Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Device Story
Sclerotherapy & Endoscopic Needles are endoscopic accessories used in hospitals or clinics by physicians. The device consists of a flexible catheter, an inner tube connected to a distal needle, and a proximal handle with a piston and luer-lock connection. The device is inserted through an endoscope to deliver sclerosing agents, vasoconstrictors, or other solutions into the digestive system mucosa or submucosa. This delivery controls actual or potential bleeding lesions or aids in polypectomy procedures. The device is single-use and intended for contact with the digestive system mucosa for less than 60 minutes.
Clinical Evidence
No clinical testing was performed. Substantial equivalence is supported by bench testing, including mechanical evaluation, controllability, permeability, and smoothness, alongside biocompatibility testing per ISO 10993 and sterilization validation per ISO 11135.
Technological Characteristics
Device consists of a stainless steel needle and flexible catheter. Sterilized via ethylene oxide (ISO 11135). Packaging conforms to ISO 11607-1. Shelf-life validated via ASTM F1980-16 and ASTM D4169-16. Dimensions vary by model (catheter length 180-230mm, diameter 2.3mm; needle length 5mm, diameter 0.5-1.0mm).
Indications for Use
Indicated for patients with actual or potential bleeding lesions in the digestive system requiring endoscopic injection of sclerosing agents, vasoconstrictors, or other solutions, or liquid injection to aid in polypectomy. Contraindicated in patients with lesions inappropriate for injection therapy.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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April 3, 2023
G-Flex Europe SPRL Thierry Cremer OA & RA Manager 20, Rue de l'industrie Nivelles, Brabant Wallon 1400 BELGIUM
Re: K222006
> Trade/Device Name: Sclerotherapy & Endoscopic Needles Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: February 22, 2023 Received: February 27, 2023
Dear Thierry Cremer:
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. 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 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
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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 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-safetyreporting-combination-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 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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 the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/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,
## Shanil P. Haugen -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K222006
Device Name Sclerotherapy & Endoscopic Needles
Indications for Use (Describe)
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg height="16" width="16"> <path d="M2 2h12v12H2z" fill="none" stroke="black" stroke-width="1"></path> <path d="M4 4l8 8M4 12L12 4" stroke="black" stroke-width="2"></path> </svg> </span> |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> <svg height="16" width="16"> <path d="M2 2h12v12H2z" fill="none" stroke="black" stroke-width="1"></path> </svg> </span> |
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K222006 Page 1 of 5
Image /page/3/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" connected to the word "Flex". To the right of the word "Flex" are horizontal lines that give the impression of speed or movement.
Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES
510 (K) SUMMARY
Version: 3
Date: 10-AUG-2022
# 510(K) SUMMARY
### 1. SUBMITTER
| Submitter Name: | G-Flex Europe SPRL |
|--------------------|----------------------------------------------------|
| Submitter Address: | 20, Rue de l'industrie<br>1400 Nivelles<br>Belgium |
| Phone Number: | +32 67 88 36 65 |
| Fax Number: | +32 67 88 36 88 |
| Contact Person: | Thierry CREMER, QA & RA Manager |
| Email: | thierry@g-flex.com |
| Date Prepared: | March 10, 2022 |
### 2. DEVICE
| Device Trade Name: | Sclerotherapy & Endoscopic Needles |
|-----------------------|------------------------------------|
| Common Name: | Endoscopic accessory |
| Classification Name: | Endoscope and Accessories |
| Requlation Number: | 876.1500 |
| Product Code: | FBK |
| Class: | 2 |
| Classification Panel: | Gastroenterology/Urology |
#### PREDICATE DEVICE 3.
Primary Predicate Device: Boston Scientific, Interject Injection Therapy Needle Catheter (K171454).
#### 4. DEVICE DESCRIPTION
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.
Image /page/3/Figure/16 description: The image shows a diagram of a tool with several labeled parts. Part 1 is on the right side of the tool, and part 7 is on the left side. The tool is labeled with measurements of 2300mm, 2.3mm, and 5mm.
Fiqure 1 - Schematic representation of Sclerotherapy & Endoscopic Needles. (1 Back handle, 2 Front handle, 3 Protective sleeve, 4 Outer tube, 6 Guiding head, 7 Needle.)
All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.
