The ClearPetra Suction-Evacuation 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 endoscopic procedures.

Device Description

The ClearPetra Suction-Evacuation Sheath consists of a straight distal tube and a proximal bifurcated tube. The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance. One segment of the proximal bifurcated tube is straight and is contiguous with the distal tube. The other is constructed in an oblique angle with a longitudinal pressure control vent. An obturator is included for the insertion of the sheath. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator. The oblique tube is to be connected directly to a negative pressure aspirator with a clear tube or alternatively, connected to a specimen collector (packed separately) then onto a negative pressure aspirator.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "ClearPetra Suction-Evacuation Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device (K161110 - ClearPetra Suction-Evacuation Sheath) rather than presenting a performance study against specific acceptance criteria for a new AI/software device.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth are not applicable in this context, as this submission is for a modified hardware device, not an AI software.

Here's an analysis based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, etc.) for a diagnostic or AI device. Instead, it relies on comparison to a predicate device and bench testing to demonstrate that the modifications do not negatively impact safety and effectiveness.

The "acceptance criteria" can be inferred from the "Verdict" column in the comparison table and the subsequent non-clinical testing. These broadly aim to demonstrate that the modified device performs as well as or similarly to the predicate device, or within acceptable safety parameters for the new specifications.

Acceptance Criterion (Inferred)	Reported Device Performance
Material: Same as predicate device (PE, PA)	Same
Sterilization Method: Same as predicate device (EO sterilized)	Same
Size: New product specifications (24Fr, 26Fr) for Nephrostomy Sheath are safe and effective.	Different. "Since the new product specification is not far outside cleared product specification, the change could not significantly affect the device's safety or effectiveness. The new product specifications were tested as per Product Specification."
Length: Modified dimension (15cm added to Nephrostomy Sheath) is safe and effective.	Similar. "Although a modified dimension is within a range of dimensions previously cleared for the original device, the change could not significantly affect the device's safety or effectiveness. The new product specifications were tested as per Product Specification." (Note: The table also lists 13cm to 55cm for both, implying the range is similar, but new specific lengths were added.)
Component: Similar to predicate (Sheath, Obturator, Connector, Rubber Cap)	Similar
Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Irritation, Sensitization, Acute System Toxicity, Material mediated pyrogenicity)	Similar. Subject device tested for Material mediated pyrogenicity (in addition to the others already covered by the predicate), fulfilling the ISO 10993-1 standard.
Overall Performance (Bench Testing): Verify performance is substantially equivalent to predicate and performs as intended.	"A Performance Bench testing has been conducted to verify that the performance of the proposed ClearPetra Suction-Evacuation Sheath is substantially equivalent to the predicate device, and that the ClearPetra Suction-Evacuation Sheath will perform as intended."
Sterilization Efficacy: Ethylene oxide sterilization process is validated.	"A Sterilization by ethylene oxide has been validated for ClearPetra Nephrostomy Sheath."
Safety and Effectiveness: Modifications do not raise new issues of safety and effectiveness.	"No new issues of safety and effectiveness were identified during this process [Risk Analysis]."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies mentioned are primarily "Non-Clinical Testing" and "Bench Testing" rather than clinical studies with human participants. Therefore, concepts like "test set," "data provenance," and "retrospective/prospective" as they relate to clinical data are not applicable here. The testing would have likely involved physical samples of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes a hardware device modification and bench testing, not a study requiring expert-established ground truth for diagnostic accuracy (e.g., for an AI system evaluating medical images).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as above. No clinical expert adjudication is mentioned or implied for the non-clinical testing performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. This type of study is relevant for AI-powered diagnostic aids, not for the modification of a physical medical device like a suction-evacuation sheath.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm is not applicable as this submission is for a physical medical device, not an algorithm or AI software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" (in the context of expert consensus, pathology, or outcomes data) is not applicable here. The ground for determination of "acceptance" or "substantial equivalence" relies on:

Physical/material specifications comparison.
Biocompatibility testing against ISO standards.
Performance bench testing results demonstrating functional equivalence and intended performance.
Sterilization validation.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm or software being trained.

