(206 days)
Not Found
No
The summary describes a purely mechanical and electrical surgical instrument with no mention of AI/ML capabilities, data processing, or algorithms.
Yes
The device is designed to cut, dissect, manipulate, and cauterize various tissues during surgical procedures, which are therapeutic actions.
No
Explanation: The device is described as surgical instruments (graspers, dissectors, forceps, scissors) designed to cut, dissect, manipulate, and/or cauterize tissues. These are interventional functions, not diagnostic ones. Performance studies mentioned focus on mechanical and thermal effects on tissue, not on identifying a medical condition or disease.
No
The device description clearly outlines physical hardware components (disposable tips, reusable handles, shaft, insulation, RF post) and describes their physical functions (cutting, dissecting, manipulating, cauterizing, grasping, rotating, connecting to a generator). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device Function: The description clearly states that this device is used during surgical procedures to cut, dissect, manipulate, and cauterize tissues within the body. It is a surgical instrument used for direct intervention on the patient.
The intended use and device description focus entirely on surgical manipulation and electrosurgery performed directly on the patient's tissues, not on analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
Product codes
GEI
Device Description
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.
The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Nonclinical testing has been conducted to verify that the Disposable Monopolar Laparoscopic Tips and Reusable Handles met all design specifications and are substantially equivalent to the predicate device. Testing included the following:
- Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization (Recognition No. 2-174)
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity (Recognition No. 2-255)
- Medical Electrical Equipment Safety Testing performed in accordance with the following:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (Recognition No. 19-4)
- ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition No. 19-8)
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Recognition No. 6-389)
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (Recognition No. 9-114)
- Aging Study
- Autoclave Sterilization Validation
- Ethylene Oxide Sterilization per ISO 11135:2014 Sterilization of health-care products - Ethylene Oxide (Recognition No. 14-529)
In addition, The Disposable Monopolar Laparoscopic Tips and Reusable Handles have been compared to the predicate device through various performance studies designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy and thermal effects on tissue.
Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings.
Key results:
Thermal Damage on Kidney Tissue:
Power Level: 30W, Thermal Damage Width (X ±SD, mm): 0.42 ±0.26, Thermal Damage Depth (X ±SD, mm): 3.05 ±2.10
Power Level: 50W, Thermal Damage Width (X ±SD, mm): 0.28 ±0.30, Thermal Damage Depth (X ±SD, mm): 2.69 ±0.47
Power Level: 90W, Thermal Damage Width (X ±SD, mm): 0.47 ±0.36, Thermal Damage Depth (X ±SD, mm): 4.43 ±1.42
Thermal Damage on Muscle Tissue:
Power Level: 30W, Thermal Damage Width (X ±SD, mm): 1.28 ±0.58, Thermal Damage Depth (X ±SD, mm): 2.62 ±0.20
Power Level: 50W, Thermal Damage Width (X ±SD, mm): 1.51 ±0.65, Thermal Damage Depth (X ±SD, mm): 3.26 ±0.32
Power Level: 90W, Thermal Damage Width (X ±SD, mm): 1.20 ±0.85, Thermal Damage Depth (X ±SD, mm): 2.82 ±0.37
No clinical trials were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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October 28, 2021
DANNIK Olga Haberland Regulatory Compliance 941 W. Morse Blvd. Suite #100 Winter Park, Florida 32789
Re: K211019
Trade/Device Name: Disposable Monopolar Laparoscopic Tips and Reusable Handles Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 27, 2021 Received: October 1, 2021
Dear Olga Haberland:
We have reviewed vour 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
1
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
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Indications for Use
510(k) Number (if known) K211019
Device Name
Disposable Monopolar Laparoscopic Tips and Reusable Handles
Indications for Use (Describe)
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K211019 510(k) Summary
1. SUBMITTER'S CONTACT INFORMATION
Company: DANNIK Address: 941 West Morse Blvd. Suite #100 Winter Park, FL 32789 Contact Person: Mrs. Olga Haberland, President & Requlatory Compliance Phone: (407) 927-1743
2. DEVICE NAME
Trade Name – Disposable Monopolar Laparoscopic Tips and Reusable Handles Common Name - Monopolar Laparoscopic Instruments Regulation Number - 21 CFR 878.4400 Classification Name - Electrosurgical, Cutting & Coaqulation Device and Accessories Product Code - GEI Device Classification - Class II Classification Panel - General and Plastic Surgery
3. PREDICATE DEVICE
The Disposable Monopolar Laparoscopic Tips and Reusable Handles claim Substantial Equivalence to Hunan Handlike Minimally Invasive Surgery Co. Endoscopic Surgical Instruments cleared under 510(k) K171825.
4. DEVICE DESCRIPTION
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.
The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. 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.
5. INDICATIONS FOR USE
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut. dissect, manipulate and/or cauterize various tissues during endoscopic, general surgical procedures.
