(12 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver/pancreas/gall-bladder/abdominal, gynecological, fetal, neonatal, cardiac), Pediatric, Small Organ (breast/testes/thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional. Mixed mode operation includes BM, BPWD, MCD, BICD/PWD, BICWD, BICWCWD.
The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 10 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-Alpha 10 diagnostic ultrasound system and its transducers were found substantially equivalent to the predicate device, the Aloka SSD-5500 (K032875). This determination is based on the devices functioning in the same manner, having similar technological characteristics, and being indicated for the same diagnostic ultrasound applications.
The acceptance criteria for the Aloka SSD-Alpha 10 are implicitly demonstrated by its substantial equivalence to the predicate device. This means that the new device must meet the same performance and safety standards as the predicate device. The general controls provisions of the Act, including annual registration, device listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration, also serve as acceptance criteria. Additionally, the device is required to comply with specific electrical, physical, and acoustic safety standards before distribution.
Here's a breakdown of the requested information, drawing from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Same function as Aloka SSD-5500 (predicate device K032875) | Functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. |
| Similar technological characteristics to Aloka SSD-5500 | Similar in technological characteristics to its predicate system: SSD-5500 (K032875). Uses the same technologies for imaging, Doppler functions, and signal processing. |
| Indicated for the same diagnostic ultrasound applications as Aloka SSD-5500 | Indicated for the same diagnostic ultrasound applications as Aloka's SSD-5500. A series of "Indications for Use" forms specifies the clinical applications and modes of operation, indicating "P" (previously cleared by FDA) for those matching the predicate. New indications are marked "N". |
| Same gray-scale and Doppler abilities as Aloka SSD-5500 | Has the same gray-scale and Doppler abilities as Aloka's ultrasound system SSD-5500. |
| Acoustic power output levels below maximum allowed by FDA | Acoustic power output levels are below the maximum levels allowed by the FDA. (Post-clearance special report required for production units). |
| Subject to same Quality Assurance systems as SSD-5500 | Subjected to the same Quality Assurance systems in development and production as other products including the SSD-5500. |
| Patient contact materials evaluated for safety via same standards/methods as predicate | Patient contact materials have been evaluated for safety via the same standards and methods as the predicate. These materials have been found to be safe for their intended uses. |
| Complies with electrical and physical safety standards (as predicate) | Complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-5500 (K032875). Also certifies compliance with NEMA-UD2:1992, AIUM 1994, IEC-60601-1 (2001-09 Class A), UL 2601-1, 2nd edition (1997) Part 1, 2nd edition including Amendments 1&2 and ISO 10993-1:1997. |
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 does not explicitly mention a "test set" in the context of clinical performance evaluation for acceptance criteria. The clearance is based on substantial equivalence to a predicate device, not on a new clinical study with a defined test set. The data provenance is因此not applicable in this type of submission.
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)
Not applicable, as no new clinical test set with ground truth established by experts is described in this substantial equivalence summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical test set requiring expert adjudication is described.
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
Not applicable. This submission is for a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm and thus no standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as the clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical evaluation requiring independent ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. This document is a 510(k) summary for a medical device (ultrasound system), not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
{0}------------------------------------------------
043196
Date: 10/21/04
NOV 3 0 2004
510(k) Summary: Aloka Model SSD- Alpha 10
This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-Alpha 10 diagnostic ultrasound system and transducers. The address is:
10 Fairfield Boulevard Wallingford, CT 06492 (203) 269-5088
The contact person is: Richard J. Cehovsky, RA/QA Coordinator
The proprietary name is the Aloka SSD-Alpha 10 diagnostic ultrasound system and transducers. The common name for this type of device is a diagnostic ultrasound system and transducers.
The item in this submission is covered under the following classification:
| 90 IYN | Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 |
|---|---|---|
| 90 ITX | Diagnostic Ultrasound Transducer | 21 CFR 892.1570 |
| 90 IYO | Ultrasonic Pulsed Echo Imaging System. | 21 CFR 892.1560 |
The above as stated in 21CFR, part 892.1570,1560 & 1550, has been classified as regulatory Class II.
