The DiLumen Endolumenal Interventional Knife ("DiLumen |ç") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

Device Description

The DiLumen Ix is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.

AI/ML Overview

This document is a 510(k) summary for the DiLumen Endolumenal Interventional Knife (DiLumen IK™), a medical device. It does not describe a study involving algorithms, AI assistance, or human readers. Therefore, I cannot provide information on acceptance criteria or studies related to AI performance metrics (like sensitivity, specificity, or MRMC studies) for this particular device based on the provided text.

The document focuses on demonstrating the substantial equivalence of the DiLumen IK to a predicate device (DiLumen Endolumenal Interventional Scissors) and a reference device (Olympus Single Use Electrosurgical Knife) through non-clinical performance testing.

Here's what can be extracted about the device's validation:

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

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

Performance Test	Reported Device Performance
Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)	Functioned as intended; results as expected.
End Effector Articulation Test	Functioned as intended; results as expected.
Leakage Test	Functioned as intended; results as expected.
Bleb Formation Test	Functioned as intended; results as expected.
Internal Pressurization Test	Functioned as intended; results as expected.
Shaft and Handle Rotation Accuracy Test	Functioned as intended; results as expected.
Electrical Continuity Test	Functioned as intended; results as expected.
Electrical Safety Test	Functioned as intended; results as expected.
Electromagnetic Compatibility Test	Functioned as intended; results as expected.
Packaging and Transit Evaluation	Functioned as intended; results as expected.
Design Validation	Functioned as intended; results as expected.
Human Factors/Usability Testing	Functioned as intended; results as expected.

2. Sample sized used for the test set and the data provenance:

The document does not specify sample sizes for any of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the full 510(k) submission, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this is for a physical medical device, not an AI, so "ground truth" in the context of expert review of images is not relevant here. The "ground truth" for this device would be established by physical testing and adherence to engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for a physical device's performance testing.

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:

Not applicable. This device is a manual surgical tool, not an AI or imaging diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device used by a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is based on direct physical and electrical testing against pre-defined specifications and industry standards for electrosurgical devices and biocompatibility. For example, electrical safety is tested against relevant standards, and biocompatibility is tested according to ISO standards.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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August 2, 2019

Lumendi, LLC John J. Smith, M.D., Ph.D. Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004

Re: K183112

Trade/Device Name: DiLumen Endolumenal Interventional Knife ("DiLumen IK") Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2019 Received: July 3, 2019

Dear John 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Martha Betz, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K183112

Device Name

DiLumen Endolumenal Interventional Knife ("DiLumen IKTM")

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 Knife (DiLumen Ik™)

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

Date Prepared: August 1, 2019

Device Identification:

Trade Name: DiLumen Endolumenal Interventional Knife ("DiLumen II,")

Common Name: Electrosurqical cutting & coagulation device

Classification Regulation: 21 C.F.R. § 878.4400, Electrosurgical cutting and coagulation device and accessories

Product Code: GEI

Device Class: II

Predicate Device: Lumendi DiLumen Endolumenal Interventional Scissors ("DiLumen I (") (K173405)

Reference Device: Olympus Medical Systems Corporation Single Use Electrosurgical Knife (K171158)

Device Description:

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

Intended Use / Indications for Use:

The DiLumen Endolumenal Knife ("DiLumen Ik") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.

Summary of Technological Characteristics:

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

. Both are sterile, single use, monopolar instruments that allow for one-handed clinician operation.
. Both share key functional characteristics, including the control handle, a flexible shaft with the same diameter, an articulating tip, and stainless-steel end effector.
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 marking, cutting and cauterization.
. 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 proposed device can be used to inject saline into the submucosa, thus forming a bleb that will lift a lesion for enhanced visibility and to allow endoscopic removal. This added feature does not raise different questions of safety or effectiveness, because FDA has cleared other endoscopic devices that have the same functionality such as the reference device, Olympus Medical Systems Corporation's Single Use Electrosurgical Knife (K171158).

