VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7

• K Number: K992155
• Device Name: VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
• Manufacturer: MEDISON AMERICA, INC.
• Date Cleared: 1999-07-08 ( 13 days)
• Product Code: ITX
• Regulation Number: 892.1570

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transducer S-VNW 5-10: Pediatric, small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal-conventional. Transducer S-VAW 4-7: Fetal, abdominal, pediatrics, and small organs.

Device Description

Transducer S-VNW 5-10 is a multielement, mechanically steered linear array (volume) probe for use with the Combison 530D Diagnostic Ultrasound System. The center frequency is 7.5 MHz, and the nominal transmit frequency range is 5 to 10 MHz. The scan width is 40 mm and the maximum depth range is 75 mm. Transducer S-VAW 4-7 is a multielement curved array probe for use with the Combison 530D system. The center frequency is 4.5 MHz, and the nominal transmit frequency range is 4 to 7 MHz. The image starting width is approximately 70 mm and the maximum depth range is 200 mm. Operating Modes: Both Transducer S-VNW 5-10 and Transducer S-VAW 4-7 operate in B-mode (including three-dimensional volume imaging), M-mode, Pulsed Doppler, and Color Flow modes.

Predicate Devices

Kretztechnik Transducer Model S-NLM 5-10,Kretztechnik Transducer Models S-VSW 3-5, S-ACA 4-7

Reference Devices

K940942, K974813

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and operating modes of ultrasound transducers, with no mention of AI or ML capabilities for image processing, analysis, or interpretation.

Therapeutic

No
The device is described as for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is diagnosis rather than therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also mentions its use with the "Combison 530D Diagnostic Ultrasound System".

SaMD (Software as a Medical Device)

No

The device description explicitly details physical transducers (Transducer S-VNW 5-10 and Transducer S-VAW 4-7) which are hardware components.

IVD (In Vitro Diagnostic)

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 Function: The description clearly states that this device is a Diagnostic Ultrasound System and its associated transducers. Ultrasound imaging works by sending sound waves into the body and interpreting the echoes to create images of internal structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
• Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which aligns with in vivo imaging.
• Device Description: The description details the physical characteristics and operating modes of ultrasound transducers, not laboratory testing equipment or reagents.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Transducer S-VNW 5-10: Pediatric, small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal-conventional.
Transducer S-VAW 4-7: Fetal, abdominal, pediatrics, and small organs.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

For S-VNW 5-10 Small Part Volume Transducer: Pediatric, Small Organ (For example: thyroid, testicles, salivary gland, breast, lymph nodes, and pediatric patients.), Peripheral vascular, Musculo-skeletal Conventional.
Mode of Operation: A, B, M*, PWD*, CWD*, Color Doppler*, Power (Amplitude) Doppler *, Combined (PWD/Color Doppler, PWD/Power Doppler), Other (3D Volume Imaging Mode).

For S-VAW 4-7 Abdominal Volume Transducer: Fetal, Abdominal, Pediatric, Small Organ (For example: thyroid, testicles, salivary gland, breast, lymph nodes, and pediatric patients.).
Mode of Operation: B, M*, PWD*, Color Doppler*, Power (Amplitude) Doppler *, Other (3D Volume Imaging Mode).

Product codes (comma separated list FDA assigned to the subject device)

90 ITX

Device Description

Transducer S-VNW 5-10 is a multielement, mechanically steered linear array (volume) probe for use with the Combison 530D Diagnostic Ultrasound System. The center frequency is 7.5 MHz, and the nominal transmit frequency range is 5 to 10 MHz. The scan width is 40 mm and the maximum depth range is 75 mm.
Transducer S-VAW 4-7 is a multielement curved array probe for use with the Combison 530D system. The center frequency is 4.5 MHz, and the nominal transmit frequency range is 4 to 7 MHz. The image starting width is approximately 70 mm and the maximum depth range is 200 mm.
Operating Modes: Both Transducer S-VNW 5-10 and Transducer S-VAW 4-7 operate in B-mode (including three-dimensional volume imaging), M-mode, Pulsed Doppler, and Color Flow modes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic Ultrasound

Anatomical Site

For S-VNW 5-10: small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal.
For S-VAW 4-7: Fetal, abdominal, pediatric, and small organs.

