(270 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
Yes.
Explanation: The device is described as "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," which directly performs a therapeutic function by treating bleeding lesions or aiding in medical procedures.
No
The device is an endoscopic accessory used to introduce solutions for therapeutic purposes (controlling bleeding, aiding polypectomy), not for identifying or investigating a disease or condition.
No
The device description clearly outlines physical components like a flexible catheter, inner tube, needle, handle, piston, and luer-lock connection, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce solutions into the digestive system to control bleeding or aid in polypectomy. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a physical tool (a needle catheter) used for injection. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on the device's use.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose conditions, monitor health, or determine compatibility. This device is used directly within the body for a therapeutic or procedural purpose.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FBK
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.
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.
There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Digestive system / Gastrointestinal tract
Indicated Patient Age Range
Patients who have (potential) bleeding lesions in the digestive system.
Intended User / Care Setting
Hospitals or clinics
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)
- 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 half-cycle 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 ongoing.
- Clinical Performance Data: No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device.
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
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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
1
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
2
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
| 1400 Nivelles | |
| 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.
4
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
Equivalence |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name | Sclerotherapy & Endoscopic
Needles | Interject Injection Therapy
Needle Catheter | NA |
| 510(k) Number | K222006 | K171454 | NA |
| Manufacturer | G-Flex SPRL | Boston Scientific | NA |
| Regulation
Number | 876.1500 | 876.1500 | Fully similar |
| Device
Classification
Name | Endoscopic Injection Needle,
Gastroenterology-Urology | Endoscopic Injection Needle,
Gastroenterology-Urology | Fully similar |
| Product Code | FBK | FBK | Fully similar |
| Clinical
Condition | Treatment of varices in the
human digestive tract. | Treatment of varices in the
human digestive tract. | Fully similar |
| Intended Use/
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 | The Interject Injection Therapy
Needle Catheter is used for
endoscopic injection into
gastrointestinal mucosa and
submucosa to:
• Introduce a sclerosing agent,
vasoconstrictor, or other | Similar |
| Feature | Proposed Device | Primary Predicate Device | Assessment of
Equivalence |
| | bleeding lesions in the
digestive system or to inject
liquid to aid in polypectomy
procedures. | solutions into selected sites to
control actual or potential
bleeding lesions in the
digestive system
• Aid in Endoscopic Mucosal
Resection (EMR), Endoscopic
Submucosal Dissection
(ESD), or polypectomy
procedures
• Control non-variceal
hemorrhage | |
| Contra-
indications | Patients with lesions
inappropriate for injection
therapy. | Contraindications for this
device are those applicable to
injection therapy and include,
but may not be limited to,
those patients allergic to
sclerosing or vasoconstriction
agents and patients with
lesions inappropriate for
injection therapy with
sclerosing or vasoconstriction
agents. | Similar |
| Site of use | Gastrointestinal tract | Gastrointestinal tract | Fully similar |
| Duration of
contact | Less than 60 minutes | Less than 60 minutes | Fully similar |
| Intended
patient
population | Patients who have (potential)
bleeding lesions in the
digestive system. | Patients who have (potential)
bleeding lesions in the
digestive system. | Fully similar |
| Design | Needle + Catheter + Handle | Needle + Catheter + Handle | Fully similar |
| Conditions of
use | Single Use | Single Use | Fully similar |
| Environment
of use | Hospitals or clinics | Hospitals or clinics | Fully similar |
| Catheter
length (cm) | 180
230 | 200
240 | Similar |
| Sheath outer
diameter (mm) | 2.3 | 1.8
2.3 | Similar |
| Needle length
(mm) | 5 | 4
6 | Similar |
| Needle
diameter (mm) | 0.5 (25 GA)
0.7 (22GA)
1.0 (19 GA) | 0.51
0.64 | Similar |
| Needle
material | Stainless steel | Stainless steel | Fully similar |
| Sterilization | Ethylene oxide
ISO 11135 | Ethylene oxide
ISO 11135 | Fully similar |
| Biological
evaluation | ISO 10993-1
ISO 10993-7 | ISO 10993-1
ISO 10993-7 | Fully similar |
5
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:
6
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.
7
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: |
| Requirements for materials, sterile barrier systems and | |
| packaging systems | |
| ISO 11135-1:2014 | Sterilization of health |
| care products - Ethylene oxide - Part 1: Requirements for | |
| development, validation and routine control of a sterilization | |
| process for medical devices | |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier |
| Systems for Medical Devices | |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping |
| 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.