(119 days)
K#961848
Not Found
No
The summary describes a standard electronic stethoscope with amplification and frequency selection, with no mention of AI/ML features or data processing beyond basic signal amplification.
No
The device is described as a "diagnostic aid" used for "amplification of heart, lung and other body sounds," which are functions related to diagnosis rather than therapy.
Yes
The Intended Use / Indications for Use section explicitly states that "The Tytan #6xy Series Electronic Stethoscope is a diagnostic aid".
No
The device description explicitly states it is an "Electronic Stethoscope" and mentions features like "3 modes for selective frequency amplification & a 8-steps volume control," which are indicative of hardware components beyond just software. The reference to IEC 60601-1 and IEC 60601-1-2 standards also points to a physical medical device with electrical safety and electromagnetic compatibility considerations.
Based on the provided information, the Tytan #6xy Series Electronic Stethoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Tytan #6xy Series Electronic Stethoscope is used for the amplification of body sounds (heart, lung, etc.) during a physical assessment. This is a direct examination of the patient's body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic aid and used as part of a physical assessment of a patient." This aligns with the function of a stethoscope, which is a tool for physical examination.
Therefore, the Tytan #6xy Series Electronic Stethoscope falls under the category of a medical device used for physical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tytan Model # 600 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.
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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lung and other body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professional
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#961848
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 affect | ||
| the conformity test result of EMC & Safety, ie. IEC 60601-1 and IEC | ||
| 60601-1-2 ) | ||
| * 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, lung | |
| and other body sounds. This Stethoscope has 3 modes for selective | ||
| frequency amplification & a 8-steps volume control. | ||
| 6.0 Intended Use: | The Tytan Model # 600 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. | ||
| Performance | ||
| Summary: | 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. |
1
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.
2
Image /page/2/Picture/2 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 image of an eagle or bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
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.
3
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
4
Page _________________________________________________________________________________________________________________________________________________________________________
K023637 NUMBER (IF KNOWN): _ 510 (k)
Tytan #600 Series Electronic Stethoscopes DEVICE NAME: Tytan Medical Corp.
INDICATIONS FOR USE:
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.
.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)
OR
Over-The-Counter _________________ (Optional Format)
XQell Tel
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K023637