(20 days)
The Aplio XG System is intended to be used for the following types of studies: feta, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and muscoloskeletal (both conventional and superficial.
The Aplio XG Ultrasound System is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of 2 MHz to 12 MHz
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary for an ultrasound imaging system, detailing its features, intended use, and substantial equivalence to a predicate device, along with a list of compatible transducers and their cleared indications.
Therefore, I cannot extract the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- MRMC study details or effect size of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
{0}------------------------------------------------
Toshiba America Medical Systems, Inc.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K063130". The characters are written in a simple, slightly slanted style. The "K" is capitalized and the "0" is smaller and slightly raised. The remaining digits, "63130", are written in a consistent size and style.
510(k) Summary of Safety and Effectiveness (21 CFR 807.92)
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
|---|---|---|
| Address: | P.O. Box 2068,2441 Michelle DriveTustin, CA 92781-2068 | NOV - 2 2000 |
| Contact: | Paul Biggins, Senior Regulatory Affairs Manager | |
| Telephone No.: | (714) 730-5000 |
| Device Proprietary Name: | SSA-790A, Aplio™ XG Version 1.00 |
|---|---|
| Common Name: | Ultrasound Imaging System |
| Classification: | |
|---|---|
| Regulatory Class: | II |
| Review Category: | Tier II |
- Ultrasonic Pulsed Doppler Imaging System Product Code: 90-IYN . (21 CFR 892.1550)
- Ultrasonic Pulsed Echo Imaging System Product Code: 90-IYO . (21 CFR 892.1560)
- Diagnostic Ultrasonic Transducer Product Code: 90-ITX . (21 CFR No. 892 1570)
Identification of Predicate Devices:
Toshiba America Medical System believes that this device is substantially equivalent to the following device:
ToshibaSSA-770 Aplio Version 5.5 Diagnostic Ultrasound, K032281
Device Description:
The Aplio XG Ultrasound System is a mobile system. It is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of 2 MHz to 12 MHz
Intended Use:
The Aplio XG System is intended to be used for the following types of studies: feta, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and muscoloskeletal (both conventional and superficial.
Safety Considerations:
This device is designed and manufactured in conjunction with the Quality System Regulations IEC-60601 (applicable portions), and IEC 60601-1-2 (applicable portions, IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track Ultrasound Systems and the AIUM-NEMA UD3 Output Display Standard.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Toshiba Medical Systems Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313
NOV - 2 2006
Re: K063130
Trade Name: SSA-790A, Aplio™ XG Version 1.00 Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: October 10, 2006 Received: October 13, 2006
Dear Mr. Job:
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 SSA-790A, Aplio™ XG Version 1.00 System, as described in your premarket notification:
Transducer Model Numbers
PVT-375BT PVT-661VT PLT-1202S PC-20M PET-510MB PST-25BT PLT-604AT
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 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.
{2}------------------------------------------------
Page 2 - Mr. Mark Job
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 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ralph Schuping, Sc.D., at (240) 276- 3666.
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
Enclosures
{3}------------------------------------------------
System X_ Transducer________________________________________________________________________________________________________________________________________________________ Model_ SSA-790A 510(k) Number(s) 063130
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | N | N | N | N | ||||
| Abdominal | N | N | N | N | N | N | N | N | N | |||
| Intraoperative (Specify) | N | N | N | N | N | N | N | |||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | N | N | N | N | N | N | N | N | N | N | ||
| Small Organ (Specify)* | N | N | N | N | N | N | N | |||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | |||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | |||
| Cardiac | N | N | N | N | N | N | N | N | N | N | N | |
| Transesophageal | N | N | N | N | N | N | N | N | ||||
| Transrectal | N | N | N | N | N | N | N | N | ||||
| Transvaginal | N | N | N | N | N | N | N | N | ||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | |||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalSuperficial | N | N | N | N | N | N | N | |||||
| Musculo-skeletalConventional | N | N | N | N | N | N | N |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEV/2D; CHI/BDF; FEI/BDF
- : For example: thyroid, parathyroid, breast, scrotum and penis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES 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 Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________
11
{4}------------------------------------------------
062130
Transducer X System __ Model__PVT-375BT 510(k) Number(s)
Mode of Operation B THI M Color Power Dynamic TDI PW CW CHI CHI Combined Clinical Application Flow 2D (Specify) Doppler Dynamic Flow Ophthalmic P P P P P P Fetal P P P P P P P P P Abdominal P Intraoperative (Specify) Intraoperative Neurological P P P P P P Pediatric P P Small Organ (Specify)* Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral Vascular Laparoscopic Musculo-skeletal Superficial Musculo-skeletal Conventional
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Chozdon
(Division Sign Division of Reproductive and Radiological Devices 510(k) Number .
