(180 days)
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.
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: 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.
The provided text describes a 510(k) submission for the "RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set," asserting its substantial equivalence to a predicate device, the "Lawson Retrograde Nephrostomy Wire Puncture Set, Cook Medical, K833762."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission claims substantial equivalence based on similarities to the predicate device rather than specific quantitative acceptance criteria being met. The performance data section describes bench testing but does not provide specific numerical outcomes or acceptance criteria.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| N/A (Substantial Equivalence Claim) | See below for details on how this was assessed through bench testing and comparisons to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text describes bench testing, meaning tests performed in a laboratory setting, not clinical studies involving human or animal subjects that would typically have a "test set" in the context of clinical data. Therefore, details like sample size for a test set and data provenance (country, retrospective/prospective) are not applicable in the usual sense for this submission. The "test set" for the mechanical and dimensional attributes would be the manufactured devices themselves.
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 provided as the submission focuses on substantial equivalence based on material and design similarities, and bench testing, rather than a clinical study requiring expert ground truth assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the nature of the bench testing described.
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
This is not applicable. The device is a physical medical instrument (wire puncture set), not an AI diagnostic or assistance tool. Therefore, an MRMC study or AI assistance effectiveness is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" would be established engineering specifications, material properties, and expected mechanical responses. For biocompatibility, it's compliance with ISO 10993 - Part 1. For sterilization, it's compliance with ISO 11135-1 and validation of shelf life. These are based on established standards and scientific methods rather than expert consensus on clinical findings or pathology.
8. The sample size for the training set
This is not applicable as the submission does not involve a "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
Summary of Acceptance Criteria and Proving Device Meets Criteria from the Text:
The RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set seeks clearance through the 510(k) pathway by demonstrating substantial equivalence to a predicate device (Lawson Retrograde Nephrostomy Wire Puncture Set).
Acceptance Criteria (Implied by Substantial Equivalence Claim):
- Same Intended Use: The device must have the same intended use as the predicate.
- Same Indications for Use: The device must have same indications for use as the predicate.
- Comparable Technological Characteristics: The device must have comparable technological characteristics to the predicate device, or any differences must not raise new questions of safety or effectiveness.
- Safety and Effectiveness: The device must be safe and effective for its intended use. This is primarily demonstrated through bench testing and, as implied, by not raising new safety or effectiveness concerns compared to a legally marketed predicate.
- Biocompatibility: Compliant with ISO 10993 - Part 1 for a short duration indwelling device (< 24 hours).
- Sterilization: Validation to ensure sterility and compliance with ISO 11135-1.
- Shelf Life: Validation of the labeled shelf life.
Study Proving Device Meets Acceptance Criteria:
The studies presented are:
- Bench Testing:
- Focus: Assessed mechanical and dimensional attributes.
- Specifics: Insertion forces through the working channel of a ureteroscope, simulated tissue, and dimensional analyses.
- Finding: Indicated "no new safety and efficacy questions raised by the design and, when compared to the predicate device, were equivalent."
- Details on Sample Size/Provenance/Ground Truth: Not explicitly detailed beyond stating "bench testing was conducted." The ground truth would be engineering specifications and expected performance values.
- Biocompatibility Testing:
- Focus: Compliance with requirements for a short duration indwelling device (< 24 hours).
- Standard: ISO 10993 - Part 1.
- Finding: Device is compliant.
- Details on Sample Size/Provenance/Ground Truth: Not explicitly detailed; refers to the standard.
- Sterilization Validation and Shelf Life Testing:
- Focus: Confirmation of sterility and labeled shelf life.
- Standard: ISO 11135-1.
- Finding: In compliance with ISO 11135-1 and confirmed labeled shelf life.
- Details on Sample Size/Provenance/Ground Truth: Not explicitly detailed; refers to the standard.
The submission relies on a comparison of characteristics with the predicate device and a general statement that bench tests confirmed functionality, integrity, and safety, supporting the claim of substantial equivalence. No clinical studies (MRMC or otherwise), patient data, or expert consensus panels for clinical ground truth are mentioned as part of this 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a single abstract figure.
