(175 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a suction-evacuation sheath, with no mention of AI or ML capabilities.
No.
The device facilitates therapeutic procedures by creating a conduit and aiding in the removal of materials, but it does not directly treat a disease or condition itself.
No
Explanation: The device is described as a "Suction-Evacuation Sheath" used to establish a conduit during endoscopic urological procedures for treatment, such as facilitating the passage of endoscopes and instruments for treating urinary stones or removing foreign bodies. While it allows for the passage of instruments used in diagnostic procedures (like cystoscopy), the sheath itself performs a mechanical function of creating access rather than directly diagnosing conditions.
No
The device description clearly outlines physical components like a sheath, obturator, and connectors, and the performance testing focuses on physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided text, the ClearPetra Suction-Evacuation Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to establish a conduit during endoscopic urological procedures to facilitate the passage of instruments and for the treatment of urinary stones or other urinary diseases. This describes a surgical/interventional device used directly on or within the patient's body.
- Device Description: The description details the physical components of the sheath, obturator, and connectors, and how they are used to create a passage and potentially remove foreign bodies. This aligns with a surgical access and evacuation tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, and are used to analyze biological samples like blood, urine, or tissue.
Therefore, the ClearPetra Suction-Evacuation Sheath is a surgical/interventional medical device, not an In Vitro Diagnostic device.
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 the endoscopic procedures.
Product codes
FED, FAJ, FGA
Device Description
The ClearPetra Suction-Evacuation Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The intended use is for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures such as, nephroscopy, ureteroscopy, or cystoscopy. It is used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The ClearPetra Suction-Evacuation Sheath comes in three models: ClearPetra Ureteral Access Sheath, ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath. The Ureteral Access Sheath includes two versions: Access Sheath for the Semi-rigid Ureteroscope and Access Sheath for the Flexible Ureteroscope.
The ClearPetra Suction-Evacuation Sheath is comprised of the following components:
- Sheath
- Obturator
- Luer Connector
- · Y Connector
- Rubber Cap
The sheath is fitted with a Y connector on the proximal end. The Y connector is bifurcated: straight tube and oblique tube, The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance.
one seqment of the Y connector is straight and is contiguous with the sheath: The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
An obturator is included for the insertion of the sheath. The obturator is radiopaque and is fitted with a luer connector on the proximal end. 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 device is offered in French size ranging from 10Fr to 22Fr and length 13cm to 55cm. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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 was conducted for the ClearPetra Suction-Evacuation Sheath:
- 1 ) General performance testing including:
- · Connection Strength
- · Bending Resistance
- · Coefficients of Friction
- · Determining the Dimensions
Testing datas and results are included in this submission, and demonstrated that the ClearPetra Suction-Evacuation Sheath meets all the pre-determined testing and acceptance criteria.
