Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical functionality and material properties, with no mention of AI/ML terms or data-driven analysis.

Therapeutic

No
The device is described as a retriever product line intended to retrieve excised polyps, tissue samples, foreign bodies and calculi, which are retrieval and diagnostic functions, not therapeutic.

Diagnostic

No
The device is described as a retriever product line used to retrieve excised polyps, tissue samples, foreign bodies, and calculi. Its purpose is to physically collect items, not to diagnose conditions or analyze data to provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a handle, finger ring, fabric mesh basket, wire snare, drive wire, and sheath, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to retrieve excised polyps, tissue samples, foreign bodies, and calculi during flexible and rigid endoscopy procedures. This is a procedural device used in vivo (within the body) to collect samples or remove objects.
Device Description: The description details a mechanical device with a handle, wire, sheath, and fabric mesh basket. This is consistent with a surgical or procedural tool, not a device used to perform tests on samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or performing diagnostic tests on biological specimens. The device's function is purely mechanical retrieval.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's purpose is to collect those specimens or remove foreign bodies, not to analyze them.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Roth Net® retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.

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

FDI, GCJ

Device Description

The Roth Net retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures. The device is marketed in both sterile and non-sterile versions.

The fundamental design and technology of the Roth Net® retriever are the same as the predicate Polyp Snare Net originally submitted under K926104 with the exception of the changes listed below. The device consists of a proximal handle with a finger ring that controls the deployment of the fabric mesh basket (a wire snare with a fabric net attached). The snare/net is connected to a drive wire, which is then connected to the handle. The drive wire is encompassed within a sheath that makes up the catheter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Design verification tests were performed to assess the impact of modifications.

Key results: All tests passed.

Deployment and retraction workability testing: Force required to deploy and retract shall be = 12 lbs.
Simulated use testing to verify cinching does not occur: Nets shall not cinch. Proximal and distal anchors shall remain intact.
Biocompatibility testing (ISO 10993-5, 10 and -11): Material shall show no reactivity in test subjects.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K926104

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).

Summary

0

K122462

510(k) Premarket Notification: Special
Roth Net® retriever

Special 510(k) Information		SEP 11 2012
Device Name	The device trade name and common/classification name is:
	Device Trade Name: Roth Net® retriever product line
Common/Classification Name: Endoscope and accessories
Classification Panel: Gastroenterology/Urology
Address and
Registration #	Manufacturer: United States Endoscopy Group, Inc.
5976 Heisley Road
Mentor, Ohio 44060
Registration #: 1528319
Device Class	Endoscope accessories are classified with Endoscopes as Class II
devices under 21 CFR § 876.1500 (product code GCJ). No
performance standards have been established under Section 514 of
the Federal Food, Drug, and Cosmetic Act for endoscope
accessories.
Predicate
Device Information	The predicate device is the US Endoscopy Polyp Snare Net (AKA,
the Roth Net® retriever), cleared under 510(k) K926104 on April 5,

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |             |

| Labeling and
Intended Use | Since introduction of the Polyp Snare Net in 1993, the device
Instructions for Use (which now carries the Roth Net® brand name)
have been revised and Warning and Precaution statements were
added for clarity to ensure safe and effective use. Instructions for
Use can be found beginning on page 29.

Intended Use
The Roth Net® retriever product line is intended to be used to
retrieve excised polyps, tissue samples, foreign bodies and calculi
during flexible and rigid endoscopy procedures. This is the same
intended use as specified in the device labeling and the cleared
510(k) under K926104, April 5, 1993. This intended use has not
changed, or in any way been affected, as a result of the warning
and precaution modifications. None of the modifications affected
the device's indications. | |
| | The Indications for Use Statement can be found on page 16. | |

: United States Endoscopy Group, Inc.

・ ·

1

ted States Endoscopy Group, Inc.

Device Description and Comparison of Legally Marketed Devices

General Description

The Roth Net retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures. The device is marketed in both sterile and non-sterile versions.

