(259 days)
Not Found
No
The summary describes a device that amplifies sounds and displays ECG signals and heart rate, but there is no mention of AI or ML in the device description, intended use, or specific sections for AI/ML information.
No.
The "Intended Use" section clearly states, "The Techno-Scope is not intended to be used as a diagnostic device," and there is no mention of treating or alleviating any medical condition. It functions to project sounds and display ECG signals for observation, not therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The Techno-Scope is not intended to be used as a diagnostic device."
No
The device description explicitly states it is comprised of a manual stethoscope and an electrocardiograph display unit with electrodes, indicating it includes hardware components.
Based on the provided information, the Techno-Scope 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.
- Techno-Scope's Function: The Techno-Scope works by projecting sounds from within the body (auscultation) and acquiring electrical signals from the body's surface (ECG). It does not analyze samples taken from the body.
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Techno-Scope is not intended to be used as a diagnostic device." While this doesn't directly address the IVD classification, it reinforces that its purpose is not to perform diagnostic tests on biological samples.
Therefore, the Techno-Scope falls under the category of a medical device that interacts with the body externally to gather information, rather than an IVD which analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.
The Techno-Scope is not intended to be used as a diagnostic device.
Product codes
DQD
Device Description
The Techno-Scope™ Visual Stethoscope is comprised of a manual stethoscope which can project sounds associated with the heart, arteries, veins and other internal organs. It also has an electrocardiograph (ECG) display unit. The electrocardiograph consists of 3 leadless nondisposable electrodes. It is placed on the chestpiece of the stethoscope, opposite the diaphragm. It can display real time ECG through high resolution LCD. It also calculates and displays the heart rate according to the ECG. The healthcare professional can listen to internal organ sounds simultaneously while seeing the ECG signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "K 050097". The characters are written in a bold, sans-serif font, and they appear to be handwritten or generated with a slightly rough texture. The sequence likely represents a code, identifier, or serial number.
510(k) Addendum, K050097 Techno-Scope
TECHTRADE
274 MADISON AVE. S-1001 NEW YORK, NY 10016 TEL: 212-481-2515 FAX: 212-481-2487 EMAIL: salestechtrade@verizon.net Toll Free: 1-866-491-TECH
510(k) SUMMARY
| 510(k) Owner's name:
Address: | TechTrade
274 Madison Ave. S-1001
New York, NY 10016 |
|----------------------------------|-----------------------------------------------------------------------------------------|
| Phone: | 212-481-2515 |
| Fax number: | 212-481-2487 |
| Name of contact person: | Grace Holland
Regulatory Specialists, Inc
3722 Ave. Sausalito
Irvine, CA 92606 |
| | Phone: 949-262-0411 |
| | Fax: 949-552-2821 |
| Date the summary was prepared: | September 26, 2005 |
| Name of the device: | Techno-Scope™ Visual Stethoscope |
| Trade or proprietary name: | Techno-Scope™ Visual Stethoscope |
| Common or usual name: | Stethoscope |
| Classification name: | Electronic Stethoscope (21 CFR |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| Applicant | Device | 510(k) |
|---|---|---|
| CADITEC AG | CADISCOPE ELECTRONIC STETHOSCOPE | K990809 |
870.1875, Product Code DQD)
Description of the device:
The Techno-Scope™ Visual Stethoscope is comprised of a manual stethoscope which can project sounds associated with the heart, arteries, veins and other internal organs. It also has
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an electrocardiograph (ECG) display unit. The electrocardiograph consists of 3 leadless nondisposable electrodes. It is placed on the chestpiece of the stethoscope, opposite the diaphragm. It can display real time ECG through high resolution LCD. It also calculates and displays the heart rate according to the ECG. The healthcare professional can listen to internal organ sounds simultaneously while seeing the ECG signals.
Indications for Use:
The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.
The Techno-Scope is not intended to be used as a diagnostic device.
Summary of the technological characteristics of the Techno-Scope
The predicate was compared in the following areas and, with the except that the predicate device is an electronic stethoscope and the Techno-Scope is a manual stethoscope, found to have similar technological characteristics and to be equivalent to the CADIscope.
- Biocompatibility Display of cardiac biopotentials Environment Indications Intended Use LCD Display On/Off Controls Patient Contacting Materials Power Supply Signal Storage Sound Amplification Sound Pickup Target Population
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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TechTrade LLC c/o Ms. Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606
Re: K050097
Trade Name: Techno-Scope™ Visual Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: August 31, 2005 Received: August 31, 2005
Dear Ms. Holland:
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 10 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. Grace Holland
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. production of the more to begin marketing your device as described in your Section 510(k) I mo lotter with cation. 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), pleasc contact the Office of Compliance at (240) 276-0295. 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 may be obtained 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,
Blumenafer
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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Indications for Use Statement
510(k) Number (if known): K050097
Device Name: Techno-Scope
Indications For Use:
The Techno-Scope projects sounds associated with the heart, arteries, and veins and other internal organs. It also acquires the electrical signal from electrodes and produces a visual display of the electrocardiograph signal and heart rate.
The Techno-Scope is not intended to be used as a diagnostic device.
Prescription Use __ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Bhimima
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