(49 days)
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
The DANNIK Disposable Monopolar Laparoscopic Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
The provided text describes a 510(k) premarket notification for a medical device, specifically the DANNIK Disposable Monopolar Laparoscopic Instrument.
However, the content does not include any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen for AI/ML-based medical devices or devices requiring extensive performance evaluations. The submission is a "Special 510(k) Summary" which indicates a modification to a previously cleared device (from 5mm to 3mm working diameter). This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and performance study from this document. The document explicitly states:
- "There were no clinical trials performed on these devices." (Page 5, Section 8. CLINICAL TESTS)
- "NONCLINICAL TESTS: Risk analysis was conducted to assess the impact of the change on the subject device using internal design control procedures. Assessments were completed for the risk associated with Electromagnetic Energy as related to the basic safety and essential performances as detailed in IEC 60601-1 and appropriate collateral and/or particular standards. Dimensional Analysis and verification of the shaft flexural strength was completed, which showed that the devices met the same requirements as the predicate device." (Page 4, Section 7. NONCLINICAL TESTS)
This indicates that the modifications were assessed through non-clinical testing (dimensional analysis, flexural strength, risk analysis related to electrosurgical safety) to demonstrate equivalence, and not through a study with acceptance criteria measuring specific performance metrics for diagnosis or treatment effectiveness in a clinical setting against a predefined ground truth.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available or specified in the document. The filing focuses on demonstrating that the new 3mm diameter version meets the same physical/electrical safety requirements as the 5mm predicate.
- Sample sized used for the test set and the data provenance: Not applicable in the context of a clinical study. The non-clinical tests involved dimensional analysis and verification of shaft flexural strength; samples would be drawn from manufacturing lots for these tests, but specific sample sizes are not detailed beyond "showed that the devices met the same requirements as the predicate device." No patient data or clinical data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established as no clinical trials or diagnostic performance studies were performed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic or assistive device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a manual surgical instrument.
- The type of ground truth used: Not applicable in a clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications and safety standards (e.g., IEC 60601-1 for electrosurgical devices) that the predicate device also met.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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June 9, 2020
DANNIK Olga Haberland Regulatory Compliance 941 W Morse Blvd. Suite 100 Winter Park, Florida 32789
Re: K201063
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: May 8, 2020 Received: May 12, 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.
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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
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Indications for Use
510(k) Number (if known) K201063
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 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) Summary
1. SUBMITTER'S CONTACT INFORMATION
DANNIK Address: 941 West Morse Blvd. Suite #100 Winter Park, FL 32789 Phone: (407) 745-1698 Name: Olga Haberland, Requlatory Compliance
2. DEVICE NAME
Trade Name – DANNIK Disposable Monopolar Laparoscopic Instruments Common Name - Disposable Monopolar Laparoscopic Instruments Regulation Number - 21 CFR 878.4400 Classification Name - Electrosurgical, Cutting & Coagulation Device and Accessories Product Code - GEI Device Classification - Class II Classification Panel - General and Plastic Surqery
3. SUBSTANTIALLY EQUIVALENT DEVICE
The DANNIK Disposable Monopolar Laparoscopic Instruments were originally cleared under 510(k) K193019, which claimed Substantial Equivalence to Ethicon Endopath Endoscopic Instruments cleared under 510(k) K984240.
4. DEVICE DESCRIPTION
The working diameter of these devices has been reduced from 5mm to 3mm, whereas the original submission only included a 5mm working diameter. Device package labeling was been updated with the new Order Codes and Device Sizes and IFU has been updated with below device description. No other changes have been made to the information on the labeling, including warnings, operating steps, etc. No other changes have been made to these devices to date since the original clearance.