9. How the ground truth for the training set was established

This information is not applicable as there is no AI algorithm or software being trained.

Summary

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December 9, 2020

Well Lead Medical Co., LTD. Jenny Zhu RA Specialist C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, Guangdong 511434 China

Re: K203119

Trade/Device Name: ClearPetra Suction-Evacuation Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED, FAJ, FGA Dated: October 14, 2020 Received: October 16, 2020

Dear Jenny Zhu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 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 J. Antonino, M.S. Acting 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

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Indications for Use

510(k) Number (if known) K203119

Device Name ClearPetra Suction-Evacuation Sheath

Indications for Use (Describe)

The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter Information

Date:	11/18/2020
Submitter:	WELL LEAD MEDICAL CO., LTD.Address: C-4 # Jinhu Industrial Estate, Hualong, Panyu, Guangzhou511434, P.R. ChinaJenny ZhuRA Specialist
Contact Person:	WELL LEAD MEDICAL CO., LTD.Email: jenny_zhu@welllead.com.cnTel: +86-20-84758878-8029
Device Name:	ClearPetra Suction-Evacuation Sheath
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and Accessories
Product Code:	FED-Endoscopic Access Overtube, Gastroenterology-UrologyFAJ-Cystoscope And Accessories, Flexible/RigidFGA-Kit, Nephroscope
Regulatory Class:	Class II

Predicate Device(s): K161110- ClearPetra Suction-Evacuation Sheath

2. Indications for use

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3. Device Description

Modification:

The ClearPetra Suction-Evacuation Sheath differs from the predicate device as below:

(1) Product Size Change: Add 24Fr, 26Fr in product model of ClearPetra Nephrostomy Sheath;

(2) Product Length Change: Add 15cm in product model of ClearPetra Nephrostomy Sheath.

The intended use of the modified device, as described in its labeling, has not changed as a result of the modification.

4. Substantial Equivalence-Comparison to Predicate Device

The predicate device to which we claim equivalence is the ClearPetra Suction-Evacuation Sheath (K161110).

The ClearPetra Suction-Evacuation Sheath maintains the same intended use as the predicate device. 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. The proposed device and the predicate device consist of the same fundamental technology.

The ClearPetra Suction-Evacuation Sheath differs from the predicate device in product model of ClearPetra Nephrostomy Sheath as below:

(1) Product Size Change: Add 24Fr, 26Fr in product model of ClearPetra Nephrostomy Sheath; (2) Product Length Change: Add 15cm in product model of ClearPetra Nephrostomy Sheath. The modification has not altered the fundamental scientific technology of the predicate ClearPetra Suction-Evacuation Sheath. It has well-established methods are available to evaluate the change as well as all performance data necessary to support SE can be reviewed in a summary or risk analysis format.

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Therefore, the modified ClearPetra Suction-Evacuation Sheath is substantially equivalent to the current legally marketed ClearPetra Suction-Evacuation Sheath (K161110) device. The differences between the ClearPetra Suction-Evacuation Sheath and the predicate device raise no different issues of safety and effectiveness.

A Risk Analysis was conducted and is detailed in the Design Control Summary Section. No new issues of safety and effectiveness were identified during this process.

The ClearPetra Suction-Evacuation Sheath and the predicate device consist of the same fundamental technology and are sterilized with acceptable methods. Below is a comparison table that summarizes the technological characteristics of the proposed and predicate device.

