DELPHI System

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION June 6, 2025 CnS Medical Co., Ltd. % Kim Jiwon Regulatory Affairs Consultant Kmc #1709, G-Plus Tower, 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea, South Re: K242907 Trade/Device Name: DELPHI System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 7, 2025 Received: May 7, 2025 Dear Kim Jiwon: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242907 - Kim Jiwon Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical-device-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-devices/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-advice-comprehensive-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). {2} K242907 - Kim Jiwon Page 3 Sincerely, James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.06.06 14:44:01 -04'00' James Jang, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | Submission Number (if known) | | --- | | K242907 | | Device Name | | DELPHI System | | Indications for Use (Describe) | | DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode. | 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 &gt; "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." {4} K242907 CNS Medical # 510(k) Summary This summary of 510(K) – safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: September 10, 2024 # 1. Applicant / Submission Sponsor CnS Medical Co., Ltd. Address: 94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea (Zip code: 11154) Tel: +82-70-7012-5680 Fax: +82-31-531-5309 # 2. Submission Correspondent JIWON KIM (Consultant, KMC, Inc.), JeongKeun KIM (Consultant, KMC, Inc) Address: Room no. 1709, 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, REPUBLIC OF KOREA Tel: +82-10-7292-5675, +82-70-8965-5554 Email: jw.kim@kmcerti.com, jkkim@kmcerti.com # 3. Device Identification Trade/Proprietary Name: DELPHI System Common Name: Electrosurgical, Cutting &amp; Coagulation &amp; Accessories Classification Regulation: 21CFR 878.4400 Product Code: GEI Device Class: 2 # 4. Predicate Devices | | Predicate Device #1 | | --- | --- | | Manufacturer | ArthroCare Corporation | | Device Name | Ambient HipVac 50 Wand with integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION system, WEREWOLF+COBLATION System | | 510(k) number | K220563 | {5} K242907 CNS Medical # 5. Description DELPHI System is a bipolar, high radiofrequency electrosurgical device designed for coagulation and ablation of tissue and hemostasis during arthroscopic surgery. DELPHI system consists of DELPHI II (Generator), power cable, Mode Footswitch, output Footswitch, DELPHI PLUS (Electrodes) and DISCORE (Electrode). The DELPHI II is an electrically isolated radiofrequency generator designed to deliver power for soft tissue ablation (vaporization) and coagulation procedures in arthroscopic surgery. The DELPHI II offers the operator the flexibility to choose from a range of functional modes using the front panel set-up options. These modes include PETTIE MODE and GRANDE MODE for tissue ablation and coagulation. DELPHI PLUS and DISCORE bipolar electrode is a foot-controlled sterile, single-use electrosurgical electrode intended to deliver radiofrequency energy for coagulation and ablation of tissue and hemostasis during arthroscopic surgery in conjunction with DELPHI System. # 6. Indications for use DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELHI PLUS or DISCORE bipolar electrodes. DO NOT use other manufacture's or brand of electrodes with DELPHI System. # 7. Substantial Equivalence The Electrosurgical device system is substantially equivalent to the predicate device, Ambient HipVac 50 Wand with Integrated Finger Switches and RF20000 COBLATION System (K220563, ArthroCare Corporation). The following comparison table is presented to demonstrate substantial equivalence. | - | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | Manufacturer | CNS medical Co.,Ltd | ArthroCare Corporation | - | | Device Name | DELPHI System | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | - | | 510(k) Number | None | K220563 | - | | Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Regulation Name | Electrosurgical devices and accessories | Electrosurgical devices and accessories | Same | | Regulatory Class | II | II | Same | | Product Code | GEI | GEI | Same | | Indications for Use | DELPHI System is indicated for coagulation and ablation of tissue and | The Ambient HipVac 50 Wand with Integrated Finger Switches is | Same | {6} K242907 CNS Medical | | hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode. | indicated for the resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthoscopic procedures. | | | --- | --- | --- | --- | | Rated Input | 100~120 / 220~240V 50/60 Hz | 100 – 240V~, 50/60 Hz | Same | | Output Frequency | 100KHz | 100KHz | Same | | Type of protection against electric shock | Class I | Class I | Same | | Degree of protection against