This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.

Device Description

This device is intended to obtain and display B-scan and Mmode images as well as Pulsed Wave and Continuous Wave Doppler spectra, or Color Flow images. Additionally, the COMBISON 530 offers the VOLUSON 3D-scan system, which performs a number of B-scans, one adjacent to the other (only with special probes) and gives the user the possibility to visualize planes within the "volume" without the patient.

AI/ML Overview

This document describes the Kretztechnik AG COMBISON® 530 Diagnostic Ultrasound Scanner and its associated transducers. The submission is a 510(k) premarket notification, indicating the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a concise table format for performance. Instead, it refers to general compliance with standards and product specifications, and comparison to predicate devices. The main performance aspects assessed are electrical safety, imaging performance, and acoustic output.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Electrical Safety	Compliance with IEC Standard 601.1 limits for Class 1, Type BF devices regarding electrical leakage currents (ground, housing, patient device, mains voltage at patient device) and guard wire resistance.	"Measured electrical leakage currents... were measured and found to be well within the limits for Class 1, Type BF devices established by IEC Standard 601.1."
Imaging Performance	Imaging performance characteristics (image quality, frame rate, image orientation, measurement accuracy, sector angle, noise level) for each operating mode must be within product specifications as determined by the Kretztechnik AG Transducer-Software Check Protocol.	"All performance values were found to be within the limits stated in product specifications."
Acoustic Output	Maximum acoustic output for each transducer and operating mode, as measured under worst-case conditions, must be "lower than the officially published maxima for previously approved devices for the same intended uses" and comparable to predicate devices.	Detailed tables of ISPTA and ISPPA values are provided for each transducer and mode. The summary states: "All values obtained for the listed transducers during acoustic output testing were lower than the officially published maxima for previously approved devices for the same intended uses. ... the test data also indicate substantial equivalence with respect to the acoustic output."
Overall Equivalence	"Safe and effective" and performs "as well or better" than legally marketed predicate devices.	"results demonstrate that these devices are safe, effective, and perform as well or better than the legally marketed devices with which this scanner and these transducers have been compared."

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

Sample Size for Test Set: The document explicitly states "Formal clinical studies were not conducted". The tests performed were "appropriate nonclinical tests". Therefore, there is no patient-based "test set" in the context of clinical performance evaluation with a specified sample size.
Data Provenance: The data are from nonclinical tests performed by Kretztechnik AG (the manufacturer). The specific country of origin is Austria (Kretztechnik AG, Zipf, Austria). The data are prospective in the sense that they were generated specifically for this submission through controlled testing, not retrospectively collected clinical data.

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

N/A. As no formal clinical studies with human subjects were conducted and the evaluation focused on nonclinical performance, there was no "ground truth" derived from expert consensus on medical conditions for a test set. Ground truth, where applicable (e.g., for measurement accuracy), would come from the known properties of the phantoms used in the "Kretztechnik AG Transducer-Software Check Protocol". The qualifications of individuals performing these nonclinical tests are not detailed in the provided text.

4. Adjudication Method for the Test Set

N/A. There was no clinical test set requiring adjudication in the context of diagnostic performance.

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

N/A. No MRMC study was performed. The device is an ultrasound scanner, and the evaluation is for substantial equivalence to predicate devices, not improvement of human reader performance with AI assistance. The document explicitly states "Formal clinical studies were not conducted".

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

The COMBISON® 530 is a diagnostic ultrasound scanner, a hardware device with software, not an AI algorithm. Its performance is intrinsically tied to a human operator. Therefore, a standalone (algorithm only) performance study, as understood in the context of AI, is not applicable or described. The performance described relates to the device's physical and technical capabilities.

7. Type of Ground Truth Used

For the nonclinical performance tests:

Electrical Safety: Ground truth is established by the specified limits of IEC Standard 601.1.
Imaging Performance: Ground truth for characteristics like frame rate, measurement accuracy, sector angle, and noise level would be based on the known properties of the phantoms used and the product specifications defined by the manufacturer (Kretztechnik AG).
Acoustic Output: Ground truth is derived from direct physical measurements of acoustic output and comparison against "officially published maxima for previously approved devices" and FDA guidelines (TRACK III reporting procedures).

8. Sample Size for the Training Set

N/A. This document describes a new hardware device (ultrasound scanner and transducers) and does not involve an AI algorithm with a distinct "training set" of data.

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

N/A. As there is no AI algorithm training set, this question is not applicable.

Summary

{0}------------------------------------------------

1/15

-1.5 ர்க்

感

510();) SUNNEY

K940942

1.	COMPANY INFORMATION.
	Name	:	Kretztechnik AGFEB 19 1997
	Address	:	Tiefenbach 15A-4871 Zipf, Austria
	Telephone	:	011-43-7682-2261-0
	Contact Person (U.S.)	:	Jay C. Cone, PresidentCone Instruments, Inc.5201 Naiman ParkwaySolon, Ohio 44139(216) 248-1035
	Date Prepared	:	June 28, 1993 (Revised: February 18, 1994)
2.	DEVICE NOMENCLATURE.
	A. System.
	Trade Name	:	COMBISONR 530(VOLUSONR for volume scanning feature)
	Common Name	:	Diagnostic Ultrasound Scanner
	Classification Names	:	Ultrasonic Pulsed Echo Imaging SystemUltrasonic Pulsed Doppler Imaging SystemUltrasonic Obstetric-Gynecologic Imager
	B. Transducers.
	Trade Names	:	Sector Transducer Model No. AWP 3.5Sector Transducer Model No. SWP 3.5Sector Transducer Model No. VSW 3.5Sector Transducer Model No. VSW 5.0Sector Transducer Model No. VWP 3.5 BSector Transducer Model No. VWP 5.0Sector Transducer Model No. VW 7/10Transrectal Transducer Model No. VRW 77 AKTransvaginal Transducer Model No. EW 5/7 KTransvaginal Transducer Model No. VEW 7.5 R
	Common Name	:	Mechanical Sector Ultrasound Imaging Transducer
	Classification Name	:	Diagnostic Ultrasonic Transducer
	Trade Names	:	Curved Linear Array Transducer Model ACA 3.5Curved Linear Array Transducer Model ACA 5.0Linear Array Transducer Model PLA 7.5
	Common Name	:	Linear Array Ultrasound Imaging Transducer
	Classification Name	:	Diagnostic Ultrasound Transducer

{1}------------------------------------------------

3. PREDICATE DEVICES.

For Diagnostic Ultrasound Scanner COMBISON" 530: વે . Kretztechnik Diagnostic Ultrasound Scanner COMBISON® 330 Toshiba Diagnostic Ultrasound Scanner SSH-140A Siemens Diagnostic Ultrasound Scanner SONOLINE SI-450
b. For Sector Transducer AWP 3.5: Previously cleared with COMBISON® 330 as Model AWP 3.5/A
c. For Sector Transducer SWP 3.5: Kretztechnik Sector Transducer AWP 3.5/A Kretztechnik Sector Transducer AW 4/5 B/A
For Sector Transducer VSW 3.5: d. Kretztechnik Sector Transducer AWP 3.5/A
e . For Sector Transducer VSW 5.0: Kretztechnik Sector Transducer AWP 3.5/A
ェ。 For Sector Transducer VWP 3.5 B: Kretztechnik Sector Transducer AWP 3.5/A
For Sector Transducer VWP 5.0: ਕੇ • Kretztechnik Sector Transducer AWP 3.5/A
h . For Sector Transducer VW 7/10: Kretztechnik Sector Transducer NW 17.5 B/A
i. For Transrectal Transducer VRW 77 AK: Kretztechnik Transrectal Transducer VRW 177 AK/A Kretztechnik Transrectal Transducer IRW 177 AK/A
For Transvaginal Transducer EW 5/7 K: 」。 Kretztechnik Transvaginal/Urologic Transducer WIW 17.5 AP/A Kretztechnik Transvaginal Transducer IR 15/7 BG/A
k . For Transvaginal Transducer VEW 7.5 R: Kretztechnik Transvaginal/Urologic Transducer WIW 17.5 AP/A Kretztechnik Transvaginal Transducer IR 15/7 BG/A
1 For Curved Linear Array Transducer ACA 3.5: Acoustic Imaging Convex Sector Transducer CLA 3.5
m. For Curved Linear Array Transducer ACA 3.5: Acoustic Imaging Convex Sector Transducer CLA 5.0
n . For Linear Array Transducer PLA 7.5: Acoustic Imaging Linear Array Transducer MLA 7.5

{2}------------------------------------------------

DEVICE DESCRIPTION. ব .