-
- Biocompatibility testing as per ISO 10993-1:2009 including:
- · Cytotoxicity as per ISO 10993-5:2009
- · Irritation as per ISO 10993-10:2010
- · Sensitization as per ISO 10993-10:2010
- · Acute Systemic Toxicity as per ISO 10993-11:2006
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151084--Well Lead Ureteral Access Sheath, K150158--Schoelly Cystoscopes/ Hysteroscopes And Accessories, K151308--Schoelly Nephroscope Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol composed of three overlapping profiles facing right. The profiles are rendered in black and create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2016
WELL LEAD MEDICAL CO., LTD. Han Guang Yuan General Manager C-4#Jinhu Industrial Estate, Hualong, Panyu Guangzhou, Guangdong 511434 China
K161110 Re:
Trade/Device Name: ClearPetra Suction-Evacuation Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Codes: FED, FAJ, FGA Dated: September 10, 2016 Received: September 14, 2016
Dear Han Guang Yuan:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K161110
Device Name: ClearPetra Suction-Evacuation Sheath
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 the endoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 2016/09/10 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address:C-4 # Jinhu Industrial Estate, Hualong, Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Huang Kaigen |
| Regulatory Affairs Manager | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: huangkg@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | |
| Trade Name: | |
| Common Name: | ClearPetra Suction-Evacuation Sheath |
| ClearPetra Suction-Evacuation Sheath | |
| Ureteral Access Sheath, Cystoscope Sheath, Nephrostomy | |
| Sheath, Endoscopic Access Overtube | |
| Regulation Number: | 876.1500 Endoscope and accessories |
| Classification Name: | FED-Endoscopic Access Overtube, Gastroenterology-Urology |
| 21 CFR 876.1500;Class II | |
| FAJ-Cystoscope And Accessories, Flexible/Rigid | |
| 21 CFR 876.1500;Class II | |
| FGA-Kit, Nephroscope | |
| 21 CFR 876.1500;Class II | |
| Product Code: | FED-Endoscopic Access Overtube, Gastroenterology-Urology |
| FAJ-Cystoscope And Accessories, Flexible/Rigid | |
| FGA-Kit, Nephroscope | |
| Regulatory Class: | Class II |
| Predicate Device(s): | K151084--Well Lead Ureteral Access Sheath |
| K150158--Schoelly Cystoscopes/ Hysteroscopes And | |
| Accessories | |
| K151308--Schoelly Nephroscope Set |
4
1. Intended 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 the endoscopic procedures.
2. Device Description
The ClearPetra Suction-Evacuation Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The intended use is for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures such as, nephroscopy, ureteroscopy, or cystoscopy. It is used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The ClearPetra Suction-Evacuation Sheath comes in three models: ClearPetra Ureteral Access Sheath, ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath. The Ureteral Access Sheath includes two versions: Access Sheath for the Semi-rigid Ureteroscope and Access Sheath for the Flexible Ureteroscope.
The ClearPetra Suction-Evacuation Sheath is comprised of the following components:
- Sheath
- Obturator
- Luer Connector
- · Y Connector
- Rubber Cap
The sheath is fitted with a Y connector on the proximal end. The Y connector is bifurcated: straight tube and oblique tube, The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance.
one seqment of the Y connector is straight and is contiguous with the sheath: The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
An obturator is included for the insertion of the sheath. The obturator is radiopaque and is fitted with a luer connector on the proximal end. 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 device is offered in French size ranging from 10Fr to 22Fr and length 13cm to 55cm. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
5
3. Substantial Equivalence-Comparison to Predicate Devices
※ Similarities Between Proposed and Predicate Devices
ClearPetra Suction-Evacuation Sheath, comes in three models: ClearPetra Ureteral Access Sheath, ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath and the predicate devices, Well Lead Ureteral Access Sheath, Schoelly Cystoscopes/ Hysteroscopes And Accessories, Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set, have the same intended use, principle of operation, patient population, performance characteristics and technological characteristics.
※ Differences Between Proposed and Predicate Devices
The differences between proposed and predicate devices, as shown in the following:
-
(1) The proposed device comes in three model: ClearPetra Ureteral Access Sheath. ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath. Its predicate devices come from three independent submission. The indications for Use for the proposed ClearPetra Suction Sheath comprises a subset of the Indications for Use of the perdicate Well Lead Ureteral Access Sheath(K151084), perdicate Schoelly Cystoscopes/ Hysteroscopes And Accessories(K150158), and perdicate Schoelly Nephroscope Set cleared in K151308.
The proposed device is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The intended use is for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surqical procedures such as, nephroscopy, ureteroscopy, or cystoscopy. The three models have the same intended use and principle of operation, so they can be submitted in one submission. -
2 For ClearPetra Ureteral Access Sheath, the only notable difference between its predicate device is the structure of sheath connector. The sheath for proposed device is fitted with a Y connector on the proximal end. The Y connector, it is bifurcated, one segment is straight and is contiguous with the sheath which is to facilitate passage and aid advancement of endoscopes and other urological devices into body for the purpose of performing diagnostic and surgical procedures; The other is oblique and constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure. It can improved visual field and surgical efficiency. Although they have small difference in design for sheath connector, both of the two sheaths can fit over their inner obturators during application and they both are used to aid in the insertion advancement and removal of endoscopic accessories during endoscopic procedures. They are used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
6
- 3 For ClearPetra Cystoscope Sheath & ClearPetra Nephrostomy Sheath, the notable difference between their predicate devices are the materials, method of sterilization, and components/accessories.
