(163 days)
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No
The document describes a mechanical and electrosurgical device with no mention of AI or ML capabilities. The technology described relates to materials, design features, and electrosurgical function.
Yes
The device is described as a "monopolar endoscopic scissors" used to "cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials" during endoscopic procedures. The term "cauterize tissue" specifically indicates a therapeutic action on tissue.
No
Explanation: The device is described as electrosurgical scissors designed to cut, dissect, and cauterize tissue, and cut sutures and non-metallic materials, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical, single-use electrosurgical scissors with specific dimensions and materials, designed to be used with a hardware electrosurgical generator. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Ensizor® Monopolar Endoscopic Scissors is a surgical tool designed to be used inside the body during flexible endoscopic procedures. Its function is to cut, dissect, and cauterize tissue, as well as cut sutures and non-metallic materials. It directly interacts with the patient's body.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or the generation of diagnostic information about a patient's health status.
The device is clearly an electrosurgical surgical instrument used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures.
Product codes
KGE, OCZ
Device Description
The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.
The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following nonclinical testing was performed in order to evaluate the substantial equivalence of the Ensizor® Monopolar Endoscopic Scissors to the predicate devices.
Test results for Ensizor Monopolar Endoscopic Scissors:
- Product Attribute Testing: All units passed
- Product Performance Testing: All units passed
- Sample Cutting:
- .008 In. thickness rubber (Dental Dam): All units passed
- .002 In. thickness LDPE Polyethylene Sheet: All units passed
- 2-0 Polydioxanone Suture: All units passed
- 3-0 Polydioxanone Suture: All units passed
- 2-0 Polypropylene Suture: All units passed
- 3-0 Polypropylene Suture: All units passed
- 2-0 Silk Sutures: All units passed
- 3-0 Silk Sutures: All units passed
- 2-0 Vicryl Sutures: All units passed
- 3-0 Vicryl Sutures: All units passed
- Raw chicken for the electrocautery functionality test (cut at least 10 times each sample material and 10 tissue cauterization tests): All units passed
- Insulation Test: All units passed
Test results for Apollo Endosurgery Endoscopic Monopolar Scissors:
- Product Attribute Testing: All units passed
- Product Performance Testing: All units passed
- Sample Cutting:
- .008 In. thickness rubber (Dental Dam): All units passed
- .002 In. thickness LDPE Polyethylene Sheet: All units passed
- 2-0 Polydioxanone Suture: All units passed
- 3-0 Polydioxanone Suture: All units passed
- 2-0 Polypropylene Suture: All units passed
- 3-0 Polypropylene Suture: All units passed
- 2-0 Silk Sutures: All units passed
- 3-0 Silk Sutures: All units passed
- 2-0 Vicryl Sutures: All units passed
- 3-0 Vicryl Sutures: All units passed
- Raw chicken for the electrocautery functionality test (cut at least 10 times each sample material and 10 tissue cauterization tests): All units passed
- Insulation Test: All units passed
Key results: Based on the non-clinical performance data performed comparing the Ensizor® Monopolar Endoscopic Scissors to the predicate devices, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate devices.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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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 & 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2018
Slater Endoscopy, LLC % Craig Pagan Consultant C2C Development, LLC 1135 W NASA Blvd. Suite 500 Melbourne, Florida 32901
Re: K180134
Trade/Device Name: Ensizor Monopolar Endoscopic Scissors Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE, OCZ Dated: Mav 30, 2018 Received: May 30, 2018
Dear Craig Pagan:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K180134
Device Name Ensizor® Monopolar Endoscopic Scissors
Indications for Use (Describe)
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures ..
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)
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510(k) Summary
Submitter's name, address, telephone number, a contact person and date (1) summary was prepared:
Slater Endoscopy, LLC 14000 NW 58 Court Miami Lakes, FL 33014 Telephone: (305) 889-3350 Contact: John Starkey, COO / VP Quality Assurance Jan 10, 2018
Name(s) of device: (2)
| Proprietary/Trade Name: | Ensizor® Monopolar Endoscopic Scissors |
|---|---|
| Common Name: | Forceps, Biopsy, Electric |
| Regulation Number: | 876.4300 |
| Regulation Name: | Endoscopic electrosurgical unit and accessories |
| Classification Panel: | Gastroenterology/Urology |
| Product Code: | KGE, OCZ |
| Regulatory Class: | II |
Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:
The Ensizor® Monopolar Endoscopic Scissors is substantially equivalent to the Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).
Description of device(s): (4)
Ensizor® Monopolar Endoscopic Scissors
- Cat # MES-26165 2.6 mm Monopolar Endoscopic Scissors x 165cm insertion length
- Cat # MES-26235 2.6 mm Monopolar Endoscopic Scissors x 235cm insertion ● length
The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.
The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic
4
scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.
Statement of intended use: (5)
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.
Comparison of Technological Characteristics to Predicate Device: (6)
The Ensizor® Monopolar Endoscopic Scissors have the same technological characteristics as the predicate devices as described below:
- Devices are designed to dissect, cut and cauterize tissue during endoscopic procedures.
- . Devices consist principally of an actuation handle and a flexible shaft body terminating in a pair of cutting Scissors.
- . Scissors function just like standard scissors for mechanical cutting. By operating the handle, the Scissors open and close.
(7) Performance Data:
The following nonclinical testing was performed in order to evaluate the substantial equivalence of the Ensizor® Monopolar Endoscopic Scissors to the predicate devices.
| | Test | Ensizor
Monopolar
Endoscopic
Scissors | Apollo
Endosurgery
Endoscopic
Monopolar
Scissors |
|-----------------------------------------------|------------------|------------------------------------------------|--------------------------------------------------------------|
| Product Attribute Testing | All units passed | All units passed | |
| Product Performance Testing | All units passed | All units passed | |
| Sample Cutting | | | |
| .008 In. thickness rubber (Dental Dam) | All units passed | All units passed | |
| .002 In. thickness LDPE Polyethylene
Sheet | All units passed | All units passed | |
| 2-0 Polydioxanone Suture | All units passed | All units passed | |
| 3-0 Polydioxanone Suture | All units passed | All units passed | |
| 2-0 Polypropylene Suture | All units passed | All units passed | |
Table 2 510(k) Summary - Testing Summary
5
| Test | Ensizor
Monopolar
Endoscopic
Scissors | Apollo
Endosurgery
Endoscopic
Monopolar
Scissors |
|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------------|
| 3-0 Polypropylene Suture | All units passed | All units passed |
| 2-0 Silk Sutures | All units passed | All units passed |
| 3-0 Silk Sutures | All units passed | All units passed |
| 2-0 Vicryl Sutures | All units passed | All units passed |
| 3-0 Vicryl Sutures | All units passed | All units passed |
| Raw chicken for the electrocautery
functionality test (cut at least 10 times each
sample material and 10 tissue cauterization
tests). | All units passed | All units passed |
| Insulation Test | All units passed | All units passed |
(8) Conclusions:
Based on the non-clinical performance data performed comparing the Ensizor® Monopolar Endoscopic Scissors to the predicate devices, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate devices.