Cysto-Gastro-Sets

K211909 · G-Flex Europe Sprl · KNS · Jun 9, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211909
• Device Name: Cysto-Gastro-Sets
• Applicant: G-Flex Europe Sprl
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Jun 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudocysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

Device Story

Cysto-Gastro Sets are endoscopic electrosurgical accessories used to cannulate pancreatic pseudocysts. The device consists of a flexible Teflon catheter with a distal metal tip and proximal HF connector; some models include an integrated HF needle. Operated by a physician during endoscopic procedures, the device is inserted through an endoscope to puncture the transgastric or transduodenal wall into the pseudocyst. The HF energy allows for tissue perforation and hole enlargement, facilitating subsequent stent placement. The device is single-use and sterile. By providing a minimally invasive alternative to surgery or percutaneous drainage, it enables effective pseudocyst drainage, potentially reducing patient recovery time and procedural morbidity.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including mechanical, simulated use, and biocompatibility studies (ISO 10993). Safety and performance of HF electrosurgical components were verified against IEC 60601-2-2.

Technological Characteristics

Materials: Stainless steel (needle), Teflon (catheter), POM and MABS (handle). Energy: High-frequency (HF) electrosurgical. Dimensions: 6, 8.5, or 10 Fr diameter; 180 or 210 cm length. Connectivity: Manual endoscopic accessory. Sterilization: Ethylene Oxide (ETO). Standards: IEC 60601-2-2, ISO 10993, ISO 11607-1/2, ISO 11135-1, ANSI AAMI ISO 11737-1, ASTM D7386-16, ASTM F1929-15.

Indications for Use

Indicated for patients requiring endoscopic electrosurgical puncture of pancreatic pseudocysts (transgastric or transduodenal). Contraindicated in patients with blood coagulation diseases, interposing vessels, nickel sensitivity, or contraindications to electrical scalpel use. Not recommended for pseudocysts <4cm in diameter.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Wilson-Cook Cystotome (K022595)

Submission Summary (Full Text)

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June 9, 2022

G-Flex Europe SPRL Thierry Cremer OA & RA Manager 20, Rue de l'industrie Nivelles, Brabant Wallon 1400 BELGIUM

Re: K211909

> Trade/Device Name: Cysto-Gastro-Sets Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: May 2, 2022 Received: May 4, 2022

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 Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-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 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-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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Je Hi An, 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

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# Indications for Use

510(k) Number (if known) K211909

Device Name Cysto-Gastro Sets

Indications for Use (Describe)

Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudo-cysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 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: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Thierry CREMER, QA & RA Manager |
| Email: | [e-mail] |
| Date Prepared: | June 3, 2021 |

## 2. DEVICE

| Device Trade Name: | Cysto-Gastro Sets |
|-----------------------|-------------------------------------------------|
| Common Name: | Endoscopic electrosurgery device |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 876.4300 |
| Product Code: | KNS |
| Class: | 2 |
| Classification Panel: | Gastroenterology/Urology |

#### 3. PREDICATE DEVICE

Primary Predicate Device: Wilson-Cook Cystotome (K022595).

#### 4. DEVICE DESCRIPTION

Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudocysts endoscopically (via the transgastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

Each device is made of an outer flexible Teflon tube equipped with a metal tip at the distal end and an HF (high frequency) connector at the proximal end. Some models included an inner Teflon sheet that slides inside the outer sheet and are equipped with an HF needle at the distal tip and an HF connector 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 5 variations of the Cysto-Gastro Sets with different catheter length and diameter, with or without HF needle. However, all variations are delivered sterile and intended for single use.

Variety of Cysto-Gastro Sets are described in the table below. The main difference between models is the presence or not of the HF needle, which gives the Cysto-Gastro Sets the possibility to perforate the tissue with the needle before enlarging the hole with the diathermic bigger tip. The other variation is the diameter which will define the final size of the perforation and ultimately the size of the stent that will be used in the next procedure. All devices of this family group are sterile by ETO and intended for single use:

| Reference | Dimensions | | |
|-----------|-------------|---------------|------------------------------|
| | Length (cm) | Diameter (Fr) | Details |
| CYSTO06U | 180 | 6 | Without HF Needle Single Use |

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| CYSTO08UK | 210 | 8.5 | With HF Needle | Single Use |
|-----------|-----|-----|-------------------|------------|
| CYSTO10U | 180 | 10 | Without HF Needle | Single Use |
| CYSTO10UK | 210 | 10 | With HF Needle | Single Use |
| CYSTO85U | 180 | 8.5 | Without HF Needle | Single Use |

### 5. INDICATIONS FOR USE

Cysto-Gastro Sets are intended to be used to electrosurgically cannulate pancreatic pseudocysts endoscopically (via the transqastric or transduodenal wall) as an alternative to surgical or percutaneous treatment.

#### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The comparison chart below provides evidence to facilitate the substantial equivalence determination between the Cysto-Gastro Sets to the predicate device (K022595) with respect to intended use, technological characteristics and principles of operation.

| Feature | Proposed Device | Primary Predicate Device | Assessment of<br>Equivalence |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Cysto-Gastro Sets | Cystotome | NA |
| 510(k) Number | K211909 | K022595 | NA |
| Manufacturer | G-Flex Europe SPRL | Wilson-Cook Medical Inc | NA |
| Regulation<br>Number | 876.4300 | 876.4300 | Fully similar |
| Device<br>Classification<br>Name | Endoscopic electrosurgical<br>unit and accessories | Endoscopic electrosurgical<br>unit and accessories | Fully similar |
| Product Code | KNS | KNS | Fully similar |
| Clinical<br>Condition | For electrosurgical<br>puncture of the transgastric<br>or transduodenal<br>wall and into pancreatic<br>pseudocysts | For electrosurgical<br>puncture of the<br>transgastric or<br>transduodenal<br>wall and into pancreatic<br>pseudocysts | Fully similar |
| Intended Use/<br>Indications for<br>use | Cysto-Gastro Sets are<br>intended to be used to<br>electrosurgically cannulate<br>pancreatic pseudocysts<br>endoscopically (via the<br>transgastric or<br>transduodenal wall) as an<br>alternative to surgical or<br>percutaneous treatment. | This device is designed to<br>electrosurgically<br>puncture a hole in the<br>transgastric or<br>transduodenal wall and<br>into a pancreatic<br>pseudocyst, when it is<br>visibly bulging into the<br>gastrointestinal tract. | Fully similar |
| Contra-<br>indications | Contraindications include<br>blood coagulation<br>diseases, interposing<br>vessels, nickel sensitivity,<br>and contraindications<br>related to the use of<br>electrical scalpel. Cysto-<br>Gastro Sets are not<br>recommended to be used<br>on pancreatic pseudocysts<br>that are less than 4cm in<br>diameter similar. | Contraindications include<br>those specific to blood<br>coagulation disease,<br>interposing vessels<br>between the pseudocyst<br>wall and that of the<br>stomach or the duodenum.<br>If the pseudocyst is <4 cm<br>in diameter do not<br>proceed. | Similar, the safety and<br>effectiveness are not<br>impacted.<br>Nickel sensitivity is<br>included as a warning<br>in the predicate<br>device. |
| Site of use | Endoscopic pancreatic<br>pseudocyst | Endoscopic pancreatic<br>pseudocyst | Fully similar |

