(69 days)
Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows:
- Fetal-OB/GYN
- Abdominal
- Small Organs (breast, thyroid, testicle)
- Trans-Vaqinal
- Trans-Rectal
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- First, second and third trimester pregnancy studies.
- Prostate, bladder and rectum visualization.
The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M. The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.
The provided 510(k) summary for the Sounmed SD-2000 Plus Portable Ultrasound scanner indicates that clinical tests were "Not Required" for this device. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its performance in clinical use.
The document states that the conclusion drawn from testing is that the device "is as safe, as effective as well as the legally marketed predicate devices." This implies that the acceptance criteria are met through substantial equivalence to a predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) rather than new clinical performance data.
However, based on the information provided, here's a breakdown of what can be inferred about the acceptance criteria and the "study" that supports the device's clearance:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical studies were not required and no specific performance metrics beyond "safe and effective" equivalence are reported from patient data, a direct table of quantitative acceptance criteria and device performance is not available in the provided text.
The "acceptance criteria" in this context are primarily qualitative and based on demonstrating that the new device shares similar technological characteristics, intended uses, and safety standards with a legally marketed predicate device, thereby inferring similar performance.
Implicit Acceptance Criteria (based on substantial equivalence):
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Safety | The device is designed, manufactured, and operates in a manner that does not pose undue risk to patients or users. Conforms to relevant safety standards (e.g., EN60601-1, ISO 14971). | "The device is as safe... as the legally marketed predicate devices." Conforms to listed safety standards. |
| Effectiveness | The device is capable of performing its intended diagnostic ultrasound imaging and fluid flow analysis functions as described in its indications for use, without significant differences in imaging quality or diagnostic capability compared to the predicate device. Conforms to relevant performance standards (e.g., EN61157 for acoustic output, functional similarity to predicate). | "The device is as... effective as the legally marketed predicate devices." Operating modes and supported probes are comparable to predicate. |
| Intended Use | The clinical applications for which the device is indicated are consistent with those of the predicate device or a subset thereof. | Intended uses (Fetal-OB/GYN, Abdominal, Small Organs, Trans-Vaginal, Trans-Rectal) are listed, similar to predicate. |
| Technological Equivalence | The fundamental technological characteristics (e.g., piezoelectric material, operation modes, imaging principles) are substantially similar to the predicate device. | "operates identical to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body." |
| Quality System | Device manufacturing meets established quality management system standards (e.g., ISO 13485:2003, ISO 9001:2000). | Conforms to ISO 13485:2003 and ISO 9001:2000. |
| Electromagnetic Compatibility | The device meets electromagnetic compatibility requirements (e.g., EN60601-1-2). | Conforms to EN60601-1-2. |
| Acoustic Output | The device's acoustic output falls within safe and declared limits. | Compliance with EN61157, with a post-clearance special report required for production line devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set data from human subjects is mentioned for performance evaluation.
- Data Provenance: Not applicable. The "study" relied on technical comparisons and adherence to standards, not patient data in the context of a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Since no clinical test set was required, there was no ground truth establishment by experts for such a set described in this document.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was utilized.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Tests: Not Required".
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an ultrasound system and transducers, which are hardware components for imaging. The concept of "standalone algorithm performance" is not relevant here as there's no mention of an embedded AI algorithm being evaluated separately. The clearance is for the imaging system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is effectively the predicate device's established safety and effectiveness, and compliance with international and national standards for medical electrical equipment and diagnostic ultrasound. The FDA's determination of "substantