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.

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.

AI/ML Overview

The Roth Net® retriever product line, subject of K122462, is intended for retrieving excised polyps, tissue samples, foreign bodies, and calculi during flexible and rigid endoscopy procedures. The submission details several modifications from the predicate device (Polyp Snare Net, K926104). The studies conducted focus on verifying that these modifications do not adversely affect the device's performance, safety, or effectiveness, and that the device remains substantially equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Reason for Modification	Acceptance Criteria	Verification Results
Changes for Clinical Ease of Use
Change in snare shape (round to octagonal) and snare loop wire shape (braided to flat)	To better allow the loop to maintain its shape and allow for greater capacity.	1. Force required to deploy and retract shall be ≤ 3.25 lbs. 2. Net can be fully retracted without any parts left outside of the sheath. 3. Net can be fully deployed without exposing the proximal end of the connector.	PASS
Change in the mesh size of the net	To improve visibility when capturing multiple polyp fragments.	1. Must maintain ability to grasp and retrieve simulated polyps and foreign bodies. 2. Net is capable of securing material that measures 2cm x 1.5cm x 2.5cm. 3. 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 endoscopes.	1. Length shall be 138.00 ± 2.5 inches (350.5 ± 6.35 cm). 2. 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. 3. Device shall capture simulated food bolus, foreign bodies or polyps while maintaining structural integrity. 4. Insertion force of less than or equal to 2.5 lbs.	PASS
Dimensional Changes: Net size changed to largest size: 3 cm (l) x 4 cm (w)	To allow device to be used with endoscopes with larger channels.	1. Max deployment/retraction force shall be ≤ 3.25 lbs. 2. The length of the fully deployed net shall be 2.59 - 3.29 inches (6.6 – 8.4 cm). 3. 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.	Max deployment force shall be ≤ 3.25 lbs. Max retraction force shall be ≤ 3.25 lbs.	PASS
Change in the mesh configuration to add bidirectional mesh	Increased manufacturability.	1. Grasp the objects and held securely in the net. 2. Beads are captured and controlled.	PASS
Change in the length of the wire loop ends of the snare loop assembly and flat wire	To facilitate the change from a crimp to a resistance welding connection.	Tensile pull must be ≥ 12 lbs (Test connection between drive cable to wire form of the snare loop).	PASS
Addition of a mesh net tail on the distal and proximal sides of the net	Eliminate the need for thread as an anchor to prevent net cinching.	1. Nets shall not cinch. 2. Proximal and distal anchors shall remain intact.	PASS
Material Change
Catheter material modified from TFE to PE	Cost Reduction without reducing performance.	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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each specific test, nor does it detail the provenance of the data (e.g., country of origin, retrospective/prospective). However, for the tensile strength testing, it is mentioned that the "Test connection between drive cable to wire form of the snare loop" was performed on 30 devices. For other functional tests, terms like "simulated polyps and foreign bodies," "variety of items," and "test subjects" are used, implying in-vitro or bench testing rather than human clinical data. The studies are described as "verification and validation testing" and "design verification tests," which are typically internal development and testing activities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical interpretation or diagnosis. The testing performed is focused on the physical and functional performance of the device's modifications against engineering specifications and simulated use scenarios. Therefore, the concept of qualified experts establishing a ground truth in an interpretive sense (like radiologists for imaging) is not applicable here. The "ground truth" for these tests would be the established engineering specifications and successful completion of the functional tasks.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or appears applicable, as the tests described are objective measurements of physical performance and functional capabilities against predefined specifications (e.g., force measurements, dimensions, grasping ability). These are not subjective interpretations requiring adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was conducted or mentioned. This type of study (comparing human readers with and without AI assistance) is not relevant for a physical medical device like the Roth Net® retriever, which is a tool for retrieval during endoscopy, not an AI-powered diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable. The Roth Net® retriever is a physical medical device that is used by a human during an endoscopy procedure; it does not involve any algorithms or standalone AI performance.

7. The Type of Ground Truth Used

The "ground truth" used for these studies is based on:

Engineering Specifications: Predefined numerical values for dimensions, forces, and material properties.
Functional Performance Criteria: The ability of the device to successfully perform its intended functions in simulated environments (e.g., grasp simulated polyps, retract fully, maintain structural integrity).
Biocompatibility Standards: Compliance with ISO 10993 standards for material safety, where "no reactivity in test subjects" serves as the ground truth for biocompatibility.

8. The Sample Size for the Training Set

No training set is applicable. This device is not an AI/ML-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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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 lineCommon/Classification Name: Endoscope and accessoriesClassification Panel: Gastroenterology/Urology
Address andRegistration #	Manufacturer: United States Endoscopy Group, Inc.5976 Heisley RoadMentor, Ohio 44060Registration #: 1528319
Device Class	Endoscope accessories are classified with Endoscopes as Class IIdevices under 21 CFR § 876.1500 (product code GCJ). Noperformance standards have been established under Section 514 ofthe Federal Food, Drug, and Cosmetic Act for endoscopeaccessories.
PredicateDevice Information	The predicate device is the US Endoscopy Polyp Snare Net (AKA,the Roth Net® retriever), cleared under 510(k) K926104 on April 5,1993.
Labeling andIntended Use	Since introduction of the Polyp Snare Net in 1993, the deviceInstructions for Use (which now carries the Roth Net® brand name)have been revised and Warning and Precaution statements wereadded for clarity to ensure safe and effective use. Instructions forUse can be found beginning on page 29.Intended UseThe Roth Net® retriever product line is intended to be used toretrieve excised polyps, tissue samples, foreign bodies and calculiduring flexible and rigid endoscopy procedures. This is the sameintended use as specified in the device labeling and the cleared510(k) under K926104, April 5, 1993. This intended use has notchanged, or in any way been affected, as a result of the warningand precaution modifications. None of the modifications affectedthe device's indications.
	The Indications for Use Statement can be found on page 16.

