Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bipolar electrosurgical electrode and its intended use for ablation and coagulation. There is no mention of AI or ML in the device description, intended use, or performance studies. The device appears to be a standard electrosurgical instrument.

Therapeutic

Yes
The device is indicated for "ablation and coagulation of soft tissue" and "submucosal tissue shrinkage and tissue coagulation" for conditions like snoring and hypertrophic nasal turbinates, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is an electrosurgical instrument indicated for ablation and coagulation of soft tissue, primarily for therapeutic purposes (tissue shrinkage and coagulation), not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is an electrosurgical instrument (hardware) and is provided sterile and is single-use, indicating a physical component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery." This involves direct interaction with the patient's body for therapeutic purposes.
Device Description: The device is described as an "electrosurgical instrument" used for tissue modification.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are designed for testing samples in vitro.

Therefore, the Sutter RaVoR™ Bipolar Electrodes are a surgical device used in vivo (within the living body), not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar Electrodes are indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery.
The RaVoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring.
The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments available in different angled sheath configurations. They are to be connected to the bipolar output of the Sutter CURIS® RF Generator. The electrodes are provided sterile and are single-use devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue in otorhinolaryngology (ENT) surgery (uvula/soft palate, nasal turbinates)

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)

Bench Testing:

Electromagnetic Compatibility and Electrical Safety: Pass
Mechanical strength: Pass
System Performance /Bench-top validation testing: Pass
Thermal effects on tissue: Pass
Transport and Storage: Pass

Electrical and electromagnetic tests have been performed to demonstrate that design specifications and performance requirements are met. Compliance to the voluntary standards IEC 60601-1 (AAMI/ANSI ES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 has been shown.
Shelf-life testing has been conducted in accordance to of FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" – Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. Sutter RaVoR™ Bipolar Electrodes have been subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for up to 3 years.
Biological evaluation and Biocompatibility testing has been performed in compliance to ISO 10993-1 Fourth edition 2009-10-15, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”.
Thermal damage / thermal spread experiments were performed for the subject and predicate device. It was possible to examine and determine the tissue cool-down time from RF activation to baseline temperature. Furthermore, results of these experiments showed that subject and predicate device generate comparable thermal effects in tissue with regards to lesion size and cool-down time.
No animal studies have been performed.
No clinical studies have been performed.

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.

K032838

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

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes 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 30, 2019

Sutter Medizintechnik GmbH Ulrike Zeissler Manager Regulatory Affairs Tullastrasse 87 79108 Freiburg, Germany

Re: K191732

Trade/Device Name: Sutter RaVoR Bipolar Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 25, 2019 Received: June 28, 2019

Dear Ulrike Zeissler:

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. 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 located 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.

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

1

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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).

Sincerely,

for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191732

Device Name Sutter RaVoR™ Bipolar Electrodes

Indications for Use (Describe)

Sutter RaVoR™ Bipolar Electrodes are to be connected to the Sutter CURIS® RF Generator. Sutter Ra VoR™ Bipolar Electrodes are indicated for ablation of soft tissue in otorhinolaryngology (ENT) surgery.

The Ra VoR™ Bipolar Electrode for the soft palate is indicated for submucosal tissue coagulation in the uvula/soft palate for the treatment of snoring.

The RaVoR™ Bipolar Electrode for the turbinates is indicated for submucosal tissue shrinkage for reduction of hypertrophic nasal turbinates in patients with nasal turbinate airway obstruction.

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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510(k) Summary

Section 807.92

Date:	August 29, 2019
Submitter:	Name:
Address:	SUTTER MEDIZINTECHNIK GmbH
Tullastrasse 87
79108 Freiburg
Germany
	Contact person:
Titel:
Telephone:
Fax:	Ulrike Zeissler
Manager Regulatory Affairs
+49 (0) 761 51551-14
+49 (0) 761 51551-30
Product:	Trade Name:
Common Name:
Classification
name:
Product Code:	Sutter RaVoR™ Bipolar Electrodes
Bipolar Electrodes
Electrosurgical, cutting & coagulation &
accessories
GEI
	Regulation
Number:
Classification:
Classification
Panel:	CFR 21 § 878.4400
Class II
General and Plastic Surgery
Predicate
Device:	Predicate device to which Sutter RaVoR™ Bipolar Electrodes are
claimed to be substantially equivalent is manufactured by Celon AG medical instruments, Celon ENT System (K032838)
Device
Description:	Sutter RaVoR™ Bipolar Electrodes are electrosurgical instruments
available in different angled sheath configurations. They are to be
connected to the bipolar output of the Sutter CURIS® RF Generator. The
electrodes are provided sterile and are single-use devices.
Indications
for Use:	Sutter RaVoR™ Bipolar Electrodes are to be connected to the bipolar
output of the Sutter CURIS® RF Generator. Sutter RaVoR™ Bipolar
Electrodes are indicated for ablation and coagulation of soft tissue in
otorhinolaryngology (ENT) surgery.
The RaVoR™ Bipolar Electrode for the soft palate is indicated for
submucosal tissue shrinkage and tissue coagulation in the uvula/soft
palate for the treatment of snoring.
The RaVoR™ Bipolar Electrode for the turbinates is indicated for
submucosal tissue shrinkage for reduction of hypertrophic nasal
turbinates in patients with nasal turbinate airway obstruction.

