(166 days)
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.
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.
The device is the Optimos™ Cystotome. The study described focuses on bench testing to demonstrate substantial equivalence to a predicate device, the Wilson-Cook Cystotome.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. The ability to puncture 2 type tissues (Porcine stomach and Duodenum). | The test results showed that all test samples meet the required performance, puncture tissues. The Optimos™ Cystotome successfully punctured both porcine stomach and duodenum tissues. |
| 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. | The thermal effects were evaluated on both the subject device and the equivalent device (Wilson-Cook CST-10 Cystotome Cystoenterostomy Needle Knife). The performance of the Optimos™ Cystotome was comparable to the predicate device at 18, 100, and 120W on porcine stomach tissue and duodenum in the mucosa, submucosa, and muscularis propria. The damage zone was measured under a microscope and analyzed using histological strain and NADH. The test results met the acceptance criteria, indicating comparable thermal damage. |
| Additional Bench Testing: | |
| 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 (with corresponding acceptance criteria for each) | All tests passed the set acceptance criteria. System tests confirmed compatibility with fine needle aspiration, guidewire, endoscope, and ESU. |
| Biocompatibility Testing (for various test items) | All biocompatibility tests (Cytotoxicity, Intracutaneous reactivity, Sensitization (GPMT), Acute systemic toxicity, Material mediated pyrogenicity test) passed. For example, Cytotoxicity showed a reactivity grade of 0, Intracutaneous reactivity showed no abnormal signs and a mean score of 0.00, and Sensitization showed a score of 0.0. |
| Electrical Safety and Electromagnetic Compatibility (EMC) against standards: EN 60601-1 (2006) + A1:2013, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2, IEC 60601-2-2:2017, IEC 60601-2-18 | All listed electrical safety and EMC standards were passed (P). |
2. Sample size used for the test set and the data provenance
- Sample Size for Thermal Effects Comparison:
- Optimos™ Cystotome (Subject Device): 18 samples (Model number OCT1906)
- Cystotome™ Cystoenterostomy Needle Knife (Predicate Device): 18 samples (Model number CST-10)
- Data Provenance: This was a bench test conducted in a laboratory setting using porcine stomach and duodenum tissue. The document does not specify the country of origin of the data beyond the manufacturer (Taewoong Medical Co., Ltd. from Korea) performing the tests. It is retrospective in the sense that the data has already been collected and analyzed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the use of experts to establish ground truth for the bench testing. The ground truth for thermal damage was established by quantitative measurements of thermal damage zones under a microscope, analyzed using histological strain and NADH.
4. Adjudication method for the test set
- An explicit adjudication method (e.g., 2+1, 3+1) is not mentioned or implied. The measurements and evaluations appear to be made against objective criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is an electrosurgical accessory, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a medical device (Cystotome), not an algorithm. The performance described is for the device itself (its ability to puncture tissue and the thermal effects it produces) in controlled bench testing.
7. The type of ground truth used
- For the thermal effects comparison, the ground truth was objective physical measurements derived from histological analysis of tissue samples (porcine stomach and duodenum). This involved measuring the length, width, and depth of the thermal damage zone under a microscope and analyzing it using histological strain and NADH.
8. The sample size for the training set
- N/A. This device does not involve machine learning or AI, so there is no concept of a training set.
9. How the ground truth for the training set was established
- N/A. As there is no training set, this question is not applicable.
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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
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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,
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
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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) |
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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, 10022Phone: +82-31-996-0641Fax: +82-31-996-0645 |
|---|---|
| Contact: | Yonjin Jeff KimRegulatory Affairs / Quality Management DeptPhone: +82-31-993-0641-4 (Ext.# 125)Fax: 82-31-996-0645-6E-mail: jinjeff@stent.net |
| Submission Correspondent: | Christy Foreman, M.B.E.Senior Consultant, Medical DevicesPhone: (301) 325-4245Fax: (703) 548-7457Email: 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).
