Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a diagnostic ultrasound transducer and its operating modes, but there is no mention of AI or ML technology in the device description, intended use, or any other section.

Therapeutic

No
The device is described as a "diagnostic ultrasound transducer" used for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is to aid in diagnosis, not to provide therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Laparoscopic". Additionally, the "Device Description" refers to it as a "Track 3 diagnostic ultrasound transducer" and mentions its use with "Hitachi Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Laparoscopic Probe," which is a hardware component (a transducer).

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
Device Description: The description clearly states the device is a "diagnostic ultrasound transducer" intended for "laparoscopic clinical applications." Ultrasound is an imaging modality that works by sending sound waves into the body and receiving the echoes to create images. This is an in vivo (within the living body) diagnostic method.
Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Laparoscopic." This confirms it's used for imaging within the body during a laparoscopic procedure.

The information provided describes a device used for direct imaging of internal structures within the body, which is the opposite of an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Laparoscopic (Mode of Operation: B, M, PWD, Color Doppler, Other* (Amplitude Doppler)).

Product codes

90 ITX

Device Description

The Hitachi EUP-OL334 Laparoscopic Probe is a Track 3 diagnostic ultrasound transducer capable of the following operating modes: B, M., Pulsed Doppler, and Color Flow (including Amplitude Doppler). It is intended for laparoscopic clinical applications with the EUB-525, EUB-555, and EUB-8000 Hitachi Diagnostic Ultrasound Systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Laparoscopic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K961459

Reference Device(s)

K926209, K954220

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K981434 April 17, 19

April 17, 1998

Hitachi EUP-OL334 Laparoscopic Probe Hitachi EUP-OL354 Laparoscopes -----------------------------------------------------------------------------------------------------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS IMAKI Of SAL 334 Laparoscopic Probe

Device Description

The Hitachi EUP-OL334 Laparoscopic Probe is a Track 3 diagnostic ultrasound
er, and the collected by the since species: B. M. Pulsed Doppler, an The Hitachi EUP-OL334 Laparoscopic Frobe Is a Huas. B M. Pulsed Doppler, and
transducer capable of the following operating modes: B, M., Pulsed Doppic transducer capable of the following opelatify insuced for laparoscopic
Color Flow (including Amplitude Doppler). It is intended for laparoscopic
Color Flow (including Amplitu Color Flow (including Amplitude Doppler). It is Interior .
clinical applications with the EUB-525, EUB-555, and EUB-8000 Åitachi
Clinical applications with the EUB-525, and E Diagnostic Ultrasound Systems.

Safety

As a Track 3 ultrasound device, the Hitachi EUP-OL334 Laparoscopic Probe As a Track 3 ultrasound device, the Hitacul EDI -OB67 - 12601 - 12 Mechanical
complies with the "Standard for Real-time Display of Thermal (1992)", publish complies with the "Standard for Real-time Display of Inicination of States of States of States of States of States of States Acoustic Output Indices on Dagnosuc Onlines Association as UD-3. With respect to
by the National Electrical Manufacturers Association as UD-3. With respect to by the National Electrical Manufacturers Associations on a complies
limits on accustic outputs, the Hitachi EUP-OL334 Laparoscopic Probe complies limits on acoustic outputs, the Hitachi EUF-OLSS4 Laparosesperation of 510(k) Diagnostic
with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Hitachi EUP-OL334 Laparoscopic Probe is
t Particle Court Childrently III (1988) Modical Flectrical Equipment, Part With regard to general satery, the Hilacia EU1-OL01 Lap 2011
designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.

1

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 1998

Charles F. Hottinger Hitachi Medical Corp. of America 19030 Fortos Drivc Saratoga, CA 95070

K981434 Re : R961459
Trade Name; Hitachi EUP-OL334 Laparoscopic Probe Regulatory Class: II/21 CFR 892.1570 Product Code: 90 ITX July 16, 1998 Dated: Received: July 17, 1998

Dear Mr. Hottinger:

We have reviewed your Section 510(k) notificalion of intent to market the We nave reviewed your bection of have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally equivalent (for the marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to May 26, 1976, the enactment assified in accordance with the provisions of the devices that have been recrassic Act (Act) . You may, therefore, market the The general device, subject to the general controls provisions of the Act. device, subject to the general concrols provisements for annual registration, concrois provisions of the new its aturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the Ritachi BUP-01334 Inis deceimination of Subscantan- Carrascass Spilowing Hitachi diagnostic ultrasound systems, as described in your premarket notification:

System Model Number

EUB-555 EUB-525 EUB-8000

If your device is classified (see above) into either class I (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major regulations affecting your device can be additional controls. 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 Failure to comply with the GMP regulation may result in assumptions. 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.

