The Lumendi DiLumen C2 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

Device Description

The DiLumen C² consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 comes into limited (<24 hour) contact with breached or compromised surfaces of the patient. The C2 is provided sterile and intended only for single patient use.

To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned and sterilized prior to each use following the instructions in the device labeling.

AI/ML Overview

The provided text describes a medical device called the DiLumen C2 and its accessory, the Tool Mount, and generally states their performance and equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and the results of a specific clinical study in the format requested.

The document is a 510(k) Premarket Notification summary from the FDA, aiming to demonstrate substantial equivalence to a legally marketed predicate device (DiLumen Endolumenal Interventional Platform, K162428). This typically relies on comparing technological characteristics and demonstrating that any differences do not raise new questions of safety or effectiveness, often through bench testing rather than extensive clinical trials with specific performance metrics against pre-defined acceptance criteria.

The "Performance Data" section lists various tests performed (e.g., Biocompatibility, Balloon Diameter, Inflation/Deflation and Leakage Test, User Validation), but it does not provide quantitative acceptance criteria or the specific performance results from these tests. It merely states, "In all instances, the device functioned as intended and the results observed were as expected." It also explicitly states, "No animal or clinical testing was required to demonstrate substantial equivalence to the predicate."

Therefore, I cannot fill in the requested table and answer many of the specific questions about clinical study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set) because this information is not present in the provided document.

Here's what I can extract and state based on the provided text, and where I must indicate information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., specific thresholds for force, leak rate, etc.)	Reported Device Performance
Not provided in the document. The document states:	"In all instances, the device functioned as intended and the results observed were as expected."
Specific criteria for:
- Biocompatibility
- Balloon Diameter, Inflation/Deflation and Leakage Test
- Device Slip Relative to Scope Test
- Fore Balloon Extension Test
- Articulation Test
- Colon Grip Test
- Therapeutic Zone Creation Test
- Tuohy Leak Force / Bond Leak Test
- Insertion Force Test
- Packaging and Transit Test
- User Validation
- EO residuals
- Tool Mount Cleaning and Sterilization Validation
- Tool Mount Positioning and Locking Test
- Tool Mount Validation

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document indicates "No animal or clinical testing was required," implying that the performance data primarily comes from bench testing, for which sample sizes are not detailed in this summary.
Data Provenance: Not applicable for a clinical study, as the document states no clinical testing was required. For bench testing, provenance details like country of origin or whether data was retrospective/prospective are not provided.

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

This information is not applicable as no clinical study or expert-adjudicated ground truth for a test set is described.

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

This information is not applicable as no clinical study with a test set requiring adjudication is described.

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 MRMC comparative effectiveness study was done. The device (DiLumen C2 and Tool Mount) is an endoscope accessory, not an AI diagnostic or assistive imaging tool that involves "human readers" in the context of an MRMC study.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Ground truth in the traditional sense of clinical studies (e.g., pathology, outcomes) is not mentioned as "No animal or clinical testing was required." For the enumerated performance tests, the "ground truth" would be the engineering specifications and functional requirements of the device.

8. The sample size for the training set

Not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable.

Summary of what the document does provide regarding performance:
The document states that "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate." The listed tests (Biocompatibility, Balloon Diameter, etc.) are bench tests. The conclusion is that the device is "substantially equivalent" to its predicate based on these tests and similar technological characteristics, not based on a clinical trial with acceptance criteria for specific performance metrics against clinical outcomes.

Summary

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April 17, 2018

Lumendi, LLC % John J. Smith, MD, JD Partner Hogan Lovells U.S. LLP 553 13th Street NW Washington, DC 20004

Re: K173317

Trade/Device Name: DiLumen C2: DiLumen Tool Mount Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: March 6, 2018 Received: March 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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible and well-spaced.

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) K173317

Device Name DiLumen C2; DiLumen Tool Mount

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)

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 C2 and Tool Mount

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: April 5, 2018

Device Identification:

Trade Name: DiLumen C2 and Tool Mount Common Name: Endoscope Accessory Classification Regulation: 21 C.F.R. § 876.1500 (Endoscope and accessories) Product Codes: FDF Device Class: II

Predicate Device: DiLumen Endolumenal Interventional Platform (K162428)

Reference Device: FISSO Holding System (K070509)

Device Description:

Intended Use / Indications for Use:

The Lumendi DiLumen C is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

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The identified predicate device for the DiLumen C2 has similar indications for use as the subject device. Like the predicate Lumen (K162428), the DiLumen C² device is intended for use as an accessory to an endoscope to position/stabilize the endoscope and assist in optical visualization, diagnosis, and endoscopic treatment in the large intestine. Accordingly, the differences in indications for use between the DiLumen C2 and its predicate device are not critical to the intended therapeutic/diagnostic use of the device and do not affect its safety or effectiveness when used as labelled.

Technological Characteristics and Principles of Operation:

The DiLumen C2 Endolumenal Interventional Platform is a sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope.

The DiLumen C2 utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen C2 is installed over the endoscope, a collet is secured to the endoscope distal tip. The endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen C2 sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of the endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled independently using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area.

The flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) of the endoscope are unaffected by the presence of the DiLumen C2. The DiLumen C2 has two 6-mm diameter tool channels. The tool channels are located 180° apart at the distal end of the sleeve. The tool channels provide the clinician access at the therapeutic site so that the clinician can use flexible endoscopic tools such as graspers, scissors, knives, etc. to perform endolumenal interventions.