The Aloka SSD- Alpha 10 and its transducers are substantially equivalent to its predicate; the Aloka SSD-5500 (K032875) and its transducers.
The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-Alpha 10 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-Alpha 10, like other Aloka marketed diagnostic ultrasound systems and transducers are indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-Alpha 10 diagnostic ultrasound system and transducers are similar in technological characteristics to its predicate system: SSD-5500 (K032875).
- The Aloka SSD-Alpha 10 is indicated for the same diagnostic ultrasound applications to Aloka's . ultrasound system: SSD-5500 (K032875).
- The Aloka SSD-Alpha 10 has the same gray-scale and Doppler abilities to Aloka's ultrasound . system as mentioned above.
{1}------------------------------------------------
510(k) Summary: Aloka Model SSD- Alpha 10
- . The SSD-Alpha 10 uses the same technologies for imaging, Doppler functions and signal processing as the following product currently marketed by Aloka : SSD-5500 (K032875).
- The SSD-Alpha 10 has the same method of use as the following product currently marketed by . Aloka: SSD-5500 (K032875).
- . The SSD-Alpha 10 acoustic power output levels are below the maximum levels allowed by the FDA.
- The SSD- Alpha 10 is subjected to the same Quality Assurance systems in development and . production as other products including the SSD-5500 (K032875) currently marketed by Aloka,
- . The patient contact materials used in the SSD-Alpha 10 have been evaluated for safety via the same standards and methods as the above mentioned product marketed by Aloka. These materials have been found to be safe for their intended uses,
- . The SSD-Alpha 10 complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-5500 (K032875).
- Aloka Co., Ltd. Certifies that the SSD-Alpha 10 complies with NEMA-UD2: 1992, AIUM 1994 . "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment", IEC-60601-1 (2001-09 Class A), UL 2601-1, 2nd edition (1997), Part 1, 2nd edition including Amendments 1&2 and ISO 10993-1:1997. All testing will be completed, prior to distribution, to meet the requirements of the standards listed above.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions, representing the department's mission of protecting the health of all Americans. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
· Aloka Co., Ltd. % Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K043196
Trade Name: Aloka Model SSD-Alpha 10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: November 17, 2004 Received: November 18, 2004
Dear Mr. Lehtonen:
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 Model SSD-Alpha 10 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| ASU-1010 |
|---|
| ASU-1012 |
UST-547 UST-675P
{3}------------------------------------------------
| UST-5293-5 | UST-9118 |
|---|---|
| UST-5411 | UST-9120 |
| UST-5412 | UST-9128 |
| UST-5543 | UST-9130 |
| UST-5712 | UST-52101 |
| UST-5713T | UST-52108 |
| UST-9115-5 |
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.
[f 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,
{4}------------------------------------------------
Page 2 - Mr. Lehtonen
《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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
4.3.1
Diagnostic Ultrasound Indications for Use Form SSD-Alpha 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 | N | N | N | N | N | See Below | ||||
| Abdominal | N | N | N | N | N | See Below | ||||
| Intraoperative (specify) | N | N | N | N | N | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | See Below | ||||
| 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 |
N= new indication; P= previously cleared by FDA; E= added under Appendix A
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, BICD/PWD, BICD/PWD
Applications: Small Parts-breast/tested thyroid, Intra-operative- liver/ pascreas/ gall-bladder/ abdominal, gyncological, fetal, noonala, cardiac.
