(166 days)
No
The description focuses on the electrosurgical mechanism and physical characteristics of the device, with no mention of AI or ML.
Yes
The device is intended to cannulate the transgastric or transduodenal wall to drain pancreatic pseudocysts, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is an electrosurgical accessory used to puncture and drain pancreatic pseudocysts, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an electrode and consists of physical parts (handle, sheath, and tip), indicating it is a hardware device. The performance studies also involve bench testing on tissue, further confirming it is not software-only.
Based on the provided information, the Optimos™ Cystotome is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Optimos™ Cystotome Function: The Optimos™ Cystotome is a surgical tool used directly on tissue within the body ("in vivo") to puncture and drain a pancreatic pseudocyst. It uses electrosurgical energy to create a hole.
- Lack of Specimen Analysis: The device does not analyze any bodily fluids or tissues in vitro to diagnose a condition or monitor health. Its purpose is a therapeutic/interventional procedure.
The description clearly indicates it's an electrosurgical accessory used for a surgical procedure, not for laboratory testing of specimens.
N/A
Intended Use / 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.
Product codes
KNS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transgastric or transduodenal wall, pancreatic pseudocyst
Indicated Patient Age Range
Not Found
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)
Biocompatibility Testing:
- Cytotoxicity: Reactivity grade - test sample: 0, reagent control: 0, negative control: 0, positive control: 4 (P)
- Intracutaneous reactivity: No abnormal signs, Normal body weight increase, Mean score was 0.00 in sterile saline extracts and 0.00 in cottonseed oil extracts (P)
- Sensitization (GPMT): No abnormal signs, Normal body weight increase, The sensitization score was observed 0.0 (P)
- Acute systemic toxicity: No abnormal signs, Normal body weight increase, No abnormal signs (P)
- Material mediated pyrogenicity test: No abnormal signs, Normal body weight increase, No animal showed body temperature increase of 0.5 °C or above (P)
Electrical safety and electromagnetic compatibility (EMC):
- 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 included: 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.
- 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 (Optimos™ Cystotome, Model: OCT1906, Sample size: 18) and the predicate device (Cystotome™ Cystoenterostomy Needle Knife, Manufacturer: Wilson-Cook, Model: CST-10, Sample size: 18) at 18, 100, and 120W on porcine stomach tissue and duodenum in the mucosa, submucosa, and muscularis propria.
- 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.
- Thermal damage zone measurement: Measured under microscope and depth analyzed using histological strain, NADH.
- Temperature-time history: Digital Thermometer used, highest temperature of stomach and duodenum tissue applied by subject device/predicate device were 69.7/60.6°C and 2.5/66.2°C respectively. Damage zone measured after tissue samples cooled to 37°C.
- Results: The performance of the Optimos™ Cystotome was comparable to the Wilson-Cook CST-10 Cystotome Cystoenterostomy Needle Knife. The test results met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022595, Wilson-Cook Cystotome
Reference Device(s)
K150692, AXIOS Stent with Electrocautery Enhanced Delivery System
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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
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,
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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) |
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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 |
- Maximum rated input:
1kV peak-to-peak - Recommended generator
settings:
Pure cut mode, 80-120 Watts
(400-500Vp) | 1. Energy: Monopolar - Maximum rated input:
2kV peak-to-peak - 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
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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 |
- Normal body weight increase
- Mean score was 0.00 in sterile saline extracts
and
0.00 in cottonseed oil extracts | P |
| Sensitization
(GPMT) | 1. No abnormal signs - Normal body weight increase
- The sensitization score was observed 0.0 | P |
| Acute systemic toxicity | 1. No abnormal signs - Normal body weight increase
- No abnormal signs | P |
| Material mediated
pyrogenicity test | 1. No abnormal signs - Normal body weight increase
- 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.
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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.
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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.