electric shock of applied part | Type BF | Type BF | Same | | Ablation Output Voltage | 100-275.68 Vrms | 100-314 Vrms | Similar¹ | | Coagulation Output Voltage | 63-100 Vrms | 65-100 Vrms | Similar² | | Output Control Mechanism | Wired Foot switch | Wired or Wireless foot pedal | Same | | Weight | 9.86Kg | <5Kg | - | | Controller waveforms | Square wave | Square wave | Same | | Output Voltage | Set point: 0-275 Vrms Coag: 63, 100 Vrms | Set point: 0-320 Vrms Coag: 65,98 Vrms | Similar³ | | Software Program | DELPHI II PGM, Ver 1.0 | Software for Quantum II, V 2.03 | - | | Wand Specifications / Features | | | | | Shaft Length | DP Model: 110mm, 130mm, 150mm, 280mm DPS Model: 150, 280mm DD Model: 150, 240, 380mm | 176 mm | Similar⁴ | | Handle Length | DP Model: 180mm DPS Model: 180mm DD Model: 146mm | 141.75 mm | Similar⁵ | | Distal Bend Angle | 15°, 45°, 90° | 50° | Similar⁶ | | Outer Diameter of Shaft | DP Model: 4.0mm, 2.3mm DPS Model: 4.0mm DD Model: 2.1mm | 4.6mm | Similar⁷ | | Sterilization | EO gas | Radiation | Different⁸ | | Electrical Safety EMC | IEC 60601-2-2 IEC 60601-1 IEC 60601-1-2 compliant | IEC 60601-2-2 compliant | Same | | Suction and/or Irrigation | Yes | Yes | Same | | Packaged Sterile | Yes | Yes | Same | | Tyvek Packaging/adhesive | Yes | Yes | Same | | Operates in Saline | Yes | Yes | Same | 3 / 5 {7} K242907 CNS Medical # Technical Characteristics 1) Same Points between subject device and predicate device | Item | Description | | --- | --- | | Indications for Use | The indications for use is same between subject device and predicate device. | | Rated Input | The rated input of subject device is “100~120 / 200~240V, 50/60 Hz”. It is same with the predicate device. | | Output Frequency | The subject device is 100KHz. It is same with the predicate device. | | Type of protection against electric shock | The subject device is class I. It is same with the predicate device. | | Degree of protection against electric shock of applied part | The subject device is Type BF. It is same with the predicate device. | | Output Control Mechanism | The subject device is Wired Foot switch. It is same with the predicate device. | | IEC 60601-1 | The subject device complies with IEC 60601-1. It is same with the predicate device. | | IEC 60601-1-2 | The subject device complies with IEC 60601-1-2. It is same with the predicate device. | | IEC 60601-2-2 | The subject device complies with IEC 60601-1-2. It is same with the predicate device. | | ISO 14971 | The subject device complies with ISO 14971. It is same with the predicate device. | 2) Different Points between subject device and predicate device | Item | Description | | --- | --- | | 1 Ablation Output Voltage | The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance. | | 2 Coagulation Output Voltage | The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance. | | 3 Output Voltage | The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance. | | 4 Shaft Length | More available shaft lengths are designed for different clinical application, it will not impact device safety and effectiveness. | | 5 Handle Length | More available Handle lengths are designed for different clinical application, it will not impact device safety and effectiveness. | | 6 Distal Bend Angle | More available distal bend angles are designed for different clinical application, it will not impact device safety and effectiveness. | | 7 Outer Diameter of | More available outer diameter of shaft are designed for different clinical application, it will not impact device safety and effectiveness. | {8} K242907 CNS Medical | Item | Description | | --- | --- | | Shaft | | | 8 Sterilization | Both the predicate device and the subject device are sterilized as single-use product. But the sterilization method used does not affect the efficacy or safety or the devices. | # 8. Electromagnetic Compatibility (EMC) and Electrical Safety The Electromagnetic Compatibility (EMC) and Electrical Safety tests were performed in accordance with the following FDA recognized standards. - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) - IEC 60601-2-2:2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. - IEC 60601-1-2:2014, Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests # 9. Clinical Test No clinical studies were considered for this submission. # 10. Conclusion In comparing between the subject device and the predicate device, there are the same Indications for Use, rated input, output frequency, protection rating of the applied part, and compliance with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 and ISO 14971. Although the output voltage differs slightly, it is within the tolerance and falls within the output the output range of the predicate device. While the hand length and sterilization method differ, they do not raise further questions regarding safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device. 5 / 5