The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by Health Care Professional. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency.

Device Description

This electronic Stethoscope is used for the amplification of of heart, lung and other body sounds. This Stethoscope has 3 modes for selective frequency amplification & a 8-steps volume control.

AI/ML Overview

The Tytan Model #600 series Electronic Stethoscope does not include a study proving device performance against acceptance criteria. Instead, it relies on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Tytan Model #600 Series Electronic Stethoscope Performance
Performance Specification	Conforms to applicable standards: IEC 60601-1 and	"In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements."
Safety	Conforms to applicable standards: IEC 60601-1 and	"In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements."
EMC (Electromagnetic Compatibility)	Conforms to applicable standards: IEC 60601-1-2	"In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements."
Intended Use	Same as predicate device (3M Littmann Model 2000 Electronic Stethoscope)	"The Tytan Model # 600 series Electronic Stethoscope have the same intended use... as the 3M Littmann Model 2000 Electronic Stethoscope (K#961848)..."
Technological Characteristics	Similar to predicate device; any differences do not raise new questions of safety or effectiveness.	"Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance:

Not applicable. The submission does not describe a clinical test set with human subjects or a dataset for evaluating an algorithm. The evidence presented focuses on bench testing and adherence to general safety and EMC standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an electronic stethoscope; it is not an AI-powered diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical instrument for sound amplification, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth, in this context, would imply a reference standard for diagnostic accuracy, which is not evaluated. The "ground truth" for the performance claims appears to be adherence to recognized electrical and safety standards through bench testing.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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510(K) SUMMARYFEB 2 6 2003

K023637
page 1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with ' 've requirements of SMDA and 21 CFR §807.92

1.0	Submitter's Name:	Tytan Medical Corp.
	Address:	1F, No. 2, First Lane, Juang Shing Rd., 1 , Wu Gu, Taipei, 248, Taiwan,
		R.O.C.
	Phone:	886-2-8988-3828
	Fax:	886-2-8981-2254
	Contact:	Michael Shieh
2.0 Device Name:		Tytan Model # 600 series Electronic Stethoscope
		Model no.: 6XY (X,Y = 0-9, A-Z, or blank)
		* The first Character (0-9, A-Z, or blank)is for the minor change revision
		of device (The Minor change meaning device change that do not affectthe conformity test result of EMC & Safety, ie. IEC 60601-1 and IEC60601-1-2 )
		* The second Character(0-9, A-Z, or blank) is for the color of the device
		(for example 0 for Black housing & tubing)Tytan #600 Electronic Stethoscope is the 1st revision design of Black
		housing & tubing
3.0	Classification:	Class II
	4.0 Predicate Device:	3M Littmann Model 2000 Electronic Stethoscope (K#961848)marketed by 3M Health care
	5.0 Device Description:	This electronic Stethoscope is used for the amplification of of heart, lungand other body sounds. This Stethoscope has 3 modes for selectivefrequency amplification & a 8-steps volume control.
	6.0 Intended Use:	The Tytan Model # 600 series Electronic Stethoscope is a diagnosticaid and used as part of a physical assessment of a patient by Health CareProfessional. It can be used for the amplification of heart, lung and otherbody sounds with the use of selective frequency.
	PerformanceSummary:	In terms of performance specification, Safety & EMC requirements, thedevice conforms to applicable standards included IEC 60601-1 and IEC60601-1-2 & related requirements.

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8. Conclusions:

The Tytan Model # 600 series Electronic Stethoscope have the same intended use and similar ාchnological characteristics as the 3M Littmann Model 2000 Electronic Stethoscope (K#961848) marketed by 3M Health care. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Tytan Model # 600 series Electronic Stethoscope is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2003

Tytan Medical Corp. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

Re: K023637

Trade Name: Tytan #600 Series Electronic Stethoscopes Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: February 10, 2003 Received: February 12, 2003

Dear Ms. Reich:

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.

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Page 2 -- Ms. Jennifer Reich

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 Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K. DeWitt Tull

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023637

Page _________________________________________________________________________________________________________________________________________________________________________

K023637 NUMBER (IF KNOWN): _ 510 (k)

Tytan #600 Series Electronic Stethoscopes DEVICE NAME: Tytan Medical Corp.

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter _________________ (Optional Format)

XQell Tel

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K023637

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.