The two devices also have slightly different end effector designs and associated operation, but this difference does not raise different questions of safety or effectiveness as both have the same fundamental mechanism of action, and the previously cleared predicate can serve as a knife when used with the blades closed. In addition, the cleared reference device has a very similar end effector design as the DiLumen IK.

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

	Lumendi DiLumenEndolumenalInterventional Knife (IK)	Lumendi DiLumenEndolumenalInterventional Scissor (IS)	Olympus Single UseElectrosurgical Knife
	Subject Device	Predicate Device	Reference Device
510(k)	TBD	K173405	K171158
IntendedUse /Indications	The DiLumen EndolumenalInterventional Knife("DiLumen IKTM") is a	The DiLumen EndolumenalInterventional Scissors("DiLumen IS") is a	These instruments havebeen designed to be usedwith Olympus endoscopes
	Lumendi DiLumenEndolumenalInterventional Knife (IK)	Lumendi DiLumenEndolumenalInterventional Scissor (Is)	Olympus Single UseElectrosurgical Knife
for Use	disposable monopolarelectrosurgical deviceintended to be used formarking, cutting, dissecting,and cauterizing tissue withinthe digestive tract duringendoscopic procedures. Thedevice is also indicated forthe induction of sterilenormal saline into thesubmucosa to lift mucosallesions under directendoscopic visualization.	disposable monopolarelectrosurgical deviceintended to be used forcutting, dissecting, andcauterizing tissue within thedigestive tract duringendoscopic procedures.	and electrosurgical units tocut tissue within thedigestive tract using high-frequency current. Theseinstruments are indicated forthe induction of sterilenormal saline into thesubmucosa to lift lesionsusing direct visualizationthrough an endoscope.
Sterility	Sterile - EO	Sterile - EO	Sterile - EO
Shelf Life	One year	One year	Unknown
Singleuse/reusable	Single Use, fully disposable	Single Use, fully disposable	Single Use, fully disposable
BasicDesign	Proximal handle withcontrols, flexible shaft,articulating section,retractable / extendableknife tip;Flush tube inside shaft	Proximal handle withcontrols, flexible insulatedshaft, articulating sectionand rotating scissor tip	Proximal handle withcontrols, flexible shaft,retractable / extendableknife tip;Flush tube inside shaft
Patient-ContactingMaterials	Stainless steel (knife tip),medical-grade polymers	Stainless steel (blades),medical-grade polymers	Stainless steel (knife tip),medical-grade polymers
End Effector	Shaft with ball tip (knob-shape)	Scissor Blades	Shaft with ball tip (knob-shape)
Electricalconnector	Banana plug at bottom ofhandle	Banana plug at bottom ofhandle	Banana plug in handle
Type ofworkingchannel	Channel external toendoscope	Channel external toendoscope	Endoscope's workingchannel
Compatiblediameter ofchannel	6 mm	6 mm	2.8 mm to 6.0 mm
Shaft length	95 cm, 140 cm	95 cm, 140 cm	195 cm, 230 cm
Syringe port	Luer lock in handle	None	Luer lock in handle

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Performance Data:

Performance testing has demonstrated that the DiLumen Ik meets specifications and is as safe and effective as the predicate device. The following non-clinical performance data were provided in support of this 510(k) notice:

1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
1. End Effector Articulation Test
1. Leakage Test

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1. Bleb Formation Test
1. Internal Pressurization Test
1. Shaft and Handle Rotation Accuracy Test
1. Electrical Continuity Test
1. Electrical Safety Test
1. Electromagnetic Compatibility Test
1. Packaging and Transit Evaluation
1. Design Validation
1. Human Factors/Usability Testing

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

Conclusion:

The Dilumen Ik device has the same intended use and similar indications, technological characteristics, and principles of operation as the identified predicate and reference devices. The minor differences in end effector and saline flush capabilities between the DiLumen Ik and its predicate device do not raise any new questions of safety of effectiveness, and the performance data presented in the 510(k) notice further support that the DiLumen Ik functions as safely and performs as well as the identified predicate. Thus, the DiLumen Ik is substantially equivalent to the predicate Lumendi DiLumenal Interventional Scissors ("DiLumen I.") (K173405).

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.