(91 days)
Not Required
No
The description focuses on basic ultrasound and acoustic technology for blood flow detection and pressure measurement. There is no mention of AI, ML, or any advanced data processing that would suggest the use of these technologies.
No.
The intended use is diagnostic ultrasound blood flow detection, and it facilitates detection of blood-flow and SBP measurements to determine PAD. It solely gather diagnostic information and does not provide any therapeutic function.
Yes
This device is intended for "Diagnostic ultrasound blood flow detection of the human body" and is used to facilitate "the detection of blood-flow in the peripheral arteries" and "Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI)". These functions are all diagnostic in nature.
No
The device description explicitly states it is an "Acoustic stethoscope with ultrasonic transducer" and is "Powered by one (6LR61) 9V lenium battery," indicating it is a hardware device with physical components.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Diagnostic ultrasound blood flow detection of the human body." and describes its use in "peripheral vascular investigation" and "the detection of blood-flow in the peripheral arteries". It also mentions "Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI)". These are all diagnostic purposes related to assessing physiological conditions.
- Device Description: The device uses an "ultrasonic transducer" and operates in "Doppler mode" to detect blood flow. This is a common method used in diagnostic procedures.
- Anatomical Site: The anatomical sites mentioned (peripheral vascular system, arteries, limbs) are consistent with diagnostic investigations of blood flow.
While the device also has a "stethoscopic mode (classical stethoscope)", which is typically not considered an IVD, the primary diagnostic function described is the ultrasound blood flow detection and its use in determining the ABI, which falls under the scope of in vitro diagnostics.
Therefore, the device's intended use and mechanism of action for blood flow detection and ABI determination classify it as an IVD.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound blood flow detection of the human body
The Stethoflux® is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation.
It facilitates :
- the detection of blood-flow in the peripheral arteries
- Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer
Product codes
KNG, JAF
Device Description
Acoustic stethoscope with ultrasonic transducer It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode. Powered by one (6LR61) 9V lenium battery, Doppler frequency: 8 MHz, Operating time 25 h according to use, Mass 331 g. The Stethoflux includes a 8 MHz unfocused CW transducer, indicated for the detection of the blood-flow in the peripheral vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound blood flow detection
Anatomical Site
peripheral vascular system, heart, lungs, abdomen, arteries, brachial artery, posterior tibial, anterior tibial or dorsalis pedis arteries, lower limb, upper-limb
Indicated Patient Age Range
Everybody, mainly patients having cardiovascular risk
Intended User / Care Setting
general practitioners or specialists on their own responsibility, physicians specialised in vascular pathology
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
Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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510(K) PREMARKET NOTIFICATION SUBMISSION
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Supporting file for the Doppler Stethoscope Stethoflux APR 1 0 2006
Image /page/0/Picture/2 description: This image contains text extracted from a document. The text includes "SF 510(k)", "December, 19 2005", "Page 7 / 19", and "K060064". The text appears to be related to a regulatory filing or document submission, possibly to the FDA, given the reference to "SF 510(k)". The document was created in December 2005.
