(63 days)
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
- A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data
The provided text is a 510(k) Pre-Market Notification for the ALOKA LISENDO 880 ultrasound system. It outlines the device's indications for use and compares it to a predicate device (ARIETTA 70, K134016) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantitative acceptance criteria (e.g., minimum sensitivity or specificity values, specific performance metrics) and corresponding reported performance metrics for the ALOKA LISENDO 880. Instead, it relies on a qualitative comparison to a predicate device.
The "Comparison to predicate device" section (Page 20) implicitly defines the acceptance criterion as being "substantially equivalent" to the ARIETTA 70 (K134016) in terms of:
- Indication for Use: The ALOKA LISENDO 880's indications for use are listed and shown to broadly align with those of the ARIETTA 70.
- Modes of Operation: Both devices are stated to have the same core modes of operation (B mode, M mode, PW mode, CW mode, Color Doppler, Power Doppler, TDI, 3D Imaging, 4D Imaging, and combinations).
- Probe Types: Both support Convex, Linear, Sector, and other probe types.
- Applicable Software Features: A long list of software features (e.g., DICOM, Freehand 3D, Real-time Doppler Auto Trace, Spatial Compound) are listed as being present in both the subject and predicate devices with "YES" for both, implying functional equivalence.
The "Conclusions" section (Page 21) summarizes these points, stating that the ALOKA LISENDO 880 is substantially equivalent in safety and effectiveness based on:
- Same indications for diagnostic ultrasound imaging and fluid flow analysis.
- Same gray scale and Doppler capabilities.
- Same essential technology for imaging, Doppler functions, and signal processing.
- Acoustic level below Track 3 FDA limits.
- Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
- Designed and manufactured to the same electrical and physical safety standards.
- Materials tested in accordance with ISO 10993-1.
- Reusable probes with instructions for cleaning, disinfection, and sterilization.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states under "2. Clinical testing:" that "None required." This indicates that no separate clinical test set was used to establish performance for the ALOKA LISENDO 880 for the purpose of this 510(k) submission. The FDA allows clearance of devices through the 510(k) pathway if they are shown to be substantially equivalent to a legally marketed predicate device, often without new clinical studies if the technological characteristics are similar.
Therefore, there is no information on sample size, data provenance, or whether data was retrospective or prospective, as no new clinical testing was conducted.
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)
Since no clinical testing was performed for the subject device as part of this 510(k) submission, there is no mention of experts being used to establish a ground truth for a test set specifically for the ALOKA LISENDO 880. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical testing was conducted for the subject device to evaluate its performance against a ground truth, there is no information on adjudication methods for a test set.
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
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance. The ALOKA LISENDO 880 is described as a diagnostic ultrasound system, and the submission focuses on its equivalence to a predicate ultrasound system rather than advanced AI-driven interpretation or assisted diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a diagnostic ultrasound system, not an algorithm. Therefore, "standalone" algorithm performance is not applicable or discussed. The device is intended for use by "trained personnel (doctor, sonographer, etc.)", indicating human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No new ground truth data was generated or used for the ALOKA LISENDO 880's clearance as "no clinical testing" was required. The "ground truth" for the predicate device would have been established during its own clearance process, but that information is not detailed here.
8. The sample size for the training set
The document does not discuss any training sets, as it's not describing an AI/machine learning device. The clearance is based on the device's technical specifications and substantial equivalence to a predicate, not on a machine learning model's performance.
9. How the ground truth for the training set was established
As there is no mention of a training set or machine learning components, this information is not provided.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Hitachi, Ltd. % Ms. Angela Van Arsdale RA/QA Manager Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard WALLINGFORD CT 06492-5903
Re: K162583
Trade/Device Name: ALOKA LISENDO 880 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 29, 2016 Received: September 30, 2016
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.
{1}------------------------------------------------
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/Resourcesfor You/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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K162583
Device Name ALOKA LISENDO 880
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card), Adult Cephalic clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 comments 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(@fda.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."