Materials
The proposed ClearPetra Cystoscope/Nephrostomy Sheaths are made from PE and PA disposable materials while the predicate devices are made from reusable stainless steel materials. Although the materials are not identical, but they both are manufactured from materials that meet all the requirements of biocompatibility, the materials in contact were tested as per ISO 10993-1.
Method of Sterilization
The proposed ClearPetra Cystoscope/Nephrostomy Sheaths are sterilized by EO and single use and the predicate devices, Schoelly Cystoscopes/ Hysteroscopes And Accessories and Schoelly Nephroscope Set, are reusable and steam sterilization. Although the sterilization method and reprocessing are not identical, the sterilization validation of ClearPetra has demonstrated that the method of sterilization difference provides equivalent sterility assurance.
Components/Accessories
The proposed ClearPetra Cystoscope/Nephrostomy Sheaths consist only of sheaths and obturators, do not include accessories such as endoscopes(cystoscopes/ hysteroscopes/ nephroscopes), bridges, grasping forceps, etc., the specific examples of uses involving these accessory devices that are present in the predicate indications statement are not included in the indications statement for this submission.
Since the proposed ClearPetra is not intended to be used during hysteroscope procedure, the gynecological surgery in not included in the Indications for Ues for this submission.
Although they have different accessories but the overall structure for Sheath & Obturator two components are similar and they have the same functions. Both the sheaths can fit over their inner obturators during application and they both are used to aid in the insertion advancement and removal of endoscopic accessories during endoscopic procedures. They are used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract .
※ Summary and Conclusion
The ClearPetra Suction-Evacuation Sheath described in this 510(k) has similar technological and performance characteristics to the predicate devices. The proposed device is substantially equivalent in intended use, principle of operation, patient population, performance characteristics and technological characteristics as to predicate devices. The differences in the device do not introduce new issues of safety and efficacy, or raise different questions of safety and effectiveness.
7
Therefore the proposed ClearPetra Suction-Evacuation Sheath are substantially equivalent to the Well Lead Ureteral Access Sheath(K151084), Schoelly Cystoscopes/ Hysteroscopes And Accessories(K150158), and Schoelly Nephroscope Set cleared in K151308.
4. Summary of Non-Clinical Performance Testing
The following performance testing was conducted for the ClearPetra Suction-Evacuation Sheath:
- 1 ) General performance testing including:
- · Connection Strength
- · Bending Resistance
- · Coefficients of Friction
- · Determining the Dimensions
Testing datas and results are included in this submission, and demonstrated that the ClearPetra Suction-Evacuation Sheath meets all the pre-determined testing and acceptance criteria.
-
- Biocompatibility testing as per ISO 10993-1:2009 including:
- · Cytotoxicity as per ISO 10993-5:2009
- · Irritation as per ISO 10993-10:2010
- · Sensitization as per ISO 10993-10:2010
- · Acute Systemic Toxicity as per ISO 10993-11:2006
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible.
5. Conclusion
The ClearPetra Suction-Evacuation Sheath is substantially equivalent to predicate devices Well Lead Ureteral Access Sheath cleared under 510(k) K151084, Schoelly Cystoscopes/ Hysteroscopes And Accessories cleared under 510(k) K150158, and Schoelly Nephroscope Set cleared under 510(k) K151308. Based on the intended use, principle of operation, patient population, performance characteristics, technological characteristics and non-clinical tests performed, the proposed ClearPetra Suction-Evacuation Sheath is substantially equivalent to and as effective as the legally marketed predicate devices.