Single Use Ureteral Access Sheath

K260410 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · FED · Sep 11, 2026 · Gastroenterology, Urology

Device Facts

Record IDK260410
Device NameSingle Use Ureteral Access Sheath
ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Product CodeFED · Gastroenterology, Urology
Decision DateSep 11, 2026
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 876.1500
Device ClassClass 2

Indications for Use

The Single Use Ureteral Access Sheath is indicated for use in adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures.

Device Story

Single-use sterile ureteral access sheath; facilitates endoscope/instrument passage into urinary tract. Comprised of outer sheath, dilator tube, base, joint, and optional locking clip or pressure control vent. Hydrophilic coating on outer surface reduces friction. Type B variant connects to hospital central negative pressure system to suction stones through sheath cavity. Used in clinical urologic procedures by physicians. Provides continuous working channel; aids in ureteral dilation. Benefits include improved access and stone removal efficiency.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included appearance, dimensions, guidewire compatibility, resistance to deformation, drainage flow rate, leakage resistance, fixation strength, fracture strength, dynamic friction, flexibility/kink resistance, inner cavity passability, and particle analysis. All tests passed.

Technological Characteristics

Materials: ABS, PEBAX, 06Cr19Ni10, PTFE, PE, PC. Hydrophilic coating: Polyvinylpyrrolidone/ethanol. Sterilization: Ethylene Oxide (ISO 11135). Sizes: 10Fr-14Fr; lengths 16.5cm-55cm. Mechanical design includes dilator/sheath assembly. No software or electronic components.

