(87 days)
Not Found
No
The device description and performance studies focus on mechanical function and compatibility, with no mention of AI or ML.
No
The device is described as a suture cutter, which is a surgical tool used to cut sutures, rather than a device designed to diagnose, treat, or prevent a disease or condition.
No
The device is described as a "Suture Cutter" and its purpose is to "cut sutures during all flexible endoscopic procedures." There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly outlines physical components such as a handle assembly, catheter, core wire, and blade, and the performance studies involve bench and functional testing of these physical components.
Based on the provided information, the SimpleSnip Suture Cutter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "cut sutures during all flexible endoscopic procedures." This is a surgical/procedural function performed in vivo (within the living body), not a diagnostic test performed in vitro (outside the living body) on biological samples.
- Device Description: The description details a mechanical device designed to be inserted through an endoscope to physically cut sutures. This aligns with a surgical instrument, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the SimpleSnip Suture Cutter is a surgical instrument used during endoscopic procedures, not an IVD device.
N/A
Intended Use / Indications for Use
The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCZ
Device Description
The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.
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)
Performance testing of the final, sterilized SimpleSnip Suture Cutter included bench testing and functional testing to verify specifications fundamental to the design of the device. Testing included the following:
-Visual Inspection of Components
-Dimensional Verification of Components
-Functionality Testing (ability to cut test sutures at least 20 times, endoscope compatibility)
-Destructive Testing (Product Integrity, i.e., Tensile of joints and ability to withstand minimum forces)
-Packaging Verification (following environmental conditioning and transportation simulation) and Shelf-Life Testing
-Sterilization Validation
Furthermore, comparative testing with the Ensizor Endoscopic Scissors as it relates to the ability to rotate cutting blades in a tortuous path, actuation testing (ability to cut various suture types/sizes and force to cut sutures), and bending stiffness established that the SimpleSnip Suture Cutter performed as well or better than the Ensizor Endoscopic Scissors.
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.
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
§ 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/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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2024
Envision Endoscopy Azadeh Khanicheh Co-Founder and President 204 Second Ave, 2nd Floor Waltham, Massachusetts 02451
Re: K242923
Trade/Device Name: SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCZ Dated: September 24, 2024 Received: September 24, 2024
Dear Azadeh Khanicheh:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Sivakami Venkatachalam -S
for Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
SimpleSnip Endoscopic Suture Cutter (SC500160) SimpleSnip Endoscopic Suture Cutter (SC500230)
Indications for Use (Describe)
The SimpleSnip Suture Cutter is intended to cut 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."
4
Traditional 510(k) – SimpleSnip Suture Cutter EnVision Endoscopy 510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for Envision Endoscopy. The logo features a stylized image of a needle and thread above the word "envision" in a sans-serif font. Below the word "envision" is the word "ENDOSCOPY" in a smaller font. The text "K242923" and "Page 1 of 5" are located in the upper right corner of the image.
510(k) Summary
Submission Type: Traditional 510(k)
Submitter Information:
Envision Endoscopy 204 Second Ave 2nd Floor Waltham, MA 02451
Contact Person:
Azadeh Khanicheh, Ph.D. Co-Founder and President EnVision Endoscopy 204 Second Ave, 2nd Floor Waltham, MA 02451 Cell: 857 998 1528 azadeh.khanicheh@envisionendoscopy.com
Date Prepared:
September 20, 2024
Subject Device Information:
| Proprietary Name: | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip
Endoscopic Suture Cutter (SC500230) |
|-----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Endoscopic Grasping/Cutting Instrument, Non-powered |
| Classification Name: | Endoscope and Accessories |
| Regulation: | 21 CFR 876.1500 |
| Product Code: Device | OCZ |
| Classification: | Class II |
| Classification Panel: | Gastroenterology and Urology |
Predicate Devices:
| Proprietary Name: | Ensizor Endoscopic Scissors |
|---|---|
| Manufacturer: | Slater Endoscopy LLC |
| 510(k) Number: | K150939 |
| Common Name: | Endoscopic Grasping/Cutting Instrument, Non-powered |
| Classification Name: | Endoscope and Accessories |
| Regulation: | 21 CFR 876.1500 |
| Product Code: | OCZ |
| Device Classification: | Class II |
5
Traditional 510(k) – SimpleSnip Suture Cutter EnVision Endoscopy 510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for Envision Endoscopy. The logo features a stylized "e" with a needle and thread, followed by the word "nvision" in a sans-serif font. Below the word "nvision" is the word "ENDOSCOPY" in a smaller font. At the top right of the image is the text "K242923" and "Page 2 of 5".
