(97 days)
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)).
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.
The provided text is a 510(k) premarket notification for the Hitachi EUP-OL334 Laparoscopic Probe. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through adherence to safety standards and the device's intended use. It does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
The document highlights the device's technical specifications and compliance with safety standards for ultrasound devices, such as acoustic output limits and general electrical safety standards (IEC 601-1). The "Indications for Use" forms list various clinical applications for which the device is cleared, including a new indication for laparoscopic use. However, these forms do not define quantitative performance criteria (e.g., sensitivity, specificity, resolution) or provide data from studies designed to measure these.
Therefore, based solely on the provided text, I cannot describe specific acceptance criteria and a study proving the device meets them in the way the request specifies (e.g., in terms of diagnostic performance). The document is a regulatory submission for substantial equivalence, not a report on clinical performance validation against specific diagnostic metrics.
Here's a breakdown of what can be inferred from the provided text, and what cannot be, based on your request:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided: The document does not define quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) nor does it report such performance metrics for the device. The focus is on safety compliance and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided: There is no mention of a test set, sample size, or study data provenance for evaluating diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided: Ground truth establishment for a diagnostic performance study is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided: No adjudication method is mentioned as there's no diagnostic performance study described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided: This document predates widespread AI in medical devices and does not describe AI assistance or MRMC comparative effectiveness studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided: The device is a diagnostic ultrasound probe, which inherently requires human operation and interpretation. There is no mention of a standalone algorithm or its performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided: No ground truth for diagnostic performance is discussed as there's no diagnostic performance study reported.
8. The sample size for the training set:
- Cannot be provided: The concept of a "training set" for an algorithm is not applicable or discussed in this 1998 regulatory submission for an ultrasound probe.
9. How the ground truth for the training set was established:
- Cannot be provided: As with point 8, the concept of a training set and its ground truth is not relevant to this document.
Summary of what the document does provide regarding "acceptance criteria" in a general sense:
The "acceptance criteria" presented in this document are primarily regulatory compliance criteria for a Class II medical device, focusing on:
- Acoustic Output Limits: The Hitachi EUP-OL334 Laparoscopic Probe "complies with the 'Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Instruments (1992)', published by the National Electrical Manufacturers Association as UD-3" and "complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance."
- General Safety Standards: The device is "designed to comply with IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety."
- Intended Use Compatibility: The device is tested for its intended use in "Diagnostic ultrasound imaging or fluid flow analysis…for laparoscopic clinical applications with the EUB-525, EUB-555, and EUB-8000 Hitachi Diagnostic Ultrasound Systems." The "Indications for Use" forms confirm the new "N= new indication" for laparoscopic use in B, M, and PWD modes, and Color Doppler.
The "study that proves the device meets the acceptance criteria" in this context is the submission of documentation to the FDA demonstrating adherence to these standards and the substantial equivalence to predicate devices (EUB-555, EUB-525, EUB-8000 systems with previously cleared probes). The FDA's issuance of the 510(k) clearance letter (K981434) on July 27, 1998, indicates that the agency found the device to be substantially equivalent based on the provided information, which included compliance with these safety and performance standards for ultrasound devices of its type. The specific studies proving this are implicit in the manufacturer's internal testing and compliance documentation submitted to the FDA, but are not detailed within this public summary.
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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.
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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.
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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".
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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
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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 | ColorDoppler | 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.) | ||||||||
| PeripheralVessel | 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}------------------------------------------------
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-OL334Intended 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 | ColorDoppler | 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.) | ||||||||
| PeripheralVessel | 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
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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 | ColorDoppler | 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.) | ||||||||
| PeripheralVessel | 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
§ 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.