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES

| Techno-
logical
Characteris-
tics: | The table below provides a comparison between the subject device and
the predicate device | | | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sutter RaVOR™
Bipolar Electrodes | Predicate device
K032838 | Discussion | | |
| | Indication for
Use | Sutter RaVOR™
Bipolar Electrodes are
to be connected to the
bipolar output of the
Sutter CURIS® RF
Generator. Sutter
RaVoR™ Bipolar
Electrodes are
indicated for ablation
and coagulation of soft
tissue in
otorhinolaryngology
(ENT) surgery.

The RaVoR™ Bipolar
Electrode for the soft
palate is indicated for
submucosal tissue
shrinkage and tissue
coagulation in the
uvula/soft palate for
the treatment of
snoring.

The RaVoR™ Bipolar
Electrode for the
turbinates is indicated
for submucosal tissue
shrinkage for reduction
of hypertrophic nasal
turbinates in patients
with nasal turbinate
airway obstruction. | This application
system, comprising the
CelonLab ENT power
control unit and the
CelonProBreafh,
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.

CelonPro Sleep PLUS:
Submucosal tissue
shrinkage and tissue
coagulation in the
uvula/soft palate for
the treatment of
snoring.

Bench Testing
Performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH

DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES

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| Electromagnetic Compatibility and Electrical Safety Testing
Electrical and electromagnetic tests have been performed to
demonstrate that design specifications and performance requirements
are met. Compliance to the voluntary standards IEC 60601-1
(AAMI/ANSI ES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 has

been shown.
Sterilization
Sutter RaVoR™ Bipolar Electrodes are sterilized by using a validated
ethylene oxide cycle. The sterilization cycle has been validated to
ensure a sterility level of (SAL) 10-6 in accordance with ISO 11137-1
and ISO 11137-2.
Shelf Life Testing
Shelf-life testing has been conducted in accordance to of FDA
guidance: "Premarket Notification [510(k)] Submissions for
Electrosurgical Devices for General Surgery" – Guidance for Industry
and Food and Drug Administration Staff, August 15, 2016. Sutter
RaVoR™ Bipolar Electrodes have been subjected to accelerated aging.
The aging studies established that the device and packaging remain
functional and maintain sterility for up to 3 years.
Biocompatibility Testing
Biological evaluation and Biocompatibility testing has been performed in
compliance to ISO 10993-1 Fourth edition 2009-10-15, “Biological
evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process”.
Thermal damage / thermal spread testing
Thermal damage / thermal spread experiments were performed for the
subject and predicate device. It was possible to examine and determine
the tissue cool-down time from RF activation to baseline temperature.
Furthermore, results of these experiments showed that subject and
predicate device generate comparable thermal effects in tissue with
regards to lesion size and cool-down time.
Animal Studies
No animal studies have been performed as appropriate verification and
validation of the subject device has been achieved based on
comparison to the predicate device and from results of the bench
testing, biocompatibility evaluation, and electrical/safety testing.
Clinical Studies
No clinical studies have been performed as appropriate verification and
validation of the subject device has been achieved based on
comparison to the predicate device and from results of the bench
testing, biocompatibility evaluation, and electrical/safety testing.
Conclusion:	In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR
Part 807 and based on the similarity to the predicate device in terms of
technology, performance, and indications for use, Sutter Medizintechnik
GmbH concludes that the subject device, Sutter RaVoR™ Bipolar
Electrodes, does not raise any issues of safety or effectiveness and are
substantially equivalent to the predicate device as described above.

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH

DEVICES: SUTTER RaVoR™ BIPOLAR ELECTRODES