RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Device Facts
| Record ID | K160077 |
|---|---|
| Device Name | RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set |
| Applicant | Jbw7 Innovations, LLC |
| Product Code | LJE · GU |
| Decision Date | Jul 12, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Intended Use
Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.
Device Story
Device facilitates percutaneous renal access via retrograde wire puncture. Input: manual manipulation of puncture wire through flexible ureteroscope working channel. Operation: stainless steel puncture wire advanced from within renal collecting system through kidney, perirenal tissue, and fascia to exit at patient flank; exchange catheter placed over wire; wire removed; standard 0.038 inch wire guide inserted; tract dilated. Used in operating room by urologists. Output: established percutaneous nephrostomy tract. Benefits: precise access to non-dilated collecting systems for endourological interventions.
Clinical Evidence
Bench testing only. Evaluated mechanical/dimensional attributes including insertion forces through ureteroscope working channel and simulated tissue. Biocompatibility testing performed per ISO 10993-1 for short-duration indwelling devices (<24 hours). Sterilization validation performed per ISO 11135-1.
Technological Characteristics
Components: stainless steel puncture wire, TFE tip protector sheath, polyethylene exchange catheter, polyethylene fascial dilators (6, 8, 10 Fr). Energy: manual. Connectivity: none. Sterilization: ethylene oxide (EO). Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheters), ISO 11135-1 (sterilization).
Indications for Use
Indicated for patients requiring percutaneous nephrostomy creation during endourological surgery. Suitable for gaining access to unobstructed, non-dilated collecting systems. Requires fluoroscopic control.
Predicate Devices
- Lawson Retrograde Nephrostomy Wire Puncture Set, Cook Medical (K833762)
Related Devices
- K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set · Cook Incorporated · Dec 16, 2019
- K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe · Cook Incorporated · Oct 19, 2017
- K222705 — Introducer Needle · Youcare Technology Co.,Ltd. (Wuhan) · May 22, 2023
- K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle · Cook Incorporated · May 17, 2019
- K171601 — Ultraxx Nephrostomy Balloon Catheter · Cook Incorporated · Feb 23, 2018
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
JBW7 Innovations, LLC Jason B. Wynberg, MD President 17197 Adrian Road Southfield. MI 48075
Re: K160077
Trade/Device Name: RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: May 25, 2016 Received: June 1, 2016
Dear Jason B. Wynberg:
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.
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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 (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,
# Joyce M. Whang -S
for
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
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# Indications for Use
510(k) Number (if known) K160077
#### Device Name
RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Indications for Use (Describe)
Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;">☑</div> |
|----------------------------------------------|--------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;">☐</div> |
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# 510(k) Summary
| Sponsor: | JBW7 Innovation, LLC |
|------------------------------------|-------------------------------------------------------------------------------------|
| Contact Person: | Jason B. Wynberg, MD |
| Telephone: | 248 996 2775 |
| Email: | jbw7innovations@gmail.com |
| Submission Date: | January 12, 2016 |
| Device Name: | RetroPerc™ Flexible Ureteroscopy-Guided Retrograde<br>Nephrostomy Wire Puncture Set |
| Common Name: | RetroPerc™ Wire Puncture Set |
| Classification | |
| Regulatory Class: | Unclassified |
| Product Code: | LJE |
| Classification Panel: | None |
| Legally Marketed Predicate Device: | Lawson Retrograde Nephrostomy Wire Puncture |
Set, Cook Medical, K833762
#### Device Description
The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. The RetroPerc™ Wire Puncture Set consists of a puncture wire, tip protector sheath with mounted pin-vise actuator, radiopaque exchange catheter, and fascial dilators.
A stainless steel puncture wire is advanced within a protective sheath via the working channel of a flexible ureteroscope positioned in the targeted calyx, at which time the puncture wire is advanced through the kidney, perirenal tissue and fascia, until it emerges at the patient's flank skin. An exchange catheter (coaxial catheter in CX set or single lumen catheter in the LX set) is then positioned over the puncture wire at the flank, after which the puncture wire is removed. A standard 0.038 inch wire guide is then advanced through the exchange catheter until it advances out of the urethra. The exchange catheter is then removed, and finally the tract is dilated with fascial dilators, as clinically indicated. The RetroPerc Wire Puncture Set will be available in two configurations: CX and LX. Each set will perform well for the same patient populations and kidney stones, has the same indications, etc. The choice of set will be driven by physician preference:
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the CX set if the surgeon wishes to use a coaxial exchange catheter, and the LX set if the surgeon wishes to use non-coaxial exchange catheter.
### Indication for Use
Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This set and suggested procedure are particularly well-suited for gaining percutaneous access to an unobstructed, non-dilated collecting system when pursuing a planned course of endourological intervention. Fluoroscopic control is necessary throughout this procedure. Intended for one-time use.
