(98 days)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML, image processing, or data analysis.
Yes.
The device facilitates endoscopic treatment and creates an isolated therapeutic zone, indicating its role in therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended to "assist with optical visualization, diagnosis, and endoscopic treatment." The 'Device Description' also mentions that the balloons create an "isolated diagnostic or therapeutic zone." While the device itself is an accessory to an endoscope, it aids in diagnostic procedures by improving visualization and creating a suitable zone for diagnosis.
No
The device is a physical accessory to an endoscope, consisting of a sleeve, balloons, and an inflation handle. It is not software-only.
Based on the provided information, the Lumendi DiLumen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- DiLumen's Function: The DiLumen is an accessory to an endoscope used within the patient's large intestine. Its primary functions are to:
- Ensure complete positioning of the endoscope.
- Assist with optical visualization.
- Assist with endoscopic treatment.
- Stabilize the endoscope and the therapeutic area.
- No Specimen Analysis: The description does not mention the DiLumen being used to analyze any specimens taken from the patient. It facilitates the use of the endoscope and other tools in situ.
Therefore, the DiLumen is a medical device used for in-vivo procedures (within the body), not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
Product codes (comma separated list FDA assigned to the subject device)
FDF
Device Description
The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope.
The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, 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 sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an 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 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 and are inflated or deflated independently.
The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals in a healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of this Premarket Notification:
- Biocompatibility (cytotoxicity, sensitization, and systemic toxicity)
- Balloon Burst Pressure Test
- Balloon Diameter, Inflation/Deflation and Leakage Test
- Relief Valve Test
- Device Slip Relative to Scope Test
- Sleeve Buckling Test
- Fore Balloon Extension Test
- Colon Grip Test
- Articulation Test
- Sleeve Leak Test
- Therapeutic Zone Creation Test
- Fatigue/Cycling Test
- Extension Position Locking Test
- Flexibility Test
- Force/Bond Test
- Insertion Force Test
- Packaging and Transit Test
- User Validation
Bench testing data demonstrate that the DiLumen has substantially equivalent performance to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Smart Medical Systems NaviAID™ BGE (K060923), Smart Medical Systems NaviAID™ BGC (K102616)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Lumendi, LLC % John Smith Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
Re: K162428
Trade/Device Name: DiLumen Endolumenal Interventional Platform Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF Dated: October 24, 2016 Received: October 24, 2016
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. 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 device
1
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 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,
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
2
Indications for Use
510(k) Number (if known) K162428
Device Name
DiLumen Endolumenal Interventional Platform
Indications for Use (Describe)
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
| 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 Platform
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 Director, Regulatory Affairs and Quality Assurance Telephone: (203) 557-6335 Fax: (203) 557-0459 Email: Dennis.Daniels@Lumendi.com
Date Prepared: August 30, 2016
Device Identification:
Trade Name: DiLumen Endolumenal Interventional Platform Common Name: Endoscope Accessory Device Class: II Device Panel: Gastroenterology/Urology
Classification:
21 C.F.R. § 876.1500 (Endoscope and accessories) Product Code: FDF
Predicate/Reference Devices:
- . Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116)
- Smart Medical Systems NaviAID™ BGE (K060923) (reference device) ●
- Smart Medical Systems NaviAID™ BGC (K102616) (reference device) ●
Intended Use / Indications for Use:
The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 – 14.3 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
Device Description/Technological Characteristics:
The DiLumen Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope.
4
The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, 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 sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an 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 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 and are inflated or deflated independently.
The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.
Substantial Equivalence:
The DiLumen device has the same intended use and similar indications and technological characteristics as the Fujinon EC-450B15 system (K090116) and Smart Medical Systems' NaviAID™ BGE (K060923) and NaviAID™ BGC (K102616) devices.
The subject device and the Fujinon predicate consist of the same basic components to ensure complete positioning of the endoscope - specialized balloons, an over-tube/sleeve, and an inflation system; the NaviAid reference devices do not have a sleeve but include a balloon(s) and inflation/extension tube. While the DiLumen is not used to advance the endoscope to the target location like the Fujinon predicate, it shares key functional characteristics including balloon inflation pressure, extension of a balloon from the endoscope distal tip at a variable distance, and use of the balloons to stabilize the endoscope. The balloon diameter is also the same in the DiLumen and the NaviAID™ BGC; the balloons in the NaviAid™ BGE and Fujinon predicate are slightly smaller to accommodate use in the small intestine.
The DiLumen and its predicate and reference devices are prescription-use devices used by medical professionals in a healthcare facility. Each device is intended for single use only and should not be re-used. Performance testing has demonstrated that the DiLumen meets specifications and is as safe and effective as the cited predicates.
In sum, the minor technological differences between the DiLumen and its predicate and reference devices do not raise different types of safety or efficacy questions; as such, the DiLumen can be found substantially equivalent.
Performance Data:
The following performance data were provided in support of this Premarket Notification:
-
- Biocompatibility (cytotoxicity, sensitization, and systemic toxicity)
-
- Balloon Burst Pressure Test
-
- Balloon Diameter, Inflation/Deflation and Leakage Test
5
-
- Relief Valve Test
-
- Device Slip Relative to Scope Test
-
- Sleeve Buckling Test
-
- Fore Balloon Extension Test
-
- Colon Grip Test
-
- Articulation Test
-
- Sleeve Leak Test
-
- Therapeutic Zone Creation Test
-
- Fatigue/Cycling Test
-
- Extension Position Locking Test
-
- Flexibility Test
-
- Force/Bond Test
-
- Insertion Force Test
-
- Packaging and Transit Test
-
- User Validation
Conclusion:
From the data presented it is concluded that the subject device is substantially equivalent to the predicates based on intended use/indications for use and technological characteristics. The minor technological differences between the DiLumen and its predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrate that the DiLumen has substantially equivalent performance to the predicates.