The bipolar applicator, in combination with the compatible electrosurgical generator, is indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Device Description

The CELON ProCurve V is a bipolar applicator that uses Radiofrequency Induced Thermotherapy (RFITT) technology for treating varicose veins. The medical purpose of the Radiofrequency Induced Thermotherapy is to achieve controlled tissue coagulation. The CELON ProCurve V is used in conjunction with a compatible generator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Bipolar applicator "CELON ProCurve V"
Intended Use: Endovascular coagulation of blood vessels in patients with superficial vein reflux, in combination with a compatible electrosurgical generator.

Acceptance Criteria and Reported Device Performance

The provided document describes various performance tests conducted to establish substantial equivalence. These tests serve as the basis for the acceptance criteria.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 standards for:	Successfully tested or assessed for all listed biocompatibility and hemocompatibility tests.
	- Cytotoxicity
	- Chemical Analysis
	- Sensitization (biological-toxicological eval)
	- Irritation (biological-toxicological eval)
	- Acute systemic toxicity (biological-toxicological eval)
	- In vitro Hemocompatibility (thrombogenicity)
	- Hemolysis
Electrical Safety & EMC	Compliance with recognized 60601 standards (e.g., AAMI/ANSI ES 60601-1:2005, IEC 60601-1-2)	Complies with recognized 60601 standards.
Thermal Safety	Compliance with recognized standard IEC 60601-2-2.	Complies with recognized standard IEC 60601-2-2.
Functional Performance	Device functions as intended and meets design specifications.	Verification and comparison bench studies conducted; results confirm functionality and design specification adherence.
Stability/Shelf-life	Maintains functionality and meets specifications over stated shelf-life.	Accelerated age testing successful, demonstrating stability for the stated shelf-life (3.25 years). Real-time testing in progress.
Environmental/Shipping	Tolerates environmental conditions and shipping.	Samples subjected to environmental conditioning and ship testing; implicit success as "all tests passed."
Tissue Effects	Comparable performance and tissue effects to the predicate device in relevant aspects.	Ex vivo bench tests demonstrated comparable performance and tissue effects to the predicate device across various generator modes, power settings, and tissue types (porcine muscle, liver, kidney, intraluminal animal tissue). All tests passed.
Usability/Risk Management	User interface assessed, hazardous situations mitigated, residual risk acceptable.	Assessed according to risk management plan; use-related hazardous situations assessed, risk mitigation defined, and residual risk evaluated as acceptable (based on ISO 14971:2007).
Sterilization	Achieves a sterility assurance level (SAL) of 10^-6^ for sterilization.	Sterilization (ionizing radiation/GAMMA rays) validated to ISO 11137-1, achieving a SAL of 10^-6^. Packaging conforms to ISO 11607-1.

Study Details

The primary study supporting the "CELON ProCurve V" is a series of non-clinical and preclinical performance tests.

Sample Size used for the test set and the data provenance:
- Biocompatibility: Not explicitly stated as a "sample size" in terms of number of devices, but rather the tests performed on "patient contacting materials." The provenance is indicated by compliance with ISO 10993 international standards and FDA guidance.
- Electrical Safety, EMC, Thermal Safety: Compliance with standards is stated, implying testing against those criteria. Sample size for these electrical/physical tests is typically a representative number of devices, but not specified in the document.
- Performance (Functional): Verification and comparison bench studies were conducted. Sample size not specified.
- Stability: "Sterile samples" were subjected to accelerated aging; "samples" were also subjected to environmental conditioning and ship testing. Specific numbers not provided.
- Preclinical (Simulated Use/Tissue Effects):
  - "three generator modes and three power settings which were applied five times to each of three different types of tissue" (porcine muscle, liver, and kidney). This means 3 x 3 x 5 x 3 = 135 applications to tissue.
  - "ten ex vivo bench tests based on three generator modes and three power settings were applied to intraluminal animal tissue." This means 10 x 3 x 3 = 90 applications to intraluminal animal tissue.
  - Data Provenance: The tissue types specified are porcine (pig) and generic "animal tissue" for intraluminal use. This indicates ex-vivo (outside a living organism) animal tissue studies. The document does not specify a country of origin for the data, but the manufacturer is German.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes "quantitative and qualitative assessment" for tissue effects and "assessment of non-clinical performance data" for substantial equivalence. It also mentions "risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007."
- Not explicitly stated. The evaluation of tissue effects and comparison to the predicate device would typically involve trained personnel in a laboratory setting, but the number and specific qualifications (e.g., histology technicians, engineers, medical professionals assessing tissue changes) are not provided. The assessment of risk and usability would involve different experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None explicitly stated. The document refers to "assessment" and "comparing" performance to the predicate. This suggests laboratory-based evaluations against defined metrics rather than a multi-reader adjudication process typically seen in image analysis or diagnostic studies.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was NOT done. This device is an electrosurgical applicator, not an AI-powered diagnostic or assistive tool. The studies focused on the performance of the device itself, not human interaction with an AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was assessed for the device. The primary performance testing (biocompatibility, electrical, thermal, functional, stability, tissue effects) evaluated the device's intrinsic characteristics and output without direct continuous human intervention during the "use" phase of the test (though humans operate the device for the test). The device itself (CELON ProCurve V) does not contain software and thus isn't an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and comparative performance to a legally marketed predicate device. For tissue effects, the ground truth was the observed effect on various tissue types (e.g., coagulation pattern, lesion size, thermal spread) which was then compared to the effects produced by the predicate device. For other tests (electrosurgical, biocompatibility), the ground truth was compliance with recognized international standards and internal design specifications.
The sample size for the training set:
- Not applicable. This device is a hardware medical device and does not involve machine learning or AI models that require a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.