Indications for Use

Indicated for adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

Submission Summary (Full Text)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 11, 2026 Zhejiang Chuangxiang Medical Technology Co., Ltd. Haishao Wei RA Specialist Rm. 101-1, 201-1, 301, 401, Bldg. 50, #650 Hongfeng Rd. Donghu St., Linping District Hangzhou, 311100 CHINA Re: K260410 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: August 20, 2026 Received: August 20, 2026 Dear Haishao Wei: 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. {1} K260410 - Haishao Wei Page 2 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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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} K260410 - Haishao Wei Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260410 | ? | | Please provide the device trade name(s). | | ? | | Single Use Ureteral Access Sheath | | | | Please provide your Indications for Use below. | | ? | | The Single Use Ureteral Access Sheath is indicated for use in adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures. | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K260410 Page 1 of 21 ![img-0.jpeg](img-0.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. # ---**510(k) Summary( 21CFR 807.92)** # **1. Submitter's information** Name: Zhejiang Chuangxiang Medical Technology Co., LTD. Address: Room 101-1, 201-1, 301, 401, Building 50, No.650 Hongfeng Road, Donghu Street, Linping District, Hangzhou City,311100 Zhejiang Province, P.R. China. Contact person: Haishao Wei Email: weihaishao@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086 # **2. Date of Submission** August 31, 2026 # **3. Device Identification** 510(k) Number: K260410 Trade/Device name: Single Use Ureteral Access Sheath Common or usual name: Endoscope and accessories Classification name: Endoscopic Access Overtube, Gastroenterology-Urology Regulation Number: 21 CFR 876.1500 Regulation class: II Product code: FED # **4. Predicative device identification** 510(k) Number: K220065 Device Name: Single Use Ureteral Access Sheath Product Code: FED # **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 six components: outer sheath base, outer sheath, dilator tube, locking clip (for Type A only), pressure control vent (for Type B only) 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 five French sizes: 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr, and range in effective length of sheath from 16.5cm (shortest) to 55cm (longest). 1 / 21 {5} K260410 Page 2 of 21 ![img-1.jpeg](img-1.jpeg) **Zhejiang Chuangxiang Medical Technology Co., LTD.** The device is packaged in a peel-open pouch with a two-year shelf life. Principle of operation for the Type B only: The device creates a working channel for endoscopes and other instruments to access the urinary tract. It connects to the hospital’s central negative pressure system. The stones are expelled through the outer sheath cavity under negative pressure suction. #### **6. Indications for use** The Single Use Ureteral Access Sheath is indicated for use in adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures. 2 / 21 {6} K260410 Page 3 of 21 ![img-2.jpeg](img-2.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. # **7. Comparison of Technological Characteristics with the predicate device:** | Item | Proposed device | Predicate device | Remark | | --- | --- | --- | --- | | Device name | Single Use Ureteral Access Sheath | Single Use Ureteral Access Sheath | / | | 510K number | K260410 | K220065 | / | | Product code | FED | FED | Same | | Regulation No. | 876.1500 | 876.1500 | Same | | Manufacturer | Zhejiang Chuangxiang Medical Technology Co., LTD. | Zhejiang Chuangxiang Medical Technology Co., LTD. | Same | | Classification | II | II | Same | | Sterilization | EO | EO | Same | | Material | ABS/PEBAX/06Cr19Ni10/PTFE/PE /PC Hydrophilic coating: Polyvinylpyrrolidone+ Anhydrous ethanol | ABS/PEBAN5533/06Cr19Ni10/PTFE/PE Hydrophilic coating: (Primer Coating: Polyacrylamide + deionized water mixture Top Coating: Polyacrylamide + isopropanol + | The proposed device was evaluated in accordance with the FDA guidance “use of international standard ISO 10993-1”, and it was concluded that | 3 / 21 {7} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 4 of 21 | | | deionized water mixture) | the proposed device is biological safe, so this difference will not raise new questions of safety and effectiveness. | | --- | --- | --- | --- | | Configuration | Dilator tube, Outer sheath, Outer sheath base, Joint, locking clip (for Type A only), pressure control vent (for Type B only), hydrophilic coating | Dilator tube, Outer sheath, Outer sheath base, Joint, Locking clip, hydrophilic coating | Similar | | Sheath ID | 10Fr,11Fr,12Fr,13Fr,14Fr | 10Fr, 12Fr, 14Fr | The proposed device is available in multiple sizes, and the ID dimensions fall within the size range of the predicate device. Different ID dimensions device will be selected by the physician per patient's condition, this difference will not raise new questions of safety and effectiveness. | | Sheath Effective Length | 16.5cm, 20cm, 25cm, 35cm, 36cm, 37cm, 38cm, 39cm, 40cm, 41cm, 42cm, 43cm, 44cm, 45cm, 46cm, 47cm, 48cm, 49cm, 50cm, 51cm, 52cm, 53cm, 54cm, 55cm | 10cm, 16.5cm, 20cm, 25cm, 35cm, 45cm, 55cm | The proposed device is available in multiple sizes, and the effective length dimensions fall within the size range of the predicate device. Different effective length dimensions device will be selected by the physician per patient's condition, this | 4 / 21 {8} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 5 of 21 | | | | difference will not raise new questions of safety and effectiveness. | | --- | --- | --- | --- | | Indications for Use | The Single Use Ureteral Access Sheath is indicated for use in adult patients (aged 18 years and older) to facilitate the passage of endoscopes during urologic procedures. | The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes. | Same | | Single Use | Yes | Yes | Same | | Packaging | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Same | | Shelf Life | 2 years | 2 years | Same | 5 / 21 {9} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 6 of 21 # 8. Models List | Model | Specifications | I.D. of outer sheath (Fr) | O.D. of outer sheath D(mm) ±0.1 | I.D. of outer sheath D1(mm) ±0.1 | O.D. of dilator tube D2(mm) ±0.1 | O.D. of tip D3(mm) ±0.1 | Effective length of outer sheath L(mm) ±5% | Effective length of dilator tube L1(mm) ±5% | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Type A | MD-A-AS-1416 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 165 | 186 | | | MD-A-AS-1420 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 200 | 221 | | | MD-A-AS-1425 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 250 | 271 | | | MD-A-AS-1435 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 350 | 371 | | | MD-A-AS-1436 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 360 | 381 | | | MD-A-AS-1437 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 370 | 391 | | | MD-A-AS-1438 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 380 | 401 | | | MD-A-AS-1439 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 390 | 411 | | | MD-A-AS-1440 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 400 | 421 | | | MD-A-AS-1441 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 410 | 431 | | | MD-A-AS-1442 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 420 | 441 | | | MD-A-AS-1443 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 430 | 451 | | | MD-A-AS-1444 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 440 | 461 | 6 / 21 {10} K260410 Page 7 of 21 ![img-3.jpeg](img-3.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. | | MD-A-AS-1445 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 450 | 471 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-A-AS-1446 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 460 | 481 | | | MD-A-AS-1447 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 470 | 491 | | | MD-A-AS-1448 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 480 | 501 | | | MD-A-AS-1449 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 490 | 511 | | | MD-A-AS-1450 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 500 | 521 | | | MD-A-AS-1451 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 510 | 531 | | | MD-A-AS-1452 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 520 | 541 | | | MD-A-AS-1453 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 530 | 551 | | Type A | MD-A-AS-1454 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 540 | 561 | | | MD-A-AS-1455 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 550 | 571 | | | MD-A-AS-1316 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 165 | 186 | | | MD-A-AS-1320 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 200 | 221 | | | MD-A-AS-1325 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 250 | 271 | | | MD-A-AS-1335 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 350 | 371 | | | MD-A-AS-1336 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 360 | 381 | | | MD-A-AS-1337 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 370 | 391 | | | MD-A-AS-1338 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 380 | 401 | 7 / 21 {11} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 8 of 21 | MD-A-AS-1339 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 390 | 411 | | --- | --- | --- | --- | --- | --- | --- | --- | | MD-A-AS-1340 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 400 | 421 | | MD-A-AS-1341 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 410 | 431 | | MD-A-AS-1342 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 420 | 441 | | MD-A-AS-1343 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 430 | 451 | | MD-A-AS-1344 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 440 | 461 | | MD-A-AS-1345 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 450 | 471 | | MD-A-AS-1346 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 460 | 481 | | MD-A-AS-1347 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 470 | 491 | | MD-A-AS-1348 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 480 | 501 | | MD-A-AS-1349 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 490 | 511 | | MD-A-AS-1350 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 500 | 521 | | MD-A-AS-1351 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 510 | 531 | | MD-A-AS-1352 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 520 | 541 | | MD-A-AS-1353 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 530 | 551 | | MD-A-AS-1354 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 540 | 561 | | MD-A-AS-1355 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 550 | 571 | | MD-A-AS-1216 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 165 | 186 | 8 / 21 {12} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 9 of 21 | | MD-A-AS-1220 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 200 | 221 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-A-AS-1225 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 250 | 271 | | | MD-A-AS-1235 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 350 | 371 | | | MD-A-AS-1236 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 360 | 381 | | | MD-A-AS-1237 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 370 | 391 | | | MD-A-AS-1238 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 380 | 401 | | Type A | MD-A-AS-1239 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 390 | 411 | | | MD-A-AS-1240 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 400 | 421 | | | MD-A-AS-1241 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 410 | 431 | | | MD-A-AS-1242 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 420 | 441 | | | MD-A-AS-1243 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 430 | 451 | | | MD-A-AS-1244 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 440 | 461 | | | MD-A-AS-1245 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 450 | 471 | | | MD-A-AS-1246 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 460 | 481 | | | MD-A-AS-1247 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 470 | 491 | | | MD-A-AS-1248 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 480 | 501 | | | MD-A-AS-1249 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 490 | 511 | | | MD-A-AS-1250 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 500 | 521 | 9 / 21 {13} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 10 of 21 | MD-A-AS-1251 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 510 | 531 | | --- | --- | --- | --- | --- | --- | --- | --- | | MD-A-AS-1252 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 520 | 541 | | MD-A-AS-1253 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 530 | 551 | | MD-A-AS-1254 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 540 | 561 | | MD-A-AS-1255 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 550 | 571 | | MD-A-AS-1116 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 165 | 186 | | MD-A-AS-1120 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 200 | 221 | | MD-A-AS-1125 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 250 | 271 | | MD-A-AS-1135 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 350 | 371 | | MD-A-AS-1136 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 360 | 381 | | MD-A-AS-1137 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 370 | 391 | | MD-A-AS-1138 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 380 | 401 | | MD-A-AS-1139 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 390 | 411 | | MD-A-AS-1140 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 400 | 421 | | MD-A-AS-1141 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 410 | 431 | | MD-A-AS-1142 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 420 | 441 | | MD-A-AS-1143 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 430 | 451 | | MD-A-AS-1144 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 440 | 461 | 10 / 21 {14} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 11 of 21 | | MD-A-AS-1145 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 450 | 471 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-A-AS-1146 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 460 | 481 | | | MD-A-AS-1147 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 470 | 491 | | Type A | MD-A-AS-1148 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 480 | 501 | | | MD-A-AS-1149 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 490 | 511 | | | MD-A-AS-1150 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 500 | 521 | | | MD-A-AS-1151 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 510 | 531 | | | MD-A-AS-1152 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 520 | 541 | | | MD-A-AS-1153 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 530 | 551 | | | MD-A-AS-1154 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 540 | 561 | | | MD-A-AS-1155 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 550 | 571 | | | MD-A-AS-1016 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 165 | 186 | | | MD-A-AS-1020 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 200 | 221 | | | MD-A-AS-1025 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 250 | 271 | | | MD-A-AS-1035 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 350 | 371 | | | MD-A-AS-1036 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 360 | 381 | | | MD-A-AS-1037 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 370 | 391 | | | MD-A-AS-1038 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 380 | 401 | 11 / 21 {15} K260410 Page 12 of 21 ![img-4.jpeg](img-4.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. | | MD-A-AS-1039 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 390 | 411 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-A-AS-1040 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 400 | 421 | | | MD-A-AS-1041 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 410 | 431 | | | MD-A-AS-1042 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 420 | 441 | | | MD-A-AS-1043 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 430 | 451 | | | MD-A-AS-1044 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 440 | 461 | | | MD-A-AS-1045 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 450 | 471 | | | MD-A-AS-1046 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 460 | 481 | | | MD-A-AS-1047 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 470 | 491 | | | MD-A-AS-1048 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 480 | 501 | | | MD-A-AS-1049 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 490 | 511 | | | MD-A-AS-1050 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 500 | 521 | | | MD-A-AS-1051 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 510 | 531 | | | MD-A-AS-1052 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 520 | 541 | | | MD-A-AS-1053 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 530 | 551 | | | MD-A-AS-1054 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 540 | 561 | | | MD-A-AS-1055 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 550 | 571 | | Type B | MD-B-AS-1416 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 165 | 186 | 12 / 21 {16} K260410 Page 13 of 21 ![img-5.jpeg](img-5.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. | | MD-B-AS-1420 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 200 | 221 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-B-AS-1425 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 250 | 271 | | | MD-B-AS-1435 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 350 | 371 | | | MD-B-AS-1436 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 360 | 381 | | | MD-B-AS-1437 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 370 | 391 | | | MD-B-AS-1438 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 380 | 401 | | | MD-B-AS-1439 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 390 | 411 | | | MD-B-AS-1440 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 400 | 421 | | | MD-B-AS-1441 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 410 | 431 | | | MD-B-AS-1442 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 420 | 441 | | | MD-B-AS-1443 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 430 | 451 | | | MD-B-AS-1444 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 440 | 461 | | | MD-B-AS-1445 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 450 | 471 | | | MD-B-AS-1446 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 460 | 481 | | | MD-B-AS-1447 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 470 | 491 | | | MD-B-AS-1448 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 