(133 days)
No
The device description and performance studies focus on mechanical aspects and physical properties, with no mention of AI/ML capabilities or data processing.
No
The device is an endoscope accessory intended for positioning, stabilization, visualization, diagnosis, and assisting with endoscopic treatment, but it does not directly provide therapy itself.
No
The device is an endoscope accessory intended to assist with visualization and treatment, but the "Intended Use / Indications for Use" section explicitly states it is for "optical visualization, diagnosis, and endoscopic treatment" as an accessory, not a standalone diagnostic device. The "Device Description" also focuses on its mechanical function of facilitating endoscope positioning and stabilization.
No
The device description clearly outlines physical components (sleeve with inflatable balloons, tool mount) and performance testing related to these physical components (balloon integrity, insertion force, deflection). There is no mention of software as a component or its function.
Based on the provided information, the Lumendi DiLumen C² is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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." This describes a device used during a medical procedure to aid in visualization and manipulation, not a device used to test a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical accessory that fits over an endoscope with inflatable balloons. This is consistent with a mechanical aid for positioning and stabilization during an endoscopic procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics. The performance studies focus on mechanical and functional aspects of the device's operation within the body.
Therefore, the Lumendi DiLumen C² is a medical device used in vivo (within the body) during an endoscopic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FDF
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 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is 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 surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.
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
clinicians
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)
Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope. The following performance data were provided in support of this 510(k) notice:
-
- Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
-
- Fore and Aft Balloon Diameter
-
- Therapeutic Zone Creation
-
- Balloon/Endoscope Centering
-
- Endoscope Insertion Force
-
- Instrument Insertion and Removal Force
-
- Tool Channel Deflection
-
- User Verification Testing
In all instances, the device functioned as intended and the results observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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October 22, 2021
Lumendi, LLC % John Smith Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
Re: K211819
Trade/Device Name: DiLumen C2 and Tool Mount Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: September 17, 2021 Received: September 17, 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 and Part 809 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/23/2023 See PRA Statement below
510(k) Number (if known) K211819
Device Name
DiLumen C2 and Tool Mount
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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3
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: June 11, 2021
Device Identification:
| Trade Name: | DiLumen C² and Tool Mount |
|---|---|
| Common Name: | Endoscope Accessory |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
| Regulation / Product Code: | 21 C.F.R. § 876.1500; FDF |
Predicate/Reference Devices:
- Lumendi, LLC's DiLumen C2 (K173317) (predicate device) .
- Lumendi, LLC's DiLumen Endolumenal Interventional Platform (K210851) (reference device)
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.
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 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is 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 surqical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling.
4
Technical Characteristics / Substantial Equivalence:
The subject device is identical to the predicate device except for minor technological differences. These include provision of the device in two shorter lengths, instead of the original 168 cm length; addition and removal of certain secondary components to further facilitate use of the device by clinicians without altering the clinical workflow; modifying certain dimensions and features of other components (again, without altering how the device is used); the endoscope insertion tube seal type; lengthening the Tool Flange to accommodate changes in a 510(k)-exempt accessory used with the device; and adding a hydrophilic coating to the inner lumen of the Sleeve. None of the changes alter the device's intended use/indications for use, principles of operation, or ability to meet key performance specifications as previously cleared by FDA. As such, they do not raise different questions of safety or effectiveness.
| | Subject Device:
Lumendi DiLumen
C² and Tool Mount | Predicate Device :
Lumendi DiLumen C²
and Tool Mount
(K173317) | Reference Device :
Lumendi DiLumen
Endolumenal Interventional
Platform (K210851) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 C.F.R. 876.1500, Product Code FDF | | |
| Common Name | Endoscope Accessory | | |
| Intended Use /
Indications for
Use | 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. | 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. | The Lumendi DiLumen is an
accessory to an endoscope. The
DiLumen dual balloon accessory
is intended for use with any
endoscope that has an outer
diameter of 12.5 - 14.3 mm and a
minimum working length of 1680
mm. The device is indicated to
ensure complete positioning of an
endoscope in the large intestine,
and assist with optical
visualization, diagnosis, and
endoscopic treatment. |
| Sterility | Non-sterile | Sterile EO | Non-sterile |
| Single
use/reusable | Single Use | Single Use | Single Use |
| Balloons | Low durometer
Polyurethane | Low durometer
Polyurethane | Low durometer Polyurethane |
| Sleeve | Extruded polyurethane
with main lumen having
a hydrophilic coating. | Extruded polyurethane | Extruded polyurethane with main
lumen having a hydrophilic
coating. |
| Tool Channel
Tubing | FEP; Pellethane;
stainless steel internal
coil | FEP; Pellethane;
stainless steel internal
coil | NA |
| Fore and Aft
Balloon Outer
Diameter | 60 mm | 60 mm | 60 mm |
| Fore Balloon
Inner Diameter | 17.6 mm | 28.5 mm | 17.6 mm |
| Balloon
Pressure | $45 ± 12 mmHg$ | $45 ± 12 mmHg$ | $45 ± 12 mmHg$ |
| Relief Pressure | 55 mmHg | 55 mmHg | 55 mmHg |
| Working Length | 130 cm and 103 cm | 168 cm | 130 cm and 103 cm |
| | Subject Device:
Lumendi DiLumen
C2 and Tool Mount | Predicate Device :
Lumendi DiLumen C2
and Tool Mount
(K173317) | Reference Device :
Lumendi DiLumen
Endolumenal Interventional
Platform (K210851) |
| Inflation Source | Manual inflation bulb | Manual inflation bulb | Manual inflation bulb |
| Shelf Life | 24 months | 12 months | 24 months |
| Accessories | A designated Tool Mount (DiLumen Tool Mount
model D-4000) that is intended to mount to a
surgical table rail and hold the DiLumen C2 tool
channels during endoscopic treatment. The Tool
Mount is made of stainless steel and is provided
non-sterile. | A designated Tool Mount (DiLumen Tool Mount
model D-4000) that is intended to mount to a
surgical table rail and hold the DiLumen C2 tool
channels during endoscopic treatment. The Tool
Mount is made of stainless steel and is provided
non-sterile. | Can be used with various
additional endoscope
accessories but is not supplied
with any designated
accessories. |
5
Performance Data:
Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope. The following performance data were provided in support of this 510(k) notice:
-
- Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
-
- Fore and Aft Balloon Diameter
-
- Therapeutic Zone Creation
-
- Balloon/Endoscope Centering
-
- Endoscope Insertion Force
-
- Instrument Insertion and Removal Force
-
- Tool Channel Deflection
-
- User Verification Testing
In all instances, the device functioned as intended and the results observed were as expected.
Conclusion:
In sum, the subject device has the same intended use/indications for use and principles of operation, and very similar technological characteristics, as 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 similarities in technology to the reference device. 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 C° and Tool Mount can be found substantially equivalent to the predicate DiLumen C2 and Tool Mount.