Device Description
The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.
Indications for Use:
The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.
Comparison of Technological Characteristics to the Predicate Device:
The SimpleSnip Suture Cutter is substantially equivalent in intended use, principles of operation and fundamental technological characteristics to the legally marketed predicate device. The table below summarizes the similarities and differences in design, materials, and dimensions between the subject and predicate device.
| Product
Characteristics | SimpleSnip Suture
Cutter | Ensizor Endoscopic Scissors
(K150939) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR Part 876.1500 | 21 CFR Part 876.1500 |
| Product Code | OCZ | OCZ |
| Intended Use | The EnVision Endoscopic Suture
Cutter is intended to cut sutures
during all flexible endoscopic
procedures. | Slater Endoscopy Ensizor
Endoscopic Scissors are designed to
cut and dissect tissue and sutures
during all flexible endoscopic |
| Product Configuration | Proximal actuation handle,
flexible catheter (shaft), pull wire
terminating with a single blunt-
tipped cutting blade.
Image: SimpleSnip Suture Cutter | Proximal actuation handle, flexible
shaft terminating in a pair of blunt-
tipped cutting scissors.
Image: Ensizor Endoscopic Scissors |
| Product
Characteristics | SimpleSnip Suture
Cutter | Ensizor Endoscopic Scissors
(K150939) |
| | Dimensions
- Device length
- Shaft Diameter
- Blade Length | - 160 cm or 230 cm working lengths
- 2.5 mm
- 5.0 mm |
| Compatible Scopes | Flexible colonoscopes or endoscopes with ≥2.8mm working channel | Flexible colonoscopes or endoscopes with ≥2.8mm working channel |
| Principal of Operation | Cutter device is inserted into the working channel of the endoscope while the blade is inside the catheter shaft, the blade is advanced from the catheter by advancing the handle slide forward, the suture is captured by the “J-hook” shaped blade. The blade cuts the suture when the blade is pulled back toward the catheter by moving the handle slide backward. | The device is advanced through the working channel of an endoscope to the target area. Scissors function just like standard scissors for mechanical cutting. By operating the handle, the scissors are opened and closed to cut the suture. |
| Electrocautery Capability | No | No |
| Packaging configuration | Single Unit Packaged in a Tyvek/LDPE-Nylon Pouch and 10 each placed in a shelf-box | Single unit packaged in a Tyvek/Clear film Pouch and placed in a shelf-box shipped in single or by 3. |
| Disposable, Single Patient Use | Yes | Yes |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method | Terminally sterilized to SAL 10-6 using a validated EO method |
Substantial Equivalence Comparison Chart of the SimpleSnip Suture Cutter to the Ensizor Endoscopic Scissors
6
Image /page/6/Picture/1 description: The image shows the logo for Envision Endoscopy. The logo includes a stylized letter "e" with a needle and thread incorporated into the design. Above the logo, the text "K242923 Page 3 of 5" is displayed.
