(95 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization, and biocompatibility of a mechanical guide sheath, with no mention of AI or ML.
No
The device is described as a "Disposable Ureteral Guide Sheath" used to establish a conduit for other instruments, rather than directly treating a condition or disease. It facilitates a procedure but isn't itself a therapy.
No
The device is described as a "Ureteral Guide Sheath" used to establish a conduit for instruments during endoscopic urological procedures, rather than to diagnose a condition.
No
The device description explicitly states it is composed of a guide sheath and dilator, which are physical components, and mentions sterilization and packaging, indicating 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 "establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a surgical/procedural device used in vivo (within the body) to aid in a medical procedure.
- Device Description: The description details a physical device (guide sheath and dilator) used for accessing the urinary tract. It does not mention any components or functions related to testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the Disposable Ureteral Guide Sheath is a medical device used during a surgical procedure, not a device used for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Disposable Ureteral Guide 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 propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. This device is divided into 4 types: Straight type (ZSR-UA), Y type (ZSR-UAY), W type (ZSR-UAW), Cross type (ZSR-UAC). The device is composed of guide sheath and dilator. The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
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)
Non-Clinical Testing:
Performance testing: A EN 1618 Catheters other than intravascular catheters - Test methods for common properties.
Biocompatibility testing: Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity. Evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1".
Sterility and Shelf-life testing based on ISO 11135:2014, ISO 11737-1:2018, ISO11737-2:2019, ISO 10993-7: 2008, ASTM F1980-2016, ASTM D3078-02-2021, ASTMF 1929-15, ASTM F88/F88M-15.
Results: Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device.
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.
0
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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2024
Dongguan ZSR Biomedical technology Company Limited % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza West Guangzhong Road 555, Jingan District Shanghai, 200072 CHINA
Re: K241181
Trade/Device Name: Disposable Ureteral Guide Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Received: July 15, 2024
Dear Kyra Kang:
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
K241181 - Kyra Kang
(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.
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
2
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,
Mark R. 2024.08.02 13:46:16 Kreitz -S -04'00'
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
510(k) Number (if known) K241181
Device Name Disposable Ureteral Guide Sheath
Indications for Use (Describe)
The Disposable Ureteral Guide 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
l. Submitter
Dongguan ZSR Biomedical technology Company Limited Unit 448, Qingfeng Road, Taihu Village, Sanzhong Village Committee, Qingxi Town, 523651 Dongguan City, Guangdong Province,PEOPLE'S REPUBLIC OF CHINA
Date of Preparation: July 25, 2024
Contact person: Mrs. Wen Xiuyun Position: Management Representative Tel.: +86-13728363586 E-mail: Sharon@zsrbiomedical.com
Submission Correspondent
Ms. Kyra Kang Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: kyra.kang@landlink-health.com
II. Proposed Device
| Device Trade Name: | Disposable Ureteral Guide Sheath |
|---|---|
| Common name: | Endoscope and accessories |
| Classification Name: | Endoscopic access overtube |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product code: Review | FED |
| Panel: | Gastroenterology/Urology |
| III. Predicate Devices | K230748 |
|---|---|
| 510(k) Number: Trade | Disposable Ureteral Access Sheath |
| name: Common | Endoscope and accessories |
| name: Classification: | Class II |
| Product Code: | FED |
| Manufacturer | YouCare Technology Co., Ltd.(Wuhan). |
5
IV. Device description
The propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
This device is divided into 4 types:
- Straight type (ZSR-UA)
- Y type (ZSR-UAY)
- W type (ZSR-UAW)
- Cross type (ZSR-UAC)
The device is composed of guide sheath and dilator.The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
V. Indication for use
The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract
VI. Comparison of technological characteristics with the predicate devices
| Character
istics | Proposed device | Predicate device
(K230748) | Discussio
n |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Manufactu
rer | Dongguan ZSR Biomedical
technology Company Limited | YouCare Technology Co.,
Ltd.(Wuhan) | / |
| Regulation
| 876.1500 | 876.1500 | Same |
| Product
code | FED | FED | Same |
| Classificati
on
name | Endoscope and accessories | Endoscope and accessories | Same |
| Intended
use | The Disposable Ureteral Guide
Sheath is used to establish a
conduit during endoscopic
urological procedures | The Disposable Ureteral
Access Sheath is used to
establish a conduit during
endoscopic urological | Same |
| | facilitating the passage of
endoscopes and other
instruments into the urinary
tract | procedures facilitating the
passage of endoscopes and
other instruments into the
urinary tract | |
| Regulatory
Class | Class II | Class II | Same |
| Sterility | Yes | Yes | Same |
| Sterilizatio
n
Method | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Sheath ID | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr,
15Fr, 16Fr | 12Fr | Different 1 |
| Sheath
length | 10Fr, 11Fr, 12Fr, 13Fr,
14Fr:35cm, 40cm, 45cm,
50cm, 55cm
15Fr, 16Fr:40cm, 45cm | 45cm, 35cm | Different 2 |
| Primary
structure | The device is composed of
guide sheath and dilator. The
guide sheath consists of guide
sheath tube and connector
(straight, Y-shaped, W-shaped
and cross-shaped). | The product is composed of
sheath tube, sheath tube
base, dilator and center base
of dilator. The sheath tube
base contains a backwater
interface. The center base of
dilator consists of upper
cover of dilator base, lower
cover of dilator base , fiber
image channel interface F,
irrigation channel interface I,
equipment channel interface
E, obturator, two-way water
valve, needle free joint. | Different 3 |
| Materials | Sheath tube:
Pebax,SUS304,PTFE
Connector: polyamide (PA) ,
silica gel
Dilator connector:
polypropylene (PP)
Dilator tube: polyethylene
(PE) | sheath tube: Pebax6333
SA01
MED, SUS 304、PTFE、
PAM
sheath tube base: ABS, PC
(backwater interface: PC)
dilator: LDPE
center base of dilator
upper cover of the dilator | Different 4 |
| | Hydrophilic coating:
Polyvinylpyrrolidone (PVP) | base: ABS
lower cover of the dilator
base: ABS
fiber image channel
interface F: PC
irrigation channel interface
I: PC
equipment channel
interface E: PC
obturator: PC, silica gel
two-way water valve: PC,
POM
needle-free joint: PC, silica
gel | |
| Package | Single-use EO sterilized pouch
with one device per pouch | Single-use EO sterilized
pouch with one device per
pouch | Same |
| Biocompat
ible | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Bending
Resistanc
e | The guiding sheath tube and
the dilating tube were bent
90 ° in both directions by
grasping the head and the tail.
After 20 times of repetition, the
tube body was free of cracks,
creases, cracks and fractures,
the coating was free of falling
off, and the steel wire was not
separated from the inner and
outer rubber layers. | Bending any section of the
dilator, sheath tube or the
assembly of sheath tube and
dilator into a ring with a
radius of 5cm for 1min, there
should be no crease, crack or
other undesirable
phenomena. | Similar 1 |
| Coefficient
s of
Friction | After being dipped in water,
the surface is smooth, and the
friction force is not more than
0.5 N;
The average dynamic friction
force of 25 repeated tests shall
not be greater than 0.5 N | When the sheath tube is
tested for friction, the friction
coefficient shall not exceed
0.03. | Similar 2 |
| Peak
tensile
force | The joint between the guiding
sheath tube and the tube body
of the dilating tube and the
connector shall be able to bear
a force of $[0.3em] ">=$ 20 N and shall not
break for 15 s; | The peak tensile force of the
sheath tube and dilator
should not be less than 15N.
And the peak tensile force of
the junction between sheath
tube and sheath tube base,
the dilator and center base of
dilator also shall meet the | Similar 3 |
| The fracture force test shall be carried out when the guiding sheath tube connector and the expansion tube connector are locked. The minimum fracture force shall be ≥ 15N and shall not break for 15 s. | requirement. | | |
Table 1 General Comparison of Disposable Ureteral Guide Sheath
6
7
8
Different 1 - Sheath ID
This difference is in sheath ID. Different sheath inner diameter device will be selected by physician per patient's condition, this difference will not raise any issues in safety and effectiveness.
Different 2 - Sheath length
Different sheath length device will be selected by physician per patient's condition, this difference will not raise any issues in safety and effectiveness.
Different 3 - Primary structure
The predicate device has three instrument channels --- image channel, irrigation channel and equipment channel, it only increases the operation requirements for doctors. All the performance of the proposed device was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness.
Different 4 - Materials
Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", this difference will not raise any issues in safety and effectiveness.
Similar 1&2&3 – Performance
The subject device has similar performance to the predicate device. All performance of the subject device has been tested according to relevant standards and meets the requirements of the standards,this difference will not raise any issues in safety and effectiveness.
VII. Non-Clinical Testing
The device described in this summary Disposable Ureteral Guide Sheath, were
9
tested and demonstrated to be in conformance with the following standards:
Performance testing:
- A EN 1618 Catheters otherthan intravascular catheters - Test methods for commonproperties
Biocompatibility testing
Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:
- Cytotoxicity >
-
Sensitization
-
Irritation
-
Acute Systemic
-
Pyrogenicity
Sterility and Shelf -life
- ISO 11135:2014 >
-
ISO 11737-1:2018
- ISO11737-2:2019 >
-
ISO 10993-7: 2008
-
ASTM F1980-2016
-
ASTM D3078-02-2021
-
ASTMF 1929-15
-
ASTM F88/F88M-15
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.