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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 RetrogradeNephrostomy 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 DeviceCOOK® LawsonWire Puncture Set(K833762) | RetroPerc™ WirePuncture Set - CXThis Submission | RetroPerc™ WirePuncture Set -LXThis Submission | |
|---|---|---|---|
| Intended Use | A nephrostomypuncture set toestablish anephrostomy tractin the setting ofendourologicalsurgery. | A nephrostomypuncture set toestablish anephrostomy tractin the setting ofendourologicalsurgery. | A nephrostomypuncture set toestablish anephrostomy tractin the setting ofendourologicalsurgery. |
| Indications forUse | This set is intendedto gain precisepercutaneousaccess to the kidney | This set is intendedto gain precisepercutaneousaccess to the kidney | This set is intendedto gain precisepercutaneousaccess to the kidney |
| by directing a finepuncture wirethrough afluoroscopicallydirected catheterthat has beencarefully positionedat the papilla of aselected renalcalyx. This isperformed whilepursuing a plannedcourse ofendourologicalinterventions. | by directing a finepuncture wirethrough afluoroscopicallydirected catheterthat has beencarefully positionedat the papilla of aselected renalcalyx. This isperformed whilepursuing a plannedcourse ofendourologicalinterventions. | by directing a finepuncture wirethrough afluoroscopicallydirected catheterthat has beencarefully positionedat the papilla of aselected renalcalyx. This isperformed whilepursuing a plannedcourse ofendourologicalinterventions. | |
| TargetPopulation | Patients requiringpercutaneousnephrostomycreation in thesetting ofendourologicalsurgery. | Patients requiringpercutaneousnephrostomycreation in thesetting ofendourologicalsurgery. | Patients requiringpercutaneousnephrostomycreation in thesetting ofendourologicalsurgery. |
| Whereperformed | Operating room | Operating room | Operating room |
| Anatomical Site | Kidney | Kidney | Kidney |
| SurgicalTechnique | Puncture isretrograde throughthe kidney and outthe flank | Puncture isretrograde throughthe kidney and outthe flank | Puncture isretrograde throughthe kidney and outthe flank |
| Patient Positionat the time ofthe Procedure | Modifiedlithotomy position,with flank slightlyelevated1,2 | Modified lithotomyposition, with flankslightly elevated3 | Modifiedlithotomy position,with flank slightlyelevated3 |
| Method oftargeting calyxfor puncture | Fluoroscopy | Fluoroscopy +Visual from anindwellingureteroscope | Fluoroscopy +Visual from anindwellingureteroscope |
| Components ofthe Set | 3 Fr sheath0.017 inchpuncture wire7 Fr Torconcatheter, 0.045 inchdeflecting wireguide | 2.7 Fr sheath,0.0174 inchpuncture wire(flexibleureteroscope servessteering / targetingfunction) | 2.6 Fr sheath0.0175 inchpuncture wire(flexibleureteroscope servessteering /targetingfunction) |
| 22 ga & 18 ga coaxial needles for wire exchange0.038 inch wire guide | 5 Fr coaxial catheter for wire exchange6, 8 & 10 Fr fascial dilators | 5 Fr single lumen catheter for wire exchange6, 8, & 10 Fr fascial dilators | |
| Puncture wireStainless 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 length130 cm | 163 cm | 190 cm | |
| Puncture wire – diameter of distal 29 cm (puncture segment)0.017 inch | 0.0174 inch | 0.0175 inch | |
| Puncture wire – diameter of proximal wire (proximal to distal 29 cm)0.017 inch | 0.020 inch | 0.0175 inch | |
| Wire Tip Protector SheathTFE construction | TFE construction | TFE construction | |
| Length of TFE tip protector Sheath85 cm | 90 cm | 150 cm | |
| Outer diameter of TFE wire protector sheath3 French | 2.7 French | 2.6 French | |
| Puncture wire exchange system22 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 | |
| AccessoriesWire 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 | |
| PackagingThermoformed 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,packaged devicesstored and shippedinside a singlesealed cardboardbox. | 5 sterilized,packaged devicesstored and shippedinside a singlesealed cardboardbox | ||
| 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")
-
- 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.
-
- Sivalingham S. et al. Percutaneous nephrolithotomy with retrograde nephrostomy access: a forgotten technique revisited. J Urol 2013; 189(5): 1753-1756.
-
- 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.
N/A