510(K) SUMMARY
[As Required by 21 CFR 807 92]
| 1 | Submitter's information | ODVI
20 rue de la Croix Nivert
75015 Paris
France
Phone and fax number (+33) 1 43 06 10 18
Contact person. Dr Herve BINDEFELD. Technical and Scientific Director |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Preparation date of the summary | December. 19 2005 |
| 2 | Name of the device | Acoustic and doppler stethoscope Stethoflux® |
| | Code product | KNG |
| | Classification | Monitor, blood flow, class il according to 21CFR 884.2660
884 2660 Fetal ultrasonic monitor and accessories |
| 3 | Predicate substantially equivalent device | K030466. HandyDop TM. Elcat GmbH |
| 4 | Description of the device | Acoustic stethoscope with ultrasonic transducer |
| | Concept | |
| | Explanation of how the device operates | It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode |
| | Physical and performance characteristics | Powered by one (6LR61) 9V lenium battery
Doppler frequency . 8 MHz
Operating time 25 h according to use
Mass 331 g |
| | Differences from predicate devices | A single probe 8 MHZ which is built-in the housing, instead of 3 which are connected
A single battery instead of 2 rechargeable batteries |
| 5 | Intended use | Detection and listening of the blood-flow in the peripheral vascular system
The Stethoflux is designed for use by general practitioners or specialists on their own responsibility It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation. |
| | Conditions that the device diagnoses | Classical clinical investigation - It allows dual stethoscopic and Doppler vascular investigation in a single examination. facilitating the detection of blood-flow
When associated with a sphygmomanometer. Systolic Blood Pressures (SBP) measurement of the lower limb and upper-limb in order to determine the possible PAD in the concerned limb |
| | Troubles and diseases | Cardiovascular diseases such as atherothrombosis and Penpheral Artery |
| Target patient population | Everybody, mainly patients having cardiovascular risk | |
| Target users population | dedicated to physicians specialised in vascular pathology : general practitioners or specialists on their own responsibility | |
| Examination sites | Standard acoustic examination heart lungs, abdomen, arteries
Doppler examination of the peripheral vessels, mainly brachial artery and
posterior tibial, anterior tibial or dorsalis pedis arteries | |
| | Non invasive device | |
| Differences of the indication
statements from predicate
device | None for the common application with the 8 MHz probe | |
| Explanations arguing that
they are minor | The differences concern the presentation of the device, such as the built-in probe and battery number. They do not affect the safety and effectiveness of the device. | |
| Comparison between
predicate device
specifications and those of
the Stethoflux® | Similar specifications for the common application with the 8 MHz probe | |
| Performance data | There are no section 514 performance standards for this class of device for assisting in the determination of its substantial equivalence. | |
| Conclusions drawn from
clinical and non clinical test
data | Not required for determination of substantial equivalence for this class of device, though publication of some clinical data are contained in this premarket submission | |
| Substantial equivalence
summary | Stethoflux® is comparable and substantially equivalent to the legally marketed predicate device concerning the 8 MHz mode. The intended use is the same as that of the predicate devices. The subject device has substantially equivalent technological characteristics, features, specifications, materials, mode of operation, and intended use as a legally marketed predicate device. | |
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510(K) PREMARKET NOTIFICATION SUBMISSION
Supporting file for the Doppler Stethoscope Stethoflux
SF 510(k)
December, 19" 2005
Page 8 / 19
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border.
APR 1 0 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OVDI % Mr. Armelle LAPRELLE Project Leader CEISO 69 rue de Paris 91400 Orsay FRANCE
Re: K060064
Trade Name: Stethoflux® Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: II Product Code: JAF Dated: December 29, 2005 Received: January 9, 2006
Dear Mr. LAPRELLE:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the Stethoflux® and 8 MHz CW Split Crystal transducer as described in your premarket notification.
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)
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Protesting and Promoting Public Health
3
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 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) 276-0120. 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/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at (301) 594-1212.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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4.3 - INDICATIONS FOR USE
510(k) Number (if known):
Frida
Device Name
Stethoflux®
Indications for Use.
Diagnostic ultrasound blood flow detection of the human body
The Stethoflux® is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation.
It facilitates :
-
the detection of blood-flow in the peripheral arteries
-
Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer
Nancy C. Broadon
Division Sign Off
5
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ו ארצות
510(K) PREMARKET NOTIFICATION SUBMISSION
Supporting file for the Doppler Stethoscope Stetho/lux
SF 510(k)
December, 19" 2005 Page 10 / 19
- 1
Diagnostic Ultrasound Indications for Use Form (as required in appendix F of the FDA Guidance) Fill out one form for each ultrasound system and each transducer.
Intended Use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows' . . . . _
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N= new indication: P= previously cleared by FDA: E= added under Appendix E
Additional Comments: The Stethoflux includes a 8 MHz unfocused CW transducer, indicated for the detection of the blood-flow in the peripheral vessels
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
Concurrence of CDRH, Office of Device Evaluation (ODE) KD00064
Prescription Use (Per 21 CFR 801.109)