(54 days)
Not Found
No
The description focuses on the mechanical components and function of a suction-evacuation sheath, with no mention of AI or ML capabilities.
No.
The device facilitates a medical procedure, but it does not directly treat a disease or medical condition.
No
Explanation: The device is described as a "Suction-Evacuation Sheath" used to "establish a conduit" and facilitate the passage of instruments for the "treatment of urinary stones or other urinary diseases." Its function is mechanical (establishing access and suction/evacuation), not to collect or analyze data for diagnosis.
No
The device description clearly outlines physical components like tubes, metal wires, an obturator, and a rubber cap, indicating it is 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 clearly states that the device is used to "establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a surgical or procedural device used in vivo (within the body) to aid in treatment.
- Device Description: The description details a physical sheath, obturator, and connections for suction and potentially a specimen collector. This aligns with a surgical access device, not a device used to perform tests on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like urine, blood, etc.) to diagnose, monitor, or predict disease. The focus is on facilitating access and removal of materials during a procedure.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment decisions. This device's function is purely procedural.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FED, FAJ, FGA
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.
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)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, Guangzhou | |
| 511434, P.R. China | |
| Jenny Zhu | |
| RA Specialist | |
| Contact Person: | WELL LEAD MEDICAL CO., LTD. |
| Email: jenny_zhu@welllead.com.cn | |
| Tel: +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-Urology |
| FAJ-Cystoscope And Accessories, Flexible/Rigid | |
| FGA-Kit, Nephroscope | |
| Regulatory Class: | Class II |
Predicate Device(s): K161110- ClearPetra Suction-Evacuation Sheath
2. Indications for use
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.
4
3. 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.
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.
5
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-Evacuation | ||
| Sheath | ClearPetra Suction-Evacuation | ||
| Sheath | 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 conduit | ||
| during endoscopic urological | |||
| procedures facilitating the passage | |||
| of endoscopes and other | |||
| instruments into the urinary tract. It | |||
| is designed to establish a conduit | |||
| for the treatment of urinary stones | |||
| or other urinary diseases during the | |||
| endoscopic procedures. | It is used to establish a conduit | ||
| during endoscopic urological | |||
| procedures facilitating the passage | |||
| of endoscopes and other | |||
| instruments into the urinary tract. It | |||
| is designed to establish a conduit | |||
| for the treatment of urinary stones | |||
| or other urinary diseases during the | |||
| endoscopic procedures. | Same | ||
| Patient Population | Patients undergoing endoscopic | ||
| procedures, through percutaneous | |||
| passages | Patients undergoing endoscopic | ||
| procedures, through percutaneous | |||
| passages | Same | ||
| 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 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. | |||
| OD of Obturator | Compatible with 10Fr-26Fr sheath | Compatible with 10Fr-22Fr sheath | Same |
| Length | 13cm to 55cm | 13cm to 55cm | 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. | |||
| 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 10993-1 | ||
| Cytotoxicity, Irritation, Sensitization, | |||
| Acute System Toxicity, Material | |||
| mediated pyrogencity | ISO 10993-1 | ||
| Cytotoxicity, Irritation, Sensitization, | |||
| Acute System Toxicity | Similar | ||
| The subject device's | |||
| materials in contact were | |||
| tested as per ISO 10993- | |||
| 11 for Material mediated | |||
| pyrogencity. |
Table 5-1 - Comparison Between Subject Device & Predicate Device
6
7
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
8
- � 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