(173 days)
No reference devices were used in this submission.
No
The document describes a radiofrequency surgical device for ENT procedures and does not mention any AI or ML capabilities.
Yes.
The device is indicated for medical procedures such as ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels, which are therapeutic actions to treat medical conditions.
No.
The device is described as a radiofrequency (RF) surgical device indicated for ablation, resection, and coagulation of soft tissue, and hemostasis of blood vessels during ENT surgical procedures. Its purpose is to treat or alter tissue, not to diagnose conditions.
No
The device description explicitly states it is a radiofrequency (RF) surgical device with physical components like handles, shafts, electrodes, and tubing. It also mentions hardware testing (thermal, drop, electrical safety, EMC) and explicitly states "Software Verification and Validation Testing was not applicable."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for ablation, resection, coagulation, and hemostasis of soft tissue and blood vessels during ENT surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is described as a radiofrequency (RF) surgical device that performs physical actions on tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from a patient, not to directly treat or alter tissue within the patient's body during surgery.
N/A
Intended Use / Indications for Use
The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- Cysts
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including Tracheal Procedures,
- Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- Tonsillectomy (including palatine tonsils)
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Product codes
NUJ
Device Description
Reprocessed ENT Coblators are radiofrequency (RF) surgical devices which are powered by an RF generator. The device is designed for the hemostasis of blood vessels, dissection, and removal of tissue during otorhinolaryngology ( ENT) surgical procedures.
ENT probes vary in their configuration depending on intended usage in their diameter, length, electrode shape, and saline delivery/suction capabilities. The materials of constructions are generally polycarbonate handles, stainless steel shafts, Polyester or Tygon insulation material, tungsten electrodes, alumina ceramic tips and PVC saline delivery/suction tubing lines
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, blood vessels in otorhinolaryngology (ENT) surgery, Adenoids, Cysts, Head, Neck, Oral, Sinuses, Mastoids, Nasopharynx, Larynx, Trachea, Neck, Palate, Tonsils, Uvula
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)
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- Cleaning
- Residual Protein and Carbohydrates O
- Visual Inspection O
- Cleaning Performance Qualification O
- Functional
- Thermal Effects Performance Testing O
- Probe Drop Performance Testing o
- Sterilization and Packaging
- EtO Sterilization Testing O
- EtO Residuals Testing O
- Simulated Shipment Testing O
- Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
Biocompatibility Testing
The devices are identical to the OEM, except for the OEM insulation which is replaced during reprocessing with Fluorinated Ethylene Propylene (FEP). The following biocompatibility tests were conducted to ensure the safety of the devices:
- Cytotoxicity
- Irritation
- Acute Systemic
- Material Mediated Pyrogenicity
- Sensitization
Reprocessing/Cleaning Residuals Testing
Even though the devices pass biocompatibility testing, additional testing was performed on the reprocessed device to ensure that detergent residuals from the reprocessing were not present on the device.
- Detergent Residuals Testing .
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- IEC 60601-1-2 EMC Testing
- IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) ●
Software Verification and Validation Testing
Software Testing is not applicable, because the device does not contain software.
Mechanical and acoustic Testing
Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed ArthroCare ENT Coblator. Instead, substantial equivalence is based upon benchtop performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2018
ReNovo. Inc. % Robert Packard President Medical Devices Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K172647
Trade/Device Name: Reprocessed ArthroCare ENT Coblator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: September 1, 2017 Received: September 1, 2017
Dear Robert Packard:
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);
1
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/MedicalDevices/DeviceRegulationandGuidance/) 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv. Jennifer R. Stevenson -53 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
2
Indications for Use
510(k) Number (if known) K172647
Device Name Reprocessed ArthroCare ENT Coblator
Indications for Use (Describe)
The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy
- Cysts
- Head, Neck, Oral, and Sinus Surgery
- Mastoidectomy
- Myringotomy with Effective Hemorrhage Control
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
- Nasopharyngeal/Laryngeal indications including Tracheal Procedures,
- Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- Neck Mass
- Papilloma Keloids
- Submucosal Palatal Shrinkage
- Submucosal Tissue Shrinkage
- Tonsillectomy (including palatine tonsils)
- Traditional Uvulopalatoplasty (RAUP)
- Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring
| 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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Reprocessed ArthroCare ENT Coblators Device Models Subject to Clearance
| OEM Model # | OEM Marketing Name | Picture | OEM
510(k) Number |
|-------------|---------------------------|------------------------|----------------------|
| EICA5872-01 | EVAC 70 XTRA WAND | Image: Endoscopic wand | K142999 |
| EICA8872-01 | PROCISE XP Wand | Image: Endoscopic wand | K142999 |
| EICA8870-01 | PROCISE EZ COBLATION Wand | Image: Endoscopic wand | K070374 |
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K127647 - 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- l. SUBMITTER ReNovo, Inc. Mark K. Wells 340 SW Columbia St. Bend OR, 97702 USA Tel: +1.541.422.8880 Fax: +1.541.422.8881
- II. CONTACT PERSON Mary Vater, BS Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: +1.913.274-9899 Email: mary@fdaecopy.com
- III. DEVICE Name of Device: Reprocessed ArthroCare ENT Coblator Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Regulation: 21 CFR §878.4400 Regulatory Class: Class II Product Classification Code: NUJ
IV PREDICATE DEVICE
| Predicate Manufacturer: | ArthroCare Corporation |
|---|---|
| Predicate Trade Name: | Evac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable |
| Predicate 510(k): | K142999 |
| Predicate Manufacturer: | ArthroCare Corporation |
| Predicate Trade Name: | ArthroCare ENT Plasma Wand |
| Predicate 510(k): | K070374 |
No reference devices were used in this submission.
