(353 days)
Not Found
No
The summary describes a purely mechanical and electrosurgical device with no mention of AI or ML capabilities. The performance studies focus on bench tests and biocompatibility, not algorithmic performance.
Yes
The device is described as "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." This clearly indicates its function is to treat a medical condition (pancreatic pseudo-cysts), thus classifying it as a therapeutic device.
No
The Intended Use states the device is "intended to be used to electrosurgically cannulate pancreatic pseudo-cysts endoscopically... as an alternative to surgical or percutaneous treatment," which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components made of Teflon and metal, and the performance studies focus on bench tests related to these physical properties (dimensions, leaks, flow rate, corrosion resistance, mechanical). There is no mention of software as a component or function of the 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 "electrosurgically cannulate pancreatic pseudo-cysts endoscopically". This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a flexible tube with a metal tip and HF connector, designed for electrosurgical use. This is a surgical instrument.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or provide diagnostic information about a patient's condition. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
The device is clearly intended for a therapeutic/interventional purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNS
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:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreatic pseudocysts (transgastric or transduodenal wall)
Indicated Patient Age Range
Patients who are subject to endoscopic puncture of pancreatic pseudocyst
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)
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 standards for safety and performance of HF electrosurgical equipment (IEC 60601-2-2).
Biocompatibility: The Cysto-Gastro Sets was the subject of a range of biocompatibility tests in accordance with ISO 10993 series. Test results confirmed that the Cysto-Gastro Sets is biocompatible for the stated intended use.
Sterilization: The Cysto-Gastro Sets is provided sterile and is intended for single patient use only. The Cysto-Gastro Sets is sterilized by ETO to meet a minimum 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 stored under the recommended environmental conditions. The shelf-life studies confirmed that the packaging maintains the integrity of the device and its sterility throughout the shelf life of the 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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: | 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 |
4
| 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
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
Number | 876.4300 | 876.4300 | Fully similar |
| Device
Classification
Name | Endoscopic electrosurgical
unit and accessories | Endoscopic electrosurgical
unit and accessories | Fully similar |
| Product Code | KNS | KNS | Fully similar |
| Clinical
Condition | For electrosurgical
puncture of the transgastric
or transduodenal
wall and into pancreatic
pseudocysts | For electrosurgical
puncture of the
transgastric or
transduodenal
wall and into pancreatic
pseudocysts | Fully similar |
| Intended Use/
Indications for
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. | This device is designed to
electrosurgically
puncture a hole in the
transgastric or
transduodenal wall and
into a pancreatic
pseudocyst, when it is
visibly bulging into the
gastrointestinal tract. | Fully similar |
| Contra-
indications | Contraindications include
blood coagulation
diseases, interposing
vessels, nickel sensitivity,
and contraindications
related to the use of
electrical scalpel. Cysto-
Gastro Sets are not
recommended to be used
on pancreatic pseudocysts
that are less than 4cm in
diameter similar. | Contraindications include
those specific to blood
coagulation disease,
interposing vessels
between the pseudocyst
wall and that of the
stomach or the duodenum.
If the pseudocyst is