SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM

{0}------------------------------------------------ K082528 pg1 frz Image /page/0/Picture/1 description: The image shows the logo for BraunSolutions. The logo consists of a globe on the left and the text "BraunSolutions" on the right. The globe is a black and white image of the earth. The text is in a serif font, with the "Solutions" part of the name in italics and a registered trademark symbol. 6 2009 mar # 510(k) Summary (Per 21 CFR 807.92) | Submitter/Owner: | Noble Anesthesia-Air, Inc.<br>1505 Fort Clarke Blvd. 17-106<br>Gainesville, Florida 32606 | | | |---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--| | | Contact Person: James P. Noble, M.D.<br>Telephone: (352) 332-7908<br>Email: noble@anesthesia-air.com | | | | Official Correspondent: | BraunSolutions<br>377 Zane Court,<br>Elizabeth, CO 80107 | | | | | Contact Person: Alex Henderson<br>Telephone/Fax: (303) 646-3715<br>Email: alex_henderson@msn.com | | | | Date Prepared: | August 25, 2008 | | | | Device Name: | | | | | Trade/Proprietary Name:<br>Common/Generic Name:<br>Classification Name: | Snor-Scope Plus™ and/or Snor-Scope +™ System (Kit)<br>Electronic Stethoscope<br>Electronic Stethoscope, Class II (Two)<br>(21 CFR 870.1875(b), Product Code DQD) | | | | Predicate Devices: | RNK Products Stethoscope (K030446, K072026)<br>Pishon High Tech Co. Stethoscope (K062481)<br>Meditron AS Stethoscope (K991367) | | | | Related Accessories:<br>(Kit) | | | | | Classification | Description | Class | | | 21 CFR 868.5240<br>21 CFR 868.5810<br>21 CFR 868.5860<br>21 CFR 868.1930<br>21 CFR 870.1875 | Breathing Circuit (Kit)<br>Airway Connector<br>Pressure Tubing and Accessories<br>Stethoscope Head<br>Stethoscope | I<br>I<br>I<br>I<br>I | | 377 Zane Court • Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 ● Email: alex_henderson@msn.com {1}------------------------------------------------ ### Device Description: (Reference Exhibit A, Page 12) Class I ME Device The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope System is a kit comprised of the following components: (Guidance IEC60601-1 2005 Sec. 4 "General Requirements" and various other sections, where applicable). - Audio amplifier module and microphone � - Plastic T-connector / diaphragm coupler assembly (airway adapter) . - Single Plastic coupler (stethoscope adapter) ● - Stethoscope Head (standard mechanical acoustic) ● - Stethoscope (standard mechanical acoustic) ● - Wall charger (UL listed, medical grade) and eight (8) batteries (rechargeable) . shielded microphone and audio cable, with a 3.5mm plug, connects the র microphone/coupler assembly to the amplifier module. The speaker volume may be adjusted on the audio amplifier module to allow comfortable listening levels of breathing sounds passing through the airway circuit for Anesthesia Physicians and Clinical Personnel. A standard stethoscope ear piece may also be used for private listening purposes, although it does not provide the same amplification as in electronic stethoscope mode. The Snor-Scope Plus T-connector is composed of a plastic diaphragin and connector cap which holds the diaphragm tightly in place. This T-connector serves as an attachment for either the manual stethoscope (without head) or to the electronic stethoscope microphone. The device is not sterile, is outside the surgical field, and is a single-use disposable accessory. A single plastic medical grade coupler may also be used as an interface between the Snor-Scope Plus microphone and standard stethoscope dual-diaphragm head for the same purpose that would otherwise require an acoustic (non-electronic) stethoscope. The Noble Anesthesia-Air Electronic Stethoscope provides 20 times greater signal amplitude than a standard acoustic stethoscope. The overall frequency response is 15 - 1500 Hertz. This stethoscope is a stand-alone unit, has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit. The Amplifier Module is powered by rechargeable Nickel Cadmium Batteries which can be easily replaced. The charger consists of a medical grade UL listed wall adapter. The batteries and charger are of the overall packaged kit. The audio amplifier module controls charging which cannot be performed during use of the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope. {2}------------------------------------------------ #### Statement of Intended Use: The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope. In addition, the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia by an anesthesia care professional. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons. #### Substantial Equivalence: Although the Snor-Scope Plus has an additional and unique Indication for Use, the design components and functionality of the Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope are substantially equivalent to the predicate devices listed. The overall effectiveness has been, and continues to be, demonstrated in user testing with Anesthesiologists and Clinicians. The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope has the same principles of operation and technological characteristics as the auscultation function of the predicate devices. System analysis and testing have resulted in no new questions concerning safety and effectiveness. | | Predicate Devices | | | New Device | |-----------------------|---------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------|----------------------------------------------| | Device Name | RNK Products<br>Electronic<br>Stethoscope<br>K030446, K072026 | Pishon High Tech<br>Electronic<br>Stethoscope<br>K062481 | Meditron AS<br>Electronic<br>Stethoscope<br>K991367 | Snor-Scope Plus<br>Electronic<br>Stethoscope | | Classification Name | Electronic<br>Stethoscope | Electronic<br>Stethoscope | Electronic<br>Stethoscope | Electronic<br>Stethoscope | | Applicant | RNK Products | Pishon High Tech | Meditron AS | Noble Anesthesia-Air | | Frequency Response | 20 Hz - 1,500 Hz | 20 Hz - 1,500 Hz | 20 Hz - 1,500 Hz | 20 Hz - 1,500 Hz | | Amplification | Up to 20 Times | Up to 20 Times | Up to 18 Times | Up to 20 Times | | Heart Rate Display | No | No | No | No | | Data Transfer to PC | No | Yes | Yes | No | | Volume Control | Variable | 12 Step | Variable | Variable | | Energy Source | (2) AAA Batteries | (2) AAA Batteries | (4) AA Batteries | (8) AA Batteries | | Manual On/Off Button | Yes | Yes | Yes | Yes | | Low Battery Indicator | Yes | Yes | Yes | Yes | #### Substantial Equivalence Comparison Chart {3}------------------------------------------------ ## Proposed Labeling: Audio Amplifier -Front (Guidance: IEC60601-1 Sec. 15) Image /page/3/Picture/3 description: This image shows a gray label with white text and symbols. The label includes the text "STETH/MIC CHARGE -EDC 12V 200mA POWER/VOLUME", "POWER/CHARGE LED", "OFF", "DO NOT CHARGE WHILE IN USE!", "Noble Anesthesia-Air, Inc.", "Snor-Scope Plus", and "LOW FREQUENCY ELECTRONIC STETHOSCOPE". There are also two white circles and a black triangle on the label. ### T-Connector Coupler Photos Electronic Stethoscope Image /page/3/Picture/5 description: The image shows a close-up of a clear and green plastic medical connector. The connector has a cylindrical shape with a green block on top. The connector is attached to a black cable on the left side. Manual Stethoscope Image /page/3/Picture/7 description: The image shows a stethoscope and a nebulizer. The stethoscope is black and silver, and the nebulizer is green and blue. The stethoscope is in the foreground, and the nebulizer is in the background. The stethoscope is a medical device used to listen to the sounds of the heart, lungs, or other organs. The nebulizer is a medical device used to deliver medication in the form of a mist. Amplifier, Microphone, T-Connector Image /page/3/Picture/9 description: The image shows a nebulizer machine and its accessories. The nebulizer machine is a gray, rectangular device with a speaker-like grill on the front. A black power cord is plugged into the bottom of the machine. Next to the machine is a green nebulizer cup with a clear mouthpiece. #### Located on Charger: CAUTION! Only Charge Snor-Scope Plus When unit is off Unplug charger when not in use Located on Bottom: SNOR-SCOPE PLUS @ Electronic Stethoscope SERIAL NUMBER: CAUTION! FOR USE BY LICENSED ANESTHESIOLOGIST ONLY ### Located on T-Connector: CAUTION! Check Air-Way Circuit For Leaks Prior to Use 377 Zane Court · Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 · Email: alex henderson@msn.com {4}------------------------------------------------ ### Clinical Assay: (Reference Exhibit B, Page 13) ## "Pediatric Sedation Outside of the Operating Room" #### SPONSORED BY: Harvard University, San Francisco CA USA September, 2008. The data to be presented was gathered during a study that was done while Dr. James P. Noble was in private practice. The formal study involved 10 patients representative of the patient population for which Dr. Noble had cared for over nearly 10 years during the development of his special technique to improve the safety of anesthesia for cosmetic surgery patients. The Snor-Scope Plus, in various stages of its evolution, was an essential part of this technique. The formal study was approved in 2005 by the Western Institutional Review Board. The identifying information of this study is: TITLE: The Effects of CPAP on Airway Obstruction in Scdated Spontaneously Breathing Facial Rhytidectomy Patients PROTOCOL NO .: WIRB Protocol #20050216 | SPONSOR / INVESTIGATOR / SITE: | Robert N. Cooper, M.D.<br>201 East Osceola Street<br>Stuart, Florida 34994 USA | |--------------------------------|--------------------------------------------------------------------------------| |--------------------------------|--------------------------------------------------------------------------------| ### CONCLUSION SUMMARY: The stridor that was reported in the results was accurately detected by the Snor-Scope Plus. There were no adverse effects or complications. The Snor-Scope Plus passed inspection by the Biomedical Engineers at Shands Teaching Hospital at the University of Florida under ANSI C63.18-1997 and AAMI TIR 18 Recommendations for EMC / EMI in Healthcare Facilities. Test data is not present in this submission. Additional clinical study information has not been submitted for the purpose of demonstrating substantial equivalence to legally marketed electronic stethoscopes. {5}------------------------------------------------ ### Safety and Performance: (Guidance: IEC60601-1 2005, where applicable) The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stothoscope is intended for use outside of the surgical sterile field. The plastic connector couplers are intended as single-use, disposable accessories and are not sterile. The Snor-Scope plastic T-connector coupling assembly isolates the microphone electrically from the acoustic mechanical pick-up diaphragm, anesthesia airway connectors, and the patient. It is part of the fixed port (reused as standard practice) on the anesthesia machine. The internal speaker and microphone cable are shickled to eliminate Electrical Magnetiv Interference. The audio amplifier module, microphone, or cable do not introduce any signals or energy into the patient or ancsthesia airway circuit and do not pick-up signals from other medical devices (e.g. Lascrs, Telemetry, Electrocautery devices) in the room. The amplifier module plastic casing (double insulated) and all anesthesia coupler / hose components meet UL flammability ratings for medical devices. (Scc. 8 "Protection against Electrical Hazards", Sec. 9 "Protection against Mechanical Hazards'' and Sec. 17 "Electromagnetic Compatibility of ME Equipment'') Battery charging is controlled by internal management circuits of the audio amplifier module and is disabled during use. Warning labels indicate that the audio amplifier module must be recharged outside the operating room. The system is not directly connected to 120 VAC wall outlet power during use, and there are no exposed conductive metal parts, thus alleviating any patient or health practitioner shock hazards. (Sec. 8 "Protection against Electrical Hazards") There is limited skin contact with the patient or medical personnel with respect to the bell diaphragm (standard acoustic stethoscope type), as an approved Class I device. There is no skin contact with the patient or medical personnel at any time, as described under additional Indications for Use. Biocompatibility with respect to ISO10993-Part 1, Biological Evaluation of Medical Devices Part -1 (G-95-1), does not apply. Physiological Effects: (Guidance: IEC60601-1 2005 Sec. 8 "Protection against Electrical Hazards") The patient has no contact with the unit or leads. There are no physiological effects concerning Threshold of Perception. Let-Go Current, Respiratory Paralysis, Ventricular Fibrillation, Sustained Myocardial Contraction, or Burns and Physical Injury. Shock Hazards: (Guidance: IEC60601-1 2005 Sec. 8 "Protection against Electrical Hazards") The unit chassis and microphone T-connector are made of non-conductive plastic and all leads consist of insulated rubber over shielded wire. Current Leakage to ground is 0.0 mA as the unit is not connected to A-C wall power during operation. There are no exposed mctal contacts. {6}------------------------------------------------ ### Non-Clinical Testing: (Reference: T-Conncctor Assembly Test Protocol, Page 10) Under typical use as a standard acoustic stethoscope, the diaphragm head is the only component that routinely comes in contact with the patient or health practitioner. There is no possibility of current leakage, as the microphone and cable is shielded and electrically isolated by the interface coupling assembly and rubber stethoscope hose. The same holds true for the T-connector / diaphragm coupler components in the anesthesia airway circuits (conveying non-flammable gases) as they never come into to contact with the patient or health practitioner. shielding provides minimal electromagnetic field or radiated emission Internal measurements. Pressure tests were conducted on a random sample of T-connector diaphragm component assemblies. Current leakage test during operation yielded no results. Environment: System is intended for use at ambient room temperature 25 Deg. C. (Guidance IEC60601-1 2005 Sec. 5 "General Requirements for Testing ME Equipment") #### Conclusions: The indications for use as described is consistent with the labeling for electronic stethoscopes legally marketed in the United States under FDA regulation 21 CFR 870.1875(b) for this type of device. In addition, operation is also consistent with the general operating principles for electronic stethoscopes and would have minimal potential for any adverse health concerns as it does not interrupt anesthesia airway operation. The passive T-connector has been specifically designed to have no effect on the Anesthesia Devices to which it is attached and, more importantly, the patient. The Noble Ancsthesia-Air Snor-Scope Plus™ Electronic Stethoscope does not fall under FDA Regulation 21 CFR 898.12 Performance Standards and does not emit vibrations or emissions that would affect the patient or other medical devices as listed under FDA Regulation 21 CFR 1000.15 Radiological Health for "Sound Amplification Equipment". It is possible, but not likely, that the T-connector diaphragm might rupture and cause an anesthesia circuit leak. This occurrence would be detectable by routine pressure checks of the breathing circuit and by listening for a leak over the connecting port of the stethoscope. The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is a reliable monitor to detect an evolving obstruction of the upper airway. Detection of stridor should trigger the carly adjustment of flow rates and pressure within the breathing circuit until airway obstruction and its telltale stridor is eliminated. {7}------------------------------------------------ Drop Test Performance: (Guidance: 1EC60601-1 2005 Sec. 5 "General Requirements", Scc. 9 "Protection against Mechanical Hazards" and Sec. 15 "Construction of ME Equipment") ### AXIS: X: Top (Speaker) Down Y : Front (Control/Inputs) Down Z: Sideways/Angled Down (Corner) #### CRITERIA: - 1. Perform three (3) separate drop tests for each axis from a height of three (3) feet onto a hard, uniform surface (concrete floor). Note external damage, if any, on chart. - Perform function test. Note failures on chart. 2. - 3. Open case and note any internal damage, if any, on chart. Document with photos. - 4. If any major external or internal damage is indicated route to QC for Root-Cause Analysis. Note: If no structural failures indicated, enter "None". If no functional failures indicated, enter "Passed". | SnorScope<br>Plus | X Axis Notes | Y Axis Notes | Z Axis Notes | Functional Test | | |------------------------|-----------------------|-------------------|----------------------------------------------------|-------------------------------------------------------------------|------------| | | TEST 1: | TEST 2: | TEST 3: | UNIT: | BATTERIES: | | Unit #1<br>S/N: 0103 | Scratched | None | Dent - Corner | Passed | Passed | | Unit #2<br>S/N: 0107 | None | Scratched | Hairline Crack<br>-Corner | Passed | Passed | | Unit #3<br>S/N: 0124 | None | None | Dent - Corner | Passed | Passed | | Comments: | | | | Disposition: Continue tests until final<br>release. Certified by: | | | No Internal<br>Damage. | Volume<br>Control OK. | Connectors<br>OK. | Speaker<br>OK.<br>Crack did not<br>affect function | Date: 01/12/2009 | | | | | | | | | #### SUMMARY DATA {8}------------------------------------------------ ### T-Connector Assembly Test Protocol: Pressure tests are conducted on random T-Connector assemblies in the following manner: - 1. The connector is tested at the absolute extremes of pressure ventilation capable of being generated by a typical anesthesia ventilator: | Machine: Datex-Ohmeda AVANCE S5 | | |---------------------------------------------------|------------------| | Maximum Positive End-Expiratory Pressure ("PEEP") | = 30 cm of water | | Maximum Added Positive Pressure Ventilation | = 60 cm of water | - 2. The diaphragm of the Stethoscope-Connector cannot fail after being subjected to 25 cycles of 90 cm of water pressure of the ventilator, i.e., the diaphragm is not ruptured and no leak is produced. Total Pressure Discussion: - ਡ 90 cm of water pressure is about double the extreme of pressures that may be used clinically. - M The label on the packaging will include a caution to check the connector for leaks prior to starting an anesthetic and during the anesthetic should a leak be suspected in the breathing circuit. James P. Noble, M.D. = 90 cm of water James P. Noble, M.D. {9}------------------------------------------------ ### 510(k) Summary ### Noble Anesthesia-Air Electronic Stethoscope ### Hazardous Conditions Test Protocol - Liquid: (Guidance: IEC60601-1 2005 Sec. 4 "General Requirements", Sec. 8 "Protection against Electrical Hazards" and Sec. 16 "ME Systems") #### CRITERIA: Random Test - 1. NORMAL TEST: Perform current-leakage test on five (5) amplifier module, microphone, and T-connector assemblies - attach meter between microphone/T-connector body and ground (-). - With charger unplugged a. - With charger plugged in b. Record results for each unit on the chart. #### 2. DESTRUCTIVE TEST: Perform current-leakage test on ten (10) amplifier module, microphone, and T-connector assemblies - attach meter between microphone/T-connector body and ground (-). First five (5) units: - With charger unplugged; pour sodium chloride, 0.9% USP, on top of unit and on down a. cord to microphone/T-connector assembly. - b. Open case and check fuse continuity. Record results for each unit on the chart. Second five (5) units: - With charger plugged in: pour sodium chloride, 0.9% USP, on top of unit and on down c. cord to microphone/1'-connector assembly. - Open case and check fuse continuity. ರ. Record results for each unit on the chart. Send units to QC Dept. to be quarantined / scrapped. Tag: "Engineering Evaluation" Discussion: (Guidance: IEC60601-1 2005 Sec. 11 "Protection against other Hazards") - Test results from these tests have indicated that there is no current leakage, with or without the battery charger plugged in, under normal operating conditions. The unit case and microphone/Tconnector assembly impedance is infinite. - During destructive testing, there was slight current leakage between 0.02 mA - 0.03 mA with the battery charger plugged in (battery charger cannot be used during normal acoustic operation). If the internal PC board power components were shorted by the sodium chloride solution, the micro fuse (Fast Acting, 750 mA, One Time) indicated no continuity (open circuit) and leakage current was 0.0mA. Without the battery charger plugged in, current leakage was between 0.01 mA on average. Same micro fuse conditions were found (open circuit) if power components were shorted by the sodium chloride solution. Fuse open time was approximately 2 - 3 seconds as indicated by 0.0 mA current leakage measurements. {10}------------------------------------------------ ATROLLED DOCT JPN Concession, and courseles comments of a winners and consembly. Start Components and concerter commons of a creative in a transcentralized station and conceres a statistical SE (Mode) OTES NOT TO SCAL ### 510(k) Summary Noble Anesthesia-Air Electronic Stethoscope Image /page/10/Figure/2 description: This image is a technical drawing of a Snor-Scope Plus Component Configuration - Basic. The drawing includes a standard stethoscope labeled as "Device B", an anesthesia machine, and a plastic coupler assembly. The drawing was created by ABH and checked by JPN on July 25th and 28th, 2008, respectively. Image /page/10/Figure/3 description: The image shows the text "EXHIBIT A - Configuration Drawing (Full Size Copy, Page 12(a))". The text is in a sans-serif font and is left-aligned. The text is likely a title or heading for a document or presentation. DEVICE 'A" or "B" dac Cable / Mic Assen DEVICE "A" SNOR-SCOPE PLUS CTRONIC STETHOSCO Stean / Mic Inpu1 はここ aslic Film Diaphragn In Tight Fil / Bameri 377 Zane Court • Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 • Email: alex _henderson@msn.com nesinesia Prossure Tubi 0 ネ io Palient {11}------------------------------------------------ 。Noble J: Ularaglig Farcoger in the Bestledit Ligen/ pate it LTS-LTS :: : : : : : : : : : : : : : : : 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 第 1, 15 % rasive Nasally-Applied Positive Airway Pressure Prevents Upper Airway Obstruction and uate Spontaneous Respiration During Mild, Moderate and Deep Sedation, and General Ar edures) indic inway that erence cussic rtment of Anesthesiology, University of Florida College of Medicine, Gainesville, mbined procedures that included mytide rransots pronus position, mesters management of the more t 02%, using an oxygen consemblement of the more of the since of the sin Noble, * RN Coop from 84 to 380 minutes for committee sult em Institutional Review nd institutional Consert attist e oosmetic surger participation e oosmetic surgere platistics trate the ainmal ened to It patien ductio thod ## EXHIBIT B - Clinical Presentation Slide (Full Size Copy, 13(a)) 510(k) Summary Noble Anesthesia-Air Electronic Stethoscope 377 Zane Court · Elizabeth, Colorado USA 80107 Telephone: 303-646-3715 · Email: alex henderson@msn.com K082528 ps 12 of 12 mbal W. Kacanale R. BBC Brone Ringle Recollection Datan Box Box {12}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### 6 2009 Noble Anesthesia Air Inc. c/o Mr. Alex Henderson Braun Solutions 377 Zane Court Elizabeth, CO 80107 Re: K082528 Trade Name: Snor-Scope Plus Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD Dated: February 23, 2009 Received: February 26, 2009 Dear Mr. Henderson: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {13}------------------------------------------------ ### Page 2 - Mr. Alex Henderson 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, P. Attebery 81 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {14}------------------------------------------------ # Indications for Use 510(k) Number (if known): K082528 Device Name: Snor-Scope Plus Electronic Stethoscope Indications for Use: The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-clectronic) stethoscope. In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia care professional. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Artellstein for B. Zuckerman (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K082528 Page 1 of 1