Who is the manufacturer of Optimos Cystotome?

Taewoong Medical Co., Ltd. filed the 510(k) submission for Optimos Cystotome (K223256).

What is the FDA product code for Optimos Cystotome?

KNS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Optimos Cystotome?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Optimos Cystotome?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Optimos Cystotome

K223256 · Taewoong Medical Co., Ltd. · KNS · Apr 5, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K223256
Device Name	Optimos Cystotome
Applicant	Taewoong Medical Co., Ltd.
Product Code	KNS · Gastroenterology, Urology
Decision Date	Apr 5, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Device Story

Optimos™ Cystotome is a single-use, sterile electrosurgical accessory used during endoscopic procedures to drain pancreatic pseudocysts. The device consists of a handle, sheath, and monopolar electrode tip. It is operated by a physician under endoscopic visualization. The device is positioned over a guidewire to the target site; high-frequency (HF) energy is applied through the electrode to puncture the tissue wall. The device facilitates access to the pseudocyst for subsequent drainage. Performance is comparable to existing needle-knife cystotomes, with thermal damage profiles validated against predicate devices on porcine tissue models. The device is compatible with standard endoscopes and electrosurgical generators.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through unit tests (visual, dimensional, continuity, endoscopic compatibility, operability, dielectric strength, tensile strength) and system-level thermal effect testing on porcine stomach and duodenum tissue. Thermal damage zones (length, width, depth) and temperature-time history were compared against the predicate device at 80W, 100W, and 120W settings, showing no significant differences.

Technological Characteristics

Monopolar electrosurgical electrode. Materials: Electrode (SUS 304), Sheath (PTFE). Dimensions: Electrode tip 1.4-1.7 mm; Sheath 2.0-2.8 mm. Energy: Monopolar HF, 80-120W (400-500Vp). Compatibility: 0.025-0.035" guidewire, endoscope with >=3.2mm working channel. Sterilization: Ethylene Oxide (EO). Standards: EN 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18.

Indications for Use

Indicated for patients requiring cannulation of the transgastric or transduodenal wall into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract.

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)

Reference Devices

AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)

