(267 days)
No
The 510(k) summary describes a mechanical and electrical device for endoscopic procedures, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
Explanation: The device is used for cutting, marking, and cauterizing tissue, as well as inducing saline to lift lesions, which are all therapeutic interventions aimed at treating or mitigating a disease or condition within the digestive tract.
No
The DiLumen Endolumenal Interventional Knife is described as a monopolar electrosurgical device used for marking, cutting, and cauterizing tissue, and for injecting saline to lift mucosal lesions. These are interventional and therapeutic functions, not diagnostic ones.
No
The device description clearly outlines a physical, disposable electrosurgical instrument with a handle, shaft, knife tip, and connectors for an electrosurgical unit and syringe. The performance studies also focus on hardware-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The DiLumen Endolumenal Interventional Knife is a surgical tool used within the digestive tract to directly interact with tissue (marking, cutting, cauterizing, and injecting saline). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a surgical procedure performed inside the body, not a diagnostic test on a sample.
Therefore, the DiLumen Endolumenal Interventional Knife is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DiLumen Endolumenal Interventional Knife ("DiLumen IKTM") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.
Product codes
GEI
Device Description
The DiLumen Ik is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.
The DiLumen In can also be used in conjunction with other endoscopic devices such as graspers to perform endolumenal interventions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
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)
Performance testing has demonstrated that the DiLumen Ik meets specifications and is as safe and effective as the predicate device. The following non-clinical performance data were provided in support of this 510(k) notice:
- Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
- End Effector Articulation Test
- Leakage Test
- Bleb Formation Test
- Internal Pressurization Test
- Shaft and Handle Rotation Accuracy Test
- Electrical Continuity Test
- Electrical Safety Test
- Electromagnetic Compatibility Test
- Packaging and Transit Evaluation
- Design Validation
- Human Factors/Usability 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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
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August 2, 2019
Lumendi, LLC John J. Smith, M.D., Ph.D. Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
Re: K183112
Trade/Device Name: DiLumen Endolumenal Interventional Knife ("DiLumen IK") Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2019 Received: July 3, 2019
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.
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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.
for Martha Betz, Ph.D. Acting Assistant Division 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
510(k) Number (if known) K183112
Device Name
DiLumen Endolumenal Interventional Knife ("DiLumen IKTM")
Indications for Use (Describe)
The DiLumen Endolumenal Interventional Knife ("DiLumen |ç") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.
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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3
510(k) SUMMARY
Lumendi, LLC's DiLumen Endolumenal Interventional Knife (DiLumen Ik™)
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: August 1, 2019
Device Identification:
Trade Name: DiLumen Endolumenal Interventional Knife ("DiLumen II,")
Common Name: Electrosurqical cutting & coagulation device
Classification Regulation: 21 C.F.R. § 878.4400, Electrosurgical cutting and coagulation device and accessories
Product Code: GEI
Device Class: II
Predicate Device: Lumendi DiLumen Endolumenal Interventional Scissors ("DiLumen I (") (K173405)
Reference Device: Olympus Medical Systems Corporation Single Use Electrosurgical Knife (K171158)
Device Description:
The DiLumen Ix is a sterile, single patient use, disposable electrosurgical instrument. The DiLumen ly utilizes a pistol style handle, flexible shaft with an articulating section at its distal end, and a stainless-steel knife tip that can be extended and retracted. The handle incorporates controls that allow the clinician to rotate the shaft, extend or retract the knife tip, articulate the distal end of the shaft in a specific plane, and lock the articulation in a fixed position. The DiLumen Ik has a plug at the bottom of the handle that is used to connect the device to an electrosurgical unit. When connected to the generator, and used in combination with grounding pads, high-frequency current can be applied through the knife tip to mark, cut or cauterize tissue at the lesion site. There is also a female luer lock connector on the handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing the knife tip or to inject saline into the submucosa to lift lesions.
4
The DiLumen In can also be used in conjunction with other endoscopic devices such as graspers to perform endolumenal interventions.
Intended Use / Indications for Use:
The DiLumen Endolumenal Knife ("DiLumen Ik") is a disposable monopolar electrosurgical device intended to be used for marking, cutting, and cauterizing tissue within the digestive tract during endoscopic procedures. This device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization.
Summary of Technological Characteristics:
The technological principle underlying both the subject and predicate devices is monopolar electrosurgical marking, cutting, dissection, and cauterization of tissue. Both devices are based on the following same technological elements:
- . Both are sterile, single use, monopolar instruments that allow for one-handed clinician operation.
- . Both share key functional characteristics, including the control handle, a flexible shaft with the same diameter, an articulating tip, and stainless-steel end effector.
- Each device can be connected to an electrosurgical generator using a dedicated cable plugged into the handle, in order to make use of monopolar electrical current to facilitate marking, cutting and cauterization.
- . Both are prescription-use devices employed by medical professionals in a healthcare facility.
The primary technological difference between the subject and predicate devices is that the proposed device can be used to inject saline into the submucosa, thus forming a bleb that will lift a lesion for enhanced visibility and to allow endoscopic removal. This added feature does not raise different questions of safety or effectiveness, because FDA has cleared other endoscopic devices that have the same functionality such as the reference device, Olympus Medical Systems Corporation's Single Use Electrosurgical Knife (K171158).
The two devices also have slightly different end effector designs and associated operation, but this difference does not raise different questions of safety or effectiveness as both have the same fundamental mechanism of action, and the previously cleared predicate can serve as a knife when used with the blades closed. In addition, the cleared reference device has a very similar end effector design as the DiLumen IK.
The table below compares the key features of the subject device to the predicate and reference devices.
| | Lumendi DiLumen
Endolumenal
Interventional Knife (IK) | Lumendi DiLumen
Endolumenal
Interventional Scissor (IS) | Olympus Single Use
Electrosurgical Knife |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Reference Device |
| 510(k) | TBD | K173405 | K171158 |
| Intended
Use /
Indications | The DiLumen Endolumenal
Interventional Knife
("DiLumen IKTM") is a | The DiLumen Endolumenal
Interventional Scissors
("DiLumen IS") is a | These instruments have
been designed to be used
with Olympus endoscopes |
| | Lumendi DiLumen
Endolumenal
Interventional Knife (IK) | Lumendi DiLumen
Endolumenal
Interventional Scissor (Is) | Olympus Single Use
Electrosurgical Knife |
| for Use | disposable monopolar
electrosurgical device
intended to be used for
marking, cutting, dissecting,
and cauterizing tissue within
the digestive tract during
endoscopic procedures. The
device is also indicated for
the induction of sterile
normal saline into the
submucosa to lift mucosal
lesions under direct
endoscopic visualization. | disposable monopolar
electrosurgical device
intended to be used for
cutting, dissecting, and
cauterizing tissue within the
digestive tract during
endoscopic procedures. | and electrosurgical units to
cut tissue within the
digestive tract using high-
frequency current. These
instruments are indicated for
the induction of sterile
normal saline into the
submucosa to lift lesions
using direct visualization
through an endoscope. |
| Sterility | Sterile - EO | Sterile - EO | Sterile - EO |
| Shelf Life | One year | One year | Unknown |
| Single
use/reusable | Single Use, fully disposable | Single Use, fully disposable | Single Use, fully disposable |
| Basic
Design | Proximal handle with
controls, flexible shaft,
articulating section,
retractable / extendable
knife tip;
Flush tube inside shaft | Proximal handle with
controls, flexible insulated
shaft, articulating section
and rotating scissor tip | Proximal handle with
controls, flexible shaft,
retractable / extendable
knife tip;
Flush tube inside shaft |
| Patient-
Contacting
Materials | Stainless steel (knife tip),
medical-grade polymers | Stainless steel (blades),
medical-grade polymers | Stainless steel (knife tip),
medical-grade polymers |
| End Effector | Shaft with ball tip (knob-
shape) | Scissor Blades | Shaft with ball tip (knob-
shape) |
| Electrical
connector | Banana plug at bottom of
handle | Banana plug at bottom of
handle | Banana plug in handle |
| Type of
working
channel | Channel external to
endoscope | Channel external to
endoscope | Endoscope's working
channel |
| Compatible
diameter of
channel | 6 mm | 6 mm | 2.8 mm to 6.0 mm |
| Shaft length | 95 cm, 140 cm | 95 cm, 140 cm | 195 cm, 230 cm |
| Syringe port | Luer lock in handle | None | Luer lock in handle |
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Performance Data:
Performance testing has demonstrated that the DiLumen Ik meets specifications and is as safe and effective as the predicate device. The following non-clinical performance data were provided in support of this 510(k) notice:
-
- Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
-
- End Effector Articulation Test
-
- Leakage Test
6
-
- Bleb Formation Test
-
- Internal Pressurization Test
-
- Shaft and Handle Rotation Accuracy Test
-
- Electrical Continuity Test
-
- Electrical Safety Test
-
- Electromagnetic Compatibility Test
-
- Packaging and Transit Evaluation
-
- Design Validation
-
- Human Factors/Usability Testing
In all instances, the device functioned as intended and the results observed were as expected.
Conclusion:
The Dilumen Ik device has the same intended use and similar indications, technological characteristics, and principles of operation as the identified predicate and reference devices. The minor differences in end effector and saline flush capabilities between the DiLumen Ik and its predicate device do not raise any new questions of safety of effectiveness, and the performance data presented in the 510(k) notice further support that the DiLumen Ik functions as safely and performs as well as the identified predicate. Thus, the DiLumen Ik is substantially equivalent to the predicate Lumendi DiLumenal Interventional Scissors ("DiLumen I.") (K173405).