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.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Transrectal, Transvaginal.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Microhelix MHLX7EC Transducer, a replacement ultrasound transducer. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, and expert involvement is not present in the provided document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance for Microhelix MHLX7EC Transducer

The primary acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to legally marketed predicate devices, specifically the TETRAD TC-EC7-ACP transducer (K013849) and the Acuson EC7 transducer (K991805). This means the device must share similar intended use, technological characteristics, and safety and effectiveness profiles as its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary)
Intended Use	Must be for ultrasonic imaging of the human body, with specific applications (abdominal, fetal, transrectal, transvaginal) consistent with predicate devices.	Intended for use in ultrasonic imaging of the human body, with indications for abdominal, fetal, transrectal, and transvaginal applications, identical to the predicate devices.
Technological Characteristics	Must be "very similar" to predicate devices, using existing technology.	Described as "very similar" to predicate devices, used on the same ultrasound systems, with the same indications for use. "No new technology is involved."
Safety	Must meet electrical, mechanical, and thermal safety standards for medical devices. Acoustic output must be comparable to predicate devices and within approved levels.	Electrical, mechanical, and thermal safety testing was conducted and results included. Comparative performance testing showed acoustic output of MHLX7EC and Acuson EC-7 to be "comparable." (A post-clearance special report for acoustic output measurements based on production units was required as a condition of clearance).
Effectiveness (Performance)	Acoustic output and general performance must be comparable to predicate devices.	Comparative performance testing showed acoustic output to be "comparable" to the Acuson EC-7. The device is intended to be used with the Acuson 128XP and Aspen Systems, implying it performs effectively within those systems.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical studies with human subjects. The testing described is primarily focused on engineering and performance comparisons with predicate devices.

Sample Size for Comparative Performance Testing: Not explicitly stated. The text mentions "comparative performance testing was conducted" and that "the MHLX7EC and the Acuson EC-7 were tested for acoustic output." This implies a comparison between at least two devices (the new device and its predicate). However, the number of units or measurements performed is not given.
Data Provenance: Not explicitly stated, but given the nature of a 510(k) premarket notification in the US, the testing would have been submitted to the FDA (Food and Drug Administration) in the United States. The testing is likely retrospective in the sense that it's performed on pre-production or early production units to demonstrate equivalence. It's not a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The submission does not detail a study involving human subjects or clinical experts establishing a ground truth for diagnostic accuracy, as it focuses on direct device-to-device comparison and safety.

4. Adjudication Method for the Test Set

Since there is no mention of a test set involving human interpretation tasks or clinical outcomes requiring adjudication, an adjudication method is not applicable and therefore not described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not performed, or at least not described, in this 510(k) submission. This type of study would typically assess human reader performance with and without an AI-assisted device. The Microhelix MHLX7EC is a basic ultrasound transducer, not an AI-enabled device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the Microhelix MHLX7EC is an ultrasound transducer that requires human operation and interpretation. It is not an algorithm or an AI system that could be evaluated in a standalone manner.

7. Type of Ground Truth Used

The "ground truth" in this context is implicitly the established performance and safety characteristics of the predicate devices (TETRAD TC-EC7-ACP and Acuson EC7 transducers). The new device's performance (e.g., acoustic output) is compared directly against the known, approved characteristics of the predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to a diagnostic accuracy claim for the device itself, as the claim is one of equivalence.

8. Sample Size for the Training Set

This information is not applicable as the Microhelix MHLX7EC is an ultrasound transducer, not an AI or machine learning algorithm. Therefore, there is no "training set" in the conventional sense for algorithm development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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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:

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.

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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);

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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)

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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	B	M	PWD	ColorDoppler	AmplitudeDoppler	CombinedB+M;B+PWDB+CDI;B+PD;B+PWD+CDI	CombinedB+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"

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	CombinedB+M;B+PWDB+CDI;B+PD;B+PWD+CDI	CombinedB+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)

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

Regulation Number and Section

§ 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.