(131 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is limited to ultrasound transducers.
No
The device is described as "Diagnostic Ultrasound Transducers" and its "Intended Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis", without any mention of therapeutic application.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Also, the "Device Description" clearly labels the device as "Diagnostic Ultrasound Transducers".
No
The device description explicitly states "Diagnostic Ultrasound Transducers," which are hardware components. The intended use also describes diagnostic ultrasound imaging, which requires hardware transducers.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a Diagnostic Ultrasound Transducer. Ultrasound imaging 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, not an in vitro one.
- Intended Use: The intended use describes imaging or fluid flow analysis of the human body, not analysis of samples taken from the body.
Therefore, based on the provided information, this device falls under the category of diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Aloka SSD-1000:
Clinical Application:
- Fetal: Modes of operation: B, M. Combined (specify): See Below.
- Abdominal: Modes of operation: B, M. Combined (specify): See Below.
- Intraoperative (specify): Modes of operation: B, M. Combined (specify): See Below.
- Intraoperative Neurological: Modes of operation: B, M. Combined (specify): See Below.
- Pediatric: Modes of operation: B, M. Combined (specify): See Below.
- Small Organ (specify): Modes of operation: B, M. Combined (specify): See Below.
- Neonatal Cephalic: Modes of operation: B, M. Combined (specify): See Below.
- Adult Cephalic: Modes of operation: B, M. Combined (specify): See Below.
- Cardiac: Modes of operation: B, M. Combined (specify): See Below.
- Transrectal: Modes of operation: B, M. Combined (specify): See Below.
- Transvaginal: Modes of operation: B, M. Combined (specify): See Below.
- Peripheral Vascular: Modes of operation: B, M. Combined (specify): See Below.
- Laparoscopic: Modes of operation: B, M. Combined (specify): See Below.
Additional Comments: Mixed mode operation includes B/M-Mode
ASU-1003:
Clinical Application:
- Fetal: Modes of operation: B, M. Combined (specify): See Below.
- Transvaginal: Modes of operation: B, M. Combined (specify): See Below.
Additional Comments: Mixed mode operation includes B/M,
UST-9121:
Clinical Application:
- Abdominal: Modes of operation: B, M. Combined (specify): See Below.
Additional Comments: Mixed mode operation includes B/M
UST-9124:
Clinical Application:
- Fetal: Modes of operation: B, M. Combined (specify): See Below.
- Transvaginal: Modes of operation: B, M. Combined (specify): See Below.
Additional Comments: Mixed mode operation includes B/M,
Product codes (comma separated list FDA assigned to the subject device)
90 ITX, 90 IYO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Urological, Abdominal, Intraoperative, Surgical, Endoscopic, Fetal, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, 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 (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.
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
§ 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.
0
| 1
1
8.00 | forests | 19 | 2002
ﮨﮯ ﮐﮧ |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------- | ---- | --------------- |
|---|
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a signature or a short note. The text includes a combination of cursive letters and numbers, with the numbers '68' clearly visible at the end. The writing style is somewhat stylized, with loops and curves that are characteristic of handwriting.
510(k) Summary
る。
This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.
| Submitter's Name and Address | Aloka Co., Ltd.
10 Fairfield Boulevard
Wallingford, CT 06492 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact's Name, Title, Address and Telephone Number | Kelvin Burroughs
Regulatory Affairs/Quality Assurance Coordinator
Aloka Co., Ltd.
10 Fairfield Boulevard
Wallingford, CT 06492
(203) 269-5088 |
| Device Proprietary Name | ASU-1003
UST-9121
UST-9124 |
| Device Common Name | Diagnostic Ultrasound Transducers |
| Classification | The charts below list the Regulatory Class and Device Codes. |
| Subject | Description |
|---|---|
| Regulatory Class | Class II |
| Review Category | Tier II |
| Code | Description | Regulation |
|---|---|---|
| 90 ITX | Transducer, Ultrasonic, Diagnostic | 892.1570 |
Continued on next page
1
510(k) Summary, Continued
| Identification of
predicate
| devices | The following is a list of probes submitted in this notification, their predicate devices and the 510(k) clearance numbers. | ||
|---|---|---|---|
| Subject Transducer | Predicate Transducer | Predicate Transducer | |
| 510(k)/Appendix E | |||
| ASU-1003 | ASU-1000C-3.5 | K012253 | |
| UST-9121 | UST-9114-3.5 | K012080 | |
| UST-9124 | UST-9103-5 | K012253 | |
| Probes | Probes that are the subject of a submitted and cleared 510(k) for the SSD- | ||
| 1400 have already been added to the SSD-1000. New and additional probes for used with the SSD-1000 are the subjects of this submission. | |||
| Intended Use | The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications. |
್ರಾ
របស់ :
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2002
Mr. Richard J. Cehovsky Regulatory Affairs/Quality Assurance ALOKA Co., Ltd. U.S.A. 10 Fairfield Boulevard WALLINGFORD CT 06492-7502
Re: K020668
Trade Name: Aloka SSD-1000 Diagnostic Ultrasound 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 IYO and ITX Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Cehovsky:
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 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). 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 Aloka SSD-1000, as described in your premarket notification:
Transducer Model Number
| ASU-1003 |
|---|
| UST-9121 |
| UST-9124 |
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
3
Page 2 - Mr. Cehovsky
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 (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.
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
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
| System/Transducer | System |
|---|---|
| Model | SSD-1000 |
| 510(k) Number | Appendix E |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | E | E | See Below | |||||||
| Abdominal | E | E | See Below | |||||||
| Intraoperative (specify) | E | E | See Below | |||||||
| Intraoperative Neurological | E | E | See Below | |||||||
| Pediatric | E | E | See Below | |||||||
| Small Organ (specify) | E | E | See Below | |||||||
| Neonatal Cephalic | E | E | See Below | |||||||
| Adult Cephalic | E | E | See Below | |||||||
| Cardiac | E | E | See Below | |||||||
| Transesophageal | ||||||||||
| Transrectal | E | E | See Below | |||||||
| Transvaginal | E | E | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | E | See Below | |||||||
| Laparoscopic | E | E | See Below | |||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
ly cleared by FDA; E-added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M-Mode
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive and Radiological Devices 510(k) Number
Aloka Company, Ltd.
Additional Probes for SSD-5000
Page
6
| System/Transducer | Transducer |
|---|---|
| Model | ASU-1003 |
| 510(k) Number |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | See Below | |||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | N | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N=new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number J
Aloka Company, Ltd.
Additional Probes for SSD-5000
7
| System/Transducer | Transducer |
|---|---|
| Model | UST-9121 |
| 510(k) Number | K003739 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | See Below | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Mixed mode operation includes B/M
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020667
Aloka Company, Ltd.
Additional Probes for SSD-5000
です
『 Page
8
| System/Transducer | Transducer |
|---|---|
| Model | UST-9124 |
| 510(k) Number | K003739 |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes of operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Opthalmic | ||||||||||
| Fetal | P | P | See Below | |||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | See Below | |||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E;
Additional Comments:
Professor Section Monaries & Particular Researce Most Province
Mixed mode operation includes B/M,
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C Hodgon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _