DiLumen Endolumenal Interventional Scissors (DiLumen Is)

• K Number: K173405
• Device Name: DiLumen Endolumenal Interventional Scissors (DiLumen Is)
• Manufacturer: Lumendi, LLC
• Date Cleared: 2018-05-22 ( 203 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Device Description

The DiLumen I , is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure. In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically. The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

Predicate Devices

K061425

Reference Devices

K152771

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrosurgical functions, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is used to cut and cauterize tissue within the digestive tract, which directly treats a medical condition or performs a medical procedure.

Diagnostic

No

The device is described as an electrosurgical tool for cutting, dissecting, and cauterizing tissue, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical, disposable instrument with a handle, flexible shaft, articulating section, and scissor blades. It also mentions connection to an electrosurgical generator for applying electrical current, indicating a hardware component. The performance studies listed also focus on physical and electrical characteristics of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

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 about a person's health. This testing is done outside the body (in vitro).
• DiLumen Is Function: The DiLumen Is is a surgical tool used within the digestive tract (in vivo) for cutting and cauterizing tissue during endoscopic procedures. It directly interacts with tissue inside the body.

The intended use and device description clearly indicate that the DiLumen Is is a surgical instrument for performing procedures on the patient, not for testing samples from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Product codes

GEI

Device Description

The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure. In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically. The DiLumen Is can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. 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; gastrointestinal tissue; gastrointestinal 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 Is meets specifications and is as safe and effective as the predicate. The following performance data were provided in support of this Premarket Notification:

• 1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
• 2. Dissection Force Test
• 3. Tip Articulation Accuracy Test
• 4. Tip Rotation Accuracy Test
• 5. Shaft Rotation Accuracy Test
• 6. Cutting Durability Test
• 7. Monopolar Cable Insertion and Removal Force Test
• 8. Electrical Safety Test
• 9. Electromagnetic Compatibility Test
• 10. Usability Evaluation
• 11. Packaging and Transit Test
• 12. User Validation
• 13. EO Residuals
      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)

K061425

Reference Device(s)

K152771

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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May 22, 2018

Lumendi, LLC % John J. Smith, MD, JD Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004

Re: K173405

Trade/Device Name: DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: April 6, 2018 Received: April 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce M. Whang -S

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) K173405

Device Name

DiLumen Endolumenal Interventional Scissors ("DiLumen IsTM")

Indications for Use (Describe)

The DiLumen Endolumenal Interventional Scissors ("DiLumen Is™") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

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 Scissors (DiLumen I、™)

Submitter's Information:

LUMENDI, LLC 253 Post Road West Westport, CT 06880 Phone: [phone] Fax: [phone]

Contact Person:

Dennis J. Daniels Senior Director, Requlatory Affairs and Quality Assurance Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: October 31, 2017

Device Identification:

Trade Name: Dilumen Endolumenal Interventional Scissors (DiLumen III) Common Name: Electrosurgical cutting & coagulation device Classification Regulation: 21 C.F.R. § 878.4400, Electrosurgical cutting & coagulation device and accessories Product Code: GEI Device Class: II

Predicate Device: Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments (K061425)

Reference Device: Sumitomo Bakelite Co., Ltd. SB Knife (K152771)

Device Description:

The DiLumen I , is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. This allows the clinician maximum flexibility to cut, dissect and cauterize tissue during endoscopic interventions in the digestive tract. The clinician can insert the DiLumen Is into any endoscopic tool channel with a diameter of at least 6mm. With the DiLumen Is under direct visualization, the clinician can position the scissor blades as appropriate for the particular procedure using blade rotation, blade articulation, and shaft rotation as necessary. The clinician can then cut gastrointestinal tissue either with or without energizing the blades, depending on the specific need during the procedure.

In addition, the DiLumen Is has a plug at the bottom of the handle. If desired by the clinician, this plug can be used to connect the device to an electrosurgical generator via a dedicated cord in order

4

to apply monopolar electrical current through the blades to the target site in the gastrointestinal tract. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically.

The DiLumen I , can also be used in conjunction with other endoscopic devices such as graspers, knives, etc. to perform endolumenal interventions.

Intended Use / Indications for Use:

The DiLumen Endolumenal Interventional Scissors ("DiLumen I,") is a disposable monopolar electrosurgical device intended to be used for cutting, and cauterizing tissue within the digestive tract during endoscopic procedures.