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6. SUBSTANTIAL EQUIVALENCE TABLE
| Device | Disposable Monopolar Laparoscopic Tips and
Reusable Handles (510(k) TBD) | Hunan Handlike Minimally Invasive Surgery Co.
Endoscopic Surgical Instruments (510(k) K171825) |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Disposable Monopolar Laparoscopic Tips and Reusable Handles
are intended to cut, dissect, manipulate and/or cauterize various
tissues during endoscopic/laparoscopic, general surgical procedures. | Same |
| Product Picture | Image: Disposable tip and reusable handle & shaft | Image: Disposable tip and reusable handle & shaft |
| Design | The Disposable Monopolar Laparoscopic Tips and Reusable Handles
are sterile single use monopolar attachments intended for use in
combination with the Reusable Handle. These devices are made from
biocompatible plastic and stainless steel. The handle activates the
instrument jaws and scissor blades. The rotation knob provides 360
degrees of rotation for the instrument shaft and jaws. The shaft
includes an external insulation that runs from the rotation knob to the
instrument jaws and is provided in working diameters of 5 mm and
length of 34 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. | Endoscopic Surgical Instruments Tip-Detachable Type: Disposable
tip and reusable shaft/handle can be disassembled but shaft cannot
be disassembled from handle. Handles have ratchet and non-ratchet.
Tips have 14 different models available. This product is monopolar
high frequency electrode as the applied part to be used with a
matching HF surgical generator with peak output voltage 3800V and
frequency 0.3MHz-2MHz and neutral electrode. |
| Diameter | 5 mm | Same |
| Length | 34 cm | Same |
| Power Settings | Maximum Peak Voltage = 3800 Vp | Maximum Peak Voltage = 3800 Vp |
| | Operating Frequency = 300 to 2000 kHz | Operating Frequency = 300 to 2000 kHz |
| | Operating Current = 0.8 Arms | Operating Current = 0.8 Arms |
| Biocompatibility | Conforms to ISO 10993 | Same |
| Sterilization | Sterilized using Ethylene Oxide for single patient use
in accordance with ISO 11135 to an SAL of 10^-6. | Ethylene Oxide |
| Electrical Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-18
IEC 60601-2-2 | Same |
| Prescription Use | Yes | Yes |
7. NONCLINICAL TESTS
Nonclinical testing has been conducted to verify that the Disposable Monopolar Laparoscopic Tips and Reusable Handles met all design specifications and are substantially equivalent to the predicate device. Testing included the following:
- . Biocompatibility Testing performed in accordance with the following:
- ISO 10993-1: 2018 Biological evaluation of medical devices -Part 1: Evaluation and O testing within a risk management process (Recognition No. 2-258)
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity (Recognition No. 2-245)
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide o sterilization residuals (Recognition No. 14-408)
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for о irritation and skin sensitization (Recognition No. 2-174)
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Image /page/5/Picture/1 description: The image shows the logo for "DANNIK". The logo is in blue, with a purple swoosh above the text. The text is in a bold, sans-serif font. The logo is simple and modern.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for o systemic toxicity (Recognition No. 2-255)
- Medical Electrical Equipment Safety Testing performed in accordance with the following:
- o ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (Recognition No. 19-4)
- ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (Recognition No. 19-8)
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements о for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (Recognition No. 6-389)
- IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular o requirements for the basic safety and essential performance of endoscopic equipment (Recognition No. 9-114)
- Aging Study ●
- Autoclave Sterilization Validation ●
- Ethylene Oxide Sterilization per ISO 11135:2014 Sterilization of health-care . products - Ethylene Oxide (Recognition No. 14-529)
In addition, The Disposable Monopolar Laparoscopic Tips and Reusable Handles have been compared to the predicate device through various performance studies designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy and thermal effects on tissue.
Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings. Summary results are shown below.
| Power Level | Thermal Damage Width
( $$\overline{X}$$ ±SD, mm) | Thermal Damage Depth
( $$\overline{X}$$ ±SD, mm) |
|-------------|-----------------------------------------------------|-----------------------------------------------------|
| 30W | 0.42 ±0.26 | 3.05 ±2.10 |
| 50W | 0.28 ±0.30 | 2.69 ±0.47 |
| 90W | 0.47 ±0.36 | 4.43 ±1.42 |
Table 1 – Thermal Damage on Kidney Tissue
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| Power Level | Thermal Damage Width
(X ±SD, mm) | Thermal Damage Depth
(X ±SD, mm) |
|-------------|-------------------------------------|-------------------------------------|
| 30W | 1.28 ±0.58 | 2.62 ±0.20 |
| 50W | 1.51 ±0.65 | 3.26 ±0.32 |
| 90W | 1.20 ±0.85 | 2.82 ±0.37 |
Table 3 – Thermal Damage on Muscle Tissue
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.