(150 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a surgical tissue removal device and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used for the "cutting and coagulation of soft tissue" during surgery, which are therapeutic actions.
No
The device is described as a surgical accessory for cutting and coagulation of soft tissue during ENT surgery. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a single-use, surgical accessory with a physical configuration similar to forceps, an integrated loop electrode, and a banana plug for connection to a generator. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cutting and coagulation of soft tissue during surgery. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The device is a surgical accessory used with an electrosurgical generator. It's designed for direct interaction with tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue during otolaryngology (ENT) surgery including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).
Indicated Patient Age Range
Patients requiring ENT surgeries
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)
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.
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 |
| 75 Lewiston Road | |
| Grosse Pointe Farms, MI 48236 | |
| USA | |
| Tel: 1.313.922.4615 | |
| Email: Adickson@entbiotechsolutions.com | |
| Applicant's Contact Information: | Laura Yamada or Andrea Dickson |
| Email: Laura.Yamada@sbcglobal.net | |
| Device Trade/ Proprietary Name: | ENT Biotech Solutions tissue removal device |
| (Elasso™) | |
| Device Common Name: | Electrosurgical, Cutting & Coagulation Device |
| & Accessories | |
| Device Product Code: | GEI |
| Device Classification / Name: | II / Electrosurgical, Cutting & Coagulation |
| 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
Tissue Dissection Device |
|-----------------------------------------------------|---------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Medtronic (Formerly PEAK Surgical, Inc) |
| 510(k) Number: | K083415 |
| Predicate Device Common Name: | Electrosurgical, Cutting & Coagulation Device
& Accessories |
| Predicate Device Classification Name &
Citation: | Electrosurgical, Cutting & Coagulation Device &
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
4
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 | |
| cutting and coagulation of soft | ||
| tissue during otolaryngology | ||
| (ENT) surgery including | ||
| adenoidectomy and | ||
| tonsillectomy (Pharyngeal, | ||
| Tubal, Palatine). | 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). | ||
| Principles of operation | Electrosurgical cutting and | |
| coagulation device intended to | ||
| remove tissue and coagulate by | ||
| use of radio frequency (RF) | ||
| 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 | |
| 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 | |
| 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.