(127 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML.
No
The device is described as a surgical instrument for grasping, mobilization, dissection, and transection of tissue, with an RF post for electrosurgery, indicating it is used for surgical procedures rather than therapeutic treatment.
No
Explanation: The device is described as a surgical instrument for tissue manipulation (grasping, mobilization, dissection, transection) and electrosurgery (coagulation), not for identifying or investigating the nature or cause of a disease or condition.
No
The device description explicitly details physical components made of ABS thermoplastic, stainless steel, and polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "grasping, mobilization, dissection and transection of tissue" during minimally invasive procedures. This describes a surgical instrument used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details a surgical instrument with components like a handle, rotator knob, shaft, and RF post for electrosurgery. These are all characteristic of surgical tools, not diagnostic devices that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the DANNIK Disposable Monopolar Laparoscopic Instrument is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
Product codes
GEI
Device Description
The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.
This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-Clinical Tests: DANNIK Disposable Monopolar Laparoscopic Instrument has been evaluated by Design Engineers, through performance and functionality evaluations that include Thermal effects on Tissue Connection strength, clamping performance , cable connection, open and close performance, Hardness , corrosion resistance and outward.
Clinical Tests: No Clinical trials performed on the DANNIK Disposable Monopolar Laparoscopic Instrument
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2020
DANNIK Olga Haberland Regulatory Compliance 941 W Morse Blvd., Suite 100 Winter Park, Florida 32789
Re: K193019
Trade/Device Name: DANNIK Disposable Monopolar Laparoscopic Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 18, 2020 Received: February 24, 2020
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.
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 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.
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
2
Indications for Use
510(k) Number (if known) K193019
Device Name
DANNIK Disposable Monopolar Laparoscopic Instrument
Indications for Use (Describe)
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
| 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) |
| X 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
- Contact Information DANNIK 941 West Morse Blvd. Suite #100 Winter Park, Florida 32789 Phone: (407) 745-1698 Olga Haberland, Regulatory Compliance January 30, 2020
-
- Device Name
- Trade Name DANNIK Disposable Monopolar Laparoscopic . Instrument
- Common Name: Disposable Monopolar Laparoscopic Instrument .
- Classification Name : Electrosurgical, Cutting & Coagulation Device . and Accessories
- Classification: Class II General and Plastic Surgery Devices GEI, 21 . CFR878.4400
Performance Standards: Devices are manufactured according to Good Manufacturing Practices (G.M.P.), Association for Advancement of Medical Instrumentation (A.AM.I.) and American Society for Testing and Materials (A.S.T.M.) requirements and applicable Harmonized Standards ISO 13485.
-
- Substantially Equivalent Device
- Legally Marketed (unmodified Devices): .
- Ethicon Endo-Surgery Endopath Endoscopic Instrument FDA 510K . (K984240)
005 1
4
K193019
-
- Device Description
The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.
- Device Description
This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
Biocompatibility Conforms to ISO 10993 Prescription Only Yes Sterilized by ETO ( Ethelyn Oxide )
-
- Intended Use
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
- Intended Use
-
- Technological Characteristics of the Subject Device Compared to the Predicate Device
Comparison of Technological Characteristics: DANNIK Disposable Monopolar Laparoscopic Instrument is substantially equivalent to the predicate device.
- Technological Characteristics of the Subject Device Compared to 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.
5
| Device | Dannik Disposable Monopolar
Laparoscopic Instrument | Ethicon Endo-Surgery Endopath
Endoscopic Instrument FDA 510K
(K984240) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The DANNIK Disposable
Monopolar Laparoscopic
Instrument have application in a
variety of minimally invasive
procedures to facilitate grasping,
mobilization, dissection and
transection of tissue. | Same |
| Product Picture | Image: Dannik Disposable Monopolar Laparoscopic Instrument | Image: Ethicon Endo-Surgery Endopath Endoscopic Instrument |
| Device Description | The DANNIK Disposable Monopolar
Laparoscopic Instrument consists of
Handle which activates the
instruments jaws and scissor blades,
Rotator knob that provides 360
degrees rotation to shaft; both
handle and rotation knob are made
of ABS thermoplastic, and a Shaft
5mm in diameter with a working
length of 33cm made from Medical
grade Stainless Steel and insulated
with high-density polyethylene PE.
5mm in diameter with a working
length of 33cm. RF Post for
electrosurgery when attached to an
approved electrosurgical generator
to provide coagulation of tissue
when used with appropriate ground
electrode. | Same/Equivalent
"The Instruments have a rotating
insulated shaft with a diameter of
3mm, 5mm or 10mm. The Rotation
knob located on the handle rotates
the shaft 260 degrees in either
direction. The ring handles are
compressed and released to activate
the instrument jaws or scissor
blades. Each of the curved scissors
and dissectors has a monopolar
cautery connector that extends
from the top of the handle. The
connector is used for electrosurgery
when properly attached to a
standard cautery cable and proper
generator |
| Classification | Class II General and Plastic Surgery
Devices GEI, 21 CFR878.4400 | Same |
| Diameter | 5mm x 33cm | Same ( also offers additional diameters) |
| Materials | Non-Patient Contact:
• ABS Thermoplastic-
Patient Contact:
• Stainless Steel
• PE (Polyethylene) | Unknown |
| Sterilization | Ethylene Oxide ( ETO)
I.S.O 11135-1 | Unknown |
| Prescription Only | Yes | Yes |
| Biocompatibility | Conforms to ISO 10993 | Unknown |
| | | |
6
7. Non-Clinical Tests
DANNIK Disposable Monopolar Laparoscopic Instrument has been evaluated by Design Engineers, through performance and functionality evaluations that include Thermal effects on Tissue Connection strength, clamping performance , cable connection, open and close performance, Hardness , corrosion resistance and outward.
-
- Clinical Tests
No Clinical trials performed on the DANNIK Disposable Monopolar Laparoscopic Instrument
- Clinical Tests
-
- Conclusions
The subject device has equivalent indications for use as 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.
- Conclusions