Substantial Equivalence Comparison Chart of the SimpleSnip Suture Cutter to the Ensizor Endoscopic Scissors
As noted above, the SimpleSnip Suture Cutter and predicate Ensizor Endoscopic Scissors share numerous technological and operational characteristics and share similar indications for use statements. Both devices are sterile-single-use patient-only suturecutting devices designed to be used with compatible flexible gastroscopes and colonoscopes. Both the SimpleSnip and predicate Ensizor devices are referred to as
7
Image /page/7/Picture/1 description: The image shows a logo for Envision Endoscopy. The logo is a stylized letter 'e' with the word 'nvision' next to it. Below the word 'nvision' is the word 'ENDOSCOPY'. At the top right of the image is the text 'K242923' and 'Page 4 of 5'.
"through the scope" devices as they are designed to be used through the working channel of the endoscopes. Further, both devices are actuated to cut sutures using a proximal sliding handle.
Key differences between the devices are as follows:
- Indications for Use Statement: The SimpleSnip device is for suture cutting only, whereas the predicate Ensizor can be used to dissect and cut tissues in addition to cutting sutures. As the indications for use for the SimpleSnip is a subset of the Ensizor, this difference does not negatively impact a determination of substantial equivalence - both devices are intended for the same patient population, i.e., patients undergoing flexible endoscopic procedures.
- . Configuration of Cutting Blades: The SimpleSnip device has a single-cutting blade, whereas the Enzisor uses a double-blade scissor configuration. Bench testing has established that the SimpleSnip device performs as well as the predicate.
- The working lengths of the gastroscope and colonoscope versions of the ● SimpleSnip device are 5 cm shorter than that of the Ensizor device. Through performance testing, both the SimpleSnip and predicate Ensizor devices were found to be compatible with standard flexible endoscopes. The shorter working length of the SimpleSnip Suture Cutter does not adversely affect product performance.
Performance Data
Performance testing of the final, sterilized SimpleSnip Suture Cutter included bench testing and functional testing to verify specifications fundamental to the design of the device. Testing included the following:
- -Visual Inspection of Components
- -Dimensional Verification of Components
- -Functionality Testing (ability to cut test sutures at least 20 times, endoscope compatibility)
- -Destructive Testing (Product Integrity, i.e., Tensile of joints and ability to withstand minimum forces)
- -Packaging Verification (following environmental conditioning and transportation simulation) and Shelf-Life Testing
- -Sterilization Validation
Furthermore, comparative testing with the Ensizor Endoscopic Scissors as it relates to the ability to rotate cutting blades in a tortuous path, actuation testing (ability to cut various suture types/sizes and force to cut sutures), and bending stiffness established that the
8
Traditional 510(k) - SimpleSnip Suture Cutter EnVision Endoscopy 510(k) Summary
Image /page/8/Picture/1 description: The image shows a logo with the word "envision" in a stylized font, with the word "ENDOSCOPY" underneath it in smaller capital letters. Above the logo, there is the text "K242923" and "Page 5 of 5". The logo is black and white and appears to be from a document.
SimpleSnip Suture Cutter performed as well or better than the Ensizor Endoscopic Scissors.
Biocompatibility Testing
A biocompatibility evaluation was conducted in accordance with the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process, " consistent with a device with exposure to breached or compromised tissue for a limited duration (≤24 hours). The following biocompatibility tests were successfully completed on the final sterilized SimpleSnip Suture Cutter with passing results.
- Cytotoxicity 0
- Sensitization
- 0 Irritation or Intracutaneous toxicity
- 0 Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
Sterility
The SimpleSnip Suture Cutter is sterilized via a validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10 °. The sterilization process was validated per ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. EO residuals were within accepted limits.
Shelf Life
The SimpleSnip Suture cutter has a shelf life of 1 year. Shelf life studies have been conducted to demonstrate that the device maintains its performance and the packaging will maintain its sterile barrier over the entirety of the intended shelf life.
Clinical Performance Data
No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Conclusion
Envision Endoscopy has demonstrated that the SimpleSnip Suture Cutter is substantially equivalent in intended use/ indication for use, fundamental design, function, operating principle, and fundamental technology to the legally marketed predicate device, i.e., the Ensizor Endoscopic Scissors, which was cleared under 510(k) Premarket Notification K150939 on June 8, 2015.