Scanner COMBISON® 530: a.

This device is intended to obtain and display B-scan and Mmode images as well as Pulsed Wave and Continuous Wave Doppler spectra, or Color Flow images. Additionally, the 530 offers the VOLUSON® 3D-scan system, which COMBISON' performs a number of B-scans, one adjacent to the other (only with special probes) and gives the user the possibility to visualize planes within the "volume" without the patient.

b. Transducer AWP 3.5:
This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 3.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable angle ranges (80°/60°). In M-mode and Pulsed Wave Doppler-mode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary probe.
c. Transducer SWP 3.5:
This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 3.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of four selectable angle ranges (70°/60°/50°/40°). In M-mode and Pulsed Wave Dopplermode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary probe.
ರೆ . Transducer VSW 3.5:
This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Ultrasound Scanner. The nominal Diagnostic operating frequency is 3.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of four selectable angle ranges (70°/60°/50°/40°). In M-mode and Pulsed Wave Dopplermode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary probe. With the COMBISON® 530 this transducer offers the possibility of an automated t30° sweep of the scan The transducer performs a number of B-scans, plane. one adjacent to the other, to have a "volume" scanned.
Transducer VSW 5.0: e .
This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 5.0 MHz. In B-mode the transducer operates as an end-firing sector probe over either of four selectable angle ranges (70°/60°/50°/40°). In M-mode and Pulsed Wave Dopplermode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary probe. With the COMBISON® 530 this transducer offers the possibility of an automated +30° sweep of the scan plane. The transducer performs a number of B-scans, one adjacent to the other, to have a "volume" scanned.

{3}------------------------------------------------

Transducer VWP 3.5 B:

This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 The nominal operating Ultrasound Scanner. Diagnostic frequency is 3.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable angle ranges (90°/60°). In M-mode and Pulsed Wave Doppler-mode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary With the COMBISON" 530 this transducer offers the probe. possibility of an automated +15° sweep of the scan plane. The transducer performs a number of B-scans, one adjacent to the other, to have a "volume" scanned.

Transducer VWP 5.0: ਕੇ •
This device is a hand-held, annular array, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Ultrasound Scanner. The nominal operating Diagnostic frequency is 5.0 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable angle ranges (90°/60°). In M-mode and Pulsed Wave Doppler-mode the transducer is locked in one selectable position within the available sector angle ranges and operates as a stationary probe. With the COMBISON® 530 this transducer offers the possibility of an automated t15° sweep of the scan plane. The transducer performs a number of B-scans, one adjacent to the other, to have a "volume" scanned.
Transducer VW 7/10: h .
This device is a hand-held, dual-element, mechanical sector probe intended for transcutaneous use with the COMBISON® 530 Ultrasound Scanner. The nominal operating Diagnostic frequencies are 7 and 10 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable angle ranges (90°/60°). In M-mode and Pulsed Wave the transducer is locked in one selectable Doppler-mode position within the available sector anqle ranges and operates as a stationary probe. With the COMBISON® 530 this transducer offers the possibility of an automated t15° sweep of the scan plane. The transducer performs a number of Bscans, one adjacent to the other, to have a "volume" scanned.
i. Transducer VRW 77 AK:
This device is a hand-held, dual-element, mechanical sector probe intended for transrectal use with the COMBISON® 530 Ultrasound Scanner. Diagnostic The nominal operating frequency is 7.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable scan planes with different angle ranges (longitudinal angle range 100°; transversal angle range 350°). In Pulsed Wave Dopplermode the transducer is locked in one selectable position within the available sector angle ranges and operates as a probe. With the COMBISON® stationary 530 this transducer possibility of an automated #140° sweep of the offers the scan plane. The transducer performs a number of B-scans, one adjacent to the other, to have a "volume" scanned.

J. Transducer EW 5/7 K: This device is a hand-held, dual-element, mechanical sector probe intended for transvaginal use with the COMBISON® 530 Ultrasound Scanner. The Diagnostic nominal operating

£.

{4}------------------------------------------------

frequencies are 5 and 7.5 MHz. In B-mode the transducer operates as an end-firing sector probe over either of two selectable angle ranges (130°/200°). In M-mode and Pulsed Wave Doppler-mode the transducer is locked in one selectable within the available sector angle ranges and position operates as a stationary probe.

Transducer VEW 7.5 R: k.
This device is a hand-held, single-element, mechanical sector probe intended for transvaginal use with the COMBISON® 530 Ultrasound Scanner. nominal operating Diagnostic The The frequency is 7.5 MHz. In B-mode the transducer operates as an end-firing sector probe over an angle range of 100°. In Mmode and Pulsed Wave Doppler-mode the transducer is locked in one selectable position within the available sector angle range and operates as a stationary probe. With the COMBISON® 530 this transducer offers the possibility of an automated 180° rotation of the scan plane. The transducer performs a number of B-scans, one adjacent to the other, to have a "volume" scanned.
Transducer ACA 3.5: 1.
This device is a hand-held, 128 element, curved linear array probe intended for transcutaneous use with the COMBISON" 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 3.5 MHz. In B-mode the transducer operates as an end-firing sector probe over an angle range of 58°. In M-mode and Pulsed Wave Doppler-mode specific element groups can be activated within the array and operate as a stationary probe.
m. Transducer ACA 5.0:
This device is a hand-held, 128 element, curved linear array probe intended for transcutaneous use with the COMBISON® 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 5.0 MHz. In B-mode the transducer operates as an end-firing sector probe over an angle range of 64°. In M-mode and Pulsed Wave Doppler-mode specific element groups can be activated within the array and operate as a stationary probe.
n. Transducer PLA 7.5:
This device is a hand-held, 128 element, linear array probe intended for transcutaneous use with the COMBISON" 530 Diagnostic Ultrasound Scanner. The nominal operating frequency is 7.5 MHz. In B-mode the transducer operates as an end-firing probe over a width of 55 mm. In M-mode and Pulsed Wave Doppler-mode specific element groups can be activated within the array and operate as a stationary probe.

{5}------------------------------------------------

5. INTENDED USES.

Scanner COMBISON" 530: ਕੁ .
This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended ror predicate devices, COMBISON" 330, SSH-140A, and SONOLINE SI-450.
b. Transducer AWP 3.5:
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same recommended when this clinical uses were device was previously cleared with the COMBISON® 330.
Transducer SWP 3.5: C.
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended for predicate devices AWP 3.5/A and AW 14/5 B/A.
ರೆ. Transducer VSW 3.5:
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended for predicate device AWP 3.5/A.

e . Transducer VSW 5.0; This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of and functional abnormalities using physical established diagnostic criteria; and in obstetric patients for the

{6}------------------------------------------------

transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same were recommended for predicate device AWP clinical uses 3.5/A.

Transducer VWP 3.5 B: f .
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of functional abnormalities using established physical and diagnostic criteria; and in obstetric patients ior the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended for predicate device AWP 3.5/A.
Transducer VWP 5.0: ਕੇ •
This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of functional abnormalities using established physical and diaqnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures performance of fetal measurements including the ior the of assessing fetal growth and maturity. The same ourpose were recommended for predicate device AWP clinical uses 3.5/A.
h . Transducer VW 7/10: This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an detection and assessment of physical aid in the and abnormalities using established diagnostic functional criteria. The same clinical uses were recommended Ior predicate device NW 17.5 BG/A.
i. Transducer VRW 77 AK:

This device is intended for use with the COMBISON® 530 system for the transrectal imaging of the rectum and surrounding organs and structures including the rectum wall, prostate etc. as an aid in the detection and assessment of qland, physical and functional abnormalities usinq established approved biopsy attachement diagnostic criteria. An I B available for use with this transducer. The same clinical uses were recommended for predicate device VRW 177 AK/A and IRW 177 AK/A.