Related Devices

K022595 — WILSON-COOK CYSTOTOME · Wilson-Cook Medical, Inc. · Oct 17, 2002
K211909 — Cysto-Gastro-Sets · G-Flex Europe Sprl · Jun 9, 2022
K171993 — Zimmon Needle Knife Papillotome · Wilson-Cook Medical Inc./Cook Endoscopy · Aug 17, 2017
K192043 — AXIOS Stent and Electrocautery Enhanced Delivery System · Boston Scientific Corporation · Aug 26, 2019
K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System · Boston Scientific Corp · Aug 5, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 5, 2023 Taewoong Medical Co., Ltd. % Christy Foreman Senior Consultant Biologics Consulting Group Inc. 100 Daingerfield Rd., Suite 400 Alexandria, VA 22314 Re: K223256 > Trade/Device Name: Optimos™ Cystotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: March 7, 2023 Received: March 7, 2023 Dear Christy Foreman: 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, Image /page/1/Picture/5 description: The image shows the text "Je An-S" in a large, bold font. The letters are black and stand out against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text. The text is evenly spaced and centered in the image. 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) K223256 Device Name Optimos™ Cystotome Indications for Use (Describe) The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only. Type of Use (Select one or both, as applicable) | × Prescription Use (Part 21 CFR 801 Subpart D) | |---------------------------------------------------------------------------------------------------------------------------------| | □ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Optimos™ Cystotome is provided below. #### 1. SUBMITTER | Applicant: | Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea, 10022 Phone: +82-31-996-0641 Fax: +82-31-996-0645 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Yonjin Jeff Kim Regulatory Affairs / Quality Management Dept Phone: +82-31-993-0641-4 (Ext.# 125) Fax: 82-31-996-0645-6 E-mail: jinjeff@stent.net | | Submission Correspondent: | Christy Foreman, M.B.E. Senior Consultant, Medical Devices Phone: (301) 325-4245 Fax: (703) 548-7457 Email: cforeman@biologicsconsulting.com | | Date Prepared: | March 2, 2023 | #### 2. DEVICE | Device Trade Name: | Optimos™ Cystotome | |---------------------|-----------------------------------------------------------| | Device Common Name: | Cystotome | | Classification Name | 876.4300, Endoscopic electrosurgical unit and accessories | | Regulatory Class: | II | | Product Code: | KNS | #### PREDICATE DEVICE AND REFERENCE DEVICES 3. Predicate Device: K022595, Wilson-Cook Cystotome Reference Device: K150692, AXIOS Stent with Electrocautery Enhanced Delivery System > The AXIOS Stent is provided as a reference device for the sole electrode (electrode tip). {4}------------------------------------------------ ### DEVICE DESCRIPTION 4. Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip. ### INTENDED USE/INDICATIONS FOR USE ട്. The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only. ### SUBSTANTIAL EQUIVALENCE 6. ## Comparison of Indications The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only. The indications for use statement of the subject device are identical to that of the predicate device. ## Technological Comparisons The table below compares the key technological feature of the subject devices to the predicate device, Wilson-Cook Cystotome (K022595). | | Proposed Device | Predicate Device | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | TDB | K022595 | | Applicant | Taewoong Medical | Wilson-Cook | | Device Name | OptimosTM Cystotome | Cystotome | | Classification Regulation | 876.4300 Endoscopic electrosurgical unit and accessories | 876.4300 Endoscopic electrosurgical unit and accessories | | Product Code | KNS | KNS | | | Proposed Device | Predicate Device | | Indications for Use | The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only. | The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only. | | Use | Endoscopic | Endoscopic | | Number of Electrodes | 1 | 2 | | Size of Electrodes | Needle Tip – Not Applicable Electrode Tip – 1.4 - 1.7 mm (Diameter) OCT1906: 1.4 mm OCT1907: 1.7 mm OCT1908: 1.7 mm | Needle tip - 0.097 mm Electrode Tip – 2.15 mm (Diameter) CST-10: 2.15 mm | | Size of Sheath | Catheter attached to Needle - Not Applicable | Inner catheter attached to Needle Diameter X length: CST-10:1.7 mm(5Fr) X 1900 mm | | | Catheter attached to Electrode tip (Diameter X Length): OCT1906: 2.0 mm X 1850mm OCT1907: 2.4 mm X 1850mm OCT1908: 2.8 mm X 1850mm | Outer catheter attached to Electrode tip Diameter X length: CST-10: 3.3mm (10Fr) X 1650 mm | | Energy Delivered | 1. Energy: Monopolar 2. Maximum rated input: 1kV peak-to-peak 3. Recommended generator settings: Pure cut mode, 80-120 Watts (400-500Vp) | 1. Energy: Monopolar 2. Maximum rated input: 2kV peak-to-peak 3. Recommended generator settings: Pure cut mode, 80-120 Watts (400-500Vp) | | | Proposed Device | Predicate Device | | Compatible devices/equipment | 0.025 ~ 0.035" Guide wire Endoscope with 3.2mm diameter or larger working channel | 0.035" Guide wire Endoscope with 3.7mm diameter or larger working channel | | Materials | Electrode: SUS 304 Sheath: PTFE | Unknown | | Single Use | Yes | Yes | | Sterile | EO Sterilization | EO Sterilization | Table 1: Technological Comparison {5}------------------------------------------------ {6}------------------------------------------------ ### 7. PERFORMANCE DATA # Biocompatibility