Comparison between proposed device and predicate device
Comparison Items	Subject Device	Predicate Device	Verdict
Product Name	ClearPetra Suction-EvacuationSheath	ClearPetra Suction-EvacuationSheath	Same
Model Name	ClearPetra Nephrostomy Sheath	ClearPetra Nephrostomy Sheath	Same
510k Number	Applying	K161110	Same
Product Code	FED, FAJ, FGA	FED, FAJ, FGA	Same
Regulation Number	21 CFR 876.1500	21 CFR 876.1500	Same
Regulatory Class	Class II	Class II	Same
Review Panel	Gastroenterology/Urology	Gastroenterology/Urology	Same
Indications for Use	It is used to establish a conduitduring endoscopic urologicalprocedures facilitating the passageof endoscopes and otherinstruments into the urinary tract. Itis designed to establish a conduitfor the treatment of urinary stonesor other urinary diseases during theendoscopic procedures.	It is used to establish a conduitduring endoscopic urologicalprocedures facilitating the passageof endoscopes and otherinstruments into the urinary tract. Itis designed to establish a conduitfor the treatment of urinary stonesor other urinary diseases during theendoscopic procedures.	Same
Patient Population	Patients undergoing endoscopicprocedures, through percutaneouspassages	Patients undergoing endoscopicprocedures, through percutaneouspassages	Same
Comparison between proposed device and predicate device
Comparison Items	Subject Device	Predicate Device	Verdict
Material	PE, PA	PE, PA	Same
Sterilization Method	EO sterilized	EO sterilized	Same
Size	10Fr to 26Fr	10Fr to 22Fr	Different.Since the new productspecification is not faroutside cleared productspecification, the changecould not significantlyaffect the device's safetyor effectiveness. Thenew productspecifications weretested as per ProductSpecification.
OD of Obturator	Compatible with 10Fr-26Fr sheath	Compatible with 10Fr-22Fr sheath	Same
Length	13cm to 55cm	13cm to 55cm	SimilarAlthough a modifieddimension is within arange of dimensionspreviously cleared for theoriginal device, thechange could notsignificantly affect thedevice's safety oreffectiveness. The newproduct specificationswere tested as perProduct Specification.
Component	Sheath, Obturator, Connector, Rubber Cap	Sheath, Obturator, Connector, Rubber Cap	Similar
Design Drawing	Image: Design Drawing of device	Image: Design Drawing of device	Same
Sterilization Method	EO sterilized	EO sterilized	Same
Single Use	Yes	Yes	Same
Comparison between proposed device and predicate device
Comparison Items	Subject Device	Predicate Device	Verdict
Biocompatibility	ISO 10993-1Cytotoxicity, Irritation, Sensitization,Acute System Toxicity, Materialmediated pyrogencity	ISO 10993-1Cytotoxicity, Irritation, Sensitization,Acute System Toxicity	SimilarThe subject device'smaterials in contact weretested as per ISO 10993-11 for Material mediatedpyrogencity.

Table 5-1 - Comparison Between Subject Device & Predicate Device

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Discussion

Although there is a bit difference of the product specification and dimension between the predicate device and subject device, they have the same technological features, performance, intended use and manufactured in the same manner as currently marketed device. The newly change in subject device has been evaluated by a well-established method of bench testing. And the data has been reviewed in a summary or risk analysis format to show that modification does not affect the safety and effectiveness.

5. Summary of Non-Clinical Testing

The following performance testing comparing the modified device to the predicate device was conducted.

A Performance Bench testing has been conducted to verify that the performance of the proposed ClearPetra Suction-Evacuation Sheath is substantially equivalent to the predicate device, and that the ClearPetra Suction-Evacuation Sheath will perform as intended. Bench-top testing was conducted to assure conformance to the following standards:
- � Product Specification
A The following Biocompatibility testing was performed in accordance with ISO 10993-1.
- � Cytotoxicity
- � Sensitization
- � Irritation/ Intracutaneous reactivity

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� Acute System Toxicity
� Material Mediated Pyrogencity
A Sterilization by ethylene oxide has been validated for ClearPetra Nephrostomy Sheath.

Conclusions Drawn from the Non-Clinical Testing

The performance and biocompatibility testing provided in this submission demonstrate that the modified ClearPetra Suction-Evacuation Sheath is as safe and effective and performs as well as the predicate device and therefore supports the determination of substantial equivalence.

6. Conclusion

The ClearPetra Nephrostomy Sheath is substantially equivalent to predicate device. Based on the intended use, principle of operation, performance characteristics, and technological characteristics, the proposed ClearPetra Nephrostomy Sheath is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device.

7. Summary Prepared Date

18 November 2020

Regulation Number and Section

§ 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.