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.

Device Description

The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope System is a kit comprised of the following components:

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)

A shielded microphone and audio cable, with a 3.5mm plug, connects the 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 diaphragm 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Snor-Scope Plus Electronic Stethoscope, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Drop Test Performance (for each axis: X, Y, Z from 3 ft onto hard, uniform surface): - No major external or internal damage (for disposition "Continue tests until final release")	Unit #1 (S/N: 0103): Scratched (X-axis), None (Y-axis), Dent - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK).Unit #2 (S/N: 0107): None (X-axis), Scratched (Y-axis), Hairline Crack - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK. Crack did not affect function).Unit #3 (S/N: 0124): None (X-axis), None (Y-axis), Dent - Corner (Z-axis). No Internal Damage. Passed functional test (Volume Control OK, Connectors OK, Speaker OK).Overall Conclusion stated: "No Internal Damage [...] Disposition: Continue tests until final release. Certified by: [Signature] Date: 01/12/2009"
T-Connector Assembly Pressure Test: - The diaphragm of the Stethoscope-Connector cannot fail (rupture or leak) after being subjected to 25 cycles of 90 cm of water pressure (double the extreme of clinically used pressures: Max PEEP = 30 cm H2O, Max Added PPV = 60 cm H2O).	The text states: "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." This is presented as the criteria for the test, and the "Discussion" section for the T-Connector Test Protocol implies successful completion: "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." (This implies it didn't rupture during testing according to the criteria).
Hazardous Conditions Test Protocol - Liquid (Normal Test - Current Leakage): - No current leakage with or without the charger plugged in under normal operating conditions.	"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."
Hazardous Conditions Test Protocol - Liquid (Destructive Test - Current Leakage with Sodium Chloride solution): - If internal PC board power components are shorted, the micro fuse (Fast Acting, 750 mA, One Time) should indicate no continuity (open circuit) and leakage current should be 0.0mA within ~2-3 seconds. - With charger plugged in, slight current leakage 0.02 mA - 0.03 mA acceptable before fuse opens. - Without charger plugged in, current leakage ~0.01 mA acceptable before fuse opens.	"During destructive testing, there was slight current leakage between 0.02 mA - 0.03 mA with the battery charger plugged in... If the internal PC board power components were shorted by the sodium chloride solution, the micro fuse [...] 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."
Clinical Performance (Detection of Airway Obstruction): - Accurate detection of stridor in patients undergoing sedation.	"The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." (from the "Pediatric Sedation Outside of the Operating Room" study)."The Noble Anesthesia-Air Snor-Scope Plus™ Electronic Stethoscope is a reliable monitor to detect an evolving obstruction of the upper airway."
Safety (Adverse Effects): - No adverse effects or complications.	"There were no adverse effects or complications." (from the "Pediatric Sedation Outside of the Operating Room" study).

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

Clinical Study:
- Sample Size: 10 patients.
- Data Provenance: Retrospective, gathered during a study sponsored by Harvard University, San Francisco CA USA, in September 2008. The data was gathered while Dr. James P. Noble was in private practice. The formal study was approved in 2005 by the Western Institutional Review Board (WIRB Protocol #20050216). Patients were "representative of the patient population for which Dr. Noble had cared for over nearly 10 years."
Drop Test Performance:
- Sample Size: 3 units (S/N: 0103, 0107, 0124).
- Data Provenance: Non-clinical bench testing.
T-Connector Assembly Pressure Test:
- Sample Size: "Random T-Connector assemblies." (Specific number not provided).
- Data Provenance: Non-clinical bench testing.
Hazardous Conditions Test Protocol - Liquid (Current Leakage):
- Normal Test Sample Size: 5 amplifier module, microphone, and T-connector assemblies.
- Destructive Test Sample Size: 10 amplifier module, microphone, and T-connector assemblies (5 with charger unplugged, 5 with charger plugged in).
- Data Provenance: Non-clinical bench testing.

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

Clinical Study: While the study involved 10 patients and aimed to detect stridor, the documentation states "The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." It doesn't explicitly detail how the ground truth of stridor presence was independently established for each patient in the study or by how many experts. However, the study was conducted by or under the supervision of Dr. James P. Noble, who is an Anesthesiologist ("licensed Anesthesiologist only" mentioned in proposed labeling, and his experience in "improving the safety of anesthesia for cosmetic surgery patients" for nearly 10 years before the formal study). The study sponsor/investigator was Robert N. Cooper, M.D.
Bench Testing: For non-clinical tests (drop, pressure, leakage), the ground truth is determined by the test criteria themselves (e.g., visual inspection for damage, functional testing, resistance/current measurements). The tests were certified by an unnamed individual.

4. Adjudication Method for the Test Set

Clinical Study: Not explicitly stated for the clinical study. It implies Dr. Noble's clinical assessment was key, given his experience and the device's role in his "special technique." No formal adjudication method like "2+1" or "3+1" is mentioned for establishing the presence of stridor.
Bench Testing: Not applicable in the same way as clinical studies. The results are objective measurements or observations against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done.
- The submission focuses on the device's standalone performance and its equivalence to predicate electronic stethoscopes in basic functionality, with an additional indication for detecting upper airway obstruction.
- The "user testing with Anesthesiologists and Clinicians" for overall effectiveness is mentioned generally but no specifics of an MRMC study are provided.
- The clinical assay describes a study of 10 patients where the Snor-Scope Plus was used, but it does not compare human readers with and without AI assistance or any other comparative effectiveness with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, a standalone performance assessment was done for the core function of detecting stridor.
- The device is described as an "Electronic Stethoscope" that "electronically amplifies sounds of evolving obstruction." The clinical assay concludes: "The stridor that was reported in the results was accurately detected by the Snor-Scope Plus." This indicates the device, on its own, detected the stridor.
- The Snor-Scope Plus is an analog audio system; it "has no software, and operates using an analog audio system without introducing any signals or energy into the patient or anesthesia breathing circuit." Therefore, it's not an "algorithm" in the modern sense of AI, but its ability to amplify and present sounds for human interpretation is its standalone function.

7. The Type of Ground Truth Used

Clinical Study: Clinical observation/assessment by medical professionals (implied to be Dr. Noble and potentially other clinicians involved in the study) for the presence of stridor, linked to "evolving obstruction of the upper airway." The "stridor that was reported in the results was accurately detected by the Snor-Scope Plus," indicating the reported stridor was the ground truth.
Bench Testing: Objective physical and electrical measurements against predefined benchmarks and safety standards (e.g., integrity after drops, pressure resistance, current leakage measurements).

8. The Sample Size for the Training Set

Not Applicable / Not Provided.
- The Snor-Scope Plus is described as operating using an "analog audio system" and "has no software." This implies it is not a machine learning or AI-driven device that requires a training set in the typical sense. Its design is based on established acoustic and electronic engineering principles for amplification.
- The "nearly 10 years during the development of his special technique" by Dr. Noble, where the Snor-Scope Plus (in various stages) was an "essential part," could be considered a form of informal, long-term development and refinement, but not a formal 'training set' for an algorithm.

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

Not Applicable. As noted above, there's no indication of a formal 'training set' or 'ground truth' establishment for a machine learning algorithm given the device's analog nature. The development and refinement would have been guided by traditional engineering and clinical experience/observation.

Summary

{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.1505 Fort Clarke Blvd. 17-106Gainesville, Florida 32606
	Contact Person: James P. Noble, M.D.Telephone: (352) 332-7908Email: noble@anesthesia-air.com
Official Correspondent:	BraunSolutions377 Zane Court,Elizabeth, CO 80107
	Contact Person: Alex HendersonTelephone/Fax: (303) 646-3715Email: alex_henderson@msn.com
Date Prepared:	August 25, 2008
Device Name:
Trade/Proprietary Name:Common/Generic Name:Classification Name:	Snor-Scope Plus™ and/or Snor-Scope +™ System (Kit)Electronic StethoscopeElectronic Stethoscope, Class II (Two)(21 CFR 870.1875(b), Product Code DQD)
Predicate Devices:	RNK Products Stethoscope (K030446, K072026)Pishon High Tech Co. Stethoscope (K062481)Meditron AS Stethoscope (K991367)
Related Accessories:(Kit)
Classification	Description	Class
21 CFR 868.524021 CFR 868.581021 CFR 868.586021 CFR 868.193021 CFR 870.1875	Breathing Circuit (Kit)Airway ConnectorPressure Tubing and AccessoriesStethoscope HeadStethoscope	IIIII

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.

{2}------------------------------------------------

Statement of Intended Use:

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 ProductsElectronicStethoscopeK030446, K072026	Pishon High TechElectronicStethoscopeK062481	Meditron ASElectronicStethoscopeK991367	Snor-Scope PlusElectronicStethoscope
Classification Name	ElectronicStethoscope	ElectronicStethoscope	ElectronicStethoscope	ElectronicStethoscope
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"

SPONSOR / INVESTIGATOR / SITE:	Robert N. Cooper, M.D.201 East Osceola StreetStuart, 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.
1. Open case and note any internal damage, if any, on chart. Document with photos.
1. 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".

SnorScopePlus	X Axis Notes	Y Axis Notes	Z Axis Notes	Functional Test
	TEST 1:	TEST 2:	TEST 3:	UNIT:	BATTERIES:
Unit #1S/N: 0103	Scratched	None	Dent - Corner	Passed	Passed
Unit #2S/N: 0107	None	Scratched	Hairline Crack-Corner	Passed	Passed
Unit #3S/N: 0124	None	None	Dent - Corner	Passed	Passed
Comments:				Disposition: Continue tests until finalrelease. Certified by:
No InternalDamage.	VolumeControl OK.	ConnectorsOK.	SpeakerOK.Crack did notaffect 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

1. 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

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:

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

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

510(k) Summary (Per 21 CFR 807.92)

Device Description: (Reference Exhibit A, Page 12) Class I ME Device

Statement of Intended Use:

Substantial Equivalence:

Substantial Equivalence Comparison Chart

Proposed Labeling: Audio Amplifier -Front (Guidance: IEC60601-1 Sec. 15)

T-Connector Coupler Photos Electronic Stethoscope

Located on Charger:

Located on T-Connector:

Clinical Assay: (Reference Exhibit B, Page 13)

"Pediatric Sedation Outside of the Operating Room"

SPONSORED BY: Harvard University, San Francisco CA USA September, 2008.

CONCLUSION SUMMARY:

Safety and Performance: (Guidance: IEC60601-1 2005, where applicable)

Non-Clinical Testing: (Reference: T-Conncctor Assembly Test Protocol, Page 10)

Conclusions:

AXIS: X: Top (Speaker) Down

CRITERIA:

SUMMARY DATA

T-Connector Assembly Test Protocol:

510(k) Summary

Noble Anesthesia-Air Electronic Stethoscope

Hazardous Conditions Test Protocol - Liquid:

CRITERIA: Random Test

2. DESTRUCTIVE TEST:

510(k) Summary Noble Anesthesia-Air Electronic Stethoscope

EXHIBIT B - Clinical Presentation Slide (Full Size Copy, 13(a))

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

6 2009

Page 2 - Mr. Alex Henderson

Indications for Use

§ 870.1875 Stethoscope.