(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
801.109)
Daniel A. Lynn
(Division Sign-Off) Division of Reproductive, Ab and 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | P | P | P | P | P | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | See Below | ||||
| 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, BPWD, M/CD, B/CD/PWD
Applications: Small Organ- breast,testes & thyroid, Intra-Operative- liver, pancrease & gall-bladder
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Lennon
(Division Sign-Off) Division of Reproductive, Abdominal, ana Padiological Devices 5 I (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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| 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, BIPWD, 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)
David br. Lyman
(Division Sign-Off) Division of Reproductive, Abdo and 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 | N | N | N | N | N | See Below | ||||
| Intraoperative (specify) | N | N | N | N | N | See Below | ||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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, BPWD, MCD, BCD/PWD
Applications: Abdominal, Gynecological, Fetal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
01.109)
David A. Sypm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __
{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 | N | N | N | N | N | See Below | ||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | N | N | N | N | 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/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 8017109)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{10}------------------------------------------------
.
Diagnostic Ultrasound Indications for Use Form UST- 5293-5
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) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | 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, BCD/CWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David An. Bergman
(Division Sign-Off) Division of Reproductive, Abdomina and 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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | N | N | N | N | N | See Below | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | See Below | ||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | See Below | ||||
| Musculo-skeletalSuperficial | ||||||||||
| Other |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD
Application: Small Parts: breasts, testes & thyroid
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
801.109)
Division Sign Off)
(Division Sign-Off) (Division of Reproductive, Abdomina and Radiological Devices 510/k) Number ________________________________________________________________________________________________________________________________________________________________
{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 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | N | N | N | N | N | See Below | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | See Below | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | 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/WD, M/CD, B/CD/PWD
Applications: Small Parts- breast, testes and thyroid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Kenyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{13}------------------------------------------------
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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| 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 B/M, B/PWD, M/CD, B/CD/PWD
Applications: Small Parts- breast, testes and thyroid.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, diciogical Devices ar : ్నా x: vumber ____________________________________________________________________________________________________________________________________________________________________
{14}------------------------------------------------
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) | |||||||||||
| Intraoperative Neurological | |||||||||||
| 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/WD, M/CD, B/CD/PWD
Applications: Small Parts- breast, testes and 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)
David R. Ingram
(Division Sign-Off)
Division Sign-Off)
A
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043196
28
{15}------------------------------------------------
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 | |||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | See Below | |||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | See Below | |||||
| 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
Applications: Small Parts- breast, testes and thyroid, 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)
David A. Sayre
(Division Sign-Off) Division of Reproductive, Abdomi anni finincical Devices 5 Van Number _________________________________________________________________________________________________________________________________________________________________
{16}------------------------------------------------
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 | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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, BRWD, MICD, BCDPWD
(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)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{17}------------------------------------------------
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) | |||||||||||
| Intraoperative Neurological | |||||||||||
| 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 |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode operation includes BM, BRWD, 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)
Daniel A. Seymour
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices ", "The Number________________________________________________________________________________________________________________________________________________________________
{18}------------------------------------------------
.
Diagnostic Ultrasound Indications for Use Form UST- 9120
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 | |||||
| Intraoperative Neurological | |||||||||||
| 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)
David A. Sayam
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devices and and completer - ----------
{19}------------------------------------------------
.
Diagnostic Ultrasound Indications for Use Form UST-9128
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 | P | P | P | P | P | See Below | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | See Below | ||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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, 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)
Daniel R. Leggmm
(Division Sign-Off) Division of Reproductive, Abdomi : 0 Opri
. The My Normaless
{20}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| 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, BPWD, M/CD, B/CD/PWD
Applications: Gynecological, Fetal , Abdominal (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)
David A. Pearson
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number .
{21}------------------------------------------------
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) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | 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, BICD/PWD, BICWD, BICWD, BICWCWD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Leggans
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _
{22}------------------------------------------------
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) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | See Below | ||||
| Adult Cephalic | P | P | P | P | P | P | See Below | ||||
| 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, B/CD/WD, B/CWD, B/CWD, B/CD/CWD Application: Neonatal
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Ingram
(Division Sign-Off) (Division of Reproductive, Abdo and Radiological Devices · Numher _____________________________________________________________________________________________________________________________________________________________________
§ 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.