(62 days)
No
The device description and performance studies focus on mechanical cutting and dissection, with no mention of AI or ML.
No.
The device is described as surgical scissors used to cut and dissect tissue and sutures, which are tools used during a procedure, not for treating a condition itself.
No
This device is designed for cutting and dissecting tissue and sutures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a sterile, single-use, non-electrocautery device consisting of an actuation handle, flexible shaft, and cutting scissors. This describes a physical, mechanical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and dissect tissue and sutures during all flexible endoscopic procedures." This describes a surgical or procedural tool used within the body, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details a mechanical device with a handle, flexible shaft, and cutting scissors. This aligns with a surgical instrument, not an IVD which typically involves reagents, analyzers, or other components for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical cutting and dissection during a procedure.
N/A
Intended Use / Indications for Use
Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and sutures during all flexible endoscopic procedures
Product codes (comma separated list FDA assigned to the subject device)
OCZ
Device Description
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 and the cutting of sutures 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 and suture materials during all 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
- 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 materials:
- LDPE Polyethylene Sheet
- Polypropylene Suture
- Vicryl Suture
- Polydiaxonone Suture
- Silk Sutures
All units met the requirement of cutting each material at least 10 times.
Comparative Testing – US Endoscopy Suture Cutter (Ref K133736 test results)
- Functional Testing the ability of the jaws to the US Endoscopy Endoscpic Suture Cutter Device to open and close repetitively. After operation in a straight configuration the endoscope was reconfigured into a tortuous pathway and functional testing repeated. All units met the acceptance criteria of being able to open and close in straight and tortuous conditions to perform the simulation of cutting and removing sutures from the human body.
- Simulation testing the ability of the US Endoscopy Endoscopic Suture Cutter Device to function under simulated real use conditions to grasp and cut.
- o 0, 3-0 Vicryl
- 0 0, 3-0 Prolene
- o 0, 3-0 Silk
All units met the acceptance criteria of being able to effectively cut, grasp and remove suture.
| Criteria | EnsizorTM Endoscopic Scissors | US Endoscopy Endoscopic Suture Cutter Device |
|---|---|---|
| Operation in Tortuosity | Pass | Pass |
| Suture Cutting | Pass | Pass |
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.
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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a graphic representation of a human figure, with three profiles layered on top of each other to create a sense of depth and dimension.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2015
Slater Endoscopy, LLC % Craig Pagan Consultant C2C Development, LLC 1135 W Nasa Blvd, Suite 500 Melbourne, FL 32901
Re: K150939
Trade/Device Name: Ensizor Endoscopic Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCZ Dated: March 25, 2015 Received: April 7, 2015
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 801); medical device reporting (reporting of medical device
1
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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold, sans-serif font. The text is black and appears to be the main subject of the image. The background is plain and does not distract from the text.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Slater Endoscopy Ensizor™ Endoscopic Scissors
Indications for Use (Describe)
Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and sutures 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: John Starkey, Chief Operating Officer and Vice President Quality Assurance Mar 25, 2015
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 |
(3) Legally Marked Predicate Device to which the submitter claims substantial equivalence:
The Ensizor" Endoscopic Scissor is substantially equivalent to the Ensizor™ Endoscopic Scissor (K141058) and the US Endoscopy Suture Cutter Device (K133736).
(4) Description of device(s):
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 and the cutting of sutures 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 and suture materials during all 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.
4
Statement of intended use: (5)
Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.
Comparison of Technological Characteristics to Predicate Device: (6)
The Ensizor 110 Endoscopic Scissors have the same technological characteristics as the predicate devices as described below:
Comparison to K141058 – Ensizor™ Endoscopic Scissors
- The device design, materials, manufacturing, packaging and sterilization is 0 exactly the same as the Ensizor™ Endoscopic Scissors cleared under 510(k) K141058.
- The intended use / patient population of both devices is the same - for use with an endoscope
- Device 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. 0 Bv operating the handle, the Scissors open and close.
- The main difference between the Ensizor™ Endoscopic Scissor and the 0 predicate Ensizor™ Endoscopic Scissor is the addition to the indication for use of cutting sutures.
Comparison to K133736 - US Endoscopy Suture Cutter Device
- The intended use / patient population of both devices is the same for use with ● an endoscope.
- Both devices consists principally of an actuation handle and a flexible shaft 0 body terminating in a pair of cutting Scissors or jaws.
- The Suture Cutter device has jaws that can grasp and cut while the Ensizor™ ● Endoscopic scissor blades can only cut.
The intended use of cutting sutures is the same. Safety and effectiveness are not affected.
Performance Data: (7)
Ensizor™ Endoscopic Scissor - K141069
The following nonclinical testing was performed as part of the original Ensizor™ Endoscopic Scissor 510(k) submission.
- 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.
5
- Sample Cutting Each device shall cut at least 10 times each of the following ● sample materials:
- LDPE Polyethylene Sheet O
- Polypropylene Suture ೧
- Vicryl Suture 0
- O Polydiaxonone Suture
- Silk Sutures O
All units met the requirement of cutting each material at least 10 times.
Comparative Testing – US Endoscopy Suture Cutter (Ref K133736 test results)
-
Functional Testing the ability of the jaws to the US Endoscopy Endoscpic . Suture Cutter Device to open and close repetitively. After operation in a straight configuration the endoscope was reconfigured into a tortuous pathway and functional testing repeated.
All units met the acceptance criteria of being able to open and close in straight and tortuous conditions to perform the simulation of cutting and removing sutures from the human body. -
Simulation testing the ability of the US Endoscopy Endoscopic Suture Cutter ● Device to function under simulated real use conditions to grasp and cut.
- o 0, 3-0 Vicryl
- 0 0, 3-0 Prolene
- o 0, 3-0 Silk
All units met the acceptance criteria of being able to effectively cut, grasp and remove suture.
| Criteria | EnsizorTM
Endoscopic
Scissors | US Endoscopy
Endoscopic Suture
Cutter Device |
|----------------------------|-------------------------------------|----------------------------------------------------|
| Operation in
Tortuosity | Pass | Pass |
| Suture Cutting | Pass | Pass |
510(k) Summary - Testing Summary
Conclusions: (8)
Based on the non-clinical performance data performed comparing Ensizor™ Endoscopic Scissors to the predicate device, it is concluded that the data supports the safety of the device and the hardware verification demonstrate that the Ensizor"™ Endoscopic Scissors should perform as intended in the specified use conditions. The data demonstrates that the Ensizor "10 Endoscopic Scissors device performs substantially equivalent to the predicate device that is currently marketed for the same intended use.