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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 | 876.4300Endoscopic electrosurgicalunit and accessories | 876.4300Endoscopic electrosurgicalunit and accessories |
| Product Code | KNS | KNS |
| Proposed Device | Predicate Device | |
| Indications for Use | The Optimos™ Cystotome isintended for use as anelectrosurgical accessory tocannulate the transgastric ortransduodenal wall and into apancreatic pseudocyst that isvisibly bulging into thegastrointestinal tract. Thisdevice is supplied sterile andis intended for single use only. | The Wilson-Cook Cystotomeis intended for use as anelectrosurgical accessory tocannulate the transgastric ortransduodenal wall and into apancreatic pseudocyst that isvisibly bulging into thegastrointestinal tract. Thisdevice is supplied sterile andis intended for single use only. |
| Use | Endoscopic | Endoscopic |
| Number of Electrodes | 1 | 2 |
| Size of Electrodes | Needle Tip – Not ApplicableElectrode Tip – 1.4 - 1.7 mm(Diameter)OCT1906: 1.4 mmOCT1907: 1.7 mmOCT1908: 1.7 mm | Needle tip - 0.097 mmElectrode Tip – 2.15 mm(Diameter)CST-10: 2.15 mm |
| Size of Sheath | Catheter attached to Needle -Not Applicable | Inner catheter attached toNeedle Diameter X length:CST-10:1.7 mm(5Fr) X1900 mm |
| Catheter attached to Electrodetip (Diameter X Length):OCT1906: 2.0 mm X 1850mmOCT1907: 2.4 mm X 1850mmOCT1908: 2.8 mm X 1850mm | Outer catheter attached toElectrode tipDiameter X length:CST-10: 3.3mm (10Fr) X1650 mm | |
| Energy Delivered | 1. Energy: Monopolar2. Maximum rated input:1kV peak-to-peak3. Recommended generatorsettings:Pure cut mode, 80-120 Watts(400-500Vp) | 1. Energy: Monopolar2. Maximum rated input:2kV peak-to-peak3. Recommended generatorsettings:Pure cut mode, 80-120 Watts(400-500Vp) |
| Proposed Device | Predicate Device | |
| Compatibledevices/equipment | 0.025 ~ 0.035" Guide wireEndoscope with 3.2mmdiameter or larger workingchannel | 0.035" Guide wireEndoscope with 3.7mmdiameter or larger workingchannel |
| Materials | Electrode: SUS 304Sheath: PTFE | Unknown |
| Single Use | Yes | Yes |
| Sterile | EO Sterilization | EO Sterilization |
Table 1: Technological Comparison
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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) | |
| Categorizationby ISO 10993-1 | Nature of body contact | External communicating deviceContact with Tissue |
| Duration of contact | Limited exposure (A) – medical devices whosecumulative sum of single, multiple or repeatedduration of contact isup 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 |
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| Test Items | Result | P/F |
|---|---|---|
| Intracutaneous reactivity | 1. No abnormal signs2. Normal body weight increase3. Mean score was 0.00 in sterile saline extractsand0.00 in cottonseed oil extracts | P |
| Sensitization(GPMT) | 1. No abnormal signs2. Normal body weight increase3. The sensitization score was observed 0.0 | P |
| Acute systemic toxicity | 1. No abnormal signs2. Normal body weight increase3. No abnormal signs | P |
| Material mediatedpyrogenicity test | 1. No abnormal signs2. Normal body weight increase3. No animal showed body temperature increaseof 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.
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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.
| Testsample | Device name | Optimos™ Cystotome | Cystotome™Cystoenterostomy NeedleKnife |
|---|---|---|---|
| Manufacturer | Taewoong Medical Co., Ltd | Wilson-Cook | |
| Modelnumber | OCT1906 | CST-10 | |
| Sample size | 18 | 18 | |
| Acceptance criteria | 1. The ability to puncture 2 type tissues (Porcine stomach andDuodenum) | ||
| 2. Substantial equivalence of thermal damage: There should beno significant | |||
| difference in measurement of size (length, width, and depth) ofthe 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 zonemeasurement | The thermal damage zone is measured under microscope and thedepth is analyzed using histological strain, NADH((nicotinamide adenine dinucleotide). | ||
| Temperature-timehistory | Using Digital Thermometer, the temperature of the tissue surfacewas measured during the test. When the generator was activated,69.7/60.6°C and 2.5/66.2°C were the highest temperature ofstomach and duodenum tissue applied by the subjectdevice/predicate device, respectively. The damage zone wasmeasured after confirmation that the tissue samples were coolback 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.
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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.
§ 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).