J Transducer EW 5/7 K:
This device is intended for use with the COMBISON® 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of gynecological and conditions including obstetrical the performance of fetal measurements for the purpose of assessing fetal growth and maturity. An approved biopsy attachement is available for use with this transducer. The same clinical uses were recommended for the predicate devices

{7}------------------------------------------------

WIW 17.5 AP/A and IR 15/7 BG/A.

Transducer VEW 7.5 R: k.

This device is intended for use with the COMBISON® 530 system in the imaging of the fetus and uterine structures utilizing the transvaginal approach as an aid in the diagnosis of conditions including and gynecological the obstetrical for the purpose fetal measurements Of performance of fetal growth and maturity. An approved biopsy assessing attachement is available for use with this transducer. The same clinical uses were recommended for the predicate devices WIW 17.5 AP/A and IR 15/7 BG/A.

Transducer ACA 3.5: 1.
n.

This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of intraabdominal organs and structures including the gastrointestinal tract, kidney, bladder, etc. as an aid in the detection and assessment of abnormalities using established physical and functional diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended for predicate device CLA 3.5.

Transducer ACA 5.0: m. This device is intended for use with the COMBISON" 530 system for the transcutaneous imaging of intraabdominal organs and kidney, structures including the gastrointestinal tract, bladder, etc. as an aid in the detection and assessment of and functional abnormalities using established physical diagnostic criteria; and in obstetric patients for the transcutaneous imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity. The same clinical uses were recommended for predicate device CLA 5.0.

Transducer PLA 7.5: This device is intended for use with the COMBISON® 530 system for the transcutaneous imaging of peripheral vessels and small organs including breast, thyroid, testes, etc. as an physical aid in the detection and assessment of and functional abnormalities using established diagnostic criteria. The same clinical uses were recommended for predicate device MLA 7.5.

{8}------------------------------------------------

1. COMPARISON WITH PREDICATE DEVICES (S).
- a. Scanner COMBISON" 530:

This scanner is capable of B-, M-, Pulsed Wave and Continuous Wave Doppler, and Color Flow Mapping Modes. The predicate scanner COMBISON" 330 is only capable of B- and M-Mode, while the Siemens SONOLINE SI-450 scanner also includes Pulsed Wave and Continuous Wave Doppler, and the Toshiba SSH-140A offers Color Flow Mapping in addition. The COMBISON" 530 volumescanning feature is an extension of the cine-loop storage/ retrieval capability found in all three predicate devices.

Transducer AWP 3.5: b. This transducer was already approved for use with the scanner There has been no change performed to the COMBISON' 330. original version. Safety and effectiveness are not affected.
Transducer SWP 3.5: C.

This transducer differs from the predicate device only in minor respects; none of these minor differences adversely effects safety or effectiveness. The nominal frequency of both transducers is 3.5 MHz and both utilize a mechanically sectored annular array; a three-phase motor is used to provide the rocking motion in transducer SWP 3.5, a stepper motor in the AWP 3.5/A. Both have similar sector angle ranges-70°, 60°, 50°, or 40° selectable in the case of the SWP 3.5, 80° fixed in the case of AWP 3.5/A.

Both of the patient contact materials utilized in transducer SWP 3.5 (UDEL polysulphone and TPX) have been employed in the prviously marketed transducer AWP 3.5/A.

ದ -Transducer VSW 3.5:
This transducer differs from the predicate device only in minor respects; none of these minor differences adversely effects safety or effectiveness. The nominal frequency of both transducers is 3.5 MHz and both utilize a mechanically sectored annular array; a three-phase motor is used to provide the rocking motion in transducer VSW 3.5, a stepper motor in the AWP 3.5/A. Both have similar sector angle ranges---- 70°, 60°, 50°, or 40° selectable in the case of the 80° fixed in the case of AWP 3.5/A. SWP 3.5. The VSW 3.5 is also able to move the B-scan plane to obtain a VOL-scan.

