(99 days)
Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.
The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
The provided text is a 510(k) Summary for the Slater Endoscopy Ensizor Endoscopic Scissors, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with all the specific elements requested for acceptance criteria and device performance evaluation.
Therefore, much of the requested information, particularly regarding the methodology of a detailed clinical or comparative effectiveness study (like MRMC studies, details on ground truth establishment for large datasets, or specific expert qualifications for adjudication), is not present in this type of regulatory submission. The document primarily details non-clinical bench testing.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated as capability of predicate device or "All units passed") | Reported Device Performance (Ensizor™ Endoscopic Scissors) |
|---|---|
| Operation in Tortuosity: Device shall open and close when the distal shaft is formed into an approximately 20 cm or 8-inch diameter circle. | Baseline: All units passed |
| Operation in Tortuosity: (Predicate device performance: "Unit had difficulty opening and closing in the tortuous configuration") | Post 1 year Accelerated Aging: All units passed |
| Operation in Tortuosity: (Predicate device performance: "Unit had difficulty opening and closing in the tortuous configuration") | Post 1 Transportation & Distribution Testing: All units passed |
| Sample Cutting (LDPE Polyethylene Sheet): Each device shall cut at least 10 times. | Baseline: All units Passed |
| Sample Cutting (LDPE Polyethylene Sheet): (Predicate device performance: "Passed") | Post 1 year Accelerated Aging: All units Passed |
| Sample Cutting (LDPE Polyethylene Sheet): (Predicate device performance: "Passed") | Post 1 Transportation & Distribution Testing: All units Passed |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set (Ensizor™ Endoscopic Scissors):
- 15 units of 235 cm length
- 15 units of 165 cm length
- Sample Size for Predicate Device (Apollo Endosurgery Endoscopic Monopolar Scissors):
- 1 unit of 235 cm length
- Data Provenance: The data appears to be from in-house bench testing conducted by the manufacturer, Slater Endoscopy, LLC. The document does not specify country of origin for the data or if it's retrospective/prospective, but given it's a 510(k) submission for a new device, it's inherently prospective testing for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical bench testing, not a study requiring expert-established ground truth. The "ground truth" here is the objective performance of cutting and operation in tortuosity as measured by the testing protocols.
4. Adjudication method for the test set
Not applicable. There was no clinical study involving human assessment or adjudication described. The tests were objective performance evaluations.
5. 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 document is for a mechanical surgical device (endoscopic scissors), not an AI/imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device. The "standalone" performance here refers to the device's mechanical function, which was indeed tested independently.
7. The type of ground truth used
For the non-clinical testing described, the "ground truth" was established by the objective physical performance criteria for cutting and operation in tortuosity (e.g., successful cutting of LDPE sheet 10 times, successful opening and closing in a tortuous path).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Slater Endoscopy, LLC % Craig Pagan Regulatory Consultant C2C Development, LLC 1135 W NASA Blvd., Suite 500 Melbourne, FL 32901
Re: K141058
Trade/Device Name: Slater Endoscopy Ensizor Endoscopic Scissors Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ Dated: June 23, 2014 Received: June 25, 2014
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.
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
| 510(k) Number (if known) | |
|---|---|
| -------------------------- | -- |
K141058
Device Name
Slater Endoscopy Ensizor Endoscopic Scissors
Indications for Use (Describe)
Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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 Ct. Miami Lakes, FL 33014 Telephone: (305) 889-3350 Contact: Charles Slater July 17, 2014
Name(s) of device: (2)
| Proprietary/Trade Name: | Ensizor™ Endoscopic Scissors |
|---|---|
| Common Name: | Endoscope and/or Accessories |
| Classification Name: | Endoscope and Accessories (21 CFR 876.1500) |
| Classification Panel: | Gastroenterology/Urology |
| Product Code: | OCZ |
| Regulatory Class: | II |
Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:
The Ensizor"14 Endoscopic Scissor is substantially equivalent to the Apollo Endosurgery Endoscopic Scissors (K090583).
Description of device(s): (4)
Ensizor™ Endoscopic Scissor
- Cat # ES-26165 2.6 mm Endoscopic Scissors x 165cm working length ●
- Cat # ES-26235 2.6 mm Endoscopic Scissors x 235cm working length ●
The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
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Statement of intended use: (5)
Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.
Comparison of Technological Characteristics to Predicate Device: (6)
The Ensizor™ Endoscopic Scissors have the same technological characteristics as the predicate devices as described below:
- devices are designed to cut and dissect tissue during endoscopic procedures ●
- . devices consists 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. . Bv operating the handle, the Scissors open and close.
Differences:
The main difference between the Ensizor™ Endoscopic Scissor and the predicate device - Apollo Endosurgery Endoscopic Scissor (K090583) is that the Ensizor™ Endoscopic Scissors do not have an electrocautery function.
(7) Performance Data:
The following nonclinical testing was performed in order to evaluate the substantial equivalence of the Ensizor™ Scissors to the predicate devices:
-
Operation in Tortuosity each device shall open and close with the distal ● shaft of the device is formed into approximately a 20 cm or 8 in diameter circle.
This test simulated operation of the device in a flexible endoscope. The results of the tests shows that the Ensizor™ Endoscopic Scissor is substantially equivalent to the predicate devices tested as they actuated as good as or better than the predicate devices in a tortuous path. -
Sample Cutting Each device shall cut at least 10 times each of the ● following sample material:
- o LDPE Polyethylene Sheet
The sample cutting test simulated the functionality of the Ensizor™ Endoscopic Scissor in cutting material. The results of the tests shows that the Ensizor "10 Endoscopic Scissor is substantially equivalent to the predicate devices tested as they cut the materials tested as good as or better than the predicate devices.
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| EnsizorTMEndoscopicScissorsBaseline | EnsizorTMEndoscopicScissorsPost 1 yearAcceleratedAging | EnsizorTMEndoscopicScissorsPost 1Transportation& DistributionTesting | ApolloEndosurgeryEndoscopicMonopolarScissors | |
|---|---|---|---|---|
| Test | EnsizorTMEndoscopicScissorsBaseline | EnsizorTMEndoscopicScissorsPost 1 yearAcceleratedAging | EnsizorTMEndoscopicScissorsPost 1Transportation& DistributionTesting | ApolloEndosurgeryEndoscopicMonopolarScissors |
| Sample Size | 15 – 235 cm15 – 165 cm | 15 – 235 cm15 – 165 cm | 15 – 235 cm15 – 165 cm | 1 – 235 cm |
| Operation inTortuosity | All unitspassed | All unitspassed | All unitspassed | Unit haddifficultyopening andclosing in thetortuousconfiguration |
| Sample CuttingLDPEPolyethyleneSheet | All unitsPassed | All unitsPassed | All unitsPassed | Passed |
Table 3 510(k) Summary - Testing Summary
Conclusions: (8)
Based on the non-clinical performance data performed comparing the Ensizor™ Endoscopic Scissors to the predicate device, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.