The EndoChoice Retrieval Net is a disposable, single-use sterile device comprised of a flexible wire cable and snare loop with net which can be extended and retracted form the flexible outer sheath using a three ring handle. Objects are retrieved by advancing the finger rings of the handle to open the retracted net. The net is then endoscopically manipulated over the foreign object, food bolus, tissue fragment or excised tissue, in which the finger rings of the handle are retracted to close the net once the article has been retrieved.

AI/ML Overview

This document, a 510(k) premarket notification, describes the "EndoChoice Retrieval Net," a retrieval device intended for use in endoscopic procedures. The document aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device, the Roth Net® retriever product line (K122462). The core acceptance criterion is that the new device performs at least as safely and effectively as the predicate, based on comparable characteristics.

While a formal table of "acceptance criteria" with specific quantitative targets and reported performance isn't explicitly provided, the substantial equivalence table (Section 7.5) serves this purpose by comparing key characteristics of the new device to the predicate. The "reported device performance" is implicitly that the device meets or matches the predicate in the listed attributes.

Characteristic	Acceptance Criteria (Predicate: Roth Net® retriever product line K122462)	Reported Device Performance (EndoChoice Retrieval Net)
Product Code	FDI, GCJ	FDI, GCJ
Regulation No.	21CFR § 876.4300	21CFR § 876.4300
Classification	Endoscopic electrosurgical unit and accessories	Endoscopic electrosurgical unit and accessories
Supplied Sterile	Yes	Yes
Sheath length	160cm, 230cm (at least one matching)	230cm
Single use	Yes	Yes
Sheath diameter	2.5mm, 3.0mm (at least one matching)	2.5mm
Compatibility	2.8mm, 3.2mm endoscope channel (at least one matching)	2.8mm endoscope channel
Net Size	3 x 6 cm, 2 x 4.5 cm, 4 x 5.5 cm, 4 x 8 cm (at least one matching)	3 x 6 cm
Configuration	Oval, Octagonal, Hexagonal (at least one matching)	Oval
Indications for use	Intended for use in endoscopic retrieval of excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.	Intended for use in endoscopic retrieval of foreign objects, food boluses, tissue fragments and excised tissue such as polyps.
Packaging	Single-use pouch	Single-use pouch

Study Information:

Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a specific outcome. Instead, it relies on non-clinical testing (sterilization, shelf-life, biocompatibility, and general performance testing) to demonstrate that the device functions as intended and is safe. No specific sample sizes for these tests are provided in the summarized information, nor is data provenance (country of origin, retrospective/prospective) for a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission does not involve a "test set" requiring expert ground truth in the context of diagnostic or interpretive performance. The non-clinical tests rely on established scientific methods and standards.
Adjudication method for the test set:
Not applicable. There is no clinical "test set" or expert review process described for adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a physical retrieval tool, not an AI-assisted diagnostic or interpretive product. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument, not an algorithm, and intrinsically requires human operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests:
- Sterilization and Shelf-Life: Ground truth is established by adherence to recognized international standards (ISO 11135:2014, AAMI ANSI ISO 11737-2:2009, AAMI ANSI ISO 11138-1:2006).
- Biocompatibility: Ground truth is established by adherence to AAMI ANSI ISO 10993-1:2009.
- Performance Testing: While details are not given, this would typically involve engineering tests against internal specifications or industry standards to confirm functional performance (e.g., net opening/closing, retrieval capability, material integrity).
The sample size for the training set:
Not applicable. As this is not an AI/machine learning device, there is no "training set."
How the ground truth for the training set was established:
Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

November 3, 2015

Endochoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Rd. Alpharetta, GA 30009

Re: K152580 Trade/Device Name: Rescuenet™ Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic and electrosurgical unit and accessories Regulatory Class: II Product Code: FDI, GCJ Dated: September 9, 2015 Received: September 10, 2015

Dear Daniel Hoefer,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Herbert P. Lerner -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)

K152580

Device Name EndoChoice Retrieval Net

Indications for Use (Describe)

The retrieval net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k) Summary

1. Company Identification

EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 878 3373 Establishment Registration: 3007591333

2. Contact Person

Daniel Hoefer Regulatory Affairs Manager

3. Device Name

rescuenet™ Trade name: Common/Usual Name: Retrieval Net

4. Device Classification

Common Name:	Retrieval Net
Classification:	Endoscopic electrosurgical unit and accessories, 21CFR § 876.4300
Product Code:	FDI, GCJ
Committee:	Gastroenterology/Urology

5. Intended Use

The Retrieval Net is intended for use in endoscopic retrieval of foreign objects, food bolus, tissue fragments and excised tissue such as polyps.

