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.

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.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (Reusable Interface Cable 1.5 m), which is an electrosurgical accessory. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed acceptance criteria and study results for clinical efficacy or sophisticated AI performance.

Therefore, the document does not contain information relevant to:

A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
Sample size used for a test set in the context of an accuracy study or provenance of data.
Number of experts for ground truth establishment or their qualifications.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
Standalone algorithm performance.
Type of ground truth (expert consensus, pathology, outcomes data).
Sample size for training set.
How ground truth for the training set was established.

Instead, the document focuses on:

Device Description: A flexible, low-loss coaxial cable connecting a Creo Medical Instrument to a CROMA Electrosurgical Generator for delivering RF and/or Microwave energy. It specifies a lifetime of 20 uses.
Intended Use/Indications for Use: Connection of compatible Creo Medical Instrument to the CROMA Electrosurgical Generator to deliver RF/Microwave energy for cutting, coagulation, and ablation of gastrointestinal tissue. This indication is stated to be the same as the predicate device, with reworded readability.
Technological Comparison: The subject device is a reusable version of the predicate device. The conductor cable was modified for durability while maintaining identical electrical properties. Principles of operation, electrical properties, energy source, materials, dimensions, and cleaning methods are identical to the predicate.
Non-Clinical Tests:
- Electrical safety testing: Conducted in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
- Performance bench testing: Conducted to establish device durability over its established lifetime for:
  - Cleaning between uses (reprocessing)
  - Rotation load
  - Cyclic load
  - Connector connection and disconnection forces.

Conclusion:

This submission is for an accessory device (cable) that facilitates the use of an electrosurgical unit. The "acceptance criteria" and "study" described are primarily related to electrical safety and physical durability/reusability of the cable, ensuring it functions as intended for its specified lifespan and remains substantially equivalent to the predicate device. It does not involve complex performance metrics or clinical studies in the context of diagnostic accuracy or AI-driven decision support.

Since the provided text does not contain the requested information about diagnostic performance, AI, or specific clinical study details as implied by the questions, I cannot populate the table or answer those specific points. The information available is about engineering and regulatory compliance testing for a reusable medical cable.

Summary

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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)

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.

Regulation Number and Section

§ 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).