(255 days)
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.
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.
This FDA 510(k) clearance letter and summary for the DELPHI System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical performance.
The document focuses on demonstrating substantial equivalence to a predicate device based primarily on technical characteristics and safety/EMC standards. It explicitly states: "No clinical studies were considered for this submission."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as it is not present in the provided text.
However, I can extract information related to the technical comparisons and safety testing that were used to establish substantial equivalence.
Here's what can be extracted based on the provided text, categorized as much as possible according to your request, but with the caveat that it does not cover clinical performance:
No Acceptance Criteria or Study for Clinical Performance Found
The provided FDA 510(k) clearance letter and summary does not include any acceptance criteria or details of a study that proves the device meets clinical performance requirements. The document explicitly states: "No clinical studies were considered for this submission."
The clearance is based on demonstrating substantial equivalence to a predicate device through comparison of technical specifications, safety standards compliance, and electromagnetic compatibility.
Key Information Extracted from the Document (Technical & Safety Focus):
Since clinical performance acceptance criteria and studies are absent, the following addresses the safety and technical aspects that were evaluated for substantial equivalence:
1. Table of Acceptance Criteria (Technical/Safety) and Reported Device Performance
| Acceptance Criterion (Technical/Safety) | DELPHI System Performance (Reported) | Comparison to Predicate Device |
|---|---|---|
| Indications for Use | Coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. Designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode. | Same |
| Rated Input | 100 | Same |
| Output Frequency | 100KHz | Same |
| Type of protection against electric shock | Class I | Same |
| Degree of protection against electric shock of applied part | Type BF | Same |
| Output Control Mechanism | Wired Foot switch | Same |
| Compliance: IEC 60601-1 | Complies | Same |
| Compliance: IEC 60601-1-2 | Complies | Same |
| Compliance: IEC 60601-2-2 | Complies | Same |
| Compliance: ISO 14971 | Complies | Same |
| Ablation Output Voltage | 100-275.68 Vrms | Similar¹ (within predicate range & tolerance) |
| Coagulation Output Voltage | 63-100 Vrms | Similar² (within predicate range & tolerance) |
| Overall Output Voltage | Set point: 0-275 Vrms, Coag: 63, 100 Vrms | Similar³ (within predicate range & tolerance) |
| Sterilization Method | EO gas | Different⁸ (Predicate: Radiation; both single-use) |
| Packaged Sterile | Yes | Same |
| Operates in Saline Environment | Yes | Same |
| Bipolar / Mono-polar | Bipolar | Same |
| Single Use Disposable | Yes | Same |
Notes on "Similar" points:
- ¹ The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
- ² The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
- ³ The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.
- ⁸ Sterilization method differs (EO gas vs Radiation) but is stated to "not affect the efficacy or safety or the devices" as both are for single-use products.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set for Clinical Performance: Not applicable, as "No clinical studies were considered for this submission."
- Test Set for Technical/Safety (e.g., EMC, Electrical Safety): The document does not specify a "sample size" in the traditional sense for these tests. The tests were performed on the DELPHI System itself.
- Data Provenance: Not specified for the technical/safety tests beyond stating they were performed by the manufacturer in accordance with FDA recognized standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. No clinical ground truth was established as no clinical studies were performed or considered. The "ground truth" for substantial equivalence was based on direct comparison of technical specifications against the predicate device and compliance with established technical and safety standards (IEC, ISO).
4. Adjudication Method for the Test Set
- Not applicable. No clinical adjudication was performed as no clinical studies were considered. Technical differences were evaluated by the manufacturer for their impact on safety and effectiveness (e.g., "The output of the subject device falls within the output range of the predicate device, and all data points are within the tolerance.").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done, as "No clinical studies were considered for this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The DELPHI System is an electrosurgical device, not an AI/algorithm-only device for diagnosis or interpretation. Its performance is inherent to its physical operation. Therefore, this question is not directly applicable in the context of this device type, and no "standalone" performance study in the sense of an algorithm was conducted. The performance was assessed through technical testing and comparison to existing devices.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" was established by compliance with recognized international standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 14971) for electrical safety and EMC, and direct comparison of technical specifications (e.g., output voltage, frequency, types of protection) to the legally marketed predicate device. No clinical, pathology, or outcomes data ground truth was used for this submission.
8. The Sample Size for the Training Set
- Not Applicable. This device is an electrosurgical system, not a machine learning or AI-driven system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
FDA 510(k) Clearance Letter - DELPHI System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
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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).
Page 3
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
Page 4
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.
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Page 5
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 & Coagulation & 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 |
Page 6
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
| Parameter | 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 hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode. | The Ambient HipVac 50 Wand with Integrated Finger Switches is 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. | Same |
Page 7
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Rated Input | 100 | 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
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 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 | 15º, 45º, 90º | 50º | 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 Environment | Yes | Yes | Same |
| Bipolar / Mono-polar | Bipolar | Bipolar | Same |
| Use Limiting Feature | Yes | Yes | Same |
| Software in Wand | No | No | Same |
| Single Use Disposable | Yes | Yes | Same |
Page 8
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 |
| 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 Shaft | More available outer diameter of shaft are designed for different clinical application, it will not impact device safety and effectiveness. |
| 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. |
Page 9
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.