(199 days)
Not Found
No
The device description focuses on mechanical components and operation, and there are no mentions of AI, ML, image processing, or data sets for training or testing.
No
The device is described as being used to collect cells from the gastrointestinal tract, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is described as collecting cells from the gastrointestinal tract, which implies a specimen collection function for later analysis, rather than a direct diagnostic capability by the device itself.
No
The device description clearly outlines multiple physical components (Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter, Steel Wire) and describes a mechanical operation (moving the Finger Ring back and forth). It also mentions sterilization and packaging, all indicative of a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect cells" from the human gastrointestinal tract. This is a specimen collection device.
- Device Description: The description focuses on the mechanical components and operation for obtaining cellular material.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or interpretation of the collected cells to provide diagnostic information. IVD devices are designed to be used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening.
This device is a tool for obtaining a sample that could then be used in an IVD process (e.g., the collected cells could be sent to a lab for cytological examination). However, the device itself is solely for collection.
N/A
Intended Use / Indications for Use
This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.
Product codes
FDX
Device Description
The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.
The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human gastrointestinal tract (stomach or duodenum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The following bench tests were performed on Single Use Cytology Brush: Appearance, Dimension, Operational performance. The results of all testing were passing.
The testing performed demonstrated that the proposed device meets the same performance requirements and is Substantially Equivalent (SE) to the currently cleared predicate device (K172663).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
July 28, 2022
Zhejiang Chuangxiang Medical Technology Co., Ltd. Lucius Long, RA Manager Room 101, 201, 301, 401, 501, Building 50, No.650 Hongfeng Road Donghu Street. Yuhang District Hangzhou, Zhejiang Province 311100 CHINA
Re: K220063
Trade/Device Name: Single Use Cytology Brush Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDX Dated: June 21, 2022 Received: June 28, 2022
Dear Lucius Long:
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. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220063
Device Name Single Use Cytology Brush
Indications for Use (Describe)
This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.
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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K220063 Page 1 of 2
Image /page/3/Picture/1 description: The image contains a logo with a combination of graphic and textual elements. On the left, there is a stylized hexagon shape with a gradient fill, transitioning from green to blue. To the right of the hexagon, there are Chinese characters in blue, followed by the word "MEDNOVA" in a combination of blue and green colors. The overall design appears to represent a brand or organization, possibly related to medicine or technology, given the name and the visual elements.
g Medical Technology Co., LTD.
Page: 1 / 2
510(k) Summary( 21CFR 807.92) Section 5
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province, 311100, P.R. China
Contact person: Lucius.Long Email: lucius.long@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086
2. Date of Submission
23-Dec-2021
3. Device
Trade/Device Name: Single Use Cytology Brush Regulation name: Endoscope and accessories Regulation class: II Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: FDX
4. Predicative device
4.1) 510(k) Number: K172663 Device Name: Cytology Brush
5. Device description
The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.
The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.
4
Image /page/4/Picture/1 description: The image contains a logo with a combination of graphical and textual elements. On the left, there is a geometric shape, resembling a hexagon with an internal design that transitions from green to blue. To the right of the shape, there is the text "MEDNOVA" in a sans-serif font, with "MED" in blue and "NOVA" in green. Above the text, there are Chinese characters in blue.
ng Medical Technology Co., LTD.
Page: 2 / 2
6. Indications for use
This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.
7. Comparison of Technological Characteristics:
The Single Use Cytology Brush of Zhejiang Chuangxiang Medical Technology Co., LTD. incorporates substantially equivalent materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device (K172663).
8. Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The following bench tests were performed on Single Use Cytology Brush: Appearance, Dimension, Operational performance. The results of all testing were passing.
The testing performed demonstrated that the proposed device meets the same performance requirements and is Substantially Equivalent (SE) to the currently cleared predicate device (K172663).
9. Clinical Test Conclusion
Clinical Test is not applicable for the proposed device. No clinical study is included in this submission
10. Conclusions
Based on the indications for use, technological characteristics, and safety and performance testing, the Single Use Cytology Brush has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device (K172663).