### Substantial Equivalence
The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is substantially equivalent to the predicate device based on the following similarities:
- . The indications for use of both predicate and this device are to create a retrograde nephrostomy in the setting of endourological surgery;
- . Both devices use a puncture wire that is made of the same material (stainless steel) with a precision grind sharp point;
- . Both devices use a tip protector sheath of the same material (TFE) and with similar diameters;
- . Both devices use similar wire exchange devices; and
- . Both devices are provided sterile for single use.
## Comparison of the Lawson Wire Puncture Set (predicate) and the CX and LX Configurations of the RetroPerc™ Wire Puncture Set (this submission).
| | Predicate Device<br>COOK® Lawson<br>Wire Puncture Set<br>(K833762) | RetroPerc™ Wire<br>Puncture Set - CX<br>This Submission | RetroPerc™ Wire<br>Puncture Set -LX<br>This Submission |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A nephrostomy<br>puncture set to<br>establish a<br>nephrostomy tract<br>in the setting of<br>endourological<br>surgery. | A nephrostomy<br>puncture set to<br>establish a<br>nephrostomy tract<br>in the setting of<br>endourological<br>surgery. | A nephrostomy<br>puncture set to<br>establish a<br>nephrostomy tract<br>in the setting of<br>endourological<br>surgery. |
| Indications for<br>Use | This set is intended<br>to gain precise<br>percutaneous<br>access to the kidney | This set is intended<br>to gain precise<br>percutaneous<br>access to the kidney | This set is intended<br>to gain precise<br>percutaneous<br>access to the kidney |
| | by directing a fine<br>puncture wire<br>through a<br>fluoroscopically<br>directed catheter<br>that has been<br>carefully positioned<br>at the papilla of a<br>selected renal<br>calyx. This is<br>performed while<br>pursuing a planned<br>course of<br>endourological<br>interventions. | by directing a fine<br>puncture wire<br>through a<br>fluoroscopically<br>directed catheter<br>that has been<br>carefully positioned<br>at the papilla of a<br>selected renal<br>calyx. This is<br>performed while<br>pursuing a planned<br>course of<br>endourological<br>interventions. | by directing a fine<br>puncture wire<br>through a<br>fluoroscopically<br>directed catheter<br>that has been<br>carefully positioned<br>at the papilla of a<br>selected renal<br>calyx. This is<br>performed while<br>pursuing a planned<br>course of<br>endourological<br>interventions. |
| Target<br>Population | Patients requiring<br>percutaneous<br>nephrostomy<br>creation in the<br>setting of<br>endourological<br>surgery. | Patients requiring<br>percutaneous<br>nephrostomy<br>creation in the<br>setting of<br>endourological<br>surgery. | Patients requiring<br>percutaneous<br>nephrostomy<br>creation in the<br>setting of<br>endourological<br>surgery. |
| Where<br>performed | Operating room | Operating room | Operating room |
| Anatomical Site | Kidney | Kidney | Kidney |
| Surgical<br>Technique | Puncture is<br>retrograde through<br>the kidney and out<br>the flank | Puncture is<br>retrograde through<br>the kidney and out<br>the flank | Puncture is<br>retrograde through<br>the kidney and out<br>the flank |
| Patient Position<br>at the time of<br>the Procedure | Modified<br>lithotomy position,<br>with flank slightly<br>elevated1,2 | Modified lithotomy<br>position, with flank<br>slightly elevated3 | Modified<br>lithotomy position,<br>with flank slightly<br>elevated3 |
| Method of<br>targeting calyx<br>for puncture | Fluoroscopy | Fluoroscopy +<br>Visual from an<br>indwelling<br>ureteroscope | Fluoroscopy +<br>Visual from an<br>indwelling<br>ureteroscope |
| Components of<br>the Set | 3 Fr sheath<br>0.017 inch<br>puncture wire<br><br>7 Fr Torcon<br>catheter, 0.045 inch<br>deflecting wire<br>guide | 2.7 Fr sheath,<br>0.0174 inch<br>puncture wire<br><br>(flexible<br>ureteroscope serves<br>steering / targeting<br>function) | 2.6 Fr sheath<br>0.0175 inch<br>puncture wire<br><br>(flexible<br>ureteroscope serves<br>steering /targeting<br>function) |
| 22 ga & 18 ga coaxial needles for wire exchange<br>0.038 inch wire guide | 5 Fr coaxial catheter for wire exchange<br>6, 8 & 10 Fr fascial dilators | 5 Fr single lumen catheter for wire exchange<br>6, 8, & 10 Fr fascial dilators | |
| Puncture wire<br>Stainless steel; puncture point is ground to be sharp for puncture | Stainless steel; puncture point is ground to be sharp for puncture | Stainless steel; puncture point is ground to be sharp for puncture | |
| Puncture wire length<br>130 cm | 163 cm | 190 cm | |
| Puncture wire – diameter of distal 29 cm (puncture segment)<br>0.017 inch | 0.0174 inch | 0.0175 inch | |
| Puncture wire – diameter of proximal wire (proximal to distal 29 cm)<br>0.017 inch | 0.020 inch | 0.0175 inch | |
| Wire Tip Protector Sheath<br>TFE construction | TFE construction | TFE construction | |