{3}------------------------------------------------
Device Name: ALOKA LISENDO 880
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| Intra-operative (Spec.) | Pb | Pb | Pb | Pb | Pb | Pb | Pb | |
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Musculo-skel. (Convent.) | P | P | P | P | P | P | P | |
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | P | |
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) |
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: |
|---|
| -------------------------------------------------------------------------------------------------- |
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography). Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 2 of 17
{4}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: C251 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa | |
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (Wound) | |||||||||
| Other (Gynecological) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 3 of 17
{5}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: C252 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 | ColorDoppler | Combined*(Spe) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 4 of 17
{6}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: C35 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 5 of 17
{7}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: C42K Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation B M PWD CWD Color Other** General Specific Combined* (Track I only) (Tracks I & III) Doppler (Spe (Spec.) Ophthalmic Ophthalmic Fetal Fetal Imaging Abdominal & Other Intra-operative (Spec.) Pb Pb Pb Pb Pb Pb Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (Spec.) Pd Pd Pd Pd Pd Pd Neonatal Cephalic P P P P P P Adult Cenhalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (Wound) Other (Gynecological) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Adult/Pediatric) Other (spec.) Peripheral vessel Peripheral Vessel Other (spec.) N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 6 of 17
{8}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: L34 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 | ColorDoppler | Combined*(Spec.) | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | P | |
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery and laparoscopic procedures). Subscript "b":
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 7 of 17
{9}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: L441 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging& Other | Abdominal | Pa | Pa | Pa | Pa | Pa | Pa | Pa |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | Pd | Pd | Pd | Pd | Pd | Pd | Pd | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | P | P | P | |
| Musculo-skel. (Superfic.) | P | P | P | P | P | P | P | |
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P |
| Other (spec.) |
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW **Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery
- (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
- Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 8 of 17
{10}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: L64
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation B M PWD CWD Color Other** General Specific Combined* (Track I only) (Tracks I & III) Doppler (Spe (Spec.) Ophthalmic Ophthalmic Fetal Fetal Imaging Abdominal Pa Pa Pa Pa Pa Pa Pa & Other Intra-operative (Spec.) Intra-operative (Neuro.) Laparoscopic Pediatric P P P P P P P Small Organ (Spec.) Pd Pd Pd Pd Pd Pd Pd Neonatal Cephalic Adult Cenhalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) P P P P P P P P Musculo-skel. (Superfic.) P P P P P P Intra-luminal Other (Wound) Other (Gynecological) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Adult/Pediatric) Other (spec.) Peripheral vessel P P P P P P P Peripheral Vessel Other (spec.)
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Free Angular M-mode
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Includes imaging for guidance of trans-rectal biopsy Subscript "e":
Includes imaging for guidance of trans-vaginal biopsy. Subscript "f":
Subscript "g": For Adult and pediatric patients
Includes imaging for Cavernous/Non-Cavernous wounds Subscript "h"
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 9 of 17
{11}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: MXS1 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 | ColorDoppler | Combined*(Spec.) | Other**(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | P | P | ||
| Fetal Imaging& Other | Abdominal | P | P | P | P | P | P | P | |
| Intra-operative (Spec.) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ (Spec.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | P | P | ||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (Wound) | |||||||||
| Other (Gynecological) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | ||
| Trans-esophageal (Adult/Pediatric) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | P | P | P | P | |
| Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Dopler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 10 of 17
{12}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: MXS2ESLL Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging of 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | Abdominal | |||||||
| & Other | Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Dopler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript g. For Adult and pediatric patients.
Subscript “h.” Includes imaging for Cavernous/Naso
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 11 of 17
{13}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: S121 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | P | P | P | P | |
| Fetal Imaging | Abdominal | P | P | P | P | P | P | P |
| & Other | Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | P | P | P | |
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P |
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 12 of 17
{14}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: S31 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging of fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation |
|---|---|
| ---------------------- | ------------------- |
| Clinical ApplicationMode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging& Other | Abdominal | P | P | P | P | P | P | P |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 13 of 17
{15}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: S3ESEL Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended use. Diagnostic ultrasound imaging of 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging& Other | Abdominal | |||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (Adult/Pediatric) | Pg | Pg | Pg | Pg | Pg | Pg | Pg | |
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication; P = previously cleared in K134016, K142368
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures)
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 14 of 17
{16}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: S42 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging& Other | Abdominal | P | P | P | P | P | P | P |
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | P | |
| Small Organ (Spec.) | ||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P |
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K134016
- Combination of each operating mode, B, M, PWD, CWD and Color Doppler. B/B, B/M, B/PW, CFM-B/CFM-M, CFM-B/PW ** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode
Additional Comments:
Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis). Subscript "a":
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 15 of 17
{17}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: UST-2265-2 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging of 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 | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging | Abdominal | |||||||
| & Other | Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| 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 (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac Adult | P | |||||||
| Cardiac | Cardiac Pediatric | P | ||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | ||||||
| Vessel | Other (spec.) |
N = new indication; P = previously cleared in K134016, K142368
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures). Subscript "b":
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
Subscript "g": For Adult and pediatric patients
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 16 of 17
{18}------------------------------------------------
Device Name: ALOKA LISENDO 880 Transducer: UST-2266-5 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
intended use. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
| Clinical Application | Mode of Operation |
|---|---|
| ---------------------- | ------------------- |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined*(Spe | Other**(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Spec.) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| 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 (Wound) | ||||||||
| Other (Gynecological) | ||||||||
| Cardiac | Cardiac Adult | P | ||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Adult/Pediatric) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | ||||||
| Other (spec.) |
N = new indication; P = previously cleared in K134016
** Power Doppler (Color Flow Angiography), Tissue Doppler Imaging, Free Angular M-mode, 3D Imaging
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amnocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, and penis.
Includes thyroid, parathyroid, breast, scrotum, penis, and imaging for guidance of biopsy. Subscript "d":
Subscript "e": Includes imaging for guidance of trans-rectal biopsy
Subscript "f": Includes imaging for guidance of trans-vaginal biopsy.
For Adult and pediatric patients Subscript "g":
Subscript "h" Includes imaging for Cavernous/Non-Cavernous wounds
Prescription Use Only (Per 21 CFR 801.109)
(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)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 17 of 17
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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.
