ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)

K152702 · Ent Biotech Solutions · GEI · Feb 18, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152702
• Device Name: ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
• Applicant: Ent Biotech Solutions
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elasso™ tissue removal device is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including de-bulking of adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).

Device Story

Elasso is a single-use, sterile surgical accessory for ENT procedures; used with external electrosurgical generator, monopolar cord, and patient return electrode. Device features forceps-like geometry with integrated loop electrode at distal tip; proximal end connects to generator via banana plug. Operated by surgeon via generator footswitch. Device delivers RF energy to soft tissue to perform cutting and coagulation. Forceps design facilitates tissue access and manipulation. Benefits include effective tissue de-bulking and coagulation during tonsillectomy and adenoidectomy. Used in clinical/surgical settings.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included mechanical, electrical safety/EMC, operational, in-vivo evaluation, ex-vivo thermal effects on tissue, thermal modeling, usability/access, biocompatibility, and sterility/shelf-life. Thermal spread of Elasso was compared to the predicate and found not to significantly exceed it.

Technological Characteristics

Electrosurgical instrument using RF energy. Materials: metal electrode, polymer insulator. Dimensions: 200.4mm length. Connectivity: wired to external generator. Sterilization: Gamma radiation (ISO 11137-1:2006, ISO 11137-2:2006). Electrical standards: IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-2-2:2009. Biocompatibility: ISO 10993-1:2009.

Indications for Use

Indicated for patients requiring ENT surgery, specifically for cutting and coagulation of soft tissue including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).

Regulatory Classification

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.

Predicate Devices

• PEAK Plasmablade™ TNA Tonsil and Adenoid Tissue Dissection Device (K083415)

Reference Devices

• St. Clair Forceps

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2016

Ent Biotech Solutions Laura Yamada Regulatory Affairs 75 Lewiston Road Gross Pointe Farms, Michigan 48236

Re: K152702

Trade/Device Name: ENT Biotech Solutions Tissue Removal Device (Elasso) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 15, 2016 Received: January 19, 2016

Dear Ms. Yamada:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Eric A. Mann -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K152702

Device Name

ENT Biotech Solutions Tissue Removal Device (Elasso™)

Indications for Use (Describe)

The ENT Biotech Solutions Tissue Removal Device (Elasso™) is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).

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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| Category | Comments |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | September 8, 2015 |
| Applicant: | ENT Biotech Solutions, INC<br>75 Lewiston Road<br>Grosse Pointe Farms, MI 48236<br>USA<br>Tel: [phone]<br>Email: [e-mail] |
| Applicant's Contact Information: | Laura Yamada or Andrea Dickson<br>Email: [e-mail] |
| Device Trade/ Proprietary Name: | ENT Biotech Solutions tissue removal device<br>(Elasso™) |
| Device Common Name: | Electrosurgical, Cutting & Coagulation Device<br>& Accessories |
| Device Product Code: | GEI |
| Device Classification / Name: | II / Electrosurgical, Cutting & Coagulation<br>Device & Accessories |
| CFR Citation: | 21 CFR 878.4400 |

#### Premarket Notification [510(k)] Summary

#### Substantial Equivalence Device Information

| Predicate Device(s): | PEAK Plasmablade™™ TNA Tonsil and Adenoid<br>Tissue Dissection Device |
|-----------------------------------------------------|---------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Medtronic (Formerly PEAK Surgical, Inc) |
| 510(k) Number: | K083415 |
| Predicate Device Common Name: | Electrosurgical, Cutting & Coagulation Device<br>& Accessories |
| Predicate Device Classification Name &<br>Citation: | Electrosurgical, Cutting & Coagulation Device &<br>Accessories, 21 CFR 878.4400 |

#### 510(k) Summary - Predicate Device Information

# Description of the Device

The ENT Biotech Solutions tissue removal device (also referred to as the "Elasso™") is a single-use, surgical accessory, used with a recommended electrosurgical generator (not supplied by ENT Biotech Solutions, INC) and associated equipment (monopolar cord and patient return electrode). The Elasso device configuration is similar to a standard forceps geometry (patterned after the commercially available reference device, St. Clair Forceps), but with an integrated loop electrode at the distal tip of one of the forceps. The proximal

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end contains a single banana pluq. for connection to the generator. The hand piece is operated by the generator's footswitch controller.

The Elasso™ is a single-use, sterile packaged device.

# Indications for Use / Intended Use

The Elasso™ tissue removal device is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including de-bulking of adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).

### Technological Characteristics

The Elasso™ device is similar to the predicate device in that they are both electrosurgical instruments used to cut and coagulate soft tissue utilizing RF energy. The Elasso device differs from the PEAK device in the hand piece design. However, both devices incorporate partially exposed electrode elements which allow for application of RF energy, such that the principles of operation involved in cutting and coagulation of tissue are the same on either device with respect to energy density. Also, the results of a comparison study indicate that the thermal spread produced by the Elasso device across its specified use settings does not significantly exceed the thermal spread produced by the predicate device. In addition, the Elasso's forceplike design is patterned after the geometry of the commercially available reference device. St. Clair Forceps device which is used to remove adult and pediatric tissue and has been over many decades as an acceptable tool for access to the indicated tissues. The differences identified do not present any new concerns of safety and effectiveness.

| Description | Predicate | ENT Biotech Solutions |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use | Intended to be used for the<br>cutting and coagulation of soft<br>tissue during otolaryngology<br>(ENT) surgery including<br>adenoidectomy and<br>tonsillectomy (Pharyngeal,<br>Tubal, Palatine). | Intended to be used for the<br>cutting and coagulation of soft<br>tissue during otolaryngology<br>(ENT) surgery including de-<br>bulking of adenoid and tonsil<br>tissue (Pharyngeal, Tubal, and<br>Palatine). |
| Principles of operation | Electrosurgical cutting and<br>coagulation device intended to<br>remove tissue and coagulate by<br>use of radio frequency (RF)<br>energy. | Same |
| Anatomical Site | Soft Tissue in ENT surgeries | Same |
| Target Population | Patients requiring ENT surgeries | Same |
| Use | Single-Use | Same |
| Materials | Metal electrode element/polymer<br>insulator | Same |
| | | |
| Specifications | | |
| Energy Delivered | Radio frequency | Same |

#### Comparison Table Table 6-1:

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| Description | Predicate | ENT Biotech Solutions |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Rated Voltage | 5,000V peak to peak | 5,000V (or 10,000V peak to peak) |
| Max Power Output | 50W | 50W |
| Power Modes | Monopolar | Same |
| Design | Light weight hand piece (wand-like) connected via cable to generator | Light weight hand piece (forceps-like similar to the commercially available St. Claire Forceps) connected via cable to generator |
| Hand Piece Tip | Tonsil tip: curved electrode element housed in a plastic tip<br>Adenoid tip: straight electrode element housed in a plastic tip | Curved electrode element housed in a plastic tip |
| Overall Length | 210mm (Tonsil Tip)/245mm (Adenoid Tip)* | 200.4mm |
| Compliance | | |
| Sterilization | Provided Sterile (Ethylene Oxide) | Provided Sterile to SAL of 10-6 (Gamma Radiation, per ISO 11137-1:2006 and ISO 11137-2:2006) |
| Electrical Standards | Unknown | IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-2-2:2009 |
| Biocompatibility | Unknown | ISO 10993-1:2009, 510(k) Memorandum - #G95-1: Use of International Standard ISO-10993 |

*191.5mm (St. Claire Forceps)

# Summary of Studies

Performance testing was conducted on the Elasso device to demonstrate compliance with the product requirements and to demonstrate safety and substantial equivalence to the predicate. The following product performance tests are included: mechanical, electrical safety/electromagnetic compatibility, operational, in-vivo evaluation, ex-vivo thermal effects on tissue comparisons, thermal modeling, usability/device access, biocompatibility, sterility and packaging / shelf life evaluation. Like the predicate device, no clinical testing was deemed necessary to support substantial equivalence. The data submitted support the substantial equivalence claim for the proposed indications for use; the Elasso is as safe and effective as the predicate device.

# Conclusion

ENT Biotech Solutions, INC considers the Elasso device to be substantially equivalent to the legally marketed predicate device with respect to the device function, intended use, patient population and anatomical site. Any differences in technological characteristics between the Elasso device and the predicate device do not raise any new issues of safety and effectiveness.