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| Feature | Proposed Device | Primary Predicate Device | Assessment of<br>Equivalence |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>patient<br>population | Patients who are subject to<br>endoscopic puncture of<br>pancreatic pseudocyst | Patients who are subject to<br>endoscopic puncture of<br>pancreatic pseudocyst | Fully similar |
| Performances | Effective puncture of the<br>pseudocyst | Effective puncture of the<br>pseudocyst | Fully similar |
| Design | Diameter: 6, 8,5 or 10 Fr<br>Length: 180 or 210 cm<br>External form: diathermic<br>ring + needle (depending<br>on the model) + catheter +<br>handle with electrode<br>Needle design: Needle<br>knife | Diameter: 10 Fr<br>Length: 190 cm<br>External form: diathermic<br>ring + needle + catheter +<br>electrode<br>Needle design: Needle<br>knife | Similar, the variations<br>(diameter, length,<br>absence of the needle<br>depending on the<br>model) do not affect<br>the safety or<br>effectiveness of the<br>proposed device. |
| Conditions of<br>use | Single Use | Single Use | Fully similar |
| Sterilization<br>mode | ETO | ETO | Fully similar |
| Operation and<br>clinical<br>performance | Introduction of the device<br>in the endoscope and<br>puncture of the pseudocyst<br>following endoscopic<br>procedure.<br>Performance: Effective<br>puncture of the pseudocyst | Introduction of the device<br>in the endoscope and<br>puncture of the pseudocyst<br>following endoscopic<br>procedure.<br>Performance: Effective<br>puncture of the pseudocyst | Fully similar |
| Recommended<br>size guide | 0,035 inch | 0,035 inch | Fully similar |
| Materials | Stainless Steel (needle) /<br>teflon (catheter) / POM +<br>MABS (handle) | Needle: stainless steel | Fully similar |
| Tissues or<br>body fluids<br>in contact | Tissues near the cyst in<br>contact with the needle | Tissues near the cyst in<br>contact<br>with the needle | Fully similar |
| Duration of<br>contact | Limited exposure (<24h) | Limited exposure (<24h) | Fully similar |
| Type of<br>body-device<br>interaction | Invasive | Invasive | Fully similar |

The Cysto-Gastro Sets is comparable to predicate device with similar technological characteristics and intended use, specifically to perform electrosurgical procedures through an endoscope. The Cysto-Gastro Sets thus meets the requirements for 510(k) substantial equivalence.

As indicated in the table above, several differences were identified between the Cysto-Gastro Sets and the primary predicate, namely the contraindications, diameter, length and absence of the needle depending on the model. Performance testing was conducted to demonstrate substantial equivalence of the Cysto-Gastro Sets to the predicate device. The test results are summarized below.

#### 7. NON-CLINICAL PERFORMANCE DATA

The Cysto-Gastro Sets was subjected to bench tests including visual Bench testing inspection, dimensions verification, simulated use, leaks, flow rate, corrosion resistance, X-ray visibility and mechanical. Results demonstrate that the device meets the design specifications. Additionally, the Cysto-Gastro Sets meets the design specifications and the requirements of the relevant

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| | standards for safety and performance of HF electrosurgical equipment (IEC<br>60601-2-2). |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The Cysto-Gastro Sets was the subject of a range of biocompatibility tests in<br>accordance with ISO 10993 series. Test results confirmed that the Cysto-<br>Gastro Sets is biocompatible for the stated intended use. |
| Sterilization | The Cysto-Gastro Sets is provided sterile and is intended for single patient<br>use only. The Cysto-Gastro Sets is sterilized by ETO to meet a minimum<br>sterility assurance level (SAL) of 10⁻⁶. |
| Shelf-life | Shelf-life study supports a shelf life of 3 years for The Cysto-Gastro Sets when<br>stored under the recommended environmental conditions. The shelf-life<br>studies confirmed that the packaging maintains the integrity of the device and<br>its sterility throughout the shelf life of the device. |

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 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2:<br>Validation requirements for forming, sealing and assembly<br>processes |
| 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 |
| ANSI AAMI ISO 11737-1:2018<br>14-514 | Sterilization Of Health Care Products - Microbiological<br>Methods -- Part 1: Determination Of A Population Of<br>Microorganisms On Products |
| ASTM D7386-16 | Standard Practice for Performance Testing of Packages for<br>Single Parcel Delivery Systems |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous<br>Medical Packaging by Dye Penetration |

## 8. CLINICAL PERFORMANCE DATA

No clinical testing was performed.

### 9. CONCLUSION

The information discussed above and provided in this 510(k) submission demonstrates that the Cysto-Gastro Sets device is substantially equivalent to the predicate.