Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard audiometric functions and computer control via ASCII commands.

Therapeutic

No
The device is described as an "auditory diagnostic instrument" used to "diagnose hearing loss and ear disorders," which indicates a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

The intended use explicitly states the device is for "measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders." The device description further clarifies it combines the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer, and Auditory Acoustic Impedance/Admittance Tester, all of which are diagnostic tools in audiology.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Otogram CA3350 is a "computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer)." This indicates it is a hardware device with accompanying control software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Otogram is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Otogram's Function: The Otogram is an auditory diagnostic instrument that directly interacts with the patient's ear canal to measure audiometric parameters. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's for administering diagnostic and screening procedures related to hearing and ear disorders by directly testing the patient's auditory system.

Therefore, the Otogram falls under the category of a diagnostic medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer) The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

Pure tone air and bone conduction audiometry with automated masking
Speech recognition threshold with automated masking
Speech discrimination with automated masking
Tympanometry
Acoustic reflex threshold, both ipsilateral and contralateral
Distortion product otoacoustic emissions
Pure tone Stenger
Patient survey

Product codes (comma separated list FDA assigned to the subject device)

EWO, ETY, NAS

Device Description

The Otogram CA3350 is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer). The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

Adult and pediatric subjects

Intended User / Care Setting

Trained healthcare professional / Not Specified

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Comparison testing with predicate devices was performed by a Hearing Instrument Specialist Intern - someone who has been trained on the use of the equipment, but is not an audiologist. Test reports are contained in Exhibit 12 of the 510(k) submission.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The results of bench, user, and laboratory testing indicate that the new device is as safe and effective as the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041853, K910247, K974076

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.

Summary

0

510(k) Supplementary Information K070118

Submitters Name and Address: Tympany, Inc.

| | 2795 East Cottonwood Parkway, Suite 660
Salt Lake City, UT 84121
Phone: (801) 365-2800
FAX: (801) 365-3000 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person & Phone: | Mr. Lex J. Pearce
Phone: (801) 365-2868
FAX: (801) 365-3005
lex@sonici.com |
| 3. Date Prepared: | 26 January 2007 |
| 4. Device Name / Classification: | Audiometer, Otoacoustic Emissions Analyzer (21
CFR 874.1050, Product Code EWO)
Auditory Impedance Tester, Tympanometer (21
CFR 874.1090, Product Codes ETY, NAS) |
| 5. Proprietary / Trade Name: | Otogram CA3350 |

6. Device Description:

The Otogram CA3350 is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer). The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC.

7. Intended Use:

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

Pure tone air and bone conduction audiometry with automated masking

1. Speech recognition threshold with automated masking
1. Speech discrimination with automated masking

Tympanometry

1. Acoustic reflex threshold, both ipsilateral and contralateral
1. Distortion product otoacoustic emissions
1. Pure tone Stenger
1. Patient survey