Indicated Patient Age Range

Pediatric (for S-VNW 5-10 and S-VAW 4-7), Fetal (for S-VAW 4-7). No specific upper age limit is mentioned.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Measurement accuracy, precision of volume reconstruction, electrical and thermal safety, and software performance have been tested in accordance with applicable guidelines and standards with satisfactory results. Patient contact materials remain unchanged. Acoustic output has been measured as specified in pertinent FDA recognized standards and is reported according to Track 3.

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.

Kretztechnik Transducer Model S-NLM 5-10, Kretztechnik Transducer Models S-VSW 3-5, S-ACA 4-7

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.

K940942, K974813

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

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.

Summary

0

510(k) SUMMARY

K 992155

MODEL S-VNW 5-10 VOLUSON® SMALL PARTS TRANSDUCER MODEL S-VAW 4-7 VOLUSON® ABDOMINAL TRANSDUCER

• 1. COMPANY INFORMATION. Name: Medison America, Inc. Address: 6616 Owens Drive, Pleasanton, CA 94588. Phone: [phone]. Contact: Bob Leiker - Vice President, Regulatory and Quality. Manufacturer: Kretztechnik AG, Tiefenbach 15, A-4871, Zipf, Austria.
• 2. DEVICE IDENTIFICATION. Trade Name: (1) Model S-VNW 5-10 Voluson® Small Parts Transducer (2) Model S-VAW 4-7 Voluson® Abdominal Transducer. Common Name: Diagnostic Ultrasound Transducer. Classification Name: Diagnostic Ultrasound Transducer, 90-1TX.
• 3. PREDICATE DEVICE. For Model S-VNW 5-10: Kretztechnik Transducer Model S-NLM 5-10. For Model S-VAW 4-7: Kretztechnik Transducer Models S-VSW 3-5 and S-ACA 4-7. The three predicate devices were all cleared with the Combison 530D system under 510(k)'s K940942 and K974813. See also Combison 530D Special Report dated October 23, 1997.
• 4. DEVICE DESCRIPTION. General: Transducer S-VNW 5-10 is a multielement, mechanically steered linear array (volume) probe for use with the Combison 530D Diagnostic Ultrasound System. The center frequency is 7.5 MHz, and the nominal transmit frequency range is 5 to 10 MHz. The scan width is 40 mm and the maximum depth range is 75 mm. Transducer S-VAW 4-7 is a multielement curved array probe for use with the Combison 530D system. The center frequency is 4.5 MHz, and the nominal transmit frequency range is 4 to 7 MHz. The image starting width is approximately 70 mm and the maximum depth range is 200 mm. Operating Modes: Both Transducer S-VNW 5-10 and Transducer S-VAW 4-7 operate in B-mode (including three-dimensional volume imaging), M-mode, Pulsed Doppler, and Color Flow modes.
• 5. INTENDED USES. Transducer S-VNW 5-10: Pediatric, small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal-conventional. Transducer S-VAW 4-7: Fetal, abdominal, pediatrics, and small organs.
• 6. COMPARISON WITH PREDICATE DEVICE. Transducer S-VNW 5-10: This device is a modification of its predicate device. The major difference is that the modified transducer contains 192 elements while the predicate device has 128. Transducer S-VAW 4-7: This device is a combination of its two predicate devices. The principle difference is that the subject device is a curved array while one of the two predicate devices was an annular array. Evaluation: Transducers S-VNW 5-10 and S-VAW 4-7 are both similar in design and function to their respective predicate devices. Neither transducer introduces new modes of operation or indications for use beyond those previously cleared.
• 7. PERFORMANCE DATA. Measurement accuracy, precision of volume reconstruction, electrical and thermal safety, and software performance have been tested in accordance with applicable guidelines and standards with satisfactory results. Patient contact materials remain unchanged. Acoustic output has been measured as specified in pertinent FDA recognized standards and is reported according to Track 3.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL -8 1999

Medison America, Inc. C/O Carole Stamp TUV product Services 1775 Old Highway 8 New Brighton, MN 55112-1891

RE: K992155 Model S-VNW 5-10 Voluson Small parts Transducer Model S-VAW 4-7 Voluson Abdominal Transducer Dated: June 24, 1999 Received: June 25, 1999 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Ms. Stamp:

We have reviewed your Section 510(k) 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 following transducers intended for use with the Combison 530D Diagnostic Ultrasound System as described in your premarket notification:

Transducer Model Number(s):

Model S-VNW 5-10 Voluson Small Parts Model S-VAW 4-7 Voluson Abdominal

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page -2 - Ms. Stamp

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] 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 Robert Phillips, Ph.D at [phone].

