The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Device Description

The DiLumen I , is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure.

In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically.

The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the DiLumen Endolumenal Interventional Scissors (DiLumen Is™). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a study involving AI performance or human reader improvement, as typically found in AI/ML medical device submissions.

Therefore, many of the requested details about acceptance criteria, study design for AI models (sample size, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training sets), and adjudication methods cannot be extracted from the provided text.

The document details performance testing that demonstrates the device meets specifications and is as safe and effective as the predicate. These tests are primarily engineering and mechanical evaluations, rather than clinical efficacy studies in the context of AI diagnostic or assistive devices.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests but does not provide specific acceptance criteria or quantitative results for these tests. It states qualitatively that "In all instances, the device functioned as intended and the results observed were as expected."

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)	Device functioned as intended; results as expected.
Dissection Force Test	Device functioned as intended; results as expected.
Tip Articulation Accuracy Test	Device functioned as intended; results as expected.
Tip Rotation Accuracy Test	Device functioned as intended; results as expected.
Shaft Rotation Accuracy Test	Device functioned as intended; results as expected.
Cutting Durability Test	Device functioned as intended; results as expected.
Monopolar Cable Insertion and Removal Force Test	Device functioned as intended; results as expected.
Electrical Safety Test	Device functioned as intended; results as expected.
Electromagnetic Compatibility Test	Device functioned as intended; results as expected.
Usability Evaluation	Device functioned as intended; results as expected.
Packaging and Transit Test	Device functioned as intended; results as expected.
User Validation	Device functioned as intended; results as expected.
EO Residuals	Device functioned as intended; results as expected.

Regarding the other points, the information is not available in the provided text:

2. Sample sized used for the test set and the data provenance: Not mentioned. The "performance data" refers to engineering and bench testing, not clinical data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. "Ground truth" in this context would refer to device specifications and performance metrics, not expert interpretations of medical images for AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
5. 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: No, an MRMC study was not done as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in terms of common AI model ground truth. The "ground truth" for this device's performance would be engineering specifications and functional requirements.
8. The sample size for the training set: Not applicable/not mentioned. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable/not mentioned.

In summary, the provided document describes a traditional medical device submission (510(k)) that focuses on demonstrating substantial equivalence through a comparison of technological characteristics and performance testing against engineering specifications, rather than clinical studies involving AI or machine learning.

Summary

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May 22, 2018

Lumendi, LLC % John J. Smith, MD, JD Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004

Re: K173405

Trade/Device Name: DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: April 6, 2018 Received: April 6, 2018

Dear John J. Smith:

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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K173405

Device Name

DiLumen Endolumenal Interventional Scissors ("DiLumen IsTM")

Indications for Use (Describe)

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

Lumendi, LLC's DiLumen Endolumenal Interventional Scissors (DiLumen I、™)

Submitter's Information:

LUMENDI, LLC 253 Post Road West Westport, CT 06880 Phone: (203) 463-2669 Fax: (203) 557-0459

Contact Person:

Dennis J. Daniels Senior Director, Requlatory Affairs and Quality Assurance Telephone: (203) 557-6335 Fax: (203) 557-0459 Email: Dennis.Daniels@Lumendi.com

Date Prepared: October 31, 2017

Device Identification:

Trade Name: Dilumen Endolumenal Interventional Scissors (DiLumen III) Common Name: Electrosurgical cutting & coagulation device Classification Regulation: 21 C.F.R. § 878.4400, Electrosurgical cutting & coagulation device and accessories Product Code: GEI Device Class: II

Predicate Device: Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments (K061425)

Reference Device: Sumitomo Bakelite Co., Ltd. SB Knife (K152771)

Device Description:

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to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically.

The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

Intended Use / Indications for Use:

The DiLumen Endolumenal Interventional Scissors ("DiLumen I,") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Summary of Technological Characteristics:

The technological principle underlying both the subject and predicate devices is manual and/or monopolar electrosurgical cutting, dissection, and cauterization of tissue. Both devices are based on the following same technological elements:

. Both are sterile, single use, monopolar scissors that allow for one-handed clinician operation.
. Both share key functional characteristics, including the control handle, an insulated working shaft with the same diameter, an articulating tip, and two curved rotating stainless-steel blades.
. Each device can be connected to an electrosurgical generator using a dedicated cable plugged into the handle, in order to make use of monopolar electrical current to facilitate or enhance the scissors' functioning.
. Both are prescription-use devices employed by medical professionals in a healthcare facility.