Testing #### Biocompatibility Characterization Table 2: | Categorization | Optimos™ Cystotome | | |----------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Contact part | Direct contact to patient | Sheath (PTFE), Electrode Tip (STS 304) | | | Indirect contact to patient | Saline port of Connector (PP), Sheath Tip (STS 304), Shaft wire (STS 304) | | Categorization by ISO 10993-1 | Nature of body contact | External communicating device Contact with Tissue | | | Duration of contact | Limited exposure (A) – medical devices whose cumulative sum of single, multiple or repeated duration of contact is up to 24 h. | | Sample preparation | Medical Device in Final Finished FormTable | | #### Table 3: Biocompatibility Test Results | Test Items | Result | P/F | |--------------|----------------------------------------------------------------------------------------------------------------|-----| | Cytotoxicity | Reactivity grade - test sample: 0 - reagent control: 0 - negative control: 0 - positive control: 4 | P | {7}------------------------------------------------ | Test Items | Result | P/F | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | Intracutaneous reactivity | 1. No abnormal signs 2. Normal body weight increase 3. Mean score was 0.00 in sterile saline extracts and 0.00 in cottonseed oil extracts | P | | Sensitization (GPMT) | 1. No abnormal signs 2. Normal body weight increase 3. The sensitization score was observed 0.0 | P | | Acute systemic toxicity | 1. No abnormal signs 2. Normal body weight increase 3. No abnormal signs | P | | Material mediated pyrogenicity test | 1. No abnormal signs 2. Normal body weight increase 3. No animal showed body temperature increase of 0.5 °C or above | P | ## Electrical safety and electromagnetic compatibility (EMC) | Table 4: | Electrical Safety and Electromagnetic Compatibility Summary Results | | | |----------|---------------------------------------------------------------------|--|--| |----------|---------------------------------------------------------------------|--|--| | Standard | Results | | |-----------------------------|-------------------------------------------------------------------------|---| | EN 60601-1 (2006) + A1:2013 | General | P | | IEC 60601-1:2005/AMD1:2012 | Assessment of Basic Safety and Essential Performance of Medical Devices | P | | IEC 60601-1-2 | Collateral standard: Electromagnetic compatibility | P | | IC 60601-2-2:2017 | Particular standards: HF surgical equipment | P | | IEC 60601-2-18 | Particular equipment: endoscopic equipment | P | ## Bench Testing Unit tests of the Optimos™ Cystotome included a visual test, dimensional test, continuity test, endoscopic compatibility test, device operability test, high frequency dielectric strength test, detachable connector retention test, injection & leakage test, and tensile strength test. All tests passed the set acceptance criteria. {8}------------------------------------------------ Page 6 of 7 System tests to examine the thermal effects on tissue was conducted with fine needle aspiration, guidewire, endoscope, ESU as a system. The test results showed that all test samples meet the required performance, puncture tissues, and are compatible with all devices/equipment working together. Thermal effects were evaluated on both the subject device and the equivalent device to validate the performance of the device. The performance of the Optimos™ Cystotome was comparable to the Wilson-Cook CST-10 Cystotome Cystoenterostomy Needle Knife at 18, 100, and 120W on porcine stomach tissue, and duodenum in the mucosa, submucosa, and muscularis propria. The test results met the acceptance criteria. | Test sample | Device name | Optimos™ Cystotome | Cystotome™ Cystoenterostomy Needle Knife | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------| | | Manufacturer | Taewoong Medical Co., Ltd | Wilson-Cook | | | Model number | OCT1906 | CST-10 | | | Sample size | 18 | 18 | | Acceptance criteria | 1. The ability to puncture 2 type tissues (Porcine stomach and Duodenum) | | | | | 2. Substantial equivalence of thermal damage: There should be no significant | | | | | difference in measurement of size (length, width, and depth) of the thermal | | | | | damage zone between subject device and predicate device. | | | | Generator power setting | Mono-polar Type, Auto Cut Mode (400 – 500Vp) | | | | | Minimum: 80W, Default: 100W, Maximum: 120W | | | | Damage zone measurement | The thermal damage zone is measured under microscope and the depth is analyzed using histological strain, NADH ((nicotinamide adenine dinucleotide). | | | | Temperature-time history | Using Digital Thermometer, the temperature of the tissue surface was measured during the test. When the generator was activated, 69.7/60.6°C and 2.5/66.2°C were the highest temperature of stomach and duodenum tissue applied by the subject device/predicate device, respectively. The damage zone was measured after confirmation that the tissue samples were cool back to 37°C, baseline temperature. | | | | Table 5: | Test Summary | |----------|--------------| |----------|--------------| # Animal Testing Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device. {9}------------------------------------------------ # Clinical Data Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device. ### 8. CONCLUSION Performance testing was conducted on all key performance attributes of the device. All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device.