6. Device Description

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7. Substantial Equivalence

7.1 Predicate devices

The EndoChoice retrieval net is substantially equivalent to the predicate device, the Roth Net retriever product line by United States Endoscopy Group, Inc. The intended use, design and materials and labeling are all substantially equivalent.

7.2 Intended Use

The indications for use of the EndoChoice retrieval net is substantially equivalent to the predicate device, the Roth Net® retrieval product line (K122462) manufactured United States Endoscopy Group, Inc. In each case, the nets are intended for use in endoscopic retrieval of objects.

7.3 Technical Characteristics

The device length is 230cm and the device catheter diameter is 2.5mm.

Image /page/4/Figure/8 description: The image shows a medical device with measurements labeled. The diameter of the circular part on the left is 30 mm. The length of the device is 230 cm and the diameter of the shaft is 2.5 mm.

7.4 Performance Characteristics

The steps for operator use of each of the devices are equivalent. The instructions for use describe how to use the device with a standard endoscope, in which the stepwise instructions are similar to that of the predicate device.

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Substantial Equivalence Comparison
	EndoChoice Retrieval Net	Roth Net® retriever	Substantial
		product line (K122462)	Equivalence
Product Code	FDI, GCJ	FDI, GCJ	Identical
Regulation No.	21CFR § 876.4300	21CFR § 876.4300	Identical
Classification	Endoscopic electrosurgical unitand accessories	Endoscopic electrosurgical unitand accessories	Identical
Manufacturer	EndoChoice Inc.	United States EndoscopyGroup, Inc.	N/A
Supplied Sterile	Yes	Yes	Identical
Sheath length	230cm	160cm, 230cm	Identical
Single use	Yes	Yes	Identical
Sheath diameter	2.5mm	2.5mm, 3.0mm	Identical
Compatibility	2.8mm endoscope channel	2.8mm, 3.2mm endoscopechannel	Equivalent
Net Size	3 x 6 cm	3 x 6 cm2 x 4.5 cm4 x 5.5 cm4 x 8 cm	Identical
Configuration	Oval	Oval, Octagonal, Hexagonal	Identical
Indications for	This device is intended for use inendoscopic retrieval of foreignobjects, food boluses, tissuefragments and excised tissuesuch as polyps.	The Roth Net® retrieverproduct line is intended to beused to retrieve excised polyps,tissue samples, foreign bodiesand calculi during flexible andrigid endoscopy procedures.	Equivalent
use
Packaging	Single-use pouch	Single-use pouch	Identical

7.5 Substantial Equivalence Table

8. Non-Clinical testing

8.1 Sterilization and Shelf-Life

The EndoChoice Retrieval Net is sterilized by Ethylene Oxide.

Validation has been completed in accordance with the following standards:
ISO 11135: 2014 Sterilization of Health-Care Products Ethylene Oxide Requirements for the ● Development, Validation and Routine Control of a Sterilization Process for Medical Devices
. AAMI ANSI ISO 11737-2: 2009 Sterilization of Medical Devices - Microbiological Methods -Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
. AAMI ANSI ISO 11138-1: 2006 Sterilization of Health Care Products - Biological Indicators -Part 1: General Requirements

The shelf life of the EndoChoice Retrieval Net is 1 year from date of manufacturing.

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8.2 Biocompatibility

Results of Biocompatibility testing in accordance with AAMI ANSI ISO 10993-1: 2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing within a Risk Management Process demonstrates that the device meets the requirements.

8.3 Performance Testing

Results from various performance testing indicates that the EndoChoice Retrieval Net functions as intended.

9. Conclusion

Retrieval nets have been in use for over 20 years. A variety of retrieval net devices are available on the market from different manufacturers with various diameters and lengths. Based on the above information, the EndoChoice Retrieval Net is substantially equivalent to the predicate device listed. The information contained in this submission supports the fact that the EndoChoice Retrieval Net is as safe and effective as its predicate device.

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).