(46 days)
No
The device description focuses on mechanical components (balloons, sleeve, push rods, inflation handle) and their manual operation. There is no mention of automated analysis, decision-making, or learning from data, which are characteristic of AI/ML. The performance studies rely on previous clearances and bench testing of mechanical additions.
Yes.
The device is indicated for assisting with "endoscopic treatment" and helps create a "therapeutic zone," explicitly mentioning its role in therapy.
Yes
The text explicitly states that the device assists with "diagnosis" and creates an "isolated diagnostic or therapeutic zone."
No
The device description clearly details physical components such as a sleeve, balloons, extension push rods, an inflation handle with a squeeze bulb, and suture loops. These are hardware components, not software.
Based on the provided information, the Lumendi DiLumen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) 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 function is to assist with positioning, stabilization, visualization, tissue manipulation, and endoscopic treatment in vivo. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its purpose is to assist with navigation, visualization, diagnosis, tissue manipulation, and treatment during an endoscopic procedure. While it assists with optical visualization and diagnosis, this is done directly within the body, not by analyzing a sample.
Therefore, the Lumendi DiLumen falls under the category of a surgical or endoscopic accessory device, not an IVD.
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. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.
Product codes
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 and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is 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 them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area. This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical visualization
Anatomical Site
large intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was conducted to assess the performance and impact of the suture loops added to the Fore Balloon. Reliability is established by previous clearance of a nearly identical device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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October 30, 2018
Lumendi, LLC % John J. Smith, M.D., J.D. Partner Hogan Lovells U.S. LLP 555 13th Street, NW Washington, DC 20004
Re: K182540
Trade/Device Name: DiLumen Endolumenal Interventional Platform Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: September 14, 2018 Received: September 14, 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 mav, 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 avare 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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Cooper -S 2018.10.30 15:07:39 -04'00'" is displayed. The text appears to be a signature or timestamp, possibly indicating the date and time of creation or modification of a document or image.
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) K182540
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. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intesting with optical visualization, diagnosis, tissue manipulation, 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 Senior Director, Regulatory Affairs and Quality Assurance Telephone: (203) 557-6335 Fax: (203) 557-0459 Email: Dennis.Daniels@Lumendi.com
Date Prepared: September 14, 2018
Device Identification:
Trade Name: DiLumen Endolumenal Interventional Platform Common Name: Endoscope Accessory Device Class: II Device Panel: Gastroenterology/Urology Classification Regulation / Product Code: 21 C.F.R. § 876.1500 Endoscope and Accessories; FDF
Predicate/Reference Devices:
- ORISE Tissue Retractor System (K173400) (predicate device) ●
- DiLumen Endolumenal Interventional Platform (K162428) (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. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment.
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 and DiLumen are navigated to the target zone with the balloons deflated. At the area of interest, the Aft Balloon, which is attached to the DiLumen sleeve, is 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
4
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 them (independently) with ambient air as they assist in stabilizing the endoscope and the therapeutic area.
This 510(k) notice encompasses a minor revision to the device's indications statement to specify that it can be used for tissue manipulation, as well as addition of suture loops to the Fore Balloon skirt to facilitate that functionality. The DiLumen is designed to permit the usage of any standard endoscopic tool through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) are unaffected by the presence of the DiLumen, including the sleeve, balloons, and suture loops.
Substantial Equivalence:
The subject and predicate devices are both intended to physically manipulate/retract tissue as needed in order to facilitate visualization and diagnosis/treatment in the gastrointestinal tract. The minor differences in the subject device's indications either represent a narrower use as compared to the predicate (e.q., reference to the large intestine as opposed to the qastrointestinal tract) or have been previously cleared in the prior version of the DiLumen (K162428, reference device), and do not alter the device's diagnostic/therapeutic effects. Both devices are intended for single use only.
The DiLumen design is similar to that of the ORISE™ System. While the predicate deploys retractor arms rather than using push rods to extend balloons, the two mechanisms both create a more stable platform in the GI tract and facilitate visualization. The devices also operate similarly to achieve tissue manipulation/retraction. Both tools allow the creation of an isolated therapeutic zone, or working chamber, within which tissue can be better visualized, maneyvered, retracted, or dissected in support of endolumenal procedures. Moreover, the subject device's design is nearly identical to that of the reference device which FDA has already reviewed and cleared, with minor design modifications as compared to the prior version performed under design controls and either verified through bench testing or supported by a rationale that additional testing was not required.
Performance Data:
Because the subject Dilumen is essentially identical in design to the previously cleared DiLumen Endolumenal Interventional Platform, the testing submitted in that 510(k) notice is relied upon to establish the device's biocompatibility and functional and mechanical performance. In addition, the company has conducted bench testing to assess the performance and impact of the suture loops added to the Fore Balloon.
Conclusion:
In sum, the subject device has the same intended use and similar indications for use, technological characteristics, and principles of operation to the predicate device. The minor differences between the devices do not raise different types of safety or effectiveness questions, and are further supported by the subject device's being nearly identical in design and indications to the reference device (the previously cleared DiLumen). Moreover, the data presented/referenced in this submission support that the subject device performs to its pre-defined specifications and is at least as safe and effective as the predicate and reference devices. As such, the subject DiLumen Endolumenal Interventional Platform can be found substantially equivalent.