Summary

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November 16, 2017 Olympus Winter & Ibe GmbH % Dolan Mills Sr. Specialist, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road Southborough, Massachusetts 01772

Re: K172535

Trade/Device Name: Bipolar applicator "CELON ProCurve V" Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 10, 2017 Received: November 13, 2017

Dear Dolan Mills:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172535

Device Name

Bipolar applicator "CELON ProCurve V"

Indications for Use (Describe)

The bipolar applicator, in combination with the compatible electrosurgical generator, is indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Notification

K172535

510(k) Summary of Safety and Effectiveness

November 10, 2017

2.1 General Information

Manufacturer:	Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermanyEstablishment Registration Number: 9610773
Official Correspondent:	Dolan MillsSr. Specialist, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 901.373.0236Fax: 901.373.0220Email: dolan.mills@olympus-osta.comEstablishment Registration Number: 300379030

2.2 Device Identification

Proprietary name:	Bipolar applicator "CELON ProCurve V"
Common name:	CELON ProCurve V
Device Classification name:	Electrosurgical, Cutting & Coagulation &Accessories
Review Panel:	General & Plastic Surgery
Regulation Number:	21 CFR 878.4400
Device class:	Class II
Product code:	GEI

Model Number: WB990207

2.3 Predicate Device

The CELON ProCurve V is considered substantially equivalent to K111887, GEI, 21CFR 878.4400:

Covidien (Medtronic) CLOSUREFAST™ ENDOVENOUS RADIOFREQUENCY ABLATION CATHETER

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According to public information this device is currently available in the US market and is designed to be used for endovascular coagulation of blood vessels in patients with superficial vein reflux.

No reference devices were used in this submission.

2.4 Device Description

2.5 Indications for Use

The subject device has the same intended use as the predicate device.

"The bipolar applicator, in combination with the compatible electrosurgical generator, is indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux."

2.6 Comparison of Technological Characteristics

The technological characteristics of the CELON ProCurve V are considered equivalent to the predicate device. Both the CELON ProCurve V and the predicate device share the following characteristics:

fundamental scientific technology (bipolar electrosurgery)
principles of operation (endovascular coagulation of blood vessels with a ● catheter electrode)
used in conjunction with an electrosurgical generator.
Comparative testing demonstrated that the subject device has equivalent performance to the predicate in respect to applicable modes.

The following differences to the predicate device exist:

While using radiofrequency technology for coagulation, the predicate . device uses the heat generated through the radiofrequency current.
While the CELON ProCurve V is pulled slowly and steadily back through the vein and activated the whole time, the predicate device is placed at the first desired position and activated. Afterwards the predicate devices is

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pulled back further until the next desired position within the vein and activated again.

minor dimensional differences exist between the subject and the predicate device
As stated above, the subject and proposed predicate devices have similar design characteristics and show comparable performance. As demonstrated in the nonclinical testing (e.g., biocompatibility, tissue effects), the different technological characteristics do not negatively affect the safety and effectiveness of the subject device.

2.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognized international standards.

Performance data was prepared in accordance with the FDA guidance. Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016. The guidance was followed for all relevant sections.

2.7.1 Biocompatibility testing

The patient contacting materials of the CELON ProCurve V have been successfully tested or assessed for biocompatibility in the following tests in compliance with ISO 10993 standards:

-Cytotoxicity
Chemical Analysis -
Sensitization assessed by biological-toxicological evaluation -
-Irritation – assessed by biological-toxicological evaluation
Acute systemic toxicity assessed by biological-toxicological evaluation
In vitro Hemocompatibility (thrombogenicity) -
Hemolysis -

Testing was done in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"", CDRH June 16, 2016.

The device is considered external communicating, blood path / indirect, for a duration of less than 24 hours.

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Traditional 510(k) Notification

2.7.2 Electrical safety and electromagnetic compatibility (EMC)

The design of the CELON ProCurve V complies with recognized 60601 standards as listed in section 2.7.8.

The FDA guidance "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices", CDRH July 11, 2016 has been followed.

Thermal Safety 2.7.3

The design of the CELON ProCurve V complies with recognized standard IEC 60601-2-2 as listed in section 2.7.8.

2.7.4 Clinical Studies

Clinical and animal studies were not necessary.

2.7.5 Software

The CELON ProCurve V does not contain software.

