The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.

Specific procedures and applications would include: Sinus / Rhinology:

FESS (Functional Endoscopic Sinus Surgery) .
Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, o
Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
Septal Spur removal ●
Endoscopic DCR .
Trans-sphenoidal procedures specifically to create access through the sinuses to the . Pituitary, Skull base, and CSF leak repair
. Turbinate Reduction / Turbinoplasty
o Including sub mucosal resection

Nasopharyngeal / Laryngeal:

Adenoidectomy / Tonsillectomy .
Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy

Head & Neck:

Soft tissue shaving .

Device Description

The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.

AI/ML Overview

The provided 510(k) summary for the DIEGO ELITE device (K123429) lists performance testing, but it does not express these in terms of specific, quantifiable acceptance criteria or provide a detailed study that measures the device's performance against such criteria. Instead, it describes various types of tests performed to ensure the device functions as intended and meets design specifications, relying on comparative performance to predicate devices for substantial equivalence.

Here's an attempt to extract and infer the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a surgical device like an electrosurgical drill/shaver, formal acceptance criteria with specific numerical targets and measured performance values are typically not explicitly stated in the public summary. The performance is primarily demonstrated through compliance with recognized standards and comparison to predicate devices.

However, based on the "Summary of Performance Testing," we can infer the intent of the acceptance criteria as substantial equivalence to predicate devices and meeting design specifications.

Acceptance Criterion (Inferred from testing goals)	Reported Device Performance (Summary Statements)
Electrical Safety (e.g., against IEC 60601-1, IEC 60601-2-2)	"Basic safety and performance testing was performed in accordance with IEC 60601-1 and IEC 60601-2-2."
Mechanical Performance (e.g., tip vibration, torque strength, endurance, force testing, reliability, durability)	"Verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: tip vibration, torque strength, endurance, dynamic seal integrity, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, aspiration, RF isolation..."
Functional Performance (e.g., cutting, coagulation, tissue removal, suction)	"Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo) studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and removal of tissue."
Biocompatibility (e.g., cytotoxicity, sensitization, irritation)	"Full biocompatibility testing (Cytotoxicity, sensitization, and irritation) to ISO10993-1 for the device category was completed... Based on the material assessment, patient contacting materials were tested in accordance with ISO 10993-1, and results are considered passing."
Sterility (e.g., Sterility Assurance Level of 10^-6 for EO sterilization)	"Sterilized using Ethylene Oxide, using a cycle validated in accordance with ISO 11135-1 to provide a sterility assurance level of 10^-6." (Inferred from ISO 11135-1 standard, not explicitly stated as SAL in text)
Shelf Life Stability (e.g., device maintains functionality and meets specifications over time)	"Accelerated shelf-life studies were conducted to support an initial one year shelf life, with real time testing in process to confirm an initial one year expiration date... The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life."
Usability/Ergonomics (e.g., device setup, tip rotation, tip malleability)	"Preclinical... studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability... Cadaver - evaluated in vivo: Ergonomics, Usability aspects such as device setup, tip rotation, and tip malleability, Overall design confidence. Animal - evaluated in vivo using porcine models: Ergonomics, Usability aspects such as device setup, tip rotation, and tip malleability, Overall design confidence."
Thermal Properties (e.g., thermal margin, thermal impact)	"Bench tissue - evaluated ex vivo using bovine tissue: Thermal margin, Thermal impact, Visual comparison of coagulation."
Overall Substantial Equivalence (to predicate devices as outline during market approval)	"Testing demonstrated that the device performs as well as or better than the predicate devices." and "The performance of the DIEGO ELITE was compared against the known performance characteristics of the predicate devices. Testing demonstrated that the performance requirements were met, and that the DIEGO ELITE exhibited comparable performance characteristics to the predicates."