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Image /page/4/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" followed by the word "Flex". To the right of the word "Flex" is a graphic that resembles a bullet or a fast-moving object, with lines suggesting speed or motion.
### Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES 510 (K) SUMMARY
Version: 3
There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).
| Reference | Catheter dimensions | | Needle dimensions | |
|-------------|---------------------|---------------|-------------------|---------------|
| | Length (cm) | Diameter (mm) | Length (mm) | Diameter (mm) |
| GF252202 | 180 | 2.3 | 5 | 0.7 (22 GA) |
| GF252203 | 230 | 2.3 | 5 | 0.7 (22GA) |
| GF262302 | 180 | 2.3 | 5 | 1.0 (19 GA) |
| GF252203-25 | 230 | 2.3 | 5 | 0.5 (25 GA) |
Table 1 - Different models of Sclerotherapy & Endoscopic Needles.
The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.
These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.
There are no accessories for this kind of devices.
#### 5. INDICATIONS FOR USE
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The comparison chart below provides evidence to facilitate the substantial equivalence determination between the Sclerotherapy & Endoscopic Needles to the predicate device (K171454) with respect to intended use, technological characteristics and principles of operation.
| Feature | Proposed Device | Primary Predicate Device | Assessment of<br>Equivalence |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name | Sclerotherapy & Endoscopic<br>Needles | Interject Injection Therapy<br>Needle Catheter | NA |
| 510(k) Number | K222006 | K171454 | NA |
| Manufacturer | G-Flex SPRL | Boston Scientific | NA |
| Regulation<br>Number | 876.1500 | 876.1500 | Fully similar |
| Device<br>Classification<br>Name | Endoscopic Injection Needle,<br>Gastroenterology-Urology | Endoscopic Injection Needle,<br>Gastroenterology-Urology | Fully similar |
| Product Code | FBK | FBK | Fully similar |
| Clinical<br>Condition | Treatment of varices in the<br>human digestive tract. | Treatment of varices in the<br>human digestive tract. | Fully similar |
| Intended Use/<br>Indications for<br>use | Sclerotherapy & Endoscopic<br>Needles are endoscopic<br>accessories intended to<br>introduce a sclerosing agent,<br>vasoconstrictor, or other<br>solutions into selected sites to<br>control actual or potential | The Interject Injection Therapy<br>Needle Catheter is used for<br>endoscopic injection into<br>gastrointestinal mucosa and<br>submucosa to:<br>• Introduce a sclerosing agent,<br>vasoconstrictor, or other | Similar |
| Feature | Proposed Device | Primary Predicate Device | Assessment of<br>Equivalence |
| | bleeding lesions in the<br>digestive system or to inject<br>liquid to aid in polypectomy<br>procedures. | solutions into selected sites to<br>control actual or potential<br>bleeding lesions in the<br>digestive system<br>• Aid in Endoscopic Mucosal<br>Resection (EMR), Endoscopic<br>Submucosal Dissection<br>(ESD), or polypectomy<br>procedures<br>• Control non-variceal<br>hemorrhage | |
| Contra-<br>indications | Patients with lesions<br>inappropriate for injection<br>therapy. | Contraindications for this<br>device are those applicable to<br>injection therapy and include,<br>but may not be limited to,<br>those patients allergic to<br>sclerosing or vasoconstriction<br>agents and patients with<br>lesions inappropriate for<br>injection therapy with<br>sclerosing or vasoconstriction<br>agents. | Similar |
| Site of use | Gastrointestinal tract | Gastrointestinal tract | Fully similar |
| Duration of<br>contact | Less than 60 minutes | Less than 60 minutes | Fully similar |
| Intended<br>patient<br>population | Patients who have (potential)<br>bleeding lesions in the<br>digestive system. | Patients who have (potential)<br>bleeding lesions in the<br>digestive system. | Fully similar |
| Design | Needle + Catheter + Handle | Needle + Catheter + Handle | Fully similar |
| Conditions of<br>use | Single Use | Single Use | Fully similar |
| Environment<br>of use | Hospitals or clinics | Hospitals or clinics | Fully similar |
| Catheter<br>length (cm) | 180<br>230 | 200<br>240 | Similar |
| Sheath outer<br>diameter (mm) | 2.3 | 1.8<br>2.3 | Similar |
| Needle length<br>(mm) | 5 | 4<br>6 | Similar |
| Needle<br>diameter (mm) | 0.5 (25 GA)<br>0.7 (22GA)<br>1.0 (19 GA) | 0.51<br>0.64 | Similar |
| Needle<br>material | Stainless steel | Stainless steel | Fully similar |
| Sterilization | Ethylene oxide<br>ISO 11135 | Ethylene oxide<br>ISO 11135 | Fully similar |
| Biological<br>evaluation | ISO 10993-1<br>ISO 10993-7 | ISO 10993-1<br>ISO 10993-7 | Fully similar |
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K222006 Page 3 of 5
Image /page/5/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized "G" followed by "-Flex". To the right of the word "Flex" is a symbol that resembles an arrow with lines trailing behind it, suggesting speed or flexibility. The logo has a modern and dynamic appearance.
### Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES 510 (K) SUMMARY
Version: 3
Date: 10-AUG-2022
Equivalence:
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K222006 Page 4 of 5
Image /page/6/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" followed by "-Flex". To the right of "Flex" are three horizontal lines that are stacked on top of each other and decrease in length from top to bottom. The lines are meant to represent speed.
Version: 3
The Sclerotherapy & Endoscopic Needles are comparable to the predicate device with similar technological characteristics and intended use, specifically to perform electrosurgical procedures through an endoscope. The Sclerotherapy & Endoscopic Needles thus meet the requirements for 510(k) substantial equivalence.
### Differences that are demonstrated to be substantially equivalent:
As indicated in the table above, several differences were identified between the Sclerotherapy & Endoscopic Needles and the primary predicate, namely the general wording of the indications for use and of the contraindications and the dimensions of the devices. While the wording of the indications for use and of the contraindications differs slightly between the proposed and predicate devices, this does not reflect any difference in the intended use and clinical application of the Sclerotherapy & Endoscopic Needles which are strictly identical to the predicate. The differences in dimensions are minor and, once again, do not impact the clinical application of the proposed device compared to the predicate.
Performance testing was conducted to demonstrate substantial equivalence of the Sclerotherapy & Endoscopic Needles to the predicate device. The test results are summarized below.
#### 7. NON-CLINICAL PERFORMANCE DATA
- Bench testing The Sclerotherapy & Endoscopic Needles were subjected to bench tests including dimensions verification, visual inspection, mechanical evaluation, controllability, permeability and smoothness. Results demonstrate that the device meets the design specifications
- Biocompatibility The Sclerotherapy & Endoscopic Needles were the subject of a range of biocompatibility tests in accordance with ISO 10993 series. Test results confirmed that the device is biocompatible for the stated intended use.
- Sterility The Sclerotherapy & Endoscopic Needles are provided sterile and are sterilized by ethylene oxide to meet a minimum sterility assurance level (SAL) of 10-6. Validation of the sterilization dose was conducted following the halfcycle method I, in accordance with ISO 11135-1:2014 and ISO 11138-2:2009.
- Shelf-life 3-year accelerated and 2-year real time ageing validations were performed to demonstrate that the dimensions, mechanical resistance, controllability, permeability, thoroughness, bio-property and sterility were not affected during the stated shelf-life of the device. A 3-year real time ageing validation is onqoing.
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Image /page/7/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" connected to the word "Flex". To the right of the word "Flex" are three horizontal lines that are stacked on top of each other, which gives the impression of speed.
Version: 3
Validation studies for sterilization, packaging and shelf-life conform to the following standard:
| Standard reference | Standard title |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1:<br>Requirements for materials, sterile barrier systems and<br>packaging systems |
| ISO 11135-1:2014 | Sterilization of health<br>care products - Ethylene oxide - Part 1: Requirements for<br>development, validation and routine control of a sterilization<br>process for medical devices |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier<br>Systems for Medical Devices |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping<br>Containers and Systems |
### CLINICAL PERFORMANCE DATA 8.
No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device. Additionally, endoscopic accessories such as the proposed and predicate devices have been on the market for many years and their use has been safe and effective.
#### 9. CONCLUSION
The information discussed above and provided in this 510(k) submission demonstrates that the Sclerotherapy & Endoscopic Needles devices are substantially equivalent to the predicate device and that they are as safe and effective for the patients.