480 | 501 | | | MD-B-AS-1449 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 490 | 511 | | | MD-B-AS-1450 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 500 | 521 | 13 / 21 {17} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 14 of 21 | | MD-B-AS-1451 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 510 | 531 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-B-AS-1452 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 520 | 541 | | | MD-B-AS-1453 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 530 | 551 | | | MD-B-AS-1454 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 540 | 561 | | | MD-B-AS-1455 | 14 | 5.3 | 4.85 | 4.7 | 2.3 | 550 | 571 | | | MD-B-AS-1316 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 165 | 186 | | | MD-B-AS-1320 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 200 | 221 | | | MD-B-AS-1325 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 250 | 271 | | | MD-B-AS-1335 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 350 | 371 | | | MD-B-AS-1336 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 360 | 381 | | | MD-B-AS-1337 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 370 | 391 | | | MD-B-AS-1338 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 380 | 401 | | | MD-B-AS-1339 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 390 | 411 | | | MD-B-AS-1340 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 400 | 421 | | | MD-B-AS-1341 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 410 | 431 | | Type B | MD-B-AS-1342 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 420 | 441 | | | MD-B-AS-1343 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 430 | 451 | | | MD-B-AS-1344 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 440 | 461 | 14 / 21 {18} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 15 of 21 | MD-B-AS-1345 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 450 | 471 | | --- | --- | --- | --- | --- | --- | --- | --- | | MD-B-AS-1346 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 460 | 481 | | MD-B-AS-1347 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 470 | 491 | | MD-B-AS-1348 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 480 | 501 | | MD-B-AS-1349 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 490 | 511 | | MD-B-AS-1350 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 500 | 521 | | MD-B-AS-1351 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 510 | 531 | | MD-B-AS-1352 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 520 | 541 | | MD-B-AS-1353 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 530 | 551 | | MD-B-AS-1354 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 540 | 561 | | MD-B-AS-1355 | 13 | 5.0 | 4.34 | 4.2 | 2.15 | 550 | 571 | | MD-B-AS-1216 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 165 | 186 | | MD-B-AS-1220 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 200 | 221 | | MD-B-AS-1225 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 250 | 271 | | MD-B-AS-1235 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 350 | 371 | | MD-B-AS-1236 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 360 | 381 | | MD-B-AS-1237 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 370 | 391 | | MD-B-AS-1238 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 380 | 401 | 15 / 21 {19} K260410 Page 16 of 21 ![img-6.jpeg](img-6.jpeg) Zhejiang Chuangxiang Medical Technology Co., LTD. | | MD-B-AS-1239 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 390 | 411 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-B-AS-1240 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 400 | 421 | | | MD-B-AS-1241 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 410 | 431 | | | MD-B-AS-1242 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 420 | 441 | | | MD-B-AS-1243 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 430 | 451 | | | MD-B-AS-1244 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 440 | 461 | | | MD-B-AS-1245 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 450 | 471 | | | MD-B-AS-1246 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 460 | 481 | | | MD-B-AS-1247 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 470 | 491 | | | MD-B-AS-1248 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 480 | 501 | | | MD-B-AS-1249 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 490 | 511 | | | MD-B-AS-1250 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 500 | 521 | | Type B | MD-B-AS-1251 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 510 | 531 | | | MD-B-AS-1252 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 520 | 541 | | | MD-B-AS-1253 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 530 | 551 | | | MD-B-AS-1254 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 540 | 561 | | | MD-B-AS-1255 | 12 | 4.7 | 4.05 | 3.9 | 2.0 | 550 | 571 | | | MD-B-AS-1116 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 165 | 186 | 16 / 21 {20} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 17 of 21 | MD-B-AS-1120 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 200 | 221 | | --- | --- | --- | --- | --- | --- | --- | --- | | MD-B-AS-1125 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 250 | 271 | | MD-B-AS-1135 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 350 | 371 | | MD-B-AS-1136 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 360 | 381 | | MD-B-AS-1137 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 370 | 391 | | MD-B-AS-1138 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 380 | 401 | | MD-B-AS-1139 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 390 | 411 | | MD-B-AS-1140 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 400 | 421 | | MD-B-AS-1141 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 410 | 431 | | MD-B-AS-1142 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 420 | 441 | | MD-B-AS-1143 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 430 | 451 | | MD-B-AS-1144 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 440 | 461 | | MD-B-AS-1145 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 450 | 471 | | MD-B-AS-1146 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 460 | 481 | | MD-B-AS-1147 