(135 days)
Not Found
No
The description focuses on the physical components and material properties of a mechanical device, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device facilitates medical procedures by providing a working channel and dilation for the introduction of endoscopes and instruments, directly aiding in the treatment or diagnosis within a patient's body.
No
The device is described as facilitating the passage of endoscopes and providing a working channel for instruments in urologic endoscopic procedures. Its function is to aid in access and delivery, not to diagnose conditions.
No
The device description clearly outlines physical components (outer sheath base, outer sheath, dilator tube, locking clip, joint) and mentions physical properties and bench testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to use in urologic endoscopic procedures to facilitate the passage of endoscopes." This describes a device used within the body for a procedural purpose, not for examining specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details a physical device (sheath, dilator, etc.) used to create a working channel during a surgical procedure. This aligns with a surgical or procedural device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the device's function is to aid in a surgical procedure, not to perform a diagnostic test on a sample outside the body.
N/A
Intended Use / Indications for Use
The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
Product codes
FED
Device Description
The Single Use Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in effective length of sheath from 10.0cm (shortest) to 55cm (longest).
The device is packaged in a peel-open pouch with a two-year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The following bench tests were performed on Single Use Ureteral Access Sheath: Appearance, Dimension, Physical properties. The results of all testing were passing.
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014-07-15"Sterilization of Health Care products Ethylene Oxide - Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices [Including: Amendment 1 (2018)]", and ISO 10993-7 Second Edition 2008-10-15 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]".
The shelf-life for two years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 Second Edition 2019-02 and ISO 11607-2 Second Edition 2019-02 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization and intracutaneous reactivity were performed to ensure the biocompatibility of the subject device set.
No clinical study is included in this submission.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 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: K220065
Trade/Device Name: Single Use Ureteral Access Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: April 27, 2022 Received: May 3, 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.
1
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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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,
for Mark J. Antonino, M.S. Assistant 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) K220065
Device Name Single Use Ureteral Access Sheath
Indications for Use (Describe)
The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
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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3
Image /page/3/Picture/1 description: The image contains a logo with a hexagonal shape on the left, transitioning from green to blue. To the right of the logo, there are Chinese characters in blue, followed by the word "MEDNOVA" in blue and green. The overall design appears to represent a company or organization, possibly in the medical or technology field, given the combination of the logo and the text.
ng Medical Technology Co., LTD.
Page: 1 / 4
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
27-Dec- 2021
3. Device
Trade/Device Name: Single Use Ureteral Access Sheath Regulation name: Endoscope and accessories Regulation class: II Regulation number: 876.1500 Panel: Gastroenterology/Urology Product code: FED
4. Predicative device
4.1) 510(k) Number: K203165 Device Name: Disposable Ureteral Access Sheath
5. Device description
The Single Use Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in effective length of sheath from 10.0cm (shortest) to 55cm (longest).
The device is packaged in a peel-open pouch with a two-year shelf life.
4
Image /page/4/Picture/1 description: The image shows a logo for MEDNOVA. The logo consists of a blue and green hexagon shape on the left, followed by the company name in blue and green text. The text is in both English and Chinese.
Zhejiang Chuangxiang Medical Technology Co., LTD.
Page: 2 / 4
6. Indications for use
The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
7. Comparison of Technological Characteristics:
The Single Use Ureteral Access Sheath has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Suzhou Beyo's Disposable Ureteral Access Sheath, K203165. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Proposed device | Predicate device | Comparison to
Predicate Devices |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device name | Single Use Ureteral Access Sheath | Disposable Ureteral Access
Sheath | / |
| Product code | FED | FED | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Indications for
Use | The device is intended to use in
urologic endoscopic procedures
to facilitate the passage of
endoscopes. | The Ureteral Access Sheath is
intended to use in urologic
endoscopic procedures to
facilitate the passage of
endoscopes. | Same |
| Configuration | Dilator tube, Outer sheath,
Outer sheath base, Joint, Locking
clip
hydrophilic coating | Sheath, sheath hub, dilator,
dilator hub, dilator clip,
hydrophilic coating | Same |
| Sheath ID | 10Fr, 12Fr, 14Fr | 10Fr, 12Fr, 14Fr | Same |
| Sheath
Effective Length | 10.0cm, 16.5cm, 20cm, 25cm,
35cm, 45cm, 55cm | 25cm, 35cm, 40cm, 45cm, 55cm | Similar |
| Supplied Sterile | Yes | Yes | Same |
5
Image /page/5/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue geometric shape on the left, followed by the text "MEDNOVA" in blue. To the right of "MEDNOVA" are three Chinese characters in blue.
g Medical Technology Co., LTD.
| Page: | |||
|---|---|---|---|
| Packaging | Single-use EO sterilized pouch | ||
| with one device per pouch | Single-use EO sterilized pouch | ||
| with one device per pouch | Same | ||
| Shelf Life | Two years (24 months) | Three years (36 months) | Similar |
8. Applicable Guidance Document
NA
9. Performance Data
The following bench tests were performed on Single Use Ureteral Access Sheath: Appearance, Dimension, Physical properties. The results of all testing were passing.
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014-07-15"Sterilization of Health Care products Ethylene Oxide - Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices [Including: Amendment 1 (2018)]", and ISO 10993-7 Second Edition 2008-10-15 "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]".
The shelf-life for two years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 Second Edition 2019-02 and ISO 11607-2 Second Edition 2019-02 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization and intracutaneous reactivity were performed to ensure the biocompatibility of the subject device set.
10. Clinical Test Conclusion
No clinical study is included in this submission.
6
Page:
Image /page/6/Picture/1 description: The image shows a logo with a hexagon shape on the left side that transitions from green to blue. To the right of the hexagon is the text "MEDNOVA" in blue and green. Above the text are four Chinese characters in blue.
Zhejiang Chuangxiang Medical Technology Co., LTD.
11. Conclusions
Chuangxiang medical has been demonstrated that the proposed device Single Use Ureteral Access Sheath is substantially equivalent to Suzhou Beyo Medical Technology Co., Ltd. currently marketed Disposable Ureteral Access Sheath (K203165).