Both of the patient contact materials utilized in transducer VSW 3.5 (LUCALEN" and ULTRADUR") have been employed in food-, drug -, and cosmetics packaging.

Transducer VSW 5.0: e .
This transducer differs from the predicate device only in minor respects; none of these minor differences adversely effects safety or effectiveness. The nominal operating frequency of the VSW 5.0 is 5.0 MHz, while, for transducer AWP 3.5/A, the nominal frequency is 3.5 MHz. Both utilize a mechanically sectored annular array; a three-phase motor is used to provide the rocking motion in transducer VSW 5.0, a stepper motor in the AWP 3.5/A. Both have similar sector
angle ranges--70°, 60°, 50°, or 40° selectable in the case of the SWP 3.5, 80° fixed in the case of AWP 3.5/A.

{9}------------------------------------------------

The VSW 3.5 is also able to move the B-scan plane to obtain a VOL-scan.

Both of the patient contact materials utilized in transducer VSW 5.0 (LUCALEN® and ULTRADUR") have been employed in food-, drug-, and cosmetics packaging.

£. Transducer VWP 3.5 B:

This transducer differs from the predicate device only in minor respects; none of these minor differences adversely The nominal frequency of effects safety or effectiveness. both transducers is 3.5 MHz and both utilize a mechanically sectored annular array; a stepper motor is used to provide the rocking motion in both transducers. Both have similar sector angle ranges--- 90°, 60° selectable in the case of the VWP 3.5 B, 80° fixed in the case of AWP 3.5/A. The VWP 3.5 B is also able to move the B-scan plane to obtain a VOL-scan.

Both of the patient contact materials utilized in transducer VWP 3.5 B (LUCALEN" and ULTRADUR") have been employed in food-, drug-, and cosmetics packaging.

Transducer VWP 5.0: ਕੇ •
This transducer differs from the predicate device only in minor respects; none of these minor differences adversely nominal operating effectiveness. The effects safety or frequency of the VWP 5.0 is 5.0 MHz, while, for transducer the nominal frequency is 3.5 MHz. Both utilize a AWP 3.5/A, mechanically sectored annular array; a stepper motor is used to provide the rocking motion in both transducers. Both have similar sector angle ranges -- 90°, 60° selectable in the case of the VWP 5.0, 80° fixed in the case of AWP 3.5/A. The VWP 5.0 is also able to move the B-scan plane to obtain a VOL-scan.

Both of the patient contact materials utilized in transducer VWP 5.0 (LUCALEN® and ULTRADUR") have been employed in food-, drug-, and cosmetics packaging.

h . Transducer VW 7/10:
This transducer differs from the predicate device only in minor respects; none of these minor differences adversely safety effectiveness. The nominal operating effects or frequencies of the VW 7/10 are 7.5 and 10 MHz, while, for transducer NW 17.5 B/A, the nominal frequency is only 7.5 MHz . Both utilize a mechanically sectored single-element; a stepper motor is used to provide the rocking motion in both transducers Both have similar sector angle ranges -- 110°, 80° selectable in the case of the VW 7/10, 80° fixed in the case of NW 17.5 B/A.

The VW 7/10 is also able to move the B-scan plane to obtain a VOL-scan.

Both of the patient contact materials utilized in transducer VW 7/10 (LUCALEN® and ULTRADUR") have been employed in food-, drug-, and cosmetics packaging.

i. Transducer VRW 77 AK: This transducer differs from the predicate device only in minor respects; none of these minor differences adversely

{10}------------------------------------------------

effects safety or effectiveness. The only difference between the transducer VRW 77 AK and the predicate transducer VRW 177 AK/A is the longitudinal scan angle range, which is 100° in ANTH 18 the 10ng cadinal roan and 90° in case of the predicate transducer VRW 177 AK/A.

Both of the patient contact materials utilized in transducer VRW 77 AK have been employed in the previously marketed transducers AWP 3.5/A and VRW 177 AK/A.