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 470 | 491 | | MD-B-AS-1148 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 480 | 501 | | MD-B-AS-1149 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 490 | 511 | | MD-B-AS-1150 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 500 | 521 | 17 / 21 {21} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 18 of 21 | | MD-B-AS-1151 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 510 | 531 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-B-AS-1152 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 520 | 541 | | | MD-B-AS-1153 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 530 | 551 | | | MD-B-AS-1154 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 540 | 561 | | | MD-B-AS-1155 | 11 | 4.35 | 3.65 | 3.5 | 1.85 | 550 | 571 | | | MD-B-AS-1016 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 165 | 186 | | | MD-B-AS-1020 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 200 | 221 | | | MD-B-AS-1025 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 250 | 271 | | | MD-B-AS-1035 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 350 | 371 | | Type B | MD-B-AS-1036 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 360 | 381 | | | MD-B-AS-1037 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 370 | 391 | | | MD-B-AS-1038 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 380 | 401 | | | MD-B-AS-1039 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 390 | 411 | | | MD-B-AS-1040 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 400 | 421 | | | MD-B-AS-1041 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 410 | 431 | | | MD-B-AS-1042 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 420 | 441 | | | MD-B-AS-1043 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 430 | 451 | | | MD-B-AS-1044 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 440 | 461 | 18 / 21 {22} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 19 of 21 | | MD-B-AS-1045 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 450 | 471 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | MD-B-AS-1046 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 460 | 481 | | | MD-B-AS-1047 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 470 | 491 | | | MD-B-AS-1048 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 480 | 501 | | | MD-B-AS-1049 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 490 | 511 | | | MD-B-AS-1050 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 500 | 521 | | | MD-B-AS-1051 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 510 | 531 | | | MD-B-AS-1052 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 520 | 541 | | | MD-B-AS-1053 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 530 | 551 | | | MD-B-AS-1054 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 540 | 561 | | | MD-B-AS-1055 | 10 | 4.0 | 3.35 | 3.2 | 1.7 | 550 | 571 | 19 / 21 {23} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 20 of 21 # 9. Performance Data The following functional and mechanical performance testing was conducted on the Single Use Ureteral Access Sheath: - Appearance - Dimension - Guidewire compatibility (Ø0.035inch Guidewire should be inserted into the dilator tube cavity and pass through smoothly.) - Resistance to deformation (under the negative pressure 150-200mmHg, keep for 3minutes.) - Drainage flow rate (negative pressure 150-200mmHg, Seal the opening on the sheath base Lateral Cavity, immerse the sheath tip in water for 3 minutes, detect product drainage flow.) - Resistance to leakage under negative pressure (negative pressure 150-200mmHg, Seal the opening on the sheath base Lateral Cavity, immerse the sheath tip in water for 3 minutes, there is no water leakage at any connection part of the product.) - Fixation strength of the pressure control vent (Test the fastening strength of the pressure control vent using the tensile testing machine.) - Fracture strength (at connection between outer sheath/base and dilator tube/joint. The part of the outer sheath tube/dilator tube inserted into the human body was placed in water at a temperature of (37± 2)°C for 2 hours for state adjustment. The rest of the outer sheath tube should be adjusted at the same time under the relative humidity of 40%~60% and temperature of (23±2)°C, and the test should be conducted immediately after placement. Tensile speed: 400mm/min.) - Dynamic friction force of the outer sheath surface (The test is performed using custom-designed test equipment, with a test speed set at 200mm/min.) - Sheath flexibility / Resistance to compression and kink. (bend the product 90° in any direction for at least 10 times, loosen the locking clip to extract and insert the dilator tube, and visually observe the appearance of the outer sheath and dilator tube, there should be no cracks, kink and other defects.) - Sheath inner cavity passability (minimum bending radius) (The outer sheath is bent under the condition that the making length is 55mm, the dilator tube pass through the sheath inner cavity.) - Particles (perform particle analysis with Light Obscuration Particle Count Test.) The results of all testing were passing. 20 / 21 {24} 创想医学 MEDNOVA Zhejiang Chuangxiang Medical Technology Co., LTD. K260410 Page 21 of 21 ### 10. Sterilization The proposed device is sold in a sterile package. The proposed device have been sterilized in a validated EO sterilization cycle. 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)]”. ### 11. Shelf Life The shelf-life of 2 years has been validated through aging testing 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 test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life. ### 12. Biocompatibility The Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 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 show that the proposed devices are biocompatible. ### 13. Conclusions There are no significant differences between the proposed device and the predicate device, the proposed device doesn’t raise any new issues of safety and effectiveness. Based on the results of the non-clinical performance testing, the proposed device is substantially equivalent to the predicate device (K220065). 21 / 21
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