The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

1

	The previous version of this chart appears in Exhibits 5, 10, and 12.
	Characteristic	Predicate
Impedance Audiometer
Madsen Zodiac 901
K910247	Predicate
Otoacoustic Emissions
Bio-Logic AuDX
K974076	Predicate
Tympany Otogram
Combined Device
Impedance Audiometer
Otoacoustic Emissions
K041853	Predicate
Tympany Otogram
CA3350
Combined Device
Impedance Audiometer
Otoacoustic Emissions
K070118
	Intended Use:	To diagnose a variety of
middle ear disorders using
impedance and static
pressure measurements
(i.e., tympanometry and
acoustic reflex) in the ear
canal.	To test cochlear function
by measuring otoacoustic
emissions.	To diagnose hearing and
otologic disorders in the
middle-ear and total ear
system, using audiometry,
Tympanometry, and
acoustic reflex. To test
cochlear function and
presence of otoacoustic
emissions.	To administer, under
supervision by a trained
healthcare professional, a
battery of diagnostic and
screening procedures that
include pure tone air and
bone conduction
audiometry with automated
masking, speech
recognition threshold with
automated masking, speech
discrimination with
automated masking,
tympanometry, acoustic
reflex threshold (both
ipsilateral and
contralateral), distortion
product emissions, pure
tone Stenger and patient
survey.
Characteristic	Predicate
Impedance Audiometer
Madsen Zodiac 901
K910247	Predicate
Otoacoustic Emissions
Bio-Logic AuDX
K974076	Predicate
Tympany Otogram
Combined Device
Impedance Audiometer
Otoacoustic Emissions
K041853	Tympany Otogram
CA3350
Combined Device
Impedance Audiometer
Otoacoustic Emissions
K070118
Physical
characteristics:
Computer
interface:	RS 232C	RS 232C	Computer included, RS
232C	Computer included, RS
232C
Internal printer	Thermal 112 mm, 4.5"	Thermal 59 mm,
2 1/4"	Thermal 58 mm,
2 1/4"	NA
Printer interface	Parallel port	RS 232C thermal printer	Parallel port or USB
Computer LCD 1024 x 768	Parallel port or USB
Computer LCD 1024 x 768
Display	Graphic supertwist LCD
backlight, 256 lines x 128
dots
White text/graphics on
blue background	LCD 1" x 3"
Black and white	Color, resistive
touchscreen	Color, resistive
touchscreen
Control interface	Keyboard	Touchpad	Keyboard, touchscreen	Keyboard, touchscreen
Size/weight-
metric	370 x 385 x 120 mm
(W x D x H), 7.6 kg	98 x 41 x 197 mm
(W x D x H), 0.45 kg	410 x 300 x 480 mm
(W x D x H), 20.4 kg	356 x 348 x 493 mm
(W x D x H), 21.1 kg
Size/weight-
American	14.8" x 15.4" x 4.8", 16.8
lbs	3 7/8" x 1 5/8" x 7 3/4", 1
lb	16" x 19", x 12", 45 lbs	14.0" x 13.7" x 19.4", 46.5
lbs
Energy source	AC 50/60 Hz, 100-240 V	AC 50/60 Hz, 100-240 V	AC 50/60 Hz, 100-120 V	AC 47-63 Hz. 90-250
VAC
Hardcopy output	Thermal paper or external
printer paper	External thermal printer	Thermal paper or external
printer paper	External printer paper
Standard and
safety
characteristics:
Performance and
calibration	IEC 1027, ANSI S3.39	NA	IEC 1027, ANSI S3.39	IEC 1027, ANSI S3.39,
IEC 60645-5
Electrical safety	EN 60601-1, class I,
type B	EN 55011: 1991 group 1
Class B	EN 60601-1, class I,
type B	IEC 60601-1 and 60601-1-
1, class I, type B and BF
and IEC 60601-1-2 (EMC)

rs in Ev 8. Updated Substantial Equivalence Chart:
The previous version of this chart appea

2

.

'

Page 5 of 6

:

and the comments of the comments of

3

9. Significant changes from predicate Tympany Otogram combination device:

Expansion of intended use to include use by "trained healthcare professional" vs. "qualified/trained audiologist"
- The indications for use stated in the 501(k) submission for the Bio-Logic AuDX device (K974076) indicates use by a "trained health care professional (for example an Audiologist)"
- Training for the Otogram CA3350 includes a thorough review and training using the User Instruction Guide included in Exhibit 13 of the 510(k) submission.
- Comparison testing with predicate devices was performed by a Hearing Instrument Specialist Intern - someone who has been trained on the use of the equipment, but is not an audiologist. Test reports are contained in Exhibit 12 of the 510(k) submission.
Different computer and improved design on various components and assemblies.
- Computer specifications and design specifications are contained in Exhibit 11 of the 510(k) submission.

10. Safety and Effectiveness comparison to predicate devices:

The results of bench, user, and laboratory testing indicate that the new device is as safe and effective as the predicate devices.

11. Conclusion:

After analyzing both bench and user testing data, it is the conclusion of Tympany Inc. that the Tympany Otogram CA3350 is safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

4

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

MAR 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tympany, Inc. c/o Lex J. Pearce 2795 East Cottonwood Parkway, Suite 660 Salt Lake City, UT 84121

Re: K070118

Trade/Device Name: Otogram CA3350 Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, NAS, ETY Dated: January 11, 2007 Received: January 12, 2007

Dear Mr. Pearce:

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.

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

5

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrb/industry/support/index.html.

Sincerely yours,

M.B. Egelman Si MD

g

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

Enclosure

6

Indications for Use

510(k) Number (if known): K070118

Device Name: Otogram CA3350

Indications for Use:

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, Distortion Product Otoacoustic Emissions Analyzer and Auditory Acoustic Impedance/Admittance Tester (i.e. Tympanometer) The Otogram is indicated for use by trained healthcare professionals on both adult and pediatric subjects for measurement of audiometric parameters to identify and supply data to help diagnose hearing loss and ear disorders.

The Otogram is an auditory diagnostic instrument intended to administer, under supervision by a trained healthcare professional, a battery of diagnostic and screening procedures that include the following:

Pure tone air and bone conduction audiometry with automated masking
Speech recognition threshold with automated masking
Speech discrimination with automated masking
Tympanometry
Acoustic reflex threshold, both ipsilateral and contralateral
Distortion product otoacoustic emissions
Pure tone Stenger
Patient survey

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___________ (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)

(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number	K070118
---------------	---------

| | Prescription Use
(Per 21 CFR 801.109) |

--	------------------------------------------

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