Transducer EW 5/7 K: יי
This transducer differs from the predicate transducers only in minor respects; none of these minor differences adversely affect safety or effectiveness. Transvaginal transducer EW 5/7 K offers selectable nominal operating frequencies of 5.0 and 7.5 MHz. Predicate transducer IR15/7BG/A operated at a fixed nominal frequency of 5.0 -MHz . . . while transducer WIW17.5AP/A operated at a fixed nominal frequency of 7.5 MHz. Mechanical sectoring of the two elements in transducer EW 5/7 K is accomplished by means of a rope drive; mechanical both transducer IR15/7BG/A and transducer sectoring of WIW17.5AP/A is accomplished using a cogwheel gear mechanism. Transducer EW 5/7 K offers two selectable sector angle ranges sector angle range of (130° 200°) . The transducer or IR15/7BG/A was fixed at 240°; the sector angle range of WIW17.5AP/A was fixed at 118°.

Both of the patient contact materials utilzed in transducer EW 5/7 K (TPX and UDEL* polysulphone) have been employed in previously marketed transducers--TPX in transducer IR15/7BG/A and WIW17.5AP/A, and UDEL" polysulphone in sector transducer AWP3.5/A.

Transducer VEW 7.5: k.
This transducer differs from the predicate transducers only in minor respects; none of these minor differences adversely affect safety or effectiveness. Transvaginal transducer VEW R offers a nominal operating frequency of 7.5 7.5 MHz . Predicate transducer IR15/7BG/A operated at a fixed nominal frequency of 5.0 MHz, while transducer WIW17.5AP/A operated at a fixed nominal frequency of 7.5 MHz. Mechanical sectoring of the single element in transducer VEW 7.5 R is accomplished by means of a rope drive; mechanical sectoring of both IR15/7BG/A transducer transducer WIW17.5AP/A and 18 accomplished using a cogwheel gear mechanism. Transducer VEW 7.5 R offers a sector angle range of 100°. The sector angle range of transducer IR15/7BG/A was fixed at 240°; the sector angle range of WIW17.5AP/A was fixed at 118°. The VEW 7.5 R is also able to rotate the B-scan plane 180°. (Combined motion in case of VOL-scan.)

Each of the patient contact materials utilzed in transducer VEW 7.5 R (TPX and ULTRADUR"/ABS) have been employed in previously marketed transducers--TPX in transducer IR15/7BG/A and WIW17.5AP/A. ULTRADUR"/ABS is widely used for food-, drug-, and cosmetics packaging.

1. Transducer ACA 3.5:
  This transducer differs from the predicate transducers in no respects adversely affecting safety or effectiveness. The ACA 3.5 type transducer is manufactured and also marketed by

{11}------------------------------------------------

Transducer ACA 5.0: m .
This transducer differs from the predicate transducers in no respects adversely affecting safety or effectiveness. The ACA 5.0 tpye transducer is manufactured and also marketed by Acoustic Imaging as model CLA 5.0 (Kretztechnik is an OEM customer of Acoustic Imaging).
Transducer PLA 7.5: n .
This transducer differs from the predicate transducers in no respects adversely affecting safety or effectiveness. The PLA 7.5 type transducer is manufactured and also marketed by Acoustic Imaging as MLA 7.5 (Kretztechnik is an OEM customer of Acoustic Imaging).

{12}------------------------------------------------

7. PERFORMANCE DATA.

Nature of Data Submitted: Appropriate nonclinical tests as ਕ . described below have been performed to assess pertinent performance variables. Formal clinical studies were not conducted because the scanner COMISON" 530, as well as the safety or effectiveness when compared with predicate devices.
Tests utilizing the listed transducers b. Electrical Safety: with COMBISON" 530 scanner were performed to measured electrical leakage currents according to IEC Standard 601.1. Guard wire resistance and the following leakage currents: (1) ground, (2) housing, (3) patient device, and (4) mains voltage at patient device were measured and found to be well within the limits for Class 1, Type BF devices established by IEC Standard 601.1.
Performance characteristics including C. Imaging Performance: Imaging rerrormando. I oriemance ontification frome rate, image orientation, measurement accuracy, sector angle, and noise level for each possible operating mode were tested using appropriate phantoms under the Kretztechnik AG Transducer-Software Check Protocol. All performance values were found to be within the limits stated in product specifications.
The maximum acoustic output for each ದೆ . Acoustic Output: transducer and each operating mode was measured under worstcase conditions and documented according to TRACK III reporting procedures as described in FDA guidelines. Results, expressed as derated values to account for assumed attenuation in tissue, were as follows: . ..

