(108 days)
No
The summary describes standard signal processing and analysis techniques for acoustic data, with no mention of AI or ML terms or concepts.
No
The device is described as an electronic stethoscope for analysis, interpretation, and documentation of lung sounds, quantifying wheezing, and listening to amplified/filtered breath sounds. Its primary function is diagnostic and monitoring, not therapeutic intervention.
Yes
The device is described as analyzing, interpreting, and documenting lung sounds, and is indicated for quantifying wheezing and listening to amplified/filtered breath sounds. It performs "wheeze detection validation test" and "breath detection validation test," which implies it is used to identify or characterize a medical condition based on data it acquires, amplified, filtered, recorded, and analyzed. This is a typical function of a diagnostic device.
No
The device description explicitly lists multiple hardware components including acoustic sensors, a sensor pod, a respiration belt, an A/D data acquisition device, and cables, in addition to the software. The performance studies also include testing of hardware components.
Based on the provided information, the WIM-PC™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- WIM-PC™ Function: The WIM-PC™ analyzes lung sounds acquired directly from the patient's body using acoustic sensors. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the analysis, interpretation, and documentation of lung sounds for use in pulmonary function testing, provocation tests, bronchodilator administration, and physical examinations. This involves direct interaction with the patient's body, not the analysis of in vitro samples.
- Device Description: The device description details the use of acoustic sensors, a respiration belt, and a computer system to acquire and analyze sounds from the trachea and thorax. This is a non-invasive method of data acquisition from the body itself.
Therefore, the WIM-PC™ falls under the category of a medical device that interacts directly with the patient's body to acquire physiological data, rather than an IVD device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The WIM-PC™ is intended for the analysis, interpretation and documentation of lung sounds.
The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
Product codes (comma separated list FDA assigned to the subject device)
BZM
Device Description
The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.
The WIM-PC™ system consists of:
- Acoustic sensors (attached to the patient using adhesive pads). .
- Sensor pod with a built-in dielectric microphone for ambient noise pick-up.
- Tension-sensitive respiration belt. .
- A/D data acquisition device ●
- USB cable and signal cable .
- Laptop PC unit with Data Analysis software. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung sounds, trachea and thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; pulmonary function testing environment
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)
The following tests were performed on the WIM-PC™ hardware components:
- · Tension-sensitive Respiration Belt:
- · Electrical response to tension.
- · Respiratory activity detection
- · Acoustic sensors: sensors frequency response and sensitivity.
- · Front End performance.
The following validation tests were performed on the WIM-PC™ software:
- · Wheeze detection validation test.
- · Breath detection validation test.
The WIM-PC™ packaging was tested for its durability to shipment conditions.
The following test was performed on the WIM-PC™ packaging:
- WIM-PC™ packaging system integrity .
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.
PulmoTrack™ model 1010 (K980878)
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.
SleepSense K042253
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
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for KarmelSonix Israel Ltd. The logo includes the word "Karmel" written in a decorative font inside of a circular floral design. The words "KarmelSonix Israel Ltd" are written in a plain font to the right of the floral design. The logo appears to be for a company based in Israel.
K071955
Page 1 of 3
KarmelSonix Israel Ltd
ATTACHMENT NO. 7: 510(K) SUMMARY WIM-PCTM
510(K) SUMMARY WIM-PCTM
NOV - 1 2007
- Applicant's Name: KarmelSonix 5 Palyam Street Haifa 33095 ISRAEL Tel: (972)4-861-5025 Fax: (972)4-866-7702
- Contact Person: Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837 Fax (972)4-638-0510 Yoram@gsitemed.com
- WIM-PCTM Trade Name:
- Classification: Name: Diagnostic pulmonary-function interpretation calculator Product Code: BZM Regulation No: 868.1900 Class: II Panel: Anesthesiology
Device Description:
The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.
The WIM-PCTM system consists of:
- Acoustic sensors (attached to the patient using adhesive pads). .
- Sensor pod with a built-in dielectric microphone for ambient noise pick-up. �
- Tension-sensitive respiration belt. .
- A/D data acquisition device ●
- USB cable and signal cable .
1
KarmelSonix Israel Ltd
K071955
Page 2 of 3
- Laptop PC unit with Data Analysis software. .
Predicate Device:
PulmoTrack™ model 1010 (K980878).
Technological Characteristics
Both the WIM-PC™ device and its predicate device (PulmoTrack™; K980878) implement an algorithm-based set of rules to interpret acoustic pulmonary function and chest impedance measurements with respect to wheeze and respiratory pattern.
Technological Modifications from Predicate Device
The modifications between the WIM-PCTM and its predicate device PulmoTrack™ 1010 (K980878) are:
- . Improved Acoustic sensors.
- Respiration belt (SleepSense K042253) instead of Impedance electrode .
- Laptop PC instead of desk-top PC .
- New version of software (Validated) .
- Improved Front End Electronics ●
.
Indications for Use Statement:
The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds.
The WIM-PCTM is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
Performance Validation:
The following tests were performed on the WIM-PCTM hardware components:
- · Tension-sensitive Respiration Belt:
- · Electrical response to tension.
- · Respiratory activity detection
- · Acoustic sensors: sensors frequency response and sensitivity.
- · Front End performance.
The following validation tests were performed on the WIM-PCTM software:
2
Image /page/2/Picture/0 description: The image shows the logo for KarmelSonix Israel Ltd. The logo includes the word "Karmel" in a decorative font, surrounded by a circular wreath. Below the logo is the text "KarmelSonix Israel Ltd" in a simpler font. The image is in black and white.
KC71955
Page 3 of 3
Karmelsonix Israel Ltd
- · Wheeze detection validation test.
- · Breath detection validation test.
The WIM-PCTM packaging was tested for its durability to shipment conditions.
The following test was performed on the WIM-PC™ packaging:
- WIM-PC™ packaging system integrity .
Materials:
Materials of the WIM-PC™ system that are in contact with the human body are biocompatible in accordance with ISO 10993-1.
Substantial Equivalence:
The WIM-PC™ and the PulmoTrack™ model 1010 predicate device, have the same intended use and indication for use, and they are implement the same technology.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its head is slightly tilted upwards. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KarmelSonix Israel Limited C/O Mr. Yoram Levy General Manager Osite 31 Haavoda Street Binyamina 33095 ISRAEL
NOV -- 1 2007
Re: K071955
Trade/Device Name: WIM-PC™ Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: October 15, 2007 Received: October 18, 2007
Dear Mr. Levy:
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.
4
Page 2 - Mr. Levy
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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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510(k) Number (if known): K071955
for
Device Name:
WIM-PCTM
. Indications Use:
The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OI
(Division Sign-off)
Device Evaluation (ODE)
(Division Sign-off)
510(k) Number
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071955
1-5 KarmelSonix, 5 Palyam St. Haifa 33095 ISRAEL Tel: (972)4- 8615025; Fax: (972)4- 8667702