2

Page 2 - Charles F. Hottinger

Please be advised that the determination above is hased on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percuean combilied blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you subted on the condition that This report should contain complete information, including acoustic cept (enclosed) of the Center) September 30, 1997 "Information of the Market Concepture of Chippendix G,
(enclosed) of the Contente 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 them approved levels), then the 510(k) clearance may not apply to the probection units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. Tt 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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. Please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 807.97) . Other general information on your responsibilities under the Art may
be obtained from the Division of Santal Manufacturers Assistance at its tolle free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

3

Page 3 - Charles F. Hottinger

If you have any questions regarding the content of this letter, please contact
Paul Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive,
Ind Throat

Abdominal, Ear, Nose and Throat,
Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

4

K981434

Hitachi EUP-OL334 Laparoscopic Probe used with EUB-525/-555 and EUB-8000 System

April 17, 1998

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

EUB-555/-525; EUB-8000_ System: EUP-OL334 Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other*
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laparoscopic	N	N	N		N	N
	Pediatric
	Small Organ (Spec.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Amplitude Doppler

Additional Comments: EUB-555 previously cleared under K926209; EUB-525 marketed as a modification to EUB-555 under Appendix I of the Feb. 17, 1993, ultrasound 510(k) guidance. EUB-8000 previously cleared under K954220,

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Wilcau/h

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

510(k) Number K981434

5

K981454

April 17, 1998

Hitachi EUP-OL334 Laparoscopic Probe intachi EUB-525/-555 and EUB-8000 System

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM (amended July 15, 1998) EUB-555/-525 System:

| Transducer: | All cleared probes + EUP-OL334
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------|----|-----|-----|------------------|---------------------|-------------------|
| Clinical Application | | Mode of Operation | | | | | | |
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Spec.) | Other*
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | P | P | P | P | P | | E |
| | Abdominal | Pa | P | P | P | P | | E |
| | Intra-operative (Spec.) | Pb | Pb | Pb | | Pb | | E |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | N | N | N | | N | | N |
| | Pediatric | P | P | P | P | P | | E |
| | Small Organ (Spec.) | Pc | Pc | Pc | | Pc | | E |
| | Neonatal Cephalic | P | P | P | | P | | E |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | Pd | P | P | | P | | E |
| | Trans-vaginal | Pe | P | P | | P | | E |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: Urology | P | P | P | | P | | E |
| | Other: Gynecology | P | P | P | | P | | E |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | | E |
| | Cardiac Pediatric | P | P | P | P | P | | E |
| | Trans-esophageal (card.) | P | P | P | | P | | E |
| | Other (spec.) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | | E |
| | Other (spec.) | | | | | | | |

N= new indications for EUP-OL334; P= previously cleared by FDA under K926208; E= added under Appendix I of the Feb. 17, 1993 guidance. * Amplitude Doppler

Additional Comments: EUB-525 marketed as a modification to EUB-555 under Appendix Lof the Feb. 17, 1993 guidance: "E": Amplitude Doppler_cleared with the EUB-8000 under K954220. "Pa"; includes imaging for guidance of percutaneous biopsy of abdominal organs and structures; "Pb": includes imaging of organs and structures exposed during surgery (excluding neurosurger) and laparoscopic procedures: "Pc": includes thyroid, parathyroid, breast, scrotum, and penis; "Pd"; includes imaging for guidance of trans-rectal biopsy:

l'e": includes imaging for guidance of trans-vaginal be IPLEASE DO NOT WRENE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (E NEEDED)

Office of Device Evaluation (ODE) Concurrence of CBRH,

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K981434

Tuly restription Use (Per 21 CFR 801.109) Hitachi Kg81234 4.3 Page Page 2

6

K981434

April 17, 1998

Hitachi EUP-OL334 Laparoscopic Probe used with EUB-525/-555 and EUB-8000 System

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:

EUB-8000 All cleared probes + EUP-OL334

Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Clinical Application		Mode of Operation
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other*
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P
	Abdominal	Pa	P	P	P	P	P
	Intra-operative (Spec.)	Pb	Pb	Pb		Pb	Pb
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic	N	N	N		N	N
	Pediatric	P	P	P	P	P	P
	Small Organ (Spec.)	Pc	Pc	Pc		Pc	Pc
	Neonatal Cephalic	P	P	P		P	P
	Adult Cephalic
	Trans-rectal	Pd	P	P		P	P
	Trans-vaginal	Pe	P	P		P	P
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P
	Trans-esophageal (card.)	P	P	P		P	P
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P
	Other (spec.)

N= new indications for EUP-OL334; P= previously cleared by FDA under K954220. * Amplitude Doppler

Additional Comments: "Pa": includes imaging for guidance of percutaneous biopsy of abdominal organs and structures: "Pb": includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures: "Pc"; includes thyroid. parathyroid. breast, scrotum, and penis; "Pd": includes imaging for guidance of trans-rectal biopsy; Pe": includes imaging for guidance of trans-vaginal biopsy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Wilcau Ch

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

Section 4.3 Page 3