| Length of TFE tip protector Sheath<br>85 cm | 90 cm | 150 cm | |
| Outer diameter of TFE wire protector sheath<br>3 French | 2.7 French | 2.6 French | |
| Puncture wire exchange system<br>22 gauge needle cannula advanced over 0.017 inch wire at flank. Then, 18 gauge needle cannula advanced over 22 gauge needle. | 30 cm 5 French coaxial microintroducer, advanced over 0.020 inch puncture wire at flank | 32 cm 5 French single lumen polyethylene catheter, advanced over 0.0175 inch wire and TFE sheath at flank | |
| Accessories<br>Wire guide - 0.038 inch | Fascial Dilators 17.8 cm; 6, 8, 10 French, polyethylene, with BaSO4 | Fascial Dilators 17.8 cm; 6, 8, 10 French, polyethylene, with BaSO4 | |
| Packaging<br>Thermoformed tray | Protective plastic | Protective plastic | |
| | | indented tabs | indented tabs |
| | Sealed Tyvek/Poly | Sealed Tyvek/Poly | Sealed Tyvek/Poly |
| | Mylar peel pack | Mylar peel pack | Mylar peel pack |
| | package. | package | package |
| | Accessories sealed | Accessories sealed | Accessories sealed |
| | in separate | in separate | in separate |
| | Tyvek/Poly Mylar | Tyvek/Poly Mylar | Tyvek/Poly Mylar |
| | peel pack, | peel pack, | peel pack, |
| | contained inside | contained inside | contained inside |
| | main Tyvek/Mylar | main Tyvek/Mylar | main Tyvek/Mylar |
| | peel pack. | peel pack. | peel pack. |
| | | 5 sterilized,<br>packaged devices<br>stored and shipped<br>inside a single<br>sealed cardboard<br>box. | 5 sterilized,<br>packaged devices<br>stored and shipped<br>inside a single<br>sealed cardboard<br>box |
| Sterilization | Exposure to | Exposure to | Exposure to |
| | ethylene oxide | ethylene oxide | ethylene oxide |
| | (EO) | (EO) | (EO) |
| Re-Use | Single use, | Single use, | Single use, |
| | disposable | disposable | disposable |
| Tissue Contact | Compliant with | Compliant with ISO | Compliant with |
| Materials | ISO 10993 | 10993 | ISO 10993 |
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REFERENCES (re: "Patient position at the time of the procedure")
- 1. Al-Otaibi KM. Retrograde upper-pole calyceal access for percutaneous nephrolithotripsy of stones in the lower-pole calyx. Arab J Urol 2012; 10(4): 353-357.
- 2. Sivalingham S. et al. Percutaneous nephrolithotomy with retrograde nephrostomy access: a forgotten technique revisited. J Urol 2013; 189(5): 1753-1756.
- 3. Wynberg JB. Flexible ureteroscopy-directed retrograde nephrostomy for percutaneous nephrolithotomy: description of a technique. J Endourol 2012; 26(10): 1268-1274.
The RetroPerc™ Wire Puncture Set has the same intended use and comparable technological characteristics as the predicate device. The RetroPerc Wire Puncture Set exhibits many of the same design features and materials of construction as the predicate device. Any differences in technological characteristics between the RetroPerc™ device and the Lawson wire puncture set do not raise any new safety or effectiveness questions. In addition, accepted scientific methods exist for assessing the effect of these new
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characteristics. Performance (bench) and biological safety (biocompatibility) testing demonstrate that the functionality, integrity, and safety of the RetroPerc Wire Puncture Set are adequate for its intended use and support a determination of substantial equivalence to the marketed predicate device.
#### Performance Data
Bench testing was conducted on the device to assess mechanical and dimensional attributes tested, such as the insertion forces through the working channel of a ureteroscope and simulated tissue and dimensional analyses, indicate that there are no new safety and efficacy questions raised by the design and, when compared to the predicate device, were equivalent.
In addition, bench testing was conducted to verify that the RetroPerc™M Wire Puncture Set is compliant with biocompatibility requirements for a short duration indwelling device (< 24 hours) as specified in ISO 10993 - Part 1. Due to its labeling as sterile, the device underwent sterilization validation and shelf life testing to confirm the label shelf life and are in compliance with the following:
ISO 10555-1:2013 Intravascular catheters -- Sterile and single-use catheters --Part 1: General requirements
ISO 11135-1 Sterilization of health care products - Ethylene oxide -Part 1: Requirements for development, validation and routine control of a sterilization process for medical device;
#### Conclusion
The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set and the predicate Lawson Retrograde Nephrostomy Wire Puncture Set have the same intended use, indications for use, and have equivalent characteristics. Furthermore, the minor differences between the RetroPerc™ Wire Puncture Set and the predicate device raise no new questions of safety or effectiveness.