Performance Testing Bench 2.7.6

Performance tests were executed to ensure that the device functioned as intended and met design specifications. The following non-clinical and preclinical tests were conducted:

non-clinical (electrical, dimensional, functional, biocompatibility, stability) 2) preclinical (simulated use) evaluation and testing of tissue effects and thermal safety

Non-clinical: Basic safety and performance testing was performed in accordance with IEC standards. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.

Stability: Sterile samples were subjected to accelerated aging to confirm that the disposable devices maintain functionality and continue to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Samples were also subjected to environmental conditioning and ship testing.

Preclinical: Evidence obtained from preclinical simulated use studies demonstrate that the device performs substantially equivalent to the predicate device in relevant aspects associated with usability, tissue effects, and thermal effects. For simulated use testing, three tissue types (porcine muscle, liver, and kidney) were evaluated in all applicable modes. The quality of intraluminal use was also verified for the applicable modes. The tissue effects testing included quantitative and qualitative assessment.

The ex vivo bench tests were based on three generator modes and three power settings which were applied five times to each of three different types of tissue. The

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testing demonstrated comparable performance and tissue effects to the predicate. Additionally, in order to verify the quality of the intraluminal use ten ex vivo bench tests based on three generator modes and three power settings were applied to intraluminal animal tissue which also showed comparable performance and tissue effects. All tests passed.

To demonstrate substantial equivalence tissue effects were compared during comparative validation testing. The simulated use testing established substantial equivalence with the predicate device for the intended use based on an assessment of non-clinical performance data, as per 807.92(b).

These comprehensive validation bench tests support equivalence to the predicate device. Testing confirmed that comparable tissue effects could be achieved for applicable modes of operation.

Usability and user interface was also assessed according to the risk management plan. The assessment was based on Olympus predecessor product. Use-related hazardous situations were assessed and risk mitigation measures in terms of usability design for safety were defined. The residual risk was evaluated as acceptable. Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007.

2.7.7 Reprocessing/ Sterilization

The CELON ProCurve V is sold in sterile condition and is defined as single use only and to be disposed of after use. Sterilization is performed according to ISO 11137-1 and packaging conforms to ISO 11607-1. The ionizing radiation (GAMMA rays) sterilization cycle has been validated. A sterility assurance level (SAL) of 10° was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices. Shelf Life testing was conducted, including performance testing and package integrity testing, to support a shelf life of 3.25 years for the CELON ProCurve V.

Standard No.	Standard Title	FDA-Recognitionno + date
AAMI/ANSI ES60601-1:2005 andA1:2012, C1:2009and A2:2010	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD)	19-407/09/2014

2.7.8 Applied standards

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Standard No.	Standard Title	FDA-Recognitionno + date
IEC 60601-1-2Ed. 3.0 b: 2007	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests	19-106/27/2016
IEC 60601-2-2Ed. 5.0: 2009	Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipment andhigh frequency surgical accessories [Including:Technical Corrigendum 1 (2014)]	6-33601/27/2015
IEC 60601-1-6Ed. 3.1: 2013	Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability	5-8906/27/2016
ISO 14971Second edition 2007	Medical devices - Application of risk management tomedical devices	5-4006/27/2016
ISO 10993-1 FourthEdition 2009-10-15	Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process	2-22007/26/2016
ISO 11607-1 FirstEdition 2006	Packaging for terminally sterilized medical devices - Part1: Requirements for materials, sterile barrier systems andpackaging systems [Including: Amendment 1 (2014)]	14-45401/27/2015
ISO 11137-1 FirstEdition 2006	Sterilization of health care products - Radiation - Part 1:Requirements for development, validation and routinecontrol of a sterilization process for medical devices[Including: Amendment 1 (2013)]	14-42804/04/2016
IEC 62366 Edition 1.12014-01	Consolidated Version Medical Devices - Application OfUsability Engineering To Medical Devices.	5-8712/23/2016
ISO 10993-4 SecondEdition 2002-10-15AMENDMENT 1	Biological Evaluation Of Medical Devices - Part 4:Selection Of Tests For Interaction With Blood[Including: Amendment 1 (2006)].	2-23507/26/2016
AAMI ANSI ISO10993-5:2009/ (R)2014	Biological Evaluation Of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity	2-15307/26/2016
ISO 10993-12 FourthEdition 2012-07-01	Biological Evaluation Of Medical Devices - Part 12:Sample Preparation And Reference Materials	2-19107/26/2016
ISO 10555-1Second Edition2013.06 15	Intravascular Catheters -- Sterile And Single-UseIntravascular Catheters -- Part 1: General Requirements.(General Plastic Surgery/General Hospital)	6-30108/14/2015

Table 2.1.8: Applied standards

2.8 Conclusion

The performance data supports the safety of the device and demonstrates that the subject device complies with the recognized standards as specified.

In summary, we believe the CELON ProCurve V is substantially equivalent to the predicate device with respect to the general design approach, function, and the intended use. Differences between subject device and predicate do not negatively affect the safety and effectiveness of the subject device and raise no new questions of safety or effectiveness.

Regulation Number and Section

§ 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.