This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:

CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates
CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
CelonProSleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Description

The Celon ENT System is comprised of a power control unit (CelonLab EN7) and bipolar coagulation electrodes. The CelonLab ENT power control unit delivers a bipolar output via the bipolar coagulation electrodes of type CelonProBreath, CelonProSleep, and CelonProSleep PLUS. A neutral electrode (return conductor) is not required. The power control unit is user-friendly with a user display showing all the necessary process parameters. After switching on the equipment, the user selects the level of power and activates the radio frequency (RF) current by depressing the foot switch. The power control unit delivers an acoustic signal as an indicator of the coaqulation status. Usually, general electrosurgical units have a fixed activation tone. However, in the case of the CelonLab ENT power control unit, the frequency of the acoustic signal is proportional to the tissue impedance. This permits acoustic monitoring of the coagulation status by the operator, since the latter is directly correlated with the impedance. If the impedance increases above a certain limit, signifying that the coagulation process is complete, this is additionally indicated by a clock pulsed sound and the power output is ceased automatically. Overdose effects in the treated tissue area are excluded by this power control function. The procedure time will be set automatically by the power control unit. The time interval between activation of the power control unit and the end of the coagulation procedure depends on applicator type, tissue properties and power setting, and can vary between 3 seconds and several minutes.

Accessories included with the power control unit include a line power cable and single pedal foot pedal (CelonFootSwitch).

AI/ML Overview

The provided text reports a 510(k) summary for the Celon ENT System, which is an electrosurgical device. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria against a predefined set of acceptance criteria with a formal study.

Therefore, a table of acceptance criteria and proven device performance as requested cannot be directly extracted or inferred.

Here's an analysis of other requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific power output range with associated tolerance) and an explicit study designed to prove the device meets these. Instead, it asserts substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general safety and biocompatibility standards.

2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a clinical or performance "test set" in the context of statistical evaluation for specific performance metrics. The submission focuses on regulatory compliance and equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "test set" and associated ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No "test set" and adjudication method is described.

5. 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:
Not applicable. The Celon ENT System is an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. As an electrosurgical device, it is inherently a human-in-the-loop system. There is no standalone algorithm performance that would be applicable to this device type.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. There is no mention of specific ground truth used for performance validation in the manner typically applied to diagnostic or AI-based devices. The "performance validation testing" mentioned generally refers to ensuring the device operates as intended and is safe, rather than validating against a clinical ground truth for a specific medical condition.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of medical device.

Summary of Device and Regulatory Basis:

The K032838 submission for the Celon ENT System primarily asserts substantial equivalence to legally marketed predicate devices (ArthroCare AccENT Electrosurgery System, ArthroCare ENTec Reflex Wand Electrodes, Somnus Somnoplasty System). The basis for this claim includes:

Intended Use: The Celon ENT System has the same intended use as the predicate devices, specifically for ablation and coagulation of soft tissue in ENT surgery (submucosal tissue shrinkage for nasal airway obstruction and snoring treatment).
Technological Characteristics: The device is described as a bipolar electrosurgical coagulation device with an automatic power control, similar to the predicate devices. Key features include a power control unit (CelonLab EN7) and bipolar coagulation electrodes (CelonProBreath, CelonProSleep, CelonProSleep PLUS).
Compliance with Standards: The materials and design comply with international electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF-18) and biocompatibility standards (ISO 10993 or USP 23 Class VI) for patient-contacting components.
Performance Validation Testing: The document states that "performance validation testing has been done to validate the performance of the device." However, the specifics of this testing, including acceptance criteria or study design, are not provided in this summary. This type of testing typically involves bench testing to confirm power output specifications, safety features, and functional performance, rather than a clinical trial with statistical performance metrics against a defined ground truth.

In essence, the submission relies on demonstrating that the new device is as safe and effective as existing legally marketed devices through design, material, and functional similarities, rather than presenting a de novo performance study against explicit acceptance criteria.

