indications for Use (Describe)
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image contains the logo for JINSHAN. The logo consists of a red circular shape with a white triangle inside, resembling a mountain. To the right of the logo is the word "JINSHAN" in black, bold letters. The overall design is simple and corporate.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)] 04/06/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Chongqing Jinshan Science & Technology (Group) Co., Ltd. |
|---|---|
| Company Address: | Yubei District No.18 Ningshang Avenue JinshanInternational Industrial City, Chongqing, |
| Contact Person: | Qing Xu |
| Phone: | 023 - 86098111 |
| Fax: | 023 - 86098777 |
| Email: | xuq@jinshangroup.net |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Hysteroscopy System |
|---|---|
| Common Name: | Vacuum Abortion System |
| Product Code: | HGH (cannula, suction, uterine) |
| Regulation Name: | Vacuum Abortion System |
| Regulation Number: | 21CFR 884.5070 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow: Manufacturer: DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD. Trade Name: Disposable Endoscopic Cannula K140213 FDA 510(k) #:
The predicate device has not been subject to a design related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
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Chongqing Jinshan Science & Technology (Group) Co., Ltd.
Image /page/4/Picture/2 description: The image contains the logo for Jinshan. The logo consists of a red circle with a white triangle inside, followed by the word "JINSHAN" in black, sans-serif font. The triangle inside the circle is pointing upwards.
The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width.
Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.
6. Indications for Use [21 CFR 807.92(a)(5)]
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
The subject and predicate device have the same intended use.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The Hysteroscopy System has different technological characteristics in comparison to the named predicate, primarily with respect to the optics and image quality, internal device construction, and materials used for device construction. However, these differences in technological characteristics do not raise different questions of safety and effectiveness.
8. Summary of Performance Data [21 CFR 807.92(b)]
The following performance data were provided to support substantial equivalence:
- Ethylene oxide sterilization validation per ISO 11135-1:2007
- Shelf Life including packaging integrity following simulated shipping and mechanical performance testing as described below
- . Biocompatibility including cytotoxicity per ISO 10993-5:2009. sensitization per ISO 10993-10:2010 and irritation per ISO 10993-10:2010
- Software documentation per the FDA Software Guidance
- Electromagnetic compatibility testing per IEC 60601-1-2:2014 ●
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Chongqing Jinshan Science & Technology (Group) Co., Ltd.
Image /page/5/Picture/2 description: The image contains the logo for Jinshan. The logo consists of a red circle with a white triangle inside, followed by the word "JINSHAN" in black, sans-serif font. The triangle inside the circle is pointing upwards and has a small notch at the top.
- Electrical safety testing per AAMI / ANSI ES60601-1:2005/(R)2012 and ● C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18: 2009
- Mechanical performance testing including dimensional analysis, tensile ● strength, vacuum integrity, vacuum performance, and leak testing
- . Image quality testing including field of view, direction of view, illumination, and resolution per the ISO 8600 series of standards
The protocol and results of all performance testing were acceptable.
9. Conclusion [21 CFR 807.92(b)(3)]
The performance data demonstrate that the Hysteroscopy System is substantially equivalent to the predicate device.
§ 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).