(171 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality for grasping, cutting, and cauterizing tissue, with no mention of AI or ML.
Yes.
The device is intended to cut and cauterize soft tissue, which constitutes a therapeutic action.
No
This device is described as surgical instruments (graspers, dissectors, scissors) used to manipulate, cut, and cauterize soft tissue during endoscopic procedures, which indicates therapeutic rather than diagnostic use.
No
The device description clearly details physical components (shafts, handles, jaws, rods, RF post) made of materials like aluminum and stainless steel, and describes mechanical functions (grasping, manipulating, cutting, rotation) and electrical functions (cauterization). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic surgical procedures" to "grasp, manipulate, cut, and cauterize soft tissue." This describes a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The description details a surgical instrument with shafts, handles, jaws (graspers, dissectors, scissors), and an RF post for electrosurgery. These are all components of a surgical device used for physical manipulation and treatment of tissue in vivo.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Disposable Monopolar Laparoscopic Shafts and Reusable Handles are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Disposable Monopolar Laparoscopic Shafts 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, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod.
The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. 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
Soft tissue (implied)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was conducted to verify that the Disposable Monopolar Laparoscopic Shafts and Reusable Handles met all design specifications and are substantially equivalent to the predicate device. Testing included: Biocompatibility Testing (ISO 10993-1, -5, -7, -10, -11), Medical Electrical Equipment Safety Testing (ANSI AAMI ES60601-1, IEC 60601-2-2, IEC 60601-2-18), Aging Study, Autoclave Sterilization Validation, and Ethylene Oxide Sterilization Validation (ISO 11135:2014).
Performance studies designed to test visual/operational use, performance and electrical safety and effectiveness were also conducted.
Cut performance across different mediums using the predicate as a baseline was completed. Testing showed the Disposable Monopolar Laparoscopic Shafts and Reusable Handles devices performed equivalent to the predicate product in terms of instances of slipping, overall cut length across testing mediums, and scissor opening.
Electrical performance was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This involved testing on three different tissue types at minimum, default, and maximum generator power to simulate thermal spread. Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings compared to the predicate product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GENICON X-Surge laparoscopic instruments cleared under 510(k) K171752.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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August 16, 2021
DANNIK LLC Mrs. Olga Haberland President 941 West Morse Blvd.. Suite 100 Winter Park, Florida 32789
Re: K210569
Trade/Device Name: Disposable Monopolar Laparoscopic Shafts 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: August 11, 2021 Received: August 11, 2021
Dear Mrs. 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 a proval 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 in formation 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
1
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/cdrl-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) K210569
Device Name
Disposable Monopolar Laparoscopic Shafts and Reusable Handles
Indications for Use (Describe)
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
| 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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K210569 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 Shafts 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 Surgerv
3. PREDICATE DEVICE
The Disposable Monopolar Laparoscopic Shafts and Reusable Handles claim Substantial Equivalence to GENICON X-Surge laparoscopic instruments cleared under 510(k) K171752.
4. DEVICE DESCRIPTION
The Disposable Monopolar Laparoscopic Shafts 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, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.
The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod.
The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. 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 Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
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6. SUBSTANTIAL EQUIVALENCE TABLE
| Device | Disposable
Monopolar Laparoscopic Shafts and
Reusable Handles (510(k) K210569) | GENICON X-Surge (510(k) K171752) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Endoscopic surgical procedures. It is a family of instruments which
includes graspers, dissectors, and scissors, which are intended to be
used to grasp, manipulate, cut, and cauterize soft tissue. | Same |
| Product Picture | Disposable Shaft
Reusable Handle | Disposable Shaft
Reusable Handle |
| Design | The Disposable Monopolar Laparoscopic Shafts 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, aluminum 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
locking knob to the instrument jaws and is provided in working
diameters of 3 to 5 mm and lengths of 20 to 45 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. | GENICON X-Surge instrumentation line is composed of single use
sterile instruments (Reposable handle option available), made from
biocompatible plastic, aluminum and stainless steel. When combined
the working length is 20cm to 45cm. Current may be supplied by an
approved electrosurgical generator which provides the ability for the
coagulation of tissue when used with an appropriate ground
electrode. |
| Diameter | 3-5mm | Same |
| Length | 20-45 cm | Same |
| 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 |
| Prescription Use | Yes | Yes |
7. NONCLINICAL TESTS
Nonclinical testing has been conducted to verify that the Disposable Monopolar Laparoscopic Shafts 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 o irritation and skin sensitization (Recognition No. 2-174)
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for o systemic toxicity (Recognition No. 2-255)
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- 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 o 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)
- IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements o 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 Validation per ISO 11135:2014 Sterilization of health-care . products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] (Recognition No. 14-529)
In addition, The Disposable Monopolar Laparoscopic Shafts and Reusable Handles have been compared to the predicate device through various performance studies designed to test visual/operational use, performance and electrical safety and effectiveness.
Cut performance across different mediums using the predicate as a baseline was completed in order to compare any instances of slipping, overall cut length across testing mediums, and scissor opening. Testing showed the Disposable Monopolar Laparoscopic Shafts and Reusable Handles devices performed equivalent to the predicate product.
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.
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.