Sincerely yours,

CAPT Daniel Schultz, M.D.

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Ultrasound Device Indications Statement

510(k) Number:
Device Name:	Voluson C530D Ultrasound System
Transducer:	S-VNW 5-10 Small Part Volume Transducer
Indications for Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation (*includes simultaneous B-mode)

Mode of Operation (* includes simultaneous B-mode)
Clinical Applications	A	B	M*	PWD*	CWD*	Color
Doppler*	Power
(Amplitude)
Doppler *	Color
Velocity
Imaging	Combined
(Specify)*
See Note 1	Other
(Specify)
See Note 2
Ophthalmic
Fetal
Abdominal
Intraoperative:
(Specify)
Intraoperative
Neurological
Pediatric	E	E	E	E	E	E	E		E	N
Small Organ
(Specify) See Note 3	E	E	E	E	E	E	E		E	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vascular	E	E	E	E	E	E	E		E	N
Laparoscopic
Musculo-skeletal
Conventional	E	E	E	E	E	E	E		E	N
Musculo-skeletal Superficial
Other (Specify)

N = new indication; P = Previously cleared in K940942, Voluson C530D Ultrasound System; P = Previously cleared in K974813, Voluson C530D Ultrasound System with Power Doppler; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler.

Note 2: 3D Volume Imaging Mode

Note 3: For example: thyroid, testicles, salivary gland, breast, lymph nodes, and pediatric patients.

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	Prescription Use (Per 21 CFR 801.109)

	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT,
	and Radiological Devices

Prescription Use
(Per 21 CFR 801.109)
510(k) Number	K992155

4

Ultrasound Device Indications Statement

510(k) Number:	Voluson C530D Ultrasound System
Device Name:
Transducer:	S-VAW 4-7 Abdominal Volume Transducer
Indications for Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body

as follows:

Mode of Operation (*includes simultaneous B-mode)

| Clinical Applications | A | B | M* | PWD* | CWD* | Color
Doppler

• | Power
  (Amplitude)
  Doppler * | Color
  Velocity
  Imaging | Combined
  (Specify)*
  See Note 1 | Other
  (Specify)
  See Note 2 |
  |----------------------------------|---|---|----|------|------|-----------------------|-----------------------------------|------------------------------|--------------------------------------|----------------------------------|
  | Ophthalmic | | | | | | | | | | |
  | Fetal | | P | P | P | | P | P¹ | | | P |
  | Abdominal | | P | P | P | | P | P¹ | | | P |
  | Intraoperative: | | | | | | | | | | |
  | (Specify) | | | | | | | | | | |
  | Intraoperative | | | | | | | | | | |
  | Neurological | | | | | | | | | | |
  | Pediatric | | P | P | P | | P | P¹ | | | P |
  | Small Organ | | P | P | P | | P | P¹ | | | P |
  | (Specify) See Note 3 | | | | | | | | | | |
  | Neonatal Cephalic | | | | | | | | | | |
  | Adult Cephalic | | | | | | | | | | |
  | Cardiac | | | | | | | | | | |
  | Transesophageal | | | | | | | | | | |
  | Transrectal | | | | | | | | | | |
  | Transvaginal | | | | | | | | | | |
  | Transurethral | | | | | | | | | | |
  | Intravascular | | | | | | | | | | |
  | Peripheral vascular | | | | | | | | | | |
  | Laparoscopic | | | | | | | | | | |
  | Musculo-skeletal
  Conventional | | | | | | | | | | |
  | Musculo-skeletal Superficial | | | | | | | | | | |
  | Other (Specify) | | | | | | | | | | |

N = new indication; P = Previously cleared in K940942, Voluson C530D Ultrasound System; P = Previously cleared in K974813, Voluson C530D Ultrasound System with Power Doppler; E = added under Appendix E

Other Indications or Modes:

Note 1: PWD/Color Doppler, PWD/Power Doppler.

Note 2: 3D Volume Imaging Mode

Note 3: For example: thyroid, testicles, salivary gland, breast, lymph nodes, and pediatric patients.

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

| (Division Sign-Off)
Division of Reproductive, Abdominal, ENT,

and Radiological Devices
510(k) Number	K992155

Prescription Use