(236 days)
Not Found
No
The document describes a replacement ultrasound transducer and its intended uses, focusing on hardware compatibility and acoustic performance. There is no mention of AI, ML, or any related image processing or analytical capabilities that would suggest the use of such technologies.
No
The device is described as an "ultrasonic imaging" transducer intended for "Diagnostic ultrasound imaging or fluid flow analysis", which points to a diagnostic rather than therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This directly indicates its role in diagnosis.
No
The device description explicitly states it consists of physical components like a lens, circuitry, handle, cable, and connector, indicating it is a hardware device.
No, 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. They are used outside of the body (in vitro).
- Device Function: The MHLX7EC Transducer is an ultrasound transducer. It uses sound waves to create images of internal structures within the human body (in vivo).
- Intended Use: The intended use clearly states "ultrasonic imaging of the human body" and lists anatomical sites within the body.
- Device Description: The description details the physical components of a transducer used for imaging, not for analyzing samples.
The device is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MHLX7EC Transducer is intended for use in ultrasonic imaging of the human body. The Indications for Use table shows specific uses as abdominal, fetal, transrectal, and transvaginal.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Fetal | Abdominal | Transrectal | Transvaginal |
|---|---|---|---|---|
| Microhelix MHLX7EC used on Acuson 128XP | X (B, M), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) |
| Microhelix MHLX7EC used on Acuson Aspen | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) | X (B, M, PWD, Color Doppler, Amplitude Doppler, Combined B+M; B+PWDB+CDI; B+PD; B+PWD+CDI), X (Combined B+M) |
Additional Comments: Cardiac is Adult and Pediatric and cardiac analysis. Intraoperative includes abdominal, thoracic and PV, Color Doppler includes Color M, Combined includes B/M, B/Color M, B/PWD, B/Color/PWD.
For Microhelix MHLX7EC used on Acuson 128XP: Fetal Doppler not indicated for MHLX7EC used on Acuson 128XP; Abdominal Doppler does not include fetal Doppler for MHLX7EC used on Acuson 128XP.
Product codes (comma separated list FDA assigned to the subject device)
90 ITX
Device Description
The Microhelix MHLX7EC is a replacement ultrasound transducer designed to be used with the Acuson 128XP and Acuson Aspen Systems. It consists of a lens and associated circuitry, a handle which fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body, abdominal, fetal, transrectal, transvaginal
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
Comparative performance testing was conducted and included in this 510(k). The MHLX7EC and the Acuson EC-7 were tested for acoustic output and were found to be comparable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical, mechanical, and thermal safety testing was conducted on this product and the results included in the 510(k) submission.
Comparative performance testing was conducted and included in this 510(k). The MHLX7EC and the Acuson EC-7 were tested for acoustic output and were found to be comparable.
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.
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.
Not Found
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).
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 Information, including doodstro output 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 ine 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.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
K6402/3
510(k) SUMMARY
| Submitter's name: | Microhelix, Inc. |
|---|---|
| 200 Innovation Blvd., State College, PA 16803 | |
| The Probe Division of Microhelix, Inc. |
December 10, 2003 Date summary prepared:
Device name:
MHLX7EC Transducer Proprietary name: Common or usual name: Transducer Classification name: Diagnostic ultrasonic transducer. Class IL 892.1570
Legally marketed devices for substantial equivalence comparison:
TETRAD TC-EC7-ACP transducer submitted by TETRAD Corporation under 510(k) "K013849 and the Acuson EC7 transducer, which has been submitted several times by Acuson Corporation as part of complete ultrasound systems, most recently as part of 510(k) "K991805 for the Aspen System.
Description of the device:
The Microhelix MHLX7EC is a replacement ultrasound transducer designed to be used with the Acuson 128XP and Acuson Aspen Systems. It consists of a lens and associated circuitry, a handle which fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
Intended use of device:
The MHLX7EC Transducer is intended for use in ultrasonic imaging of the human body. The Indications for Use table shows specific uses as abdominal, fetal, transrectal, and transvaginal.
Technological characteristics:
The device features and use parameters of the MHLX7EC are very similar to those of the predicate devices. All of them are ultrasound transducers used on the same ultrasound systems with the same indications for use. No new technology is involved in these devices. All recommend the use of transducer covers and all must be cleaned and disinfected after each use.
Testing conducted:
Electrical, mechanical, and thermal safety testing was conducted on this product and the results included in the 510(k) submission.
Performance testing:
Comparative performance testing was conducted and included in this 510(k). The MHLX7EC and the Acuson EC-7 were tested for acoustic output and were found to be comparable.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroHelix. Inc. % Mr. John So Senior Project Engineer Conformity Assessment Services Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K040213
Trade Name: MHLX7EC Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 ITX Dated: September 3, 2004 Received: September 7, 2004
Dear Mr. So:
ら
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 orovisions 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 following transducers intended for use with the Acuson 128 XP System and Acuson Aspen System, as described in your premarket notification:
Transducer Model Number
Microhelix MHLX7EC
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);
2
Page 2 - Mr. So
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 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 Information, including doodstro output 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 ine 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 41 you deate speemie ad (301) 594-4591. Additionally, for questions on the promotion contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, alle as note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely vours.
David A. Leyson
Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure(s)
3
Appendix A:
Diagnostic Ultrasound Indications for Use Form
Microhelix MHLX7EC used on Acuson 128XP
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
B+M;
B+PWDB+
CDI;
B+PD;
B+PWD+C
DI | Combined
B+M |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------------------------------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | | | | | | | X |
| Abdominal | | X | X | X | | X | X | | X | X |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | X | X | X | | X | X | | X | X |
| Transvaginal | | X | X | X | | X | X | | X | X |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
Additional Comments: Cardiac is Adult and Pediatric and cardiac analysis. Intraoperative includes abdominal, thoracic and PV, Color Doppler includes Color M, Combined includes B/M, B/Color M, B/PWD, B/Color/PWD. Fetal Doppler not indicated for MHLX7EC used on Acuson 128XP; Abdominal Doppler does not include fetal Doppler for MHLX7EC used on Acuson 128XP
Prescription Use ✓
Daniel A. Legnon
(Division Sign-Off Division of Reproductiv and Radiological Devic 510(k) Number
MHLX7EC User's Manual Part No.SP0005 Rev. "A"
4
Diagnostic Ultrasound Indications for Use Form
Microhelix MHLX7EC used on Acuson Aspen
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 | |||||||||
| B+M; | ||||||||||
| B+PWDB+ | ||||||||||
| CDI; | ||||||||||
| B+PD; | ||||||||||
| B+PWD+C | ||||||||||
| DI | Combined | |||||||||
| B+M | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | X | X | X | X | X | X | X | |||
| Abdominal | X | X | X | X | X | X | X | |||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | X | X | X | X | X | X | X | |||
| Transvaginal | X | X | X | X | X | X | X | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
Additional Comments: Cardiac is Adult and Pediatric and cardiac analysis. Intraoperative includes abdominal, thoracic and PV, Color Doppler includes Color M, Combined includes B/M, B/Color M, B/PWD, B/Color/PWD.
Image /page/4/Picture/5 description: The image contains a black and white drawing of two triangles, one inside the other. The outer triangle is larger, and the inner triangle is smaller and centered within the larger one. Both triangles are equilateral, with all sides of equal length and all angles measuring 60 degrees.
WARNING – Explosion Hazard: Do not operate the system in the presence of flammable anesthetics.
Prescription Use
MHLX7EC User's Manual Part No.SP0005 Rev. "A"
Page 17
David A. Layman
(Division Sign-Off) Division of Reproductive, Abdon and Radinlogical Device : って) Normour