| K193019 Cleared Product Codes | Additional Device Product Codes | ||
|---|---|---|---|
| Code | Description | Code | Description |
| DMP5910 | Disposable monopolar 5mm Scissor | DMP3910 | Disposable monopolar 3mm Scissor |
| DMP5920 | Disposable monopolar 5mm AutraumaticFenestrated Grasper | DMP3920 | Disposable monopolar 3mm AutraumaticFenestrated Grasper |
| DMP5905 | Disposable Monopolar 5mm CurvedMaryland Dissector | DMP3905 | Disposable Monopolar 3mm CurvedMaryland Dissector |
The DANNIK Disposable Monopolar Laparoscopic Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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Image /page/4/Picture/1 description: The image shows the logo for "DANNIK". The logo is blue with a purple line above the text. The text is in a bold, sans-serif font. The logo is simple and modern.
5. 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.
6. TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE COMPARED TO THE PREDICATE DEVICE
| Device | DANNIK Disposable MonopolarLaparoscopic Instruments with modifiedworking diameter (510(k) TBD) | DANNIK Disposable MonopolarLaparoscopic Instruments (K193019) |
|---|---|---|
| Intended Use | The DANNIK Disposable MonopolarLaparoscopic Instrument have applicationin a variety of minimally invasiveprocedures to facilitate grasping,mobilization, dissection and transection oftissue. | Same |
| Product Picture | Image: DANNIK Disposable Monopolar Laparoscopic Instruments with modified working diameter (510(k) TBD) | Image: DANNIK Disposable Monopolar Laparoscopic Instruments (K193019) |
| Design | The DANNIK Disposable MonopolarLaparoscopic Instruments are sterilesingle-use devices consisting of a handle,rotator knob and shaft. The handleactivates the instrument jaws and scissorblades. The rotator knob provides 360degrees of rotation for the instrument shaftand jaws. The shaft includes an externalinsulation that runs from the rotator knob tothe instrument jaws and is provided inworking diameters of 3 to 5 mm andlengths up to 33 cm. The handle includesan RF Post for electrosurgery whenattached to an approved electrosurgicalgenerator to provide coagulation of tissuewhen used with an appropriate ground(neutral) electrode. | The DANNIK Disposable MonopolarLaparoscopic Instruments are sterilesingle-use devices consisting of a handle,rotator knob and shaft. The handleactivates the instrument jaws and scissorblades. The rotator knob provides 360degrees of rotation for the instrument shaftand jaws. The shaft includes an externalinsulation that runs from the rotator knob tothe instrument jaws and is provided inworking diameter of 5 mm and lengths of33 cm. The handle includes an RF Post forelectrosurgery when attached to anapproved electrosurgical generator toprovide coagulation of tissue when usedwith an appropriate ground (neutral)electrode. |
| Diameter | 3 and 5mm | 5mm |
| Biocompatibility | No Change | Conforms to ISO 10993 |
| Sterilization | No Change | Sterilized using Ethylene Oxide for singlepatient use in accordance with ISO 11135to an SAL of 10^-6. |
| Prescription Use | Yes | Yes |
7. NONCLINICAL TESTS
Risk analysis was conducted to assess the impact of the change on the subject device using internal design control procedures. Assessments were completed for the risk associated with Electromagnetic Energy as related to the basic safety and essential performances as detailed in IEC 60601-1 and appropriate collateral and/or particular standards. Dimensional Analysis and verification of the shaft flexural strength was completed, which showed that the devices met the same requirements as the predicate device.
Details on ANNEX A
There was no impact the device sterilization, biocompatibility or packaging as included in the original submission.
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Image /page/5/Picture/0 description: The image shows the text 'K201063' in a simple, sans-serif font. The text is black and appears to be on a white background. The letters and numbers are evenly spaced and clearly legible.
Image /page/5/Picture/1 description: The image shows the logo for DANNIK. The logo consists of the word "DANNIK" in blue, with two curved lines above it. The top line is blue, and the bottom line is purple. The font is sans-serif and bold.
8. CLINICAL TESTS
There were no clinical trials performed on these devices.
9. 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.
§ 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.