(69 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as "the same essential technology for imaging, Doppler functions, and signal processing" as the predicate devices. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as being for "diagnostic ultrasound evaluation," which is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the diagnostic ultrasound evaluation".
No
The device description explicitly states it is a "Linear Array transducer," which is a hardware component of an ultrasound system. The summary also mentions testing for acoustic output, biocompatibility, electrical and mechanical safety, all of which are related to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states this device is a transducer for a diagnostic ultrasound scanner. Ultrasound works by sending sound waves into the body and receiving the echoes to create images. This is an in vivo (within the living body) imaging technique, not an in vitro test on a sample.
- Intended Use: The intended use is for "diagnostic ultrasound evaluation during Intra-operative and Intra-operative (neurosurgery) procedures." This involves imaging structures directly within the body during surgery.
Therefore, the Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers are diagnostic imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.
The device is not indicated for Ophthalmic applications.
Product codes (comma separated list FDA assigned to the subject device)
90-1TX
Device Description
Linear Array transducer
Mentions image processing
The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging or fluid flow analysis
Anatomical Site
Intra-operative (liver, pancreas, gall bladder..), Intra-operative (Neurosurgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained personnel (doctor, sonographer, etc.)
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)
Non-clinical Testing: No new hazards were identified with the addition of the added indications and software features. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
Clinical testing: None required
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.
UST-533 Intraoperative Ultrasound Transducer [K122537], UST-534 Intraoperative Ultrasound Transducer [K122537], UST-536 Intraoperative Ultrasound Transducer [K122537]
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.
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
§ 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.
0
Hitachi Aloka Medical, Ltd.
K140854
Page 1 of 2
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.
JUN 1 1 2014
21 CFR 807.92, Subscction a
- Submitter's Information
Hitachi Aloka Medical. Ltd. 10 Fairfield Boulevard Wallingford. CT 06492-5903
Contact: Angela Van Arsdale RA/QA Manager
Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Date Prepared: April 1, 2014
- Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name - UST-5310 and UST-5311 Common name - Diagnostic Ultrasound Transducer Classification name - Diagnostic Ultrasonic Transducer Classification: Class II Product Code: 90-1TX 892.1570 Diagnostic Ultrasonic Transducer
- Legally Marketed Predicate Device(s):
UST-533 Intraoperative Ultrasound Transducer [K122537] UST-534 Intraoperative Ultrasound Transducer [K122537] UST-536 Intraoperative Ultrasound Transducer [K122537]
-
- Device Description:
Linear Array transducer
- Device Description:
- Indication for Use:
Sterile single-use Intra-Operative Linear transducer for use in conjunction with ProSound Alpha 6 [K093488]
- Comparison to predicate device:
The Hitachi Aloka Medical, I.td. UST-5310 and UST-5311 Intraoperative transducers are technically comparable and substantially equivalent to the currently marketed UST-534 & UST-536 Intraoperative transducers. The subject and predicate systems are track 3 systems that incorporate the same fundamental and scientific technologies. The follows compares the subject and predicate devices:
| Subject devices: | Predicate devices: |
|---|---|
| Single-use sterile device - sterilized via EtO | Reusable device - Sterilized via EtO |
| New material: Ethylene Vinyl Acetate | All materials previously cleared by FDA |
| Intraoperative linear array | Intraoperative linear array |
| Modes of operation: B, M, PWD, CD, PowerFlow and | Modes of operation: B, M, PWD, CD, PowerFlow and |
| Combination of each operating mode | Combination of each operating mode |
510(K) Premarket Notification - Sterile Transducers
1
Page 2 of 2
21 CFR Part 807.92, Section b
-
- Non-clinical Testing
No new hazards were identified with the addition of the added indications and software features. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
- Non-clinical Testing
2. Clinical testing:
None required
3. Conclusions:
The Hitachi Aloka Medical. Ltd. Sterile Transducer is substantially equivalent in salety and effectiveness to the predicate device:
- . The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging.