: United States Endoscopy Group, Inc.

・ ·

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ted States Endoscopy Group, Inc.

Device Description and Comparison of Legally Marketed Devices

General Description

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

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・・・・・ 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.

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

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

ABLE 1 - Design Control Activities Summar

. .

DeviceModification	Reason forModificationChanges for Clinical Ease of Use	Risk/ Hazard	Mitigation	Verification Activity	Acceptance Criteria	VerificationResults
Change in snareshape fromround tooctagonal andchange in snareloop wire shape(braided cable toflat wire)	To better allowthe loop tomaintain itsshape; and allowfor greatercapacity.	Inability to graspobjects; net willnot open fully	Verificationtesting of thedeploymentand retractionforces; testdevice's abilityto grasp objects	Deployment and retractionworkability testingSimulated use testing for graspingability	Force required to deploy and retract shall be ≤ 3.25lbs.Net can be fully retracted without any parts leftoutside of the sheath.Net can be fully deployed without exposing theproximal end of the connector.	PASS
Change in themesh size of thenet	To improve thevisibility whencapturingmultiple polypfragments.	Inability to graspobjects; inabilityto visualize netonce objectsgrasped.	Verification ofdevice's abilityto grasp objectsand maintainvisibility.	Grasp testing using simulatedpolyps and foreign bodiesSimulated use testing to verifythat there is no obstruction ofendoscopic visibility	Must maintain ability to grasp and retrieve simulatedpolyps and foreign bodiesNet is capable of securing material that measures2cm x 1.5cm x 2.5cm.Visualization of pouch and its contents are notobstructed	PASS
Dimensional ChangesIncreased lengthand diameter ofdevicesheath/catheter	Allow use ofsubject-devicewith variousendoscopes¹	Inadequate fit tothe enteroscope(length); cathetercollapse(columnarstrength); non-deployment of thedevice.Inability to pushdevice throughaccessory channelof the endoscope	Dimensionaland functionaltesting; kinkresistancetesting.Testing ofinsertion andretractionforces;resistance tokinking	Dimensional Verification TestingKink testing.Simulate use testing by insertingthe devices through anenteroscope and grasping avariety of items.	Length shall be 138.00 ± 2.5 inches (350.5 ± 6.35cm)Visible plastic deformation due to compression mustnot occur in an insertion column length of 1.5 in (3.8cm) through the accessory channel of the endoscope.Device shall capture simulated food bolus, foreignbodies or polyps while maintaining structuralintegrity.Insertion force of less than or equal to 2.5 lbs	PASS
DeviceModification	Reason forModification	Risk/Hazard	Mitigation	Verification Activity	Acceptance Criteria	VerificationResults
Dimensional Changes	Net size changeto largest size:3 cm (l) x 4 cm (w)	To allow deviceto be used withendoscopes withlarger channels	Net fails to deploycompletely	Verificationtesting of theability of net todeploy	Simulated use testing to verify netdeployment and retraction force.Verification of deployed net lengthand width	Max deployment/retraction force shall be ≤3.25lbsThe 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 meltwas added onthe inside of thecatheter	To maintain thesmooth transitionof the snare/netinto the catheterwhen thesnare/net isretracted	Difficulty indeployment and/orretraction	Verificationtesting of theforce requiredto deploy andretract the net	Deployment and retraction forcetesting	Max deployment force shall be ≤ 3.25lbsMax retraction force shall be ≤ 3.25lbs	PASS
	Change in themeshconfiguration toadd bidirectionalmesh	Increasedmanufacturability	Inability to graspobjects.	Verificationtesting of thedevice's abilityto continue tograspsimulatedpolyps	Functional testing the net	Grasp the objects and held securely in the net.Beads are captured and controlled.	PASS
	Change in thelength of thewire loop endsof the snare loopassembly and achange in theflat wire bond tothe drive-wireform	To facilitate thechange from acrimp to aresistanceweldingconnection	Weld breaks	Tensilestrength testing	Test connection between drive cableto wire form of the snare loop (30devices)	Tensile pull must be ≥ 12 lbs	PASS

United States Endoscopy Group, Inc. Roth Net® retriever
DeviceModification	Reason forModification	Risk/Hazard	Mitigation	Verification Activity	Acceptance Criteria	Verification Results
Changes for Increased Manufacturing Efficiency
Addition of amesh net tail onthe distal andproximal sidesof the net	Eliminate theneed for threadas an anchor toprevent netcinching	Net cinches up.	Verificationtesting	Simulated use testing to verifycinching does not occur	Nets shall not cinch.Proximal and distal anchors shall remain intact.	PASS
Material Change
The cathetermaterial wasmodified fromtetrafluoro-ethylene (TFE)to polyethylene(PE) to reducecost withoutreducingperformance	Cost Reduction	Loss ofbiocompatibility	Verificationtesting foracute systemictoxicity,cytotoxicityand irritationand delayedhypersensi-tivity	Test in accordance with ISO 10993-5, 10 and -11	Material shall show no reactivity in test subjects	PASS
Appearance Change
Change handlecolor from whiteto silver	Add new color todistinguishbetween standardand platinummodels					No risks were identified in relation to this modification. No performance data were required because a change in color of the handle does not affectperformance of the subject device.

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

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United States Endoscopy Group, Inc

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

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

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

. "

: :

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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.

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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

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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

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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

Page 1 of 1

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).