(14 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo- skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The device is not indicated for ophthalmic applications.
The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display. This configuration will provide user enhancements and expanded use.
The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a medical device that received 510(k) clearance (K072285) for various diagnostic ultrasound imaging and fluid flow analysis applications in the human body. As per the provided documents, no specific acceptance criteria or a dedicated clinical study proving the device meets quantitative acceptance criteria were included in this 510(k) submission.
Instead, the submission states:
- "Clinical Tests: None Required. Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination."
- "Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-Alpha 7 Diagnostic Ultrasound System and its transducers is substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems."
This indicates that the clearance for the Aloka SSD-Alpha 7 was based on its substantial equivalence to a predicate device (Aloka SSD-Alpha 10 Diagnostic Ultrasound System K043196), not on a new clinical study demonstrating performance against specific acceptance criteria. The focus was on comparing technical characteristics, safety features, physical design, construction, materials, and intended uses to the predicate device.
Therefore, the following information cannot be provided from the given documents:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- If a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any test set.
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of available information regarding compliance and equivalence:
The device's clearance relies on:
- Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical and mechanical safety. These tests found the device to conform with applicable medical device safety standards.
- Substantial Equivalence: The device is considered technically comparable and substantially equivalent to the Aloka SSD-Alpha 10 (K043196) and other cleared Aloka systems. This substantial equivalence is the primary "proof" of its safety and effectiveness under the 510(k) pathway.
- Quality Systems: The design, development, and quality processes conform with 21 CFR 820, ISO 9001:2000, and ISO13485 quality systems.
- Post-clearance requirement: The FDA requested a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, referencing Appendix G of their "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This ensures ongoing compliance with approved acoustic output levels.
{0}------------------------------------------------
510(K) K072285
AUG 3 0 2007 510(k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92 Section a): Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 1. Submitter: Richard J. Cehovsky, RA/QA Coordinator, Contact Person: Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 Date Prepared: 07/11/2007 Aloka SSD-Alpha 7 Diagnostic Ultrasound System 2. Device Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550 , 90 IYN Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO 3. Marketed Device: Aloka SSD-Alpha 10 Diagnostic Ultrasound System K043196, (90-IYN, ITX, IYO) ( A device currently in commercial distribution) 4. Device Description: The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display. This configuration will provide user enhancements and expanded use. 5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo- skeletal Conventional, Urology (including prostate), Transesophageal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The device is not indicated for ophthalmic applications. 6.Comparison w/ Predicate Device: The Aloka SSD-Alpha 7 is technically comparable and substantially equivalent to The current Aloka Alpha 10-(K043196). It has the same technological characteristics, key safety and effectiveness features, physical design, construction, materials and has the same intended uses and basic operating modes as the predicate device. Section b): I. Non-clinical Tests: The 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 with applicable medical device safety standards. 2. Clinical Tests: None Required. Intended uses and other key features are consistent with traditional clinical 3. Conclusion: practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-Alpha 7 Diagnostic Ultrasound System and its transducers is substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
AUG 3 0 2007
Re: K072285
Trade/Device Name: Aloka SSD-Alpha 7 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: August 13, 2007 Received: August 16, 2007
Dear Mr. Borsai:
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-Alpha 7 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| TICT.52101 | |
|---|---|
| Tran1000------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
{2}------------------------------------------------
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.
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 (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
{3}------------------------------------------------
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
4.3.1
Diagnostic Ultrasound Indications for Use Form SSD-Alpha 7
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | N | N | N | N | N | See Below | |||||
| Abdominal | N | N | N | N | N | See Below | |||||
| Intraoperative (specify) | N | N | N | N | N | See Below | |||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | N | N | N | N | N | See Below | |||||
| Neonatal Cephalic | N | N | N | N | N | See Below | |||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | See Below | ||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | See Below | |||||
| Transvaginal | N | N | N | N | N | See Below | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | See Below | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | See Below | |||||
| Musculo-skeletalSuperficial | |||||||||||
| Other: Gynecological | N | N | N | N | N | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix A
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/WD, B/CD/CWD Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac. Intra-operative- Liver, pancreas & gall bladder
(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 801.189)
(CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
18
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{5}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | See Below | |||||
| Transvaginal | P | P | P | P | P | See Below | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM B/PWD, MCD, B/CD/PWD
(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. Broidon
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Al Radiological Devices 510(k) Number
{6}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | P | P | P | P | P | See Below | |||||
| Abdominal | P | P | P | 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-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other: Gynecological | P | P | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM B/PWD, MCD, B/CD/PWD
(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 a Radiological Devices 510(k) Number
{7}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | See Below | |||
| Transesophageale | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD,
(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 Radiological Devices 510(k) Number
{8}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| IntraoperativeNeurologicalPediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | See Below | ||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, BICDPWD, BICWD, BCD/CWD
(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 L. Brogdon
(Division Sign-Off) 0
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072285
{9}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | See Below | ||||
| Musculo-skeletalSuperficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments; Mixed mode operation includes BM B/PWD. M/CD, B/CD/PWD
Applications: Small Parts- Breast, testes & thyroid
(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 Sign-On)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{10}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal- | P | P | P | P | P | See Below | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other: Gynecological | P | P | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, B/WD, M/CD, B/CD/PWD
(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
24
Radiological Devices 510(k) Number
{11}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Opthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | |||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | See Below | |||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, B/WD, M/CD, B/CD/PWD
Application: Intra-operative- Liver, pancreas, & gall bladder
(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
$4072285
{12}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Modes of operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Opthalmic | ||||||||||
| Fetal | P | P | P | P | P | See Below | ||||
| Abdominal | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other: Gyneocological | P | P | P | P | P | See Below |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD
(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)
Nanon C. Boydon
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
{13}------------------------------------------------
Indications for Use
510(K) Number (if known): Device Name: Indications For Use:
Aloka SSD-Alpha 7
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular).
The Aloka SSD-Alpha 7 is not indicated for ophthalmic applications.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.