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Sizes: The document does not specify exact sample sizes for any of the non-clinical or preclinical tests (e.g., number of bench tissue samples, number of cadavers, number of animals). It only refers to "Representative samples" for stability testing.
Data Provenance:
- Bench Tissue: Ex vivo using bovine tissue.
- Cadaver: In vivo (though cadaver tissue is technically ex vivo in a surgical context, it implies human anatomy simulation). The country of origin is not specified.
- Animal: In vivo using porcine models. The country of origin is not specified.
- Non-Clinical (electrical, mechanical, functional): Performed in a lab setting; provenance not specified.
- Retrospective or Prospective: These appear to be prospective tests specifically conducted for the 510(k) submission to demonstrate device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing ground truth for the test sets.
It mentions "surgeon input" was used to confirm appropriate tissue medium for simulated use and bench testing. This suggests expert involvement, but details are absent.
For preclinical studies, outcomes like "Overall design confidence" were evaluated, implying expert assessment, but again, no specifics on the experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the test set results. The tests are primarily functional and comparative, with "ground truth" established by the design specifications, recognized standards, and direct observation of performance against predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device being a surgical tool (drill/shaver/electrosurgical unit) means its performance is assessed directly on tissue/cadavers/animals, not through human reader interpretation of images or data.
Therefore, there is no effect size reported for how human readers improve with or without AI assistance, as AI assistance in this context is not applicable in the way it is for diagnostic imaging devices.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is framed for AI/software devices. In the context of this electrosurgical and drill system, the "standalone" performance refers to the device's intrinsic functional capabilities.
Yes, standalone performance (without a human-in-the-loop in an interpretive sense) was extensively tested. All the non-clinical/preclinical tests described (electrical, mechanical, functional, biocompatibility, stability, cutting, coagulation, tissue removal, suction, thermal impact) represent the device's standalone performance characteristics. The human operator is integral to using the device, but the device's performance itself is evaluated directly.

7. The Type of Ground Truth Used

The ground truth for this device's performance testing appears to be based on:

Compliance with Recognized Standards: Meeting the requirements outlined in standards such as IEC 60601-1, IEC 60601-2-2, ISO 10993-1, ISO 14971, etc.
Design Specifications: The device's ability to "function as intended and met design specifications."
Comparative Performance to Predicate Devices: "performs substantially equivalent to the predicate devices" and "exhibited comparable performance characteristics to the predicates."
Direct Observation/Measurement: For aspects like cutting efficiency, coagulation effect, tissue removal, suction efficacy, thermal margins, and mechanical properties.
Surgeon Input: Used to confirm appropriateness of tissue models and likely for evaluation of usability aspects.

8. The Sample Size for the Training Set

Not applicable. This device is a surgical instrument, not an AI or machine learning model that requires a "training set." The concept of a training set is relevant for data-driven algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" for this type of medical device, the establishment of ground truth for a training set is not relevant. The device's design and functionality are based on engineering principles, material science, and established medical knowledge, not on learning from a data set.

Summary

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K123429

Traditional 510(k) Notification November 2012

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. DIEGO ELITE

5 2013 APR

General Information

Manufacturer:

Gyrus ENT, L.L.C. (a subsidiary of Gyrus ACMI, Inc., an Olympus company) 2925 Appling Road Bartlett , TN 38113 Phone: 1-800-262-3540 Fax: 1-901-373-0237

Southborough, MA 01772-2104

Establishment Registration Number:

510(k) Submitter:

Establishment Registration Number:

Contact Person:

Dolan Mills Specialist, Regulatory Affairs

3003790304

Gyrus ACMI, Inc.

136 Turnpike Rd.

1037007

Date Prepared:

November 6, 2012

Device Description

Classification Name:

ENT Electric or Pneumatic Surgical Drill Electrosurgical Cutting & Coagulation Device and Accessories Class 2

Electrosurgical System21 CFR 878.4400General and Plastic SurgeryPanelGEI	Drill System21 CFR 874.4250Ear, Nose, ThroatERL	Suction Pump21 CFR 878.4780General and Plastic SurgeryPanelJCX
Stereotaxic Instrument	Bur, Ear, Nose & Throat	Tray, Surgical Instrument
21 CFR 882.4560	21 CFR 874.4140	21 CFR 878.4800
Neurology	Ear, Nose & Throat	General & Plastic Surgery
HAW	EQJ	FSM

{1}------------------------------------------------

Traditional 510(k) Notification November 2012

Project Name:

Trade Name(s):

Generic/Common Name:

EPS. PKD2 System / Bullitt (09-016)

DIEGO ELITE

Electrical Surgical Drill / Shaver or Electrosurgical cutting and coagulation device and accessories, Suction Pump, Stereotaxic Instrument, Burs, Instrument Tray