TRANSDUCER	NOMINALFREQUENCY	MODE	ISPTA(mW/cm²)	ISPPA(W/cm²)
AWP 3.5	3.5 MHz	B-Mode	26.40	101.65
		M-Mode	49.00	102.00
		PW-Mode	574.00	30.00
SWP 3.5	3.5 MHz	B-Mode	10.90	145.88
		M-Mode	58.00	146.00
		PW-Mode	458.00	27.00
VSW 3.5	3.5 MHz	B-Mode	20.40	159.26
		M-Mode	65.00	159.00
		PW-Mode	676.00	21.00
		VOL-Mode	2.00	159.26
VSW 5.0	5.0 MHz	B-Mode	9.80	171.74
		M-Mode	60.00	172.00
		PW-Mode	543.00	27.00
		VOL-Mode	0.40	171.74

{13}------------------------------------------------

	1	1	1

TRANSDUCER	NOMINALFREQUENCY	MODE	ISPTA(mW/cm²)	ISPPA(W/cm²)
VWP 3.5 B	3.5 MHz	B-Mode	46.30	159.2
		M-Mode	65.00	159.0
		PW-Mode	676.00	21.0
		VOL-Mode	5.10	159.2
VWP 5.0	5.0 MHz	B-Mode	15.50	171.7
		M-Mode	60.00	172.0
		PW-Mode	396.00	22.0
		VOL-Mode	1.10	171.7
VW 7/10	7.5 MHz	B-Mode	9.00	170.3
		M-Mode	43.00	170.0
		PW-Mode	463.00	85.0
		VOL-Mode	0.60	170.3
	10 MHz	B-Mode	6.00	163.1
		M-Mode	31.00	163.0
		PW-Mode	463.00	85.0
		VOL-Mode	0.30	163.1
EW 5/7 K	5.0 MHz	B-Mode	5.40	67.8
		M-Mode	31.00	68.0
		PW-Mode	550.00	29.0
	7.5 MHz	B-Mode	5.40	145.1
		M-Mode	32.00	145.0
		PW-Mode	3.90	20.0
VEW 7.5 R	7.5 MHz	B-Mode	3.80	140.2
		M-Mode	20.00	140.0
		PW-Mode	355.00	29.0
		VOL-Mode	3.80	140.2
VRW 77 AK	7.5 MHz	B-Mode	7.80	137.5
		M-Mode	34.00	138.0
		PW-Mode	474.00	101.0
		VOL-Mode	0.50	164.9
ACA 3.5	3.5 MHz	B-Mode	3.50	50.8
		M-Mode	19.00	51.0
		PW-Mode	431.00	15.0
		CFM-Mode	564.60	61.3

{14}------------------------------------------------

	re15			)
--	----------	--	--	---	--

TRANSDUCER	NOMINALFREQUENCY	MODE	ISPTA(mW/cm2)	ISPPA(W/cm2)
ACA 5.0	5.0 MHz	B-Mode	6.90	65.30
		M-Mode	24.00	102.00
		PW-Mode	427.00	16.00
		CFM-Mode	685.70	118.20
PLA 7.5	7.5 MHz	B-Mode	3.50	77.40
		M-Mode	9.00	77.00
		PW-Mode	429.00	89.00
		CFM-Mode	703.30	70.00

All values obtained for the listed transducers during
acoustic output testing were lower than the officially published maxima for previously approved devices for the same intended uses. Since the reported acoustic output values for all transducers listed in Section 3 as predicate devices were lower than the established limits, the test data also indicate substantial equivalence with respect to the acoustic output.

testing e . Conclusions : Nonclinical performance of the scanner COMBISON® 530 and the listed transducers has been performed, and the results demonstrate that these devices are effective, and perform as well or better than the safe, legally marketed devices with which this scanner and these transducers have been compared.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.