(30 days)
Not Found
No
The document describes a conventional ultrasound system with standard imaging modes and controls, and explicitly states that AI, DNN, or ML were not found in the description.
No.
The device is explicitly stated as intended for "diagnostic ultrasound imaging," not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging..."
No
The device description explicitly states that the system comprises "a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface," which are hardware components.
Based on the provided information, this device 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 Description and Intended Use: The description clearly states that the Interson USB Ultrasound System is an ultrasound imaging system. It uses sound waves to create images of internal body structures and analyze fluid flow. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Lack of Mention of Samples: The description and intended use do not mention the collection or analysis of any biological samples.
Therefore, the Interson USB Ultrasound System falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.
No
The clearance letter explicitly states: "However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This indicates that while FDA initially may have mistakenly suggested the clearance included a PCCP, it clarified that no PCCP was actually submitted or authorized.
Intended Use / Indications for Use
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, M mode or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel
The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
Intended Use/Indications for Use
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. M mode, Color Doppler or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel
The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
Product codes
IYN, IYO, ITX
Device Description
The Interson USB Ultrasound Imaging System (Proposed) is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The system operates in B, color Doppler, M mode and combined B + color Doppler modes. The selection of transducers offered with the system permits a wide range of clinical applications including Abdominal, Fetal, Pediatric, Musculoskeletal, Cardiac, Small organ. Neuro-muscular, Urology, OB/Gyn and Peripheral vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (conventional), Musculo-skeletal (superficial), Urology, Gynecology, Pelvic Floor, Neuro-muscular, Cardiac, Peripheral Vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
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
Given the cardiac indication added to the labeling and no other changes to the device, non-clinical testing and clinical testing are not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue 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.
0
July 1, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Interson Corporation Vamsi Vangipuram Quality/Regulatory Affairs Manager 7150 Koll Center Parkway Pleasanton, California 94566
Re: K233734
Trade/Device Name: Interson USB Ultrasound Probe System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX
Dear Vamsi Vangipuram:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 22, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yanna Kang, OHT8: Office of Radiological Health, (301)796-6704, Yanna.Kang@fda.hhs.gov.
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
July 1, 2024
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Interson Corporation Vamsi Vangipuram Quality/Regulatory Affairs Manager 7150 Koll Center Parkway Pleasanton, California 94566
Re: K233734
Trade/Device Name: Interson USB Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 21, 2023 Received: November 22, 2023
Dear Vamsi Vangipuram:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 22, 2023.
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K233734
Device Name Interson USB Ultrasound System
Indications for Use (Describe)
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, M mode or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel
The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5
Special 510K
K233734 510(k) Summary
In accordance with 21CFR 807.92 the following summary of information is provided.
| Submitter Information | |
|---|---|
| Date of submission: | 11/21/2023 |
| Submitter information: | Interson Corporation |
| 7150 Koll Center Parkway | |
| Pleasanton, CA 94566 | |
| Establishment Registration No: | 2939830 |
| Contact person: | Vamsi Vangipuram |
| Quality/Regulatory Manager | |
| (925) 462-4948 (tel) | |
| (925) 462-4833 (fax) | |
| vvangipuram@interson.com |
Name of Device and Classification
| Device trade name: | Interson USB Ultrasound System |
|---|---|
| Common name: | Diagnostic ultrasound system and transducers |
| Classification: | Class II |
| 21 CFR Section | Classification Name | Product Code |
|---|---|---|
| 892.1550 | Ultrasonic pulsed doppler imaging system | IYN |
| 892.1560 | Ultrasonic pulsed echo imaging system | IYO |
| 892.1570 | Diagnostic ultrasonic transducer | ITX |
Predicate Device
| Interson USB Ultrasound Probe System | K163443 | 4/13/2017 |
|---|---|---|
| -------------------------------------- | --------- | ----------- |
Hereinafter, the Subject Device is called as "Interson USB Ultrasound System (Proposed)" in this submission because the predicate device has the same trade name.
6
Device Description
The Interson USB Ultrasound Imaging System (Proposed) is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The system operates in B, color Doppler, M mode and combined B + color Doppler modes. The selection of transducers offered with the system permits a wide range of clinical applications including Abdominal, Fetal, Pediatric, Musculoskeletal, Cardiac, Small organ. Neuro-muscular, Urology, OB/Gyn and Peripheral vessel.
Intended Use/Indications for Use
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. M mode, Color Doppler or Combined (B+ Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Trans-Rectal Trans-Vaginal Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Cardiac Peripheral Vessel
The system is intended for use by trained healthcare professionals having a general knowledge of the use of ultrasound imaging devices and imaging protocols in environments where healthcare is provided by healthcare professionals.
7
Determination of Substantial Equivalence
The subject device is a modification of the Interson USB Ultrasound System that has FDA 510(k) clearance under K163443. The proposed modification is to add the cardiac indication to the Ultrasound system with the indicated probe.
Technological Comparison
This labeling modification does not impact the technological features of the device. The subject device has the same technological characteristics as the predicate device as a general-purpose ultrasound imaging system.
Interson Corporation considers the Interson USB Ultrasound System to be safe, effective and performance is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Given the cardiac indication added to the labeling and no other changes to the device, non-clinical testing and clinical testing are not required. Interson Corporation considers the Interson USB Ultrasound System to be as safe, effective and performance is substantially equivalent to the predicate device.