(30 days)
Not Found
No
The device description focuses on mechanical components (balloons, sleeve, push rods, inflation handle) and their function in stabilizing the endoscope and manipulating tissue. There is no mention of any computational processing, algorithms, or learning capabilities. The performance studies are limited to mechanical and biocompatibility testing.
Yes
The device is intended to assist with tissue manipulation and endoscopic treatment, which are therapeutic actions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended to assist with "diagnosis." The "Device Description" also mentions creating an "isolated diagnostic / therapeutic zone."
No
The device description clearly outlines physical components like a sleeve, balloons, extension push rods, an inflation handle with a squeeze bulb, and suture loops. It is a hardware accessory for an endoscope.
Based on the provided information, the Lumendi DiLumen is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic 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, diagnosis, tissue manipulation, and endoscopic treatment in situ.
- Stabilize the endoscope and create an isolated diagnostic/therapeutic zone.
- No Specimen Analysis: The description does not mention the device being used to analyze any biological specimens removed from the body. It facilitates procedures performed directly within the patient.
Therefore, the Lumendi DiLumen is an in vivo device, 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. 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 tissue 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 intestine tissue, and in combination with the Aft Balloon, creates an isolated diagnostic / 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. The Suture Loops attached to the Fore Balloon of the DiLumen allow clinicians to manipulate tissue when used with an endoscopic clip.
The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflation, etc.) are unaffected by the presence of the DiLumen is designed to permit the usage of any standard tool through the endoscope working channel.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing to support this 510(k) notice is limited to the device's biocompatibility, functional and mechanical performance. The following evaluations and tests were performed on the subject (modified) DiLumen:
- Design Verification and Validation; including pull force and push force testing;
- Clinical User Validation Testing;
- Biocompatibility testing per ISO 10993-1:2009. 10993-7, 10993-10, 10993-11 and USP 42-NF37:2019, .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 21, 2021
Lumendi, LLC % John Smith Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
Re: K210851
Trade/Device Name: DiLumen Endolumenal Interventional Platform ("DiLumen") Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: March 22, 2021 Received: March 22, 2021
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.
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
1
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 (OS) 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 mediation-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,
Shanil P. Haugen, Ph.D. Assistant 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
2
Indications for Use
510(k) Number (if known)
Device Name
DiLumen Endolumenal Interventional Platform ("DiLumen")
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Lumendi'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, Requlatory Affairs and Quality Assurance Telephone: (203) 557-6335 Fax: (203) 557-0459 Email: Dennis.Daniels@Lumendi.com
Date Prepared: March 22, 2021
Device Identification:
| Trade Name: | DiLumen Endolumenal Interventional Platform ("DiLumen") |
|---|---|
| Common Name: | Endoscope and Accessories |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
| Regulation / Product Code: | 21 C.F.R. § 876.1500; FDF |
Predicate Device:
- 0 Lumendi. LLC's DiLumen Endolumenal Interventional Platform (K182540)
Purpose of the Special 510(k) Notice:
The subject device incorporates minor technological modifications to the DiLumen cleared under K182540; the indications for use remain the same.
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.
This intended use / indications for use statement is identical to that of the predicate device.
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,
4
which is attached to the DiLumen sleeve, is inflated until it contacts the tissue 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 intestine tissue, and in combination with the Aft Balloon, creates an isolated diagnostic / 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. The Suture Loops attached to the Fore Balloon of the DiLumen allow clinicians to manipulate tissue when used with an endoscopic clip.
The endoscope flexibility, maneuverability and functionalities (such as visualization, suction, insufflation, etc.) are unaffected by the presence of the DiLumen is designed to permit the usage of any standard tool through the endoscope working channel.
Technological Characteristics / Substantial Equivalence:
The subject device is identical to the predicate device with the exception of three minor modifications:
-
- The main lumen of the DiLumen Sleeve now has a hydrophilic coating to provide lubricity without using additional lubricants;
-
- JA Flush Port has been added to the DiLumen Base Handle so that sterile water or saline can - at the clinician's discretion - be introduced into the Sleeve to clear debris that may collect inside it, as well as to hydrate the hydrophilic coating; and
-
- The Suture Loops on the DiLumen Fore Balloon are now made from 2-0 monofilament nylon suture rather than 2-0 monofilament polypropylene suture, and the loops are now supplied in two different colors and sizes (diameters).
These added and/or modified components were initiated primarily as user conveniences to make the Dilumen easier to use and do not change the device's intended use, principles of operation, or ability to meet performance specifications as previously cleared by FDA. As such, they do not raise different questions of safety or effectiveness.
Performance Data:
Because the subject DiLumen is nearly identical in design to the previously cleared DiLumen Endolumenal Interventional Platform (K182540), the bench testing to support this 510(k) notice is limited to the device's biocompatibility, functional and mechanical performance, which are parameters that could theoretically (but were confirmed not to be) affected by the changes. The following evaluations and tests were performed on the subject (modified) DiLumen:
- · Design Verification and Validation; including pull force and push force testing;
- · Clinical User Validation Testing:
- · Biocompatibility testing per ISO 10993-1:2009. 10993-7, 10993-10, 10993-11 and USP 42-NF37:2019, .
Conclusion:
In sum, the subject device has the same intended use and indications for use as well as the same principles of operation, and very similar technological characteristics, as the predicate device. The minor material and component differences between the devices do not raise different types of safety or effectiveness questions. Moreover, the data presented and referenced in this submission support that the subject device performs to its pre-defined specifications and is as safe and effective as the predicate. As such, the subject DiLumen Endolumenal Interventional Platform can be found substantially equivalent.