Diagnostic Ultrasound Indications For Use Form
{5}------------------------------------------------
Transducer X System _______________________________________________________________________________________________________________________________________________________________________ PVT-661VT Model_________________________________________________________________________________________________________________________________________________________________________ 510(k) Number(s) 063120
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) | |
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| IntraoperativeNeurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify)* | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | P | P | P | P | P | P | P | P | |||||
| Transvaginal | P | P | P | P | P | P | P | P | |||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | |||||||||||||
| Laparoscopic | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Superficial | |||||||||||||
| Musculo-skeletal | |||||||||||||
| Conventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF; FEVBDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hodgson
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number _
Diagnostic Ultrasound Indications For Use Form
{6}------------------------------------------------
Transducer X System System Model___ PLT-1202S
510(k) Number(s)
Mode of Operation TDI PW B THI M Color Power Dynamic ('W CHI CHI Combined Clinical Application Doppler Flow 2D Dynamic (Specify) Flow Ophthalmic Fetal Abdominal Intraoperative (Specify) E E E E F E E Intraoperative Neurologica! Pediatric Small Organ (Specify)* E E E E E E E Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Transrectal Transvaginal Transurethral Intravascular Peripheral Vascular E E E E E E E Laparoscopic Musculo-skeletal E E E E భా শু E Superficial Musculo-skeletal E E E E כד E E Conventional
000 3
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. brygdon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices E ! Prs) Number _
Diagnostic Ultrasound Indications For Use Form
{7}------------------------------------------------
System _______________________________________________________________________________________________________________________________________________________________________ Transducer X Model_ PC-20M 510(k) Number(s)
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | |||||||||||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | |||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | P | |||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Conventional |
663130
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
anar (Division Sign-Off) Donsion of Reproductive, Abdominal, ··············································································································································································
" = (k) Number _______________________________________________________________________________________________________________________________________________________________
{8}------------------------------------------------
Transducer X System _ Model_ PET-510MB__ 510(k) Number(s)
K06 3130
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | Color Doppler | Power | Dynamic Flow | TDI | PW | CW | CHI 2D | CHI Dynamic Flow | Combined (Specify) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (Specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | ||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Musculo-skeletalConventional |
| N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF) |
|---|
| Additional Comments: Combined Modes: B/M; B/PWD; |
| BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; |
| CHI/2D; FEI/2D; CHI/BDF; FEI/BDF |
CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Hogdon
(Division Sign-Offy Cousion of Reproductive, Abdominal, ... . Tadınloğical Devices 5 1 0,k) Number ______________________________________________________________________________________________________________________________________________________________
{9}------------------------------------------------
3130
System _______________________________________________________________________________________________________________________________________________________________________ Transducer X PST-25BT_ Model_ 510(k) Number(s)
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | E | E | E | E | E | E | E | E | E | E | ||
| Intraoperative (Specify) | ||||||||||||
| Intraoperative | ||||||||||||
| Neurological | ||||||||||||
| Pediatric | E | E | E | E | E | E | E | E | E | E | ||
| Small Organ (Specify)* | ||||||||||||
| Neonatal Cephalic | E | E | E | E | E | E | E | E | E | E | ||
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | ||
| Cardiac | E | E | E | E | E | E | E | E | E | E | E | |
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletal | ||||||||||||
| Superficial | ||||||||||||
| Musculo-skeletalConventional |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEVBDF; FEVBDF
Letter to file against K041499
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDE!D) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off) Firelon of Reproductive, anningical Devices - Copy Number ________________________________________________________________________________________________________________________________________________________________
{10}------------------------------------------------
Transducer_X System _ PLT-604AT Model 510(k) Number(s)
Kole3130
| Mode of Operation | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | THI | M | ColorDoppler | Power | DynamicFlow | TDI | PW | CW | CHI2D | CHIDynamicFlow | Combined(Specify) | |
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | |||||||||||||
| Intraoperative (Specify) | |||||||||||||
| IntraoperativeNeurological | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify)* | P | P | P | P | P | P | P | P | |||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Cardiac | |||||||||||||
| Transesophageal | |||||||||||||
| Transrectal | |||||||||||||
| Transvaginal | |||||||||||||
| Transurethral | |||||||||||||
| Intravascular | |||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||||
| Laparoscopic | |||||||||||||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P | P | |||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P | P |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD; CHI/2D; FEI/2D; CHI/BDF; FEI/BDF; FEI/BDF
510(k) for this transducer K041499
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGES IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C Broadon
(Division Sign-Off) Asion of Reproductive, A lon only of Devices ു Number ----
§ 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.