Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities.

Therapeutic

No.
This device is described as a diagnostic ultrasound imaging system, used for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," not for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging". Additionally, the "Device Description" refers to it as a "diagnostic ultrasound system".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasound imaging platform" with hardware components like a keyboard, display, and interchangeable transducers, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to produce images or analyze flow, which is characteristic of in-vivo diagnostic devices.
Device Description: The description details an "ultrasound imaging platform" with transducers that are used internally and externally. This further supports the idea of a device used on a living patient.
Lack of IVD Characteristics: IVD devices typically involve testing samples taken from the human body (like blood, urine, tissue). There is no mention of sample collection or analysis of biological specimens in the provided text.

Therefore, the Acuson Cypress Ultrasound System, as described, is a diagnostic imaging device used on the human body, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Acuson Cypress ultrasound system with the 7L3 transducer, the 2MHz CW transducer, and additional calculations is a modification to the previously cleared Cypress system that has already been cleared by FDA for Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications. No new intended uses are claimed for the modifications.

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

For The Acuson Cypress System: Fetal, Abdominal, IntraOperative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Transesophageal, Peripheral Vascular, Other (Intra-Luminal), Other (Intra-Cardiac).

For the 6 MHz Linear Array External Transducer, Model Name: 7L3: Fetal, Abdominal, IntraOperative (Cardiac), Pediatric, Cardiac (Adult), Cardiac (Pediatric), Peripheral Vascular.

For the 2 MHz Continuous Wave Doppler External Transducer, Model Name: Auxiliary CW: Fetal, Abdominal, Pediatric, Cardiac (Adult), Cardiac (Pediatric), Peripheral Vascular.

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

90 IYN, 90 IYO, 90 ITX

Device Description

The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), Other (Intra-Cardiac)

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, Adult

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)

Not Found

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.

K010950, K982800, K991872

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).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

K021497

Section 8 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ACUSON CORPORATION'S CYPRESS ULTRASOUND SYSTEM

Acuson Corporation has not disclosed its intent to market this device modification and requests this notification be held CONFIDENTIAL by FDA, and not be released to any Freedom of Information request or addressed with any outside parties.

| Sponsor: | Acuson Corporation
1220 Charleston Road
Mountain View, CA 94039-7303 |
|------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Bob Leiker
Senior Regulatory Affairs Specialist
Telephone: (650) 694-5080
Fax: (650) 961-6158 |
| Submission Date: | May 8, 2002 |

Acuson Cypress System Device Name:

Diagnostic ultrasound system Common or Usual Name:

Classification:

Ultrasonic Pulsed Doppler Imaging System (90 IYN), class II (21 C.F.R. §892.1550) Ultrasonic Pulsed Echo Imaging System (90 IYO), class II (21 C.F.R. §892.1560) Diagnostic Ultrasound Transducer (90 ITX), class II (21 C.F.R. §892.1570)

Predicate Devices:

K010950, 6/27/2001, cleared as the Acuson Cypress Ultrasound System.

K982800, 9/22/98, cleared as the Ecton Lynx Ultrasound System, marketed as the Acuson Cypress Ultrasound System with subsequent modifications.

K991872. 6/16/99, cleared as Ecton Lynx Ultrasound System, marketed Acuson Cypress Ultrasound System with subsequent modifications.

Device Description:

The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

1

Intended Use:

The Acuson Cypress ultrasound system with the 7L3 transducer, the 2MHz CW transducer, and additional calculations is a modification to the previously cleared Cypress system that has already been cleared by FDA for Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications. No new intended uses are claimed for the modifications.

Technological Characteristics and Substantial Equivalence:

The modified Cypress System is substantially equivalent to the predicate devices with respect to intended use and indications for use, principles of operation, and technological characteristics of design construction, and materials. It is comparable in key safety and effectiveness features.

2

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the symbol in a circular fashion. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 JUL

Mr. Bob Leiker Senior Regulatory Affairs Specialist Acuson Corporation 1220 Charleston Road MOUNTAIN VIEW CA 94039

Re: K021497

Trade Name: The Acuson Cypress System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasound pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulaton Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 IYN, IYO and ITX Dated: June 11, 2002 Received: June 12, 2002

Dear Mr. Leiker:

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 Mav 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 Acuson Cypress System, as described in your premarket notification:

Transducer Model Number

6 MHz Linear Array External Model 7L3 2 MHz Continuous Wave Doppler External, Model Auxiliary CW

3

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please 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".

4

Page 3 – Mr. Leiker

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Diriel A. dozerson
for Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

5

Diagnostic Ultrasound Indications for Use For The Acuson Cypress System

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	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	(Other)
Harmonic
Imaging
Opthalmic
Fetal		P	P	P	P	P	P	P
Abdominal		P	P	P	P	P	P	P
IntraOperative
(Cardiac)		P	P	P	P	P	P	P
IntraOperative
Neurological
Pediatric		P	P	P	P	P	P	P
Small Organ
(Specify)
Neonatal Cephalic		P	P	P	P	P	P	P
Adult Cephalic
Cardiac (Adult)		P	P	P	P	P	P	P
Cardiac (Pediatric)		P	P	P	P	P	P	P
Transesophageal		P	P	P	P	P	P	P
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular		P	P	P	P	P	P	P
Laparascopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Other (Intra-Luminal)		P	P	P	P	P	P	P
Other (Intra-Cardiac)		P	P	P	P	P	P	P
N = new indication
P = previously cleared by FDA
E = added under Appendix E

Mode of Oneration

E = added under Appendix E

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Bergman
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Deyic 510(k) Number .

6

Diagnostic Ultrasound Indications for Use For The Acuson Cypress System

6 MHz Linear Array External Transducer, Model Name: 7L3

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	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	(Other)
Harmonic
Imaging
Opthalmic
Fetal		N	N	N		N	N	N
Abdominal		N	N	N		N	N	N
IntraOperative
(Cardiac)		N	N	N		N	N	N
IntraOperative
Neurological
Pediatric		N	N	N		N	N	N
Small Organ
(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac (Adult)		N	N	N		N	N	N
Cardiac (Pediatric)		N	N	N		N	N	N
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular		N	N	N		N	N	N
Laparascopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Other (Intra-Luminal)
Other (Intra-Cardiac)

Mode of Operation

N = new indication

P = previously cleared by FDA

E = added under Appendix E

Additional Comments: The transducer being added is new, but the indications are not new to the Cypress Ultrasound System.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sige 00

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021497

Prescription Use (Per 21 CFR 801.109)

,

7

Diagnostic Ultrasound Indications for Use For The Acuson Cypress System

2 MHz Continuous Wave Doppler External Transducer, Model Name: Auxiliary CW

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	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify)	(Other)
Harmonic
Imaging
Opthalmic
Fetal					N
Abdominal					N
IntraOperative
(Cardiac)
IntraOperative
Neurological
Pediatric					N
Small Organ
(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac (Adult)					N
Cardiac (Pediatric)					N
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular					N
Laparascopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Other (Intra-Luminal)
Other (Intra-Cardiac)
N = new indication		B = previously cleared by FDA		E = added under Appendix E

Moda of Oneration

Additional Comments: The transducer being added is new, but the indications are not new to the Cypress Ultrasound System.

Concurrence of CDRH, Office of D

H, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)