Predicate Devices

Gyrus ACMI Diego® RF Powered Dissector & Drill System:	K034004
Gyrus ACMI Diego® Starlink with IGS	K030343
Covidien ValleyLab Force FX	K944602
Gyrus ACMI DTAD	K121678
Olympus KV-5 Powered Suction Pump	K011725

Product Description

Technological Characteristics

The DIEGO ELITE console is a reusable, non-sterile electrosurgical generator and electrical drill system that features monopolar and bipolar cutting and coagulation modes. The maximum output power is 40 W. The console controls operational and performance aspects of the reusable motor module (MDU) handpiece and the suction module.

The front side of the console features a touch screen interface that displays the connection status of accessories. It is also used to show and modify the output settings, such as mode, output power, speed, and irrigation. The front panel has a socket for the MDU, a socket for a neutral electrode, and a socket for the footswitch. The front of the console has a power switch. The console recognizes which

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Traditional 510{k) Notification November 2012

accessories and peripherals are connected and displays default settings and any needed warning indicators. After default settings are loaded, the user may adjust settings as desired. The touch screen also has a menu button that controls various functions and settings.

The side panel offers a peristaltic irrigation pump and irrigant sensing section. The irrigation line is loaded through an air bubble sensor section and then through the irrigation pump. The sensing section identifies when the irrigation line is empty and displays a warning on the touch screen.

The rear panel offers a channel and clamping mechanism to load the console onto a standard IV pole. The rear panel also contains the mains disconnect, grounding post, connection socket for the optional powered suction pump, service port, and back panel labeling. Ventilation holes are in the rear and bottom panel.

The DIEGO ELITE includes an optional suction module that connects to the main controller and can replace the standard facility suction system. The suction system can only be used with the main console.

Application Modes:

Microdebrider only:

o Variable or Constant Speed - selected by user
. Rotation of inner blade - Oscillate, Forward

Monopolar Coagulation:

. Crest Factor (CF): 4.3
- · CF is a description of the waveform
t 390kHz damped sinusoid, everv 36 kHz

Bipolar Coagulation:

. Crest Factor (CF): 2.1 at rated load
- o CF is a description of the waveform
. Carrier Frequency: 470 KHz

The DIEGO ELITE handpiece consists of the non-sterile reusable MDU (reusable portion of the handpiece), the sterile disposable blade / burr, and the sterile disposable suction tube connector. The entire fluid pathway is contained in the disposable sections. All electrosurgical leads are contained within the MDU and the monopolar and bipolar disposable blades. The MDU is connected to the console for control. the irrigation tube line is connected through the pump and then the irrigant source. The suction tube is connected to either the facility standard suction, or the optional powered suction pump via a fluid collection canister. The monopolar or bipolar effect is limited to the disposable blade tip, and activation is controlled by the surgeon by pressing a coag button on the top of the blade nosecone.

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Traditional 510{k) Notification November 2012

The system footswitch connects to the console and is used to control microdebridement only. The footswitch also offers a toggle switch on either side of the pedal that can toggle the shaver blade cutting window open or closed when the blade is stopped.

The system blades and burrs are offered in similar working lengths and geometries as the predicate Gyrus ACMI Diego® system, and they include a capacitor that is used to determine the disposable "family" to which it belongs and establish the proper default settings and features that go along with that family.

Image Guided Surgery (IGS) instrumentation / array allows the blades and burrs to be tracked in real time in the surgical field. IGS compatibility is accomplished by moving the connector from the predicate Diego® Starlink handpiece to the top of the premium tubeset connector. This allows for the elimination of an additional handpiece for IGS. The IGS connector (boss) and assembled MDU handpiece is functionally equivalent to the predicate Starlink handpiece, and it will continue to accept the BrainLab AG IGS equipment.

Material

The DIEGO ELITE uses similar patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.

The DIEGO ELITE patient contacting items are classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (<24hrs.). ISO10993-1 and FDA Blue Book memo #G95-1 guidelines recommend that these direct patient contact parts have supporting data for cytotoxicity, sensitization and irritation. Full biocompatibility testing (Cytotoxicity, sensitization, and irritation) to ISO10993-1 for the device category was completed and is available for patient contacting materials.

Based on the material assessment, patient contacting materials were tested in accordance with ISO 10993-1, and results are considered passing. Test results are available in section 12.

Intended Use / Indications

Specific procedures and applications would include:

{4}------------------------------------------------

Sinus / Rhinology:

· FESS (Functional Endoscopic Sinus Surgery)
- o Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
Septal Spur removal .
Endoscopic DCR
Trans-sphenoidal procedures specifically to create access through the sinuses to � the Pituitary, Skull Base, and CSF leak repair
Turbinate Reduction / Turbinoplasty .
- o Including sub mucosal resection

Nasopharyngeal / Laryngeal:

. Adenoidectomy / Tonsillectomy
Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy

Head & Neck:

Soft tissue shaving .

Compliance to Voluntary Standards

The design of the DIEGO ELITE complies with the following standards:

For pro-code GEI - FDA Recognized Consensus Standards: IEC 60601-2-2

Additional voluntary standards:

IEC 60601-1, IEC 60601-1-2

ISO 10079-1:2009, Medical suction equipment - Part 1: Electrically powered suction equipment

ISO 10993-1, 5, 7, 10, Biological Evaluation of Medical Devices ISO 14971:2007. Risk Analysis

ISO 15223-1:2007 + amd1:2008, Medical Devices - Symbols to be used ISO 17664: 2004, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices.

ISO 17665-1:2006, Sterilization of Health Care Products, Moist Heat ISO 11135-1:2007, Sterilization of Health Care Products, EO Validation ISO 11138-2: 2006, Sterilization of health care products: Biological Indicators 150 11607-1:2009, Packaging for Terminally Sterilized Medical Devices ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices ISO 11737-1:2006, Sterilization of Medical Devices - Microbiological Methods

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Traditional 510(k) Notification November 2012

ISO 11737-2:2009, Sterilization of Medical Devices - Microbiological Methods

ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

ASTM F2097-10 - Flexible Primary packaging

ASTM F1886-09/F1886M-09 - Standard test method for determining integrity of seals

ASTM F1929-98 (2004) - Standard test method for detecting seal leaks with dye penetration

ASTM F88/F88M-09 - Standard test method for seal strength of flexible barrier materials

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests were identified and performed as a result of risk analysis assessment.

Summary of Sterilization and Shelf Life Discussion

The console, MDU, footswitch, and suction pump are provided non-sterile and are reusable. The console, suction pump, and footswitch are to be wiped down with cleaning / disinfecting wipes after use. The MDU is not in the fluid pathway, and any contamination it receives will be through indirect means from handling and as the disposables are removed. The MDU is to be cleaned and reprocessed according to the validated procedure provided in the instruction manual.

The blades and burrs, and tubesets are provided sterile for single-use. They are sterilized using Ethylene Oxide, using a cycle validated in accordance with ISO 11135-1 to provide a sterility assurance level of 100.

The Shelf Life period for the disposable items was determined through an analysis of the shelf-life stability of the materials used in the design of the devices, as well as an analysis of the packaging materials and processes used with other Gyrus ACMI devices. Accelerated shelf-life studies were conducted to support an initial one year shelf life, with real time testing in process to confirm an initial one year expiration date. Additional studies (accelerated and real time) are planned to support a five-year expiration date in the future.

{6}------------------------------------------------

Summary of Performance Testing

Performance tests were executed to ensure that the system functioned as intended and met design specifications. The following non-clinical and preclinical tests, and usability studies were conducted:

Non-Clinical / Preclinical Performance

Evidence of safety and effectiveness was obtained from two primary areas:

1. non-clinical (electrical, mechanical, functional, biocompatibility, stability) performance testing
1. preclinical (bench tissue, cadaver, animal) evaluations and testing

Non-clinical: Basic safety and performance testing was performed in accordance with IEC 60601-1 and IEC 60601-2-2. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: tip vibration, torque strength, endurance, dynamic seal integrity, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, aspiration, RF isolation, and many other applicable tests.

Stability: Representative samples were subjected to accelerated aging to confirm that the device maintains functionality and continues to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. Representative samples were also subjected to environmental conditioning and ship testing.

Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo) studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and removal of tissue. For simulated use and bench testing, the selected tissue medium was confirmed to be appropriate for testing based on surgeon input. Sample impedance levels were also investigated and confirmed as appropriate.

