(180 days)
No
The summary describes a mechanical endoscope accessory with inflatable balloons and a mounting system. There is no mention of image processing, AI, ML, or any software-driven analytical capabilities. The performance studies focus on mechanical and material properties.
Yes.
The device is intended to assist with "diagnosis" and "endoscopic treatment".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "assist with optical visualization, diagnosis, and endoscopic treatment."
No
The device description clearly outlines physical components (sleeve with balloons, Tool Mount) and performance studies focus on physical properties and functionality, not software.
Based on the provided information, the Lumendi DiLumen C2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to assist with positioning, visualization, diagnosis, and endoscopic treatment within the large intestine. This involves direct interaction with the patient's body and assisting with procedures performed in vivo.
- Device Description: The device is an accessory that fits over an endoscope and uses inflatable balloons to facilitate positioning and stabilization during surgical procedures. It comes into contact with breached or compromised surfaces of the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
The Lumendi DiLumen C2 is an endoscopic accessory used to facilitate procedures performed directly on the patient. This falls under the category of medical devices used for diagnosis and treatment in vivo, not in vitro.
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 (comma separated list FDA assigned to the subject device)
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 comes into limited (
§ 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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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,
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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)
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)
| 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:
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 (