The DiLumen C-is provided with a designated accessory, the Tool Mount, which holds the tool channels in a fixed position to facilitate their use. The Tool Mount consists of the previously cleared FISSO Holding System (K070509) articulating arm with an added permanently attached tool bar to firmly hold the C-tool channels in the clinician's preferred orientation. The tool bar has flanges that firmly hold the proximal ends of the DiLumen C² tool channels and are adjustable in three angular positions. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp. The Tool Mount has similar indications for use and function as the FISSO Holding System reference device, namely to hold endoscopes, equipment, and patient positioning accessories during diagnostic and therapeutic procedures, but because the Tool Mount is designed for use with only the DiLumen C2, its intended use is narrower.

Performance Data:

Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate. As the DiLumen C2 shares many of the same components as the predicate devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope and with the Tool Mount. The following performance data were provided in support of this Premarket Notification:

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1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
1. Balloon Diameter, Inflation/Deflation and Leakage Test
1. Device Slip Relative to Scope Test
1. Fore Balloon Extension Test
1. Articulation Test
1. Colon Grip Test
1. Therapeutic Zone Creation Test
1. Tuohy Leak Force / Bond Leak Test
1. Insertion Force Test
1. Packaging and Transit Test
1. User Validation
1. EO residuals
1. Tool Mount Cleaning and Sterilization Validation
1. Tool Mount Positioning and Locking Test
1. Tool Mount Validation

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

No animal or clinical testing was required to demonstrate substantial equivalence to the predicate.

Substantial Equivalence:

The subject Dilumen C² device has nearly identical technological characteristics as the DiLumen Endolumenal Interventional Platform cleared under K162428, with the main differences between the devices being:

1. The subject device has two tool channels;
1. The subject device has a dedicated Tool Mount accessory;
1. The subject device is secured to the endoscope distal tip using a collet;
1. The internal diameter of the DiLumen C2's balloons is slightly larger; and
1. The subject device is EO-sterilized.

Because the DiLumen C2 and the predicate consist of many of the same components to ensure complete positioning of the endoscope and advance the endoscope to the target location in the same manner, and as further demonstrated by performance testing, these minor technological differences do not raise different types of safety or efficacy questions. In addition, the Tool Mount accessory - which is limited to use with the C2 device - is very similar to the FISSO Holding System reference device (K070509).

A table comparing the key features of the subject and predicate devices is provided below.

	Lumendi DiLumen C2	Lumendi DiLumen EndolumenalInterventional Platform
510(k)	TBD	K162428
Intended Use /Indications for Use	The Lumendi DiLumen C2 is anendoscope accessory intended toensure complete positioning of anendoscope in the large intestine,and assist with optical	The Lumendi DiLumen is an accessory to anendoscope. The DiLumen dual balloonaccessory is intended for use with anyendoscope that has an outer diameter of 12.5 –14.3 mm and a minimum working length of 1680
	Lumendi DiLumen C2	Lumendi DiLumen EndolumenalInterventional Platform
	visualization, diagnosis, andendoscopic treatment.	mm. The device is indicated to ensure completepositioning of an endoscope in the largeintestine, and assist with optical visualization,diagnosis, and endoscopic treatment.
Sterility	Sterile - EO	Non-sterile
Single use/reusable	Single Use	Single Use
Balloon	Low durometer Polyurethane	Low durometer Polyurethane
Sleeve	Pellethane with 2.5% Glycolubetranslucent	Pellethane with 2.5% Glycolube translucent
Inflation tube/Pushrod Assembly	IsoplastPebaxPellethane	IsoplastPebaxPellethane
Collet	Lexan	NA
Tool ChannelTubing	FEP; Pellethane; stainless steelinternal braid;	NA
Tool ChannelComponents	Polyurethane; Pellethane with2.5% Glycolube ;ePTFE Lexan;silicone;	NA
CompatibleEndoscope TipDiameter	11.5 - 14.5 mm	12.5 - 14.3 mm
Fore/Aft Balloons- Inner Diameter	28.5 mm	21.5 mm
Fore/Aft Balloons- Outer Diameter	60 mm	60 mm
Balloon Pressure	45 ± 12 mmHg	45 ± 12 mmHg
Relief Pressure	55 mmHg	55 mmHg
Working Length	1680 mm	1680 mm
Inflation Source	Manual inflation bulb	Manual inflation bulb
Shelf Life	12 months	12 months
Accessories	The Lumendi DiLumen C2 has adesignated Tool Mount that isintended to mount to a surgicaltable rail and hold the DiLumenC2 tool channels duringendoscopic treatment. The ToolMount is made of stainless steel	The Lumendi DiLumen can be used with variousadditional endoscope accessories, but is notsupplied with any designated accessories.

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Conclusion:

The DiLumen C² is as safe and effective as the DiLumenal Interventional Platform cleared under K162428. The device has the same intended use and principles of operation, and similar indications for use and technological characteristics, as the predicate device, and its designated accessory (the Tool Mount) has similar indications and function as the identified reference device (the FISSO Holding System cleared under K070509). The minor differences in indications and technology do not alter the intended therapeutic use of the device and do not raise any new questions of safety or effectiveness when the device is used as labelled. In addition, bench testing data demonstrate that the DiLumen C2 is as safe and effective as the predicate device. Thus, the DiLumen C2 is substantially equivalent to the DiLumen Endolumenal Interventional Platform.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.