Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, and the procedure is guided by fluoroscopy, not AI/ML. There is no mention of AI, ML, or related concepts in the summary.

Therapeutic

No.
The device is used to gain percutaneous access to the kidney. It is a tool for a medical procedure rather than a device intended to treat a disease or condition itself.

Diagnostic

No

This device is used to gain percutaneous access to the kidney for endourological intervention, which is a therapeutic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a puncture wire, sheath, catheter, and dilators, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
Device Function: The description clearly states that this device is used to gain percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
Intended Use: The intended use is to facilitate a surgical procedure (gaining percutaneous access for endourological intervention), not to diagnose a condition based on laboratory analysis of a sample.
Device Components: The components listed (puncture wire, sheath, catheter, dilators) are all instruments used for a surgical procedure, not for performing in vitro tests.

Therefore, the RetroPerc™ Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

LJE

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: 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

Kidney

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room

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)

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 (

Regulation Number and Section

N/A

Summary

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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 Retrograde
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:

4

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
COOK® Lawson
Wire Puncture Set
(K833762) | RetroPerc™ Wire
Puncture Set - CX
This Submission | RetroPerc™ Wire
Puncture Set -LX
This Submission |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A nephrostomy
puncture set to
establish a
nephrostomy tract
in the setting of
endourological
surgery. | A nephrostomy
puncture set to
establish a
nephrostomy tract
in the setting of
endourological
surgery. | A nephrostomy
puncture set to
establish a
nephrostomy tract
in the setting of
endourological
surgery. |
| Indications for
Use | This set is intended
to gain precise
percutaneous
access to the kidney | This set is intended
to gain precise
percutaneous
access to the kidney | This set is intended
to gain precise
percutaneous
access to the kidney |
| | by directing a fine
puncture wire
through a
fluoroscopically
directed catheter
that has been
carefully positioned
at the papilla of a
selected renal
calyx. This is
performed while
pursuing a planned
course of
endourological
interventions. | by directing a fine
puncture wire
through a
fluoroscopically
directed catheter
that has been
carefully positioned
at the papilla of a
selected renal
calyx. This is
performed while
pursuing a planned
course of
endourological
interventions. | by directing a fine
puncture wire
through a
fluoroscopically
directed catheter
that has been
carefully positioned
at the papilla of a
selected renal
calyx. This is
performed while
pursuing a planned
course of
endourological
interventions. |
| Target
Population | Patients requiring
percutaneous
nephrostomy
creation in the
setting of
endourological
surgery. | Patients requiring
percutaneous
nephrostomy
creation in the
setting of
endourological
surgery. | Patients requiring
percutaneous
nephrostomy
creation in the
setting of
endourological
surgery. |
| Where
performed | Operating room | Operating room | Operating room |
| Anatomical Site | Kidney | Kidney | Kidney |
| Surgical
Technique | Puncture is
retrograde through
the kidney and out
the flank | Puncture is
retrograde through
the kidney and out
the flank | Puncture is
retrograde through
the kidney and out
the flank |
| Patient Position
at the time of
the Procedure | Modified
lithotomy position,
with flank slightly
elevated1,2 | Modified lithotomy
position, with flank
slightly elevated3 | Modified
lithotomy position,
with flank slightly
elevated3 |
| Method of
targeting calyx
for puncture | Fluoroscopy | Fluoroscopy +
Visual from an
indwelling
ureteroscope | Fluoroscopy +
Visual from an
indwelling
ureteroscope |
| Components of
the Set | 3 Fr sheath
0.017 inch
puncture wire

7 Fr Torcon
catheter, 0.045 inch
deflecting wire
guide | 2.7 Fr sheath,
0.0174 inch
puncture wire

(flexible
ureteroscope serves
steering / targeting
function) | 2.6 Fr sheath
0.0175 inch
puncture wire

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6

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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.
1. Sivalingham S. et al. Percutaneous nephrolithotomy with retrograde nephrostomy access: a forgotten technique revisited. J Urol 2013; 189(5): 1753-1756.
1. 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 (