V. DEVICE DESCRIPTION
Reprocessed ENT Coblators are radiofrequency (RF) surgical devices which are powered by an RF generator. The device is designed for the hemostasis of blood vessels, dissection, and removal of tissue during otorhinolaryngology ( ENT) surgical procedures.
ENT probes vary in their configuration depending on intended usage in their diameter, length, electrode shape, and saline delivery/suction capabilities. The materials of constructions are generally polycarbonate handles, stainless steel shafts, Polyester or Tygon insulation material, tungsten electrodes, alumina ceramic tips and PVC saline delivery/suction tubing lines
5
VI. INDICATIONS FOR USE
The Reprocessed ArthroCare ENT Coblators are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
- Adenoidectomy -
- -Cysts
- Head, Neck, Oral, and Sinus Surgery -
- -Mastoidectomy
- Myringotomy with Effective Hemorrhage Control -
- Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates -
- -Nasopharyngeal/Laryngeal indications including Tracheal Procedures,
- -Laryngeal Polypectomy, and Laryngeal Lesion Debulking
- -Neck Mass
- -Papilloma Keloids
- Submucosal Palatal Shrinkage -
- -Submucosal Tissue Shrinkage
- Tonsillectomy (including palatine tonsils) -
- Traditional Uvulopalatoplasty (RAUP) -
- -Tumors
- Tissue in the Uvula/Soft Palate for the Treatment of Snoring -
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The subject devices and predicate devices are identical in design, technological characteristic, materials, and indications for use. The devices have different product codes with GEI being the product code for an original, non-reprocessed endoscope accessory, and NUJ being the product code for the reprocessed version of the electrosurgical cutting and coagulation accessory..
The devices and predicate devices (K142999, K070374) are identical in the following ways:
- Regulation name: "Electrosurgical cutting and coagulation device and accessory" .
- . Regulation number: 21 CFR 878.4400
- . Regulatory Class: II
The fundamental technological characteristics of the subject devices are identical to the predicate (OEM) devices. The following characteristics were compared in order to demonstrate substantial equivalence:
- . Indications for Use - The predicate and subject devices have the same indications for use, both are indicated for "ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery" for the same surgical procedures.
- Materials - All of the materials are identical to the OEM with exception of the insulation. The OEM insulation was removed from the devices and was replaced with a Fluorinated Ethylene Propylene (FEB) insulation. The FEB insulating and electrical properties are equivalent to those properties of the OEM insulation. biocompatibility testing was performed on the devices with the new insulation material to ensure all of the materials of the reprocessed device were biocompatible.
- Design - The predicate and subject devices are identical in design.
- . Energy Source - The predicate and subject devices are both powered by the same energy source, external RF Generators.
6
- . Performance Testing - The subject devices are reprocessed versions of the predicate (OEM) devices. The OEM devices are performance-tested cleared medical devices; therefore the performance testing consisted of side-by-side testing of the reprocessed devices to an identical new OEM device. This testing included thermal performance, drop testing, and electrical safety and EMC testing.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- · Cleaning
- Residual Protein and Carbohydrates O
- Visual Inspection O
- Cleaning Performance Qualification O
- · Functional
- Thermal Effects Performance Testing O
- Probe Drop Performance Testing o
- · Sterilization and Packaging
- EtO Sterilization Testing O
- EtO Residuals Testing O
- Simulated Shipment Testing O
- · Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
Biocompatibility Testing
The devices are identical to the OEM, except for the OEM insulation which is replaced during reprocessing with Fluorinated Ethylene Propylene (FEP). The following biocompatibility tests were conducted to ensure the safety of the devices:
- Cytotoxicity
- · Irritation
- · Acute Systemic
- · Material Mediated Pyrogenicity
- · Sensitization
Reprocessing/Cleaning Residuals Testing
Even though the devices pass biocompatibility testing, additional testing was performed on the reprocessed device to ensure that detergent residuals from the reprocessing were not present on the device.
- Detergent Residuals Testing .
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- . IEC 60601-1-2 EMC Testing
- IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) ●
Software Verification and Validation Testing
Software Testing is not applicable, because the device does not contain software.
7
Mechanical and acoustic Testing
Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed ArthroCare ENT Coblator. Instead, substantial equivalence is based upon benchtop performance testing.
IX. CONCLUSIONS
Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed Reprocessed ArthroCare ENT Coblators are substantially equivalent to the predicate device.