Dannik Laparoscopic Suction Irrigation System

K192643 · Dannik · GCJ · Nov 19, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K192643
• Device Name: Dannik Laparoscopic Suction Irrigation System
• Applicant: Dannik
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

Device Story

DANNIK Laparoscopic Suction Irrigation System is a single-use, sterile, manual surgical instrument. It consists of a handpiece with two trumpet-style valves, a stainless steel probe, and PVC tubing lines. One line connects to an irrigation fluid supply, and the other connects to an external aspiration pump. During laparoscopic surgery, the surgeon operates the trumpet valves to manually control the delivery of irrigation fluid to the surgical site and the aspiration of blood and tissue debris. The device is used in an operating room setting by a surgeon. It provides a mechanical means for site clearance, improving visualization and surgical field management, which benefits the patient by facilitating the surgical procedure.

Clinical Evidence

No clinical data. Bench testing only, including verification of fluid flow rates and valve seal integrity.

Technological Characteristics

Handpiece: Polycarbonate; Probe: Medical grade stainless steel; Seals: Silicone; Tubing: PVC. Manual operation via trumpet-style valves. Single-use. Sterilization: Ethylene Oxide (ISO 11135-1). Biocompatibility: ISO 10993. No electrical components.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring delivery of sterile irrigation fluids and evacuation of blood and tissue debris from the surgical site.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Unimax Suction Irrigation Set (K103509)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 19, 2019

DANNIK Olga Haberland Regulatory Compliance 941 W Morse Blvd. Suite 100 Winter Park, Florida 32789

Re: K192643

Trade/Device Name: DANNIK Laparoscopic Suction Irrigation System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 11, 2019 Received: October 17, 2019

Dear Olga Haberland:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192643

Device Name

DANNIK Laparoscopic Suction Irrigation System

Indications for Use (Describe)

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the word "DANNIK" in blue, block letters. Above the word is a curved line, also in blue, with a thinner, curved line in purple inside of it. The logo is simple and modern, with the curved lines adding a touch of elegance.

K192643

# 510(k) / Summary

- 1. Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, Florida 32789 Phone: [phone] Olga Haberland, Regulatory Compliance September 15, 2019
- 2. Device Name
- Trade Name DANNIK Laparoscopic Suction Irrigation System ●
- Common Name: laparoscopic Suction Irrigation System ●
- Classification Name Endoscope and Accessories (21 CFR 876.1500, . Product Code GCJ)
- 3. Substantially Equivalent Device
- · Legally Marketed (unmodified Devices): The Unimax Suction Irrigation Set FDA 510K (K103509)
- 4. Device Description

The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site.

The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

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Image /page/4/Picture/0 description: The image shows the logo for "DANNIK". The logo is in blue and has a curved line above the text. The curved line is also blue, but has a purple line inside of it.

K192643

This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.

- 5. Intended Use
The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site.

- 6. Technological Characteristics of the Subject Device Compared to the Predicate Device

| AREA | DANNIK<br>K192643 | Unimax<br>K103509 |
|------------------|---------------------------------------|------------------------------------------------------------------|
| Intended Use | Laparoscopic Surgery | Same |
| Handpiece Design | Trumpet Valve Assembly | Same |
| Probe Length | 33cm (330mm) | Same<br>Unimax also<br>offers<br>additional<br>probe<br>lengths. |
| Materials | Probes: Medical Grade Stainless Steel | Unknown |
| | Handpiece: Poly Carbonate | Unknown |
| | Seals: Silicone | Unknown |
| | | 008_ |

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K192643

Image /page/5/Picture/1 description: The image shows the word "DANNIK" in blue, block letters. Above the word is a curved line that is blue on the outside and purple on the inside. The word is in all caps and is the main focus of the image. The background is white.

www.dannik.us

| | Tubing: PVC | Unknown |
|------------------------|------------------------------------------------------------------|---------|
| Performance<br>Testing | There are no US FDA performance standards<br>for these products. | Same |
| Sterilization | Ethelene Oxide<br>I.S.O. 11135-1 | Unknown |
| Prescription Only | Yes | Same |
| Biocompatibility | Conforms to ISO 10993 | Unknown |

Dannik will NOT be offering electrical probes as offered by the predicate device.

There are no new technologies being added to this device from the predicate, in terms of finished device functions. The device has the same intended use and application as the predicate device.

## 7. Non-Clinical Tests

The DANNIK Laparoscopic Suction Irrigation System has been evaluated by our Design Engineer, through performance studies and bench testing which included determining and verifying appropriate fluid flow rates and valve seal integrity. Testing showed that the devices met the same requirements as the predicate device.

- 8. Clinical Tests
There were no clinical trials performed on the DANNIK Laparoscopic Suction Irrigation System

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www.dannik.us

Image /page/6/Picture/1 description: The image shows the logo for "DANNIK" in blue font. Above the text is a curved line, also in blue, with a smaller curved line in purple underneath it. The logo is simple and modern, with a clean font and color scheme.

K192643

- 9. Conclusions
The subject device has equivalent indications for use as the predicate device. The technological characteristics, non-clinical testing and performance and bench testing of the DANNIK Laparoscopic Suction Irrigation Device show that the device is as safe, as effective, and meets the same performance standard. Therefore, the proposed DANNIK Laparoscopic Suction Irrigation Device is substantially equivalent to the predicate.