Bench tissue - evaluated ex vivo using bovine tissue:

-Thermal margin
Thermal impact -
Visual comparison of coagulation -

Cadaver - evaluated in vivo:

Cut, coagulation, tissue removal, and suction -
Ergonomics -
Usability aspects such as device setup, tip rotation, and tip malleability -
Overall design confidence -

{7}------------------------------------------------

Animal - evaluated in vivo using porcine models:

Cut, coagulation, and suction -
Ergonomics -
Usability aspects such as device setup, tip rotation, and tip malleability -
Overall design confidence -

Testing demonstrated that the device performs as well as or better than the predicate devices.

No clinical testing was conducted. The use of Electrosurgical Cutting and Coagulation Devices / Microdebriders has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations.

Substantial Equivalence

The DIEGO ELITE utilizes the same bipolar electrosurgical energy to cut and coagulate tissue as that used in the predicate Diego® RF Dissector and Drill System cleared under K034004.

The DIEGO ELITE utilizes similar monopolar electrosurgical energy to cut and coagulate tissue as that used in the predicate ValleyLab Force FX electrosurgical units, and the monopolar disposables operate in a similar manner as the monopolar ValleyLab disposables and the monopolar Gyrus ACMI DTAD device.

The DIEGO ELITE operates as a microdebrider in a similar manner as the predicate burrs and blades found in the currently marketed Diego® RF Dissector and Drill System cleared under K034004. The DIEGO ELITE disposable tubesets, burrs and blades are similar to the predicate devices physically and in their methods of operation. The tubeset continues to be bifurcated, offering saline irrigation to the surgical site, and suction away from the surgical site. The burrs and blades continue to operate as a rotating tube within a tube. The blades have a cutting tip and hollow inner member for resected tissue and fluid to travel through.

The DIEGO ELITE offers IGS compatibility in a similar manner as the Diego® Starlink handpiece cleared under K030343, and it is functionally equivalent with regard to IGS compatibility. The proposed premium tubeset provides a stable base and connector for the IGS equipment to connect to for tip tracking in a similar manner to the Starlink handpiece.

The DIEGO ELITE optional suction pump console operates in a similar manner to the predicate Olympus KV-5 powered suction pump.

{8}------------------------------------------------

1 11:14 [1] 1988-1971

יי איני גרייני רעיני "ע

Traditional 510(k) Notification November 2012

Por ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The DIEGO ELITE uses similar patient-contacting materials in similar quantities that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.

ン・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Conclusion

The performance of the DIEGO ELITE was compared against the known performance characteristics of the predicate devices. Testing demonstrated that the performance requirements were met, and that the DIEGO ELITE exhibited comparable performance characteristics to the predicates.

In summary, the DIEGO ELITE is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

{9}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that curve at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

April 5, 2013

Public Health Service

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

Gyrus ACMI. Incorporated % Mr. Dolan Mills Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01722-2104

Re: K123429

Trade/Device Name: DIEGO ELITE Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: GEI Dated: February 15, 2013 Received: February 19, 2013

Dear Mr. Mills:

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. Iisting 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

{10}------------------------------------------------

Page 2 – Mr. Dolan Mills

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Erich Mann

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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K123429

Traditional 510(k) Notification November 2012

Indications for Use

510(k) Number: K123429

Device Name: DIEGO ELITE

Indications for Use:

Specific procedures and applications would include: Sinus / Rhinology:

FESS (Functional Endoscopic Sinus Surgery) .
- Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, o
  - Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
Septal Spur removal ●
Endoscopic DCR .
Trans-sphenoidal procedures specifically to create access through the sinuses to the . Pituitary, Skull base, and CSF leak repair
. Turbinate Reduction / Turbinoplasty
- o Including sub mucosal resection

Nasopharyngeal / Laryngeal:

Adenoidectomy / Tonsillectomy .
Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy

Head & Neck:

Soft tissue shaving .
Prescription Use: X (Per 21 CFR 801.109)

AND/OR

Over-the-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vasant G.
Malshet

Digitally signed by Vasant G. Malshet
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Vasant G. Malshet,
0.9.2342.19200300:100.1.1=1300087
851
Date: 2013.03.19 12:04:47-04'00'

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.