(260 days)
Based on the provided text, this device does not contain an AI model.
Here's why:
- Explicitly stated "Not Found" for AI, DNN, or ML: The text specifically indicates that mentions of AI, DNN, or ML were not found.
- Focus on mechanical and material properties: The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of the sheath and dilator (e.g., rigidity, flexibility, coating, strength, biocompatibility).
- Function is purely mechanical: The device's function is to provide a physical conduit and protect the ureter. It doesn't involve any decision-making, data analysis, or pattern recognition that would typically be associated with an AI model.
- Use of X-ray (fluoroscopy) is for monitoring, not AI processing: The X-ray is used by the physician to visually monitor the placement of the device, not as input for an AI model to interpret or guide the procedure.
The device is a straightforward medical instrument designed for physical access and protection during a procedure, relying on the physician's skill and visual guidance.
No
The device is described as an "Access Sheath" used to facilitate the passage of other instruments into the urinary tract. Its primary purpose is to create and maintain a pathway, not to directly treat a medical condition or restore a function.
No
The device is a Ureteral Access Sheath, which is used to facilitate the passage of endoscopes and other instruments into the urinary tract for interventional procedures, not to diagnose a condition. While it mentions monitoring with X-ray (fluoroscopy) for accurate positioning, this is for guiding the intervention, not for diagnostic imaging itself.
No
The device description explicitly details physical components (inner semi-rigid dilator assembly, outer semi-rigid sheath assembly, stainless steel inner layer) and their material properties and physical dimensions (French sizes, lengths). It also mentions a locking mechanism and hydrophilic coating, all of which are hardware elements. The device is used to establish a physical conduit and facilitate the passage of instruments, which is a physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a surgical/interventional device used in vivo (within the body) to aid in a medical procedure.
- Device Description: The description details a physical device (sheath and dilator) used to create a pathway within the urinary tract. It mentions its physical properties, materials, sizes, and how it's used during a procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. IVDs are typically used for testing and analysis of biological samples.
- Performance Studies: The performance studies listed focus on the physical and biological safety of the device for its intended use within the body (biocompatibility, sterility, mechanical properties). They do not involve evaluating the accuracy or performance of a diagnostic test.
In summary, the Single-use Ureteral Access Sheath is a medical device used for facilitating a surgical procedure within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Product codes
FED
Device Description
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (fluoroscopy)
Anatomical Site
urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Non-Clinical Performance Data:
- Biocompatibility Testing: Evaluated in accordance with ISO 10993-1:2018 for "breached or compromised surface" with "Limited (
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.
December 2, 2024
Hunan Vathin Medical Instrument Co., Ltd. Jing Du RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re· K240167
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
Dear Jing Du:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 8, 2024. Specifically, FDA is updating this SE Letter (incorrect predicate device manufacturer name and subject device materials table in the 510(k) Summary) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark J. Antonino, OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, (240) 402-9980, Mark.Antonino@fda.hhs.gov.
Sincerely,
Mark R. Kreitz -S
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
1
Image /page/1/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 8, 2024
Hunan Vathin Medical Instrument Co., Ltd. Jing Du RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re· K240167
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: September 3, 2024 Received: September 4, 2024
Dear Jing Du:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
3
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,
Mark R. Kreitz -S
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
4
Indications for Use
510(k) Number (if known) K240167
Device Name Single-use Ureteral Access Sheath
Indications for Use (Describe)
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Production (Part 611 Subpart J) | □ Gas Storage (Part 611 Subpart G) |
|---|---|
| ----------------------------------------------------------------------------------- | ------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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5
510(k) Summary – K240167 Single-use Ureteral Access Sheath Hunan Vathin Medical Instrument Co., Ltd.
I. SUBMITTER INFORMATION
| Applicant: | Hunan Vathin Medical Instrument Co., Ltd. |
|---|---|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service |
| Center, No 9 Chuanqi west road, Jiuhua Economic Development | |
| Zone, 411100 Xiangtan, Hunan, China | |
| Contact Person: | Du Jing |
| Regulatory Affairs Manager | |
| +86-18915069265 | |
| charlene@vathin.com | |
| Date Prepared: | January 19, 2024 |
II. SUBJECT DEVICE
| Trade Name: | Single-use Ureteral Access Sheath |
|---|---|
| Common Name: | Ureteral Access Sheath |
| Classification Name: | Endoscopic Access Overtube, Gastroenterology-Urology |
| Regulatory Class: | II |
| Product Code: | FED |
| Regulation Number: | 21 CFR 876.1500 |
| Review Panel: | Gastroenterology/Urology |
III. PREDICATE DEVICE
| Trade Name: | Disposable Ureteral Access Sheath |
|---|---|
| 510(k) Number: | K203165 |
| Manufacturer: | Suzhou Beyo Medical Technology Co., Ltd. |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges.
6
Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma.
The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit.
To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process.
The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath.
The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
The subject device components are made of the following materials:
7
| Device Components | Contact Method | Material Full Name | |
|---|---|---|---|
| Inner Layer | Direct Contact | Austenitic stainless steel | |
| Sheath | Outer Layer | Low-density polyethylene (LDPE)+ Thermoplastic polyurethanes (TPU) | |
| Polyethylene terephthalate (PET) | |||
| Hub | Indirect Contact | Polycarbonate (PC) | |
| Sheath Hub | Suction Nozzle | Polycarbonate (PC) | |
| Sheath Cap | Indirect Contact | Polycarbonate (PC) | |
| Sealing Sleeve | Indirect Contact | Silicone | |
| Vent Push Button | Indirect Contact | Acrylonitrile–butadiene –styrene (ABS) | |
| Dilator | Direct Contact | Low-density polyethylene (LDPE) | |
| Dilator Hub | Hub | Indirect Contact | Polypropylene (PP) |
| Locking Clip | Polycarbonate (PC) | ||
| Hydrophilic Coatings | / | Urethane acrylate copolymer | |
| Direct Contact | Polyvinyl pyrrolidone (PVP) |
Table 1. Subject Device Materials
V. INDICATIONS FOR USE
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
8
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Single-use Ureteral Access Sheath is like the predicate device in the following areas:
- · Intended use (including application field, intended user and patient population)
- Principal operation .
- · Design and performance specifications
- · With hydrophilic coatings
- · It is single-use and delivered sterile
The following technological differences exist between the subject and predicate devices:
- · The sheath hub structure
- · The distal segment of the sheath can be passively bent
- · It allows for suction operation
- · The sheath is available in five French sizes, compared to the predicate device's three sizes
- · There are two sheath lengths available, whereas the predicate device offers five lengths
The differences between the Single-use Ureteral Access Sheath and predicate device do not alter suitability of the subject device for its intended use.
| Description | Subject Device | Predicate Device (K203165) |
|---|---|---|
| Trade Name | Single-use Ureteral Access Sheath | Disposable Ureteral Access Sheath |
| Regulation Number | 876.1500 | 876.1500 |
| Regulatory Class | II | II |
| Product Code | FED | FED |
| Indications for Use | The Single-use Ureteral Access | |
| Sheath is used to establish a conduit | ||
| during endoscopic urological | ||
| procedures, facilitating the passage | ||
| of endoscopes and other instruments | ||
| into the urinary tract. | The Ureteral Access Sheath is | |
| intended to use in urologic | ||
| endoscopic procedures to facilitate | ||
| the passage of endoscopes. | ||
| Delivered Sterile | Yes | Yes |
| Sterilization Method | EO | EO |
| Single Use | Yes | Yes |
| Sheath ID | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr | 10Fr, 12Fr, 14Fr |
| Sheath Length | 35cm, 45cm | 25cm, 35cm, 40cm, 45cm, 55cm |
| Guidewire Compatibility | 0.038" (0.97mm) guidewire can | |
| smoothly enter and exit the inner | ||
| lumen of the dilator. | 0.038" (0.97mm) guidewire can | |
| smoothly enter and exit the inner | ||
| cavity of the dilator. |
Table 2. Comparison of Technological Characteristics
9
| Description | Subject Device | Predicate Device (K203165) |
|---|---|---|
| Materials | Sheath: TPU, LDPE, PET, SUS304 | |
| Dilator: LDPE | ||
| Hydrophilic coating: PVP | Sheath: PEBAX, SUS304, PTFE | |
| Dilator: LDPE | ||
| Hydrophilic coating: PAM | ||
| Biocompatibility | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of | ||
| sensitization | ||
| Package | Single-use EO sterilized blister box | |
| with one device per box | Single-use EO sterilized pouch with | |
| one device per | ||
| pouch |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Non-Clinical Performance Data
Biocompatibility Testing
Biocompatibility of the Single-use Ureteral Access Sheath was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (