(125 days)
Not Found
No
The description focuses on the physical characteristics and function of a ureteral access sheath, a mechanical device. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device facilitates the passage of other instruments used for treatment, but it is not directly used for treating the disease itself. Its primary function is to establish a conduit.
No
The device description indicates its use for establishing a conduit and facilitating the passage of instruments for treatment, not for diagnosis.
No
The device description clearly describes a physical, invasive medical device (Ureteral Access Sheath) used in endoscopic procedures, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a surgical or procedural device used within the body, not a device used to examine specimens outside the body (in vitro).
- Device Description: The description details a physical sheath inserted into the urinary tract to facilitate procedures. This aligns with a surgical/procedural device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and mechanical.
N/A
Intended Use / Indications for Use
The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Product codes
FED
Device Description
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 provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures.
Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction.
The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm.
The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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 testing:
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity as per ISO 10993-5:2009
- Intracutaneous Irritation as per ISO 10993-10:2021
- Sensitization as per ISO 10993-21:2021
- Acute Systemic Toxicity as per ISO 10993-11:2017
- Material Mediated Pyrogenicity per ISO 10993-11:2017 and
Performance testing including:
- Dimension
- Compatibility
- Fracture Force
- Bending Resistance
- Liquid Leakage
- Surface friction coefficient
Ethylene Oxide Sterilization Validation:
- ISO 11135:2014
- ISO 11737-1:2018
- ISO 11737-2:2019
- ISO 10993-7: 2008
Shelf life and Package Validation:
- ISO 11607-1:2019
- DIN 58953-6
- ASTM F2096-11
- ASTM F88/F88M-15
- ASTM F1886/F1886M-16
- ASTM F1929-15
- ASTM D4169-22
Clinical study: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 30, 2025
Seplou (zhuhai) Co., Ltd. Vince Zeng Regulatory Affairs Manager 5th Floor, Building 1, No. 8, Keji 10th Road Tangjiawan Town Zhuhai, Guangddong 519086 CHINA
Re: K243025
Trade/Device Name: Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Received: January 3, 2025
Dear Vince Zeng:
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"
1
(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Ureteral Access Sheath (SPAS1028, SPAS1035, SPAS1045, SPAS1135, SPAS1145, SPAS1235, SPAS1245, SPAS1335, SPAS1345, SPAS1435, SPAS1445); Ureteral Access Sheath with Suction Collection (SPAS1033S, SPAS1040S, SPAS1050S, SPAS1140S, SPAS1150S, SPAS1240S, SPAS1250S, SPAS1340S, SPAS1350S)
Indications for Use (Describe)
The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
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)
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4
510k Summary
510k Summary
510(k) Premarket Notification
5
510k Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 2025/01/03
1. Submitter (Owner) of 510k
Name: SEPLOU (ZHUHAI) CO., LTD.
Address: 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, 519085 Zhuhai, Guangdong, People's Republic of China
2. Contact person
Vince Zeng Regulatory Affairs Manager Tel: +86 13650966940 Email: Vince@seplou.com
3. Subject device information
Trade Name: Ureteral Access Sheath Common Name: Ureteral Access Sheath Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology Regulation Number: 21 CFR 876.1500 Regulatory Classification: Class II Product Code: FED
4. Predicate device
| No | Device name | K number | Manufacturer |
|---|---|---|---|
| 1 | ClearPetra Suction-Evacuation Sheath | K161110 | WELL LEAD MEDICAL CO., |
| LTD. |
5. Device Description
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 provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures.
Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction.
The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm.
The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr
510(k) Premarket Notification
6
to 13Fr and length 33cm to 50cm.