21 CFR 807.92, Subsection a
1. Submitter's Information
Hitachi Aloka Medical America, Inc. 10 Fairfield Boulevard Wallingford, CT 06492-5903
On behalf of:
Hitachi, Ltd. Healthcare Business Unit 2-16-1, Higashi-Ueno, Taito-ku Tokyo 110-0015 JAPAN
Primary Contact Person: Angela Van Arsdale R.A. / O.A. Manager Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075
Date Prepared: September 9, 2016
- Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name - ALOKA LISENDO 880 Common name - Diagnostic Ultrasound System and Transducers Classification name - System, Imaging, Pulsed Doppler, Ultrasonic Classification: Class II 90-IYN 892.1550 Ultrasonic Pulsed Imaging System Product Code: 90-IYO 892.1560 Ultrasonic Pulsed Echo Imaging System 90-ITX 892.1570 Diagnostic Ultrasound Transducer
-
- Legally Marketed Predicate Device(s): ARIETTA70 (K134016)
-
- Device Description:
An ultrasound diagnostic system with the following features:
- Ultrasound transducer(s) to generate the transmitted ultrasound energy and detect the reflected echoes O
- Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
- O A computer system - to control the transducer and analyze the signals resulting from the reflected echoes
- A video monitor with optional image recorder to display the computed image or derived Doppler data O
-
- Indication for Use:
ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent. /Superfic.), Peripheral vessel, Cardiac Pediatric, Transesoph. (non-Card.), Trans-esophageal (card.), Adult Cephalic clinical applications.
The Modes of Operation are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
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predicate device:
| 6. Comparison to | |
|---|---|
| ------------------ | -- |
| SUBJECT DEVICE:ALOKA LISENDO 880 | PREDICATE DEVICE:ARIETTA 70 (K134016) | |
|---|---|---|
| INDICATION FOR USE | ALOKA LISENDO 880 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Spec.), Intra-operative (Spec.), Neonatal Cephalic, Musculo-skel. (Convent./Superfic.), Peripheral vessel, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (non-Card), Trans-esophageal (card), Adult Cephalic clinical applications. | The ARIETTA 70/ ARIETTA V70/ ARIETTA S70 is intended for use by trained personnel (doctor, songrapher, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endloscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications. |
| The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging. | The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography | |
| TRACK | 3 | 3 |
| PROBE TYPES | Convex, Linear, Sector and Other | Convex, Linear, Sector, 4D and Other |
| MODES | B, M, PW, CW and combinations of | B, M, PW, CW and combinations of |
| APPLICABLE SOFTWARE FEATURE COMPARISION | ||
|---|---|---|
| SUBJECT DEVICE:ALOKA LISENDO 880 | PREDICATE DEVICE:ARIETTA 70 (K134016) | |
| FEATURE: | YES | YES |
| PHYSIOLOGICAL SIGNAL DISPLAY | YES | YES |
| DICOM | YES | YES |
| DICOM SR | YES | YES |
| DICOM QR | YES | YES |
| PICTURE IN PICTURE | YES | YES |
| FREEHAND 3D | YES | YES |
| REAL-TIME 3D | YES | YES |
| 3D STIC | YES | YES |
| AUTOMATED IMT MEASUREMENT | YES | YES |
| AUTOMATED NT MEASUREMENT | YES | YES |
| ET (ETRACKING / ECHO TRACKING | YES | YES |
| FMD (FLOW DILATION) | YES | YES |
| WI (WAVE INTENSITY) | YES | YES |
| EFV(EXTENDED FIELD OF VIEW) | YES | YES |
| STRESS ECHO | YES | YES |
| HI REZ / AIP | YES | YES |
| EyeballEF | YES | YES |
| DSD (DYNAMIC SLOW MOTION DISPLAY) | YES | YES |
| CHI/CHE | YES | YES |
| MARKING ASSIST DISPLAY | YES | YES |
| REAL-TIME DOPPLER AUTO TRACE | YES | YES |
| SPATIAL COMPOUND | YES | YES |
| FAM (FREE ANGULAR M-MODE) | YES | YES |
| MEASUREMENT FUNCTION | YES | YES |
| DUAL DOPPLER | YES | YES |
| TRAPEZOID | YES | YES |
| TDI | YES | YES |
COLOR FLOW
YES
APPLICABLE SOFTWARE FEATURE COMPARISION
YES
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21 CFR Part 807.92, Section b
-
- Non-clinical Testing
No new hazards were identified with 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
-
- Clinical testing:
None required
- Clinical testing:
-
- Conclusions:
The ALOKA LISENDO 880 Diagnostic Ultrasound scanner is substantially equivalent in safety and effectiveness to the predicate device:
- Conclusions:
-
. The subject and predicate device are both indicated for diagnostic ultrasound imaging and fluid flow analysis.
-
The subject and predicate device(s) have the same gray 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.
-
트 The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
-
. The subject 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.
-
. The subject and predicate device(s) systems have connectable probes that are designed to be re-usable and provide instructions for cleaning, disinfection, and sterilization in the Ultrasound system and transducer manuals.
END OF SUMMARY
§ 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.