- The subject and predicate device(s) have the same grav scale and Doppler capabilities. .
- The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
- . The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
- . The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
- . The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
- . The subiect and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1: all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
- l The subject and predicate device(s) are designed to be sterilized via EtO, the only difference is that the subject device is supplied sterile and the predicate is supplied non-sterile with instructions for cleaning. disinfection, and sterilization in the transducer manuals.
END OF SUMMARY
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. The logo is black and white and appears to be of low resolution.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2014
Hitachi Aloka Medical, Ltd. % Ms. Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492
Re: K140854
Trade/Device Name: UST-5310 and UST-5311 Intra-operative Ultrasound Transducers Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: May 30, 2014 Received: June 2, 2014
Dear Ms. Van Arsdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2-Ms. Van Arsdale
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140854
Device Name UST-5310 / UST-531 !
Indications for Use (Describe)
The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.
The device is not indicated for Ophthalmic applications.
Type of Use (Select one or both. as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
.
Smh.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send commonts regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@lda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
5
DIAGNOSTICULTRASOUNDINDICATIONS FOR USE FORM
Device Name: Hitachi ProSound Alpha 6 K093488 Transducer: UST-5310 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of 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* | |||||||
| (Specify) | Other** | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify)* | E | E | E | E | 1: | 1: | ||
| Intra-operative (Neurosurgery) | E | E | 1. | E | F | E | ||
| Laparoscopic** | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify)* | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| TEE (non-cardiac) | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other: (Specify) * | ||||||||
| Other: Gynecological | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Adult, TEE | |||||||
| Cardiac - Neonatal | ||||||||
| Cardiac - Pediatric | ||||||||
| Cardiac - Pediatric, TEE | ||||||||
| Peripheral | Peripheral Vascular | |||||||
| Vessel | Other (spec.) |
N * new indication. P = previously cleared by FDA: E = added under Appendix 1 - Specifications
Combination of each operating mode includes:
- Combination of each operating mode- BRA, BIPWD, MICD, BICD/PWD, B/CD/CWD * 2 Includes: M10w, B/Bfow, Power Row.
Intra-operative (Specify)® - (liver, pancreas, gall bladder..)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
(Division Sign-Oil) Division of Radiological Health Office of In Viro Diagnostics and Radiological I tealth 510(k)
.
. . ..
. .
Page 2 of 3
510(K) Premarket Notification - Sterile Transducers
Page 3
6
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
Device Name: Hitachi ProSound Alpha 6 K093488 Transducer: UST-5311 Intended use: Diagnostic ultrasound imaging or fluid Now analysis of 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* | |||||||
| (Specify) | Other** | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | ||||||||
| & Other | Abdominal | |||||||
| Intra-operative (Specify)* | E | E | E | E | E | |||
| Intra-operative (Neurosurgery) | E | E | E | E | E | E | ||
| Laparoscopic** | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify)* | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| TEE (non-cardiac) | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other: (Specify)* | ||||||||
| Other: Gynecological | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Adult, TEE | ||||||||
| Cardiac - Neonatal | ||||||||
| Cardiac - Pediatric | ||||||||
| Cardiac - Pediatric, TEE | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vascular | |||||||
| Other (spec.) |
N = new indication. P = previously cleared by FDA: E = added under Appendix I - Specifications
Combination of each operating mode includes:
- I Combination of each operating mode- BM, BIPWD, BICD/PWD, BICD/CWD * 2 Includes: Mflow, B/B/B/V, Power Tlow.
Intra-operative (Specify)® - (liver, pancreas, gall bladder.)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)
| (Division Sign-Off) |
|---|
| Division of Radiological Health |
| Office of In Vitro Diagnostics and Radiological Health |
| 510(k) |
Page 3 of 3
510(K) Premarket Notification - Sterile Transducers
, t+ .