6. Intended use & Indication for use
The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
7. Comparison to the predicate device
The following tabulation indicates the detailed differences between the subject devices and the predicate devices.
| Features | Subject Device | Pridicate Device | Remark |
|---|---|---|---|
| Product Name | Ureteral Access Sheath | ClearPetra Suction-Evacuation Sheath | / |
| Model Name | Ureteral Access Sheath | ClearPetra Ureteral Access Sheath | / |
| 510k Number | Applying | K161110 | / |
| Applicant | SEPLOU (ZHUHAI) CO., LTD. | WELL LEAD MEDICAL CO., LTD. | / |
| Product Code | FED | FED | Same |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Regulatory Class | Class II | Class II | Same |
| Review Pannel | Gastroenterology/Urology | Gastroenterology/Urology | Same |
| Indications for Use | The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. | It is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. | Same |
| Patient Population | Patients undergoing endoscopic procedures, through percutaneous passages | Patients undergoing endoscopic procedures, through percutaneous passages | Same |
| Material | Sheath | ||
| Tube:PTFE+PEBAX+304 | |||
| Stainless steel | |||
| Outer surface:PEBAX | |||
| Inner surface:PTFE | |||
| Dilator: LDPE | Sheath Tube: | ||
| PTFE+PA+Stainless steel | |||
| Outer surface: PA | |||
| Inner surface: PTFE | |||
| Dilator: PE | Different 1 | ||
| Coating | The outer surface of the sheath | ||
| has a hydrophilic coating. | The outer surface of the sheath | ||
| has a hydrophilic coating. | Same | ||
| Sterilization | |||
| Method | EO | EO | Same |
| Sheath ID | 10Fr to 14Fr | 10Fr to 14Fr | Same |
| Sheath Length | 28cm to 50cm | 13cm to 55cm | Different 2 |
| Structure | 1) The Tip-Unbendable Ureteral | ||
| Access Sheath is comprised of | |||
| Dilator, Sheath, Dilator | |||
| Connector and Sheath Connector | |||
| Image: drawing of a medical device |
- The Tip-Bendable Ureteral
Access Sheath with suction is
comprised of Dilator, Sheath,
Dilator Connector and W
Connector, Straightway valve,
Silicone Cap, Protective Cap
Image: drawing of a medical device | The Ureteral Access
Sheath is comprised of Sheath,
Obturator, Luer Connector, Y
Connector, Rubber Cap
Image: drawing of a medical device | Different 3 |
| Single Use | Yes | Yes | Same |
| Biocompatibilit
y | Cytotoxicity, Irritation,
Sensitization, Acute System
Toxicity, Material mediated
pyrogencity | Cytotoxicity, Irritation,
Sensitization, Acute System
Toxicity, Material mediated
pyrogencity | Same |
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K243025 Page 4 of 6
SEPLOU (ZHUHAI) CO., LTD.
The subject device and predicate device have the same classification information, similar materials, same specifications, and same performance outcomes. Any differences in characteristics (material, sheath length, structure) have been supported through testing (i.e., biocompatibility testing, performance testing, and shelf-life testing). These differences do not raise different questions of safety and effectiveness.
8. Performance Data
The following performance data were provided in support of the substantial equivalence 510(k) Premarket Notification Page 4 of 6 Ureteral Access Sheath
8
K243025 Page 5 of 6 SEPLOU (ZHUHAI) CO., LTD.
determination.
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity as per ISO 10993-5:2009
- Intracutaneous Irritation as per ISO 10993-10:2021
- Sensitization as per ISO 10993-21:2021
- Acute Systemic Toxicity as per ISO 10993-11:2017
- Material Mediated Pyrogenicity per ISO 10993-11:2017 and
Performance testing
General performance testing including:
- Dimension
- Compatibility
- Fracture Force
- Bending Resistance
- Liquid Leakage
- Surface friction coefficient
Ethylene Oxide Sterilization Validation
- ISO 11135:2014
- ISO 11737-1:2018
- ISO 11737-2:2019
- ISO 10993-7: 2008
Shelf life and Package Validation
- ISO 11607-1:2019
- DIN 58953-6
- ASTM F2096-11
- ASTM F88/F88M-15
- ASTM F1886/F1886M-16 ●
510(k) Premarket Notification
9
K243025 Page 6 of 6 SEPLOU (ZHUHAI) CO., LTD.
- ASTM F1929-15
- ASTM D4169-22
Clinical study
No clinical study is included in this submission.
9. Conclusion
According to the 510(k) submission, the subject device and the predicate device have the same intended use, and the difference in technological features of the proposed devices and the predicate devices do not raise different questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device models are substantially equivalent to the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.