The fundamental design and technology of the Roth Net® retriever are the same as the predicate Polyp Snare Net originally submitted under K926104 with the exception of the changes listed below. The device consists of a proximal handle with a finger ring that controls the deployment of the fabric mesh basket (a wire snare with a fabric net attached). The snare/net is connected to a drive wire, which is then connected to the handle. The drive wire is encompassed within a sheath that makes up the catheter.

Below is a representative drawing of the Roth Net® retriever.

Image /page/1/Figure/8 description: The image shows a medical device with multiple labeled parts. Part 1 is labeled as a snare/net that is deployed. Part 2 is labeled as a catheter, while parts 3 and 4 are other components of the device.

1. Finger ring
1. Handle

Description of Modified Device

Subsequent to FDA's determination that the Polyp Snare Net was substantially equivalent to legally marketed predicate devices under 510(k) K926104 on April 5, 1993, US Endoscopy implemented modifications to the device that are summarized below in Table 1. Each modification was reviewed and documented by US Endoscopy in accordance with Company procedures and processes regarding post-market product modifications and the guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device" (K97-1).

The modified Roth Net retriever has the same intended use and same fundamental technological characteristics as the predicate Polyp Snare Net device. Each

2

・・・・・ United States Endoscopy Group, Inc. 510(k) Premarket Notification: Special Roth Net® retriever

modification was determined not to have a significant effect on the safety or effectiveness of the device, either individually and cumulatively. Determination that the modifications do not affect the performance characteristics of the device was accomplished through verification and validation testing, incorporating all device modifications made to date. This testing demonstrated that the modified device performs the same as the device cleared under K926104.

Summary of Design Control Activities

The risk management activities used to assess the impact of the modifications were performed in accordance with US Endoscopy standard operating procedures and ISO 14971:2009. The test methods used are the same as those used to test the predicate device reviewed under K926104. A declaration of conformity to design controls is included on page 26. The design verification tests that were performed as a result of this risk analysis are listed in Table 1 below.

3

1 - - - - - - - - - - United States Endoscopy Group, I

510(k) Premarket Notification: Special
Roth Net® retriever

ABLE 1 - Design Control Activities Summar

. .

| Device
Modification | Reason for
Modification
Changes for Clinical Ease of Use | Risk/ Hazard | Mitigation | Verification Activity | Acceptance Criteria | Verification
Results | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Change in snare
shape from
round to
octagonal and
change in snare
loop wire shape
(braided cable to
flat wire) | To better allow
the loop to
maintain its
shape; and allow
for greater
capacity. | Inability to grasp
objects; net will
not open fully | Verification
testing of the
deployment
and retraction
forces; test
device's ability
to grasp objects | Deployment and retraction
workability testing

Simulated use testing for grasping
ability | Force required to deploy and retract shall be ≤ 3.25
lbs.

Net can be fully retracted without any parts left
outside of the sheath.

Net can be fully deployed without exposing the
proximal end of the connector. | PASS | |
| Change in the
mesh size of the
net | To improve the
visibility when
capturing
multiple polyp
fragments. | Inability to grasp
objects; inability
to visualize net
once objects
grasped. | Verification of
device's ability
to grasp objects
and maintain
visibility. | Grasp testing using simulated
polyps and foreign bodies

Simulated use testing to verify
that there is no obstruction of
endoscopic visibility | Must maintain ability to grasp and retrieve simulated
polyps and foreign bodies

Net is capable of securing material that measures
2cm x 1.5cm x 2.5cm.

Visualization of pouch and its contents are not
obstructed | PASS | |
| Dimensional Changes
Increased length
and diameter of
device
sheath/catheter | Allow use of
subject-device
with various
endoscopes¹ | Inadequate fit to
the enteroscope
(length); catheter
collapse
(columnar
strength); non-
deployment of the
device.
Inability to push
device through
accessory channel
of the endoscope | Dimensional
and functional
testing; kink
resistance
testing.

Testing of
insertion and
retraction
forces;
resistance to
kinking | Dimensional Verification Testing

Kink testing.

Simulate use testing by inserting
the devices through an
enteroscope and grasping a
variety of items. | Length shall be 138.00 ± 2.5 inches (350.5 ± 6.35
cm)

Visible plastic deformation due to compression must
not occur in an insertion column length of 1.5 in (3.8
cm) through the accessory channel of the endoscope.

Device shall capture simulated food bolus, foreign
bodies or polyps while maintaining structural
integrity.

Verification of deployed net length
and width | Max deployment/retraction force shall be ≤
3.25lbs

The length of the fully deployed net shall be 2.59

3.29 inches (6.6 – 8.4 cm.)

The width of the fully deployed net shall be 1.41 –
2.10 inches (3.6 – 5.3 cm.) | PASS |
| | Changes for Increased Manufacturing Efficiency | | | | | | |
| | A chamfer melt
was added on
the inside of the
catheter | To maintain the
smooth transition
of the snare/net
into the catheter
when the
snare/net is
retracted | Difficulty in
deployment and/or
retraction | Verification
testing of the
force required
to deploy and
retract the net | Deployment and retraction force
testing | Max deployment force shall be ≤ 3.25lbs

Proximal and distal anchors shall remain intact. | PASS | |
| Material Change | | | | | | | |
| The catheter
material was
modified from
tetrafluoro-
ethylene (TFE)
to polyethylene
(PE) to reduce
cost without
reducing
performance | Cost Reduction | Loss of
biocompatibility | Verification
testing for
acute systemic
toxicity,
cytotoxicity
and irritation
and delayed
hypersensi-
tivity | Test in accordance with ISO 10993-
5, 10 and -11 | Material shall show no reactivity in test subjects | PASS | |
| Appearance Change | | | | | | | |
| Change handle
color from white
to silver | Add new color to
distinguish
between standard
and platinum
models | | | | | No risks were identified in relation to this modification. No performance data were required because a change in color of the handle does not affect
performance of the subject device. | |

Since intoduction of the Poly Snare Net in 1993, the variety of entosented considerably. Additional cathers lengths and diameters were

4

United States Endoscopy Group, Inc

510(k) Premarket Notification: Special
Roth Net® retriever

5

( _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

.

510(k) Premarket Notification: Special
Roth Net® retriever

. "

.

: :

.

24

:

·

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United States Endoscopy Group, Inc.

510(k) Premarket Notification: Special Roth Net® retriever

Substantial Equivalence Discussion

All currently marketed Roth Net® retriever devices share the same intended use and same fundamental technological characteristics as the US Endoscopy predicate Polyp Snare Net device cleared by the Agency under K926104. Verification and validation testing performed for each modification to the Roth Net® device demonstrates that these changes, both individually and cumulatively, do not have a significant effect on the safety or effectiveness of the device, do not raise different questions of safety and effectiveness than the predicate device and verify the Roth Net® device performs the same as the predicate device. Therefore, we conclude that the Roth Net® device is substantially equivalent to the predicate Polyp Snare Net device.

510(k) Summary /Statement

A 510(k) statement is included on page 17.

Truthful and Accurate Statement

A certification of the truthfulness and accuracy of this submission is provided on page 18.

7

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Craig Moore General Counsel United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060

SEP 11 2012

Re: K122462

Trade/Device Name: Roth Net® retriever product line Regulation Number: 21 CFR& 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI, GCJ Dated: August 10, 2012 Received: August 13, 2012

Dear Mr. Moore:

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. 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

8

Page 2-

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K-tixha

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

9

CONFIDENTIAL United States Endoscopy Group, Inc. 510(k) Premarket Notification: Special Roth Net" retriever

INDICATIONS FOR USE

510(k) Number (if known): K122462

Device Name: Roth Net® retriever product line

Indications for Use:

The Roth Net® retriever product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 1 (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Herbert Leun

tive, Gastro-Renal, and

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