(31 days)
Not Found
No
The summary describes a simple interface cable for connecting a surgical instrument to an electrosurgical generator. There is no mention of any computational processing, algorithms, or learning capabilities. The performance studies focus on electrical safety and mechanical durability.
No.
The device is an interface cable used to deliver energy from a generator to a surgical accessory. It does not directly perform the therapeutic action (cutting, coagulation, or ablation) itself.
No
The device is an interface cable used to connect a surgical instrument to an electrosurgical generator for delivering energy to tissue. Its intended use is for cutting, coagulation, and ablation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "flexible, low-loss coaxial cable" with "latching connectors," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue." This describes a surgical accessory used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a cable for transmitting energy, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, nor is there any indication of providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the delivery of energy for surgical intervention.
N/A
Intended Use / Indications for Use
The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tissue
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)
Electrical safety testing was conducted on the subject device in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
Performance bench testing was conducted to establish device durability over the established lifetime for:
- cleaning between uses (reprocessing)
- rotation load
- cyclic load
- connectors connection and disconnection forces.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
August 15, 2024
Creo Medical Ltd Diane Davis RAQA Product Lead Unit 2 Beaufort Park Beaufort Part Way Chepstow, Monmouthshire NP16 5UH United Kingdom
Re: K242061
Trade/Device Name: Reusable Interface Cable 1.5 m (PRD-IFC-002) Regulation Number: 21 CFR 876.4300 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: KNS Dated: July 15, 2024 Received: July 15, 2024
Dear Diane Davis:
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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(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 OS 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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, 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
Submission Number (if known)
K242061 Device Name
Reusable Interface Cable 1.5 m (PRD-IFC-002)
Indications for Use (Describe)
The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.
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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| 510(k) #: K242061 | 510(k) Summary |
|---|---|
| K242061 Page 1 of 2 | |
| Prepared on: 2024-08-01 | |
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | Creo Medical Ltd |
| Applicant Address | Unit 2 Beaufort Park Beaufort Park Way Chepstow NP16 5UH United Kingdom |
| Applicant Contact Telephone | +44 7899306000 |
| Applicant Contact | Dr. Diane Davis |
| Applicant Contact Email | diane.davis@creomedical.com |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | Reusable Interface Cable 1.5 m (PRD-IFC-002) |
| Common Name | Endoscopic electrosurgical unit and accessories |
| Classification Name | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Regulation Number | 876.4300 |
| Product Code(s) | KNS |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K230328 | Speedboat Flush SB1 Instrument, Creo Electrosurgical System |
| Product Code | |
| KNS | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
| The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total. | |
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
| The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue. | |
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
| The subject device has the same Indications for Use as the predicate device. The indications for use for the subject device has been reworded for readability. | |
| Technological Comparison | 21 CFR 807.92(a)(6) |
| The Interface Cable has push-fit latching connectors on each end designed to deliver energy at both Radiofrequency and Microwave frequencies between the CROMA Electrosurgical Generator and the compatible instrument. | |
| The subject device is a reusable version of the predicate device. To improve durability for reuse over the established lifetime, the conductor cable of the subject device has been modified while maintaining identical electrical properties. |
conductor cable of the subject device has been modified while maintaining identical properties.
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The subject and predicate devices have identical principles of operations, electrical properties, energy source, materials, dimensions and cleaning method.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Electrical safety testing was conducted on the subject device in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
Performance bench testing was conducted to establish device durability over the established lifetime for:
-
cleaning between uses (reprocessing)
-
rotation load
-
cyclic load
-
connectors connection and disconnection forces.