Summary

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SEP 2 6 2003

K032838 (pg 1 of 4)

510(k) Summary of Safety and Effectiveness

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.92

Submitter:	Celon AG medical instrumentsRheinstrasse 814513 TeltowGermany
Contact Person:	André Roggan, Ph. D.Director Research and Development
	Phone: +49-3328-3519-0Fax: +49-3328-3519-23
United States Agent:	Donald R. Bruce1005 California Ave.San Jose, CA 95125
	Phone: 408-691-6333Fax: 408-294-5258
Date Summary Prepared:	June 27th, 2003
Product Identification
Proprietary Name:	Celon ENT System
Classification Name:	Electrosurgical cutting and coagulationdevice and accessories (21 CFR 878.4400)
Common Name:	Electrosurgical Device and Accessories
Manufacturer:	Celon AG medical instrumentRheinstrasse 814513 TeltowGermany
Distributor:	pending

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$$\text{אַנון געון געון אַזאַז אַז אַז}$$

Legally Marketed Device:

The Celon ENT System is of comparable type and is substantially equivalent to the following currently marketed devices:

Device	510(k) Number	Date Cleared
ArthroCare AccENT Electrosurgery System	K973478	January 9th, 1998
ArthroCare ENTec Reflex Wand Electrodes	K000036	February 4th, 2000
ArthroCare ENTec Reflex Wand Electrodes	K000778	May 3rd, 2000
Somnus Somnoplasty System	K971450	July 17th, 1997
Somnus Somnoplasty System	K973618	December 19th, 1997

It complies with the same or equivalent standards and has the same intended use.

Device Description

Accessories included with the power control unit include a line power cable and single pedal foot pedal (CelonFootSwitch).

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K032838 (pg 3 of 4)

Materials: Materials and construction of the Celon ENT System are compliant with the international electrical safety standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and the American national standard ANSI/AAMI HF-18. Additionally, the materials used in the design and construction of the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, which have direct contact with the patient, are biocompatible according to ISO 10993 or USP 23 Class VI.

Design: The system is designed to be a bipolar electrosurgical coagulation device with an automatic power control, including automatic output power reduction and acoustic monitoring of coagulation status.

Intended Use of the Device

This Celon ENT System has the same intended use as the legally marketed devices. This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including:

CelonProBreath:	Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates
CelonProSleep:	Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
CelonProSleep PLUS:	Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

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K032838

Comparison with Legally Marketed Device:

It is the opinion of Celon AG medical instruments that the Celon ENT System is of a type and substantially equivalent to legally marketed devices with respect to intended use and technological characteristics. It will comply with the safety requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF-18 and applicable collateral and particular standards. Furthermore, the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, which have direct contact with the patient, are biocompatible according to ISO 10993 or USP 23 Class VI. In addition, performance validation testing has been done to validate the performance of the device. The comparison results presented in this 510(k) notification show that the device is substantially equivalent to legally marketed devices and is safe and effective in its intended use.

Conclusions

The Celon ENT System does not result in any new potential safety risks and performs as well as or better than devices legally on the market. Celon AG medical instruments consider the Celon ENT System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

Legal Notice

CelonProBreath® and CelonProSleep® are registered trademarks of Celon AG medical instruments.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, composed of three thick, curved lines.

Public Health Service

SEP 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Celon AG Medical Instruments c/o Ms. Pamela Gwynn Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K032838

Trade/Device Name: Celon ENT System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2003 Received: September 11, 2003

Dear Ms. Gwynn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Pamela Gwynn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use 6

510(k) Number:	pending KC32838
----------------	-----------------

Device Name:

Celon ENT System

Indications For Use:

CelonProBreath:	Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates
CelonProSleep:	Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring
CelonProSleep PLUS:	Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
OR Over-The-Counter Use

(Per 21 CFR 801.109)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K032838
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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.