The primary technological difference between the subject and predicate devices is that the predicate's working shaft is rigid and shorter than that of the DiLumen Is. This does not raise different questions of safety or effectiveness, because the greater flexibility and length of the DiLumen Is working shaft simply makes it easier for the device to follow the path inside a flexible tool channel within the gastrointestinal tract; it does not alter the device's principles of operation or the purposes for which it is used. Furthermore, FDA has cleared other endoscopic cutting devices with longer flexible shafts, such as the reference device, Sumitomo Bakelite's SB Knife (K152771). The DiLumen Is also has one feature that is not found in the predicate: a tethered Blades Lock attached to the bottom of the handle that can be inserted between the body of the handle to keep the trigger squeezed and the blades closed. However, this addition is for user convenience; the predicate's blades could also be kept closed by the clinician.

	Lumendi DiLumen EndolumenalInterventional Scissors (Iₛ)	Cambridge Endoscopic Devices, Inc.pureWrist™ electrocauterylaparoscopic Instruments
510(k)	TBD	K061425
Intended Use /Indications for Use	The DiLumen EndolumenalInterventional Scissors ("DiLumen Iₛ")	The pureWrist™ electrocauterylaparoscopic Instruments have
	is a disposable monopolar	application in a variety of minimally
	electrosurgical device intended to be	invasive procedures to facilitate grasping,
	used for cutting, dissecting, and	mobilization, dissection and transection of

The table below compares the key features of the subject and predicate devices.

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	Lumendi DiLumen EndolumenalInterventional Scissors (Is)	Cambridge Endoscopic Devices, Inc.pureWrist™ electrocauterylaparoscopic Instruments
	cauterizing tissue within the digestivetract during endoscopic procedures.	tissue.
Sterility	Sterile - EO	Sterile - Radiation
Shelf Life	One year	Two years
Single use/reusable	Single Use, fully disposable	Single Use, fully disposable
Basic Design	Proximal handle with controls, flexibleinsulated shaft, articulating sectionand rotating scissor tip	Proximal handle with controls, rigidinsulated shaft, articulating section androtating scissor tip
Patient-ContactingMaterials	Stainless steel (jaws), medical-gradepolymers: Pebax with embeddedAramid braid (flexible shaft),Fluoropolymer (Articulation sleeve)	Stainless steel (jaws); FEP, PEEK,Pebax, Tecoflex, Cyanoacrylate, PET
Electrical connector	Banana plug at bottom of handle	Banana plug at bottom of handle
Cautery Type	Monopolar cautery	Monopolar cautery
Shaft Outer diameter	5 mm	5 mm
Shaft length	95 cm, 140 cm	15 - 45 cm
Operating principle	The DiLumen Is are operatedmanually using one hand to controlblade position and blade actuation.The end effector can be rotated,articulated and positioned, allowingthe scissor blades to cut, dissect, andcauterize tissue either with or withoutmonopolar energy	The pureWrist™ electrocauterylaparoscopic Instruments are operatedmanually using one hand to control bladeposition and blade actuation. The endeffector can be rotated, articulated andpositioned, allowing the scissor blades tocut, dissect, and cauterize tissue with orwithout monopolar energy.

Performance Data:

Performance testing has demonstrated that the DiLumen Is meets specifications and is as safe and effective as the predicate. The following performance data were provided in support of this Premarket Notification:

1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
1. Dissection Force Test
1. Tip Articulation Accuracy Test
1. Tip Rotation Accuracy Test
1. Shaft Rotation Accuracy Test
1. Cutting Durability Test
1. Monopolar Cable Insertion and Removal Force Test
1. Electrical Safety Test
1. Electromagnetic Compatibility Test
1. Usability Evaluation
1. Packaging and Transit Test
1. User Validation
1. EO Residuals

In all instances, the device functioned as intended and the results observed were as expected.

Conclusion:

The DiLumen Is device has the same intended use and similar indications, technological

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characteristics, and principles of operation as the identified predicate. The minor technological differences between the DiLumen I, and its predicate device do not raise any new questions of safety of effectiveness. Furthermore, the performance data presented in the 510(k) notice further support that the DiLumen I functions as safely and performs as well as the identified predicate. Thus, the DiLumen I , is substantially equivalent to the predicate pureWrist™ electrocautery laparoscopic instruments (K061425).

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.