Summary of Technological Characteristics:

The technological principle underlying both the subject and predicate devices is manual and/or monopolar electrosurgical cutting, dissection, and cauterization of tissue. Both devices are based on the following same technological elements:

• . Both are sterile, single use, monopolar scissors that allow for one-handed clinician operation.
• . Both share key functional characteristics, including the control handle, an insulated working shaft with the same diameter, an articulating tip, and two curved rotating stainless-steel blades.
• . 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 or enhance the scissors' functioning.
• . 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 predicate's working shaft is rigid and shorter than that of the DiLumen Is. This does not raise different questions of safety or effectiveness, because the greater flexibility and length of the DiLumen Is working shaft simply makes it easier for the device to follow the path inside a flexible tool channel within the gastrointestinal tract; it does not alter the device's principles of operation or the purposes for which it is used. Furthermore, FDA has cleared other endoscopic cutting devices with longer flexible shafts, such as the reference device, Sumitomo Bakelite's SB Knife (K152771). The DiLumen Is also has one feature that is not found in the predicate: a tethered Blades Lock attached to the bottom of the handle that can be inserted between the body of the handle to keep the trigger squeezed and the blades closed. However, this addition is for user convenience; the predicate's blades could also be kept closed by the clinician.

| | Lumendi DiLumen Endolumenal
Interventional Scissors (Iₛ) | Cambridge Endoscopic Devices, Inc.
pureWrist™ electrocautery
laparoscopic Instruments |
|---------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) | TBD | K061425 |
| Intended Use /
Indications for Use | The DiLumen Endolumenal
Interventional Scissors ("DiLumen Iₛ") | The pureWrist™ electrocautery
laparoscopic Instruments have |
| | is a disposable monopolar | application in a variety of minimally |
| | electrosurgical device intended to be | invasive procedures to facilitate grasping, |
| | used for cutting, dissecting, and | mobilization, dissection and transection of |

The table below compares the key features of the subject and predicate devices.

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| | Lumendi DiLumen Endolumenal
Interventional Scissors (Is) | Cambridge Endoscopic Devices, Inc.
pureWrist™ electrocautery
laparoscopic Instruments |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | cauterizing tissue within the digestive
tract during endoscopic procedures. | tissue. |
| Sterility | Sterile - EO | Sterile - Radiation |
| Shelf Life | One year | Two years |
| Single use/reusable | Single Use, fully disposable | Single Use, fully disposable |
| Basic Design | Proximal handle with controls, flexible
insulated shaft, articulating section
and rotating scissor tip | Proximal handle with controls, rigid
insulated shaft, articulating section and
rotating scissor tip |
| Patient-Contacting
Materials | Stainless steel (jaws), medical-grade
polymers: Pebax with embedded
Aramid braid (flexible shaft),
Fluoropolymer (Articulation sleeve) | Stainless steel (jaws); FEP, PEEK,
Pebax, Tecoflex, Cyanoacrylate, PET |
| Electrical connector | Banana plug at bottom of handle | Banana plug at bottom of handle |
| Cautery Type | Monopolar cautery | Monopolar cautery |
| Shaft Outer diameter | 5 mm | 5 mm |
| Shaft length | 95 cm, 140 cm | 15 - 45 cm |
| Operating principle | The DiLumen Is are operated
manually using one hand to control
blade position and blade actuation.
The end effector can be rotated,
articulated and positioned, allowing
the scissor blades to cut, dissect, and
cauterize tissue either with or without
monopolar energy | The pureWrist™ electrocautery
laparoscopic Instruments are operated
manually using one hand to control blade
position and blade actuation. The end
effector can be rotated, articulated and
positioned, allowing the scissor blades to
cut, dissect, and cauterize tissue with or
without monopolar energy. |

Performance Data:

Performance testing has demonstrated that the DiLumen Is meets specifications and is as safe and effective as the predicate. The following performance data were provided in support of this Premarket Notification:

• 1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
• 2. Dissection Force Test
• 3. Tip Articulation Accuracy Test
• 4. Tip Rotation Accuracy Test
• 5. Shaft Rotation Accuracy Test
• 6. Cutting Durability Test
• 7. Monopolar Cable Insertion and Removal Force Test
• 8. Electrical Safety Test
• 9. Electromagnetic Compatibility Test
• 10. Usability Evaluation
• 11. Packaging and Transit Test
• 12. User Validation
• 13. EO Residuals

In all instances, the device functioned as intended and the results observed were as expected.

Conclusion:

The DiLumen Is device has the same intended use and similar indications, technological

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characteristics, and principles of operation as the identified predicate. The minor technological differences between the DiLumen I, and its predicate device do not raise any new questions of safety of effectiveness. Furthermore, the performance data presented in the 510(k) notice further support that the DiLumen I functions as safely and performs as well as the identified predicate. Thus, the DiLumen I , is substantially equivalent to the predicate pureWrist™ electrocautery laparoscopic instruments (K061425).