Who is the manufacturer of ROTH NET RETRIEVER?

United States Endoscopy Group, Inc. filed the 510(k) submission for ROTH NET RETRIEVER (K122462).

What is the FDA product code for ROTH NET RETRIEVER?

FDI. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for ROTH NET RETRIEVER?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like ROTH NET RETRIEVER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ROTH NET RETRIEVER

K122462 · United States Endoscopy Group, Inc. · FDI · Sep 11, 2012 · Gastroenterology, Urology

Device Facts

Record ID	K122462
Device Name	ROTH NET RETRIEVER
Applicant	United States Endoscopy Group, Inc.
Product Code	FDI · Gastroenterology, Urology
Decision Date	Sep 11, 2012
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.4300
Device Class	Class 2

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.

Device Story

Roth Net retriever is an endoscopic accessory used by physicians during flexible or rigid endoscopy. Device consists of a proximal handle with a finger ring, a drive wire, a catheter sheath, and a distal fabric mesh basket (snare/net). Physician operates handle to deploy or retract the mesh basket through the endoscope's accessory channel. Once deployed, the net captures excised polyps, tissue samples, foreign bodies, or calculi. The device facilitates secure retrieval of these items from the patient. Modifications include changes to snare shape (round to octagonal), wire type (braided to flat), mesh configuration, catheter material (TFE to PE), and dimensions to improve clinical ease of use, visibility, and manufacturing efficiency. Verification testing confirms the device maintains grasping ability, structural integrity, and compatibility with various endoscopes.

Clinical Evidence

Bench testing only. Verification activities included deployment/retraction force testing (≤ 3.25 lbs), simulated use testing for grasping ability, kink resistance testing, tensile strength testing (≥ 12 lbs), and biocompatibility testing (ISO 10993-5, 10, and 11). All tests passed, confirming performance equivalent to the predicate.

Technological Characteristics

Endoscopic accessory; consists of a proximal handle, drive wire, catheter sheath, and fabric mesh basket. Materials include polyethylene (catheter) and flat/braided wire (snare). Dimensions vary to accommodate different endoscope channels. Connectivity: None. Sterilization: Sterile and non-sterile versions available. Operation: Mechanical, manual actuation via handle.

Indications for Use

Indicated for retrieval of excised polyps, tissue samples, foreign bodies, and calculi during flexible and rigid endoscopy procedures in patients requiring such interventions.

Regulatory Classification

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.

Predicate Devices

Polyp Snare Net (K926104)

Submission Summary (Full Text)

{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, 1993. | | | 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. - - 3. Finger ring - 4. 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. Insertion force of less than or equal to 2.5 lbs | PASS | | | Device Modification | Reason for Modification | Risk/Hazard | Mitigation | Verification Activity | Acceptance Criteria | Verification Results | | | Dimensional Changes | Net size change to largest size: 3 cm (l) x 4 cm (w) | To allow device to be used with endoscopes with larger channels | Net fails to deploy completely | Verification testing of the ability of net to deploy | Simulated use testing to verify net deployment and retraction force. 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 Max retraction force shall be ≤ 3.25lbs | PASS | | | Change in the mesh configuration to add bidirectional mesh | Increased manufacturability | Inability to grasp objects. | Verification testing of the device's ability to continue to grasp simulated polyps | Functional testing the net | Grasp the objects and held securely in the net. Beads are captured and controlled. | PASS | | | Change in the length of the wire loop ends of the snare loop assembly and a change in the flat wire bond to the drive-wire form | To facilitate the change from a crimp to a resistance welding connection | Weld breaks | Tensile strength testing | Test connection between drive cable to wire form of the snare loop (30 devices) | Tensile pull must be ≥ 12 lbs | PASS | | | | | | | | | | | United States Endoscopy Group, Inc. Roth Net® retriever | | | | | | | | | Device Modification | Reason for Modification | Risk/Hazard | Mitigation | Verification Activity | Acceptance Criteria | Verification Results | | | Changes for Increased Manufacturing Efficiency | | | | | | | | | 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 | Net cinches up. | Verification testing | Simulated use testing to verify cinching does not occur | Nets shall not cinch. 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 : · {6}------------------------------------------------ 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, 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 Page 1 of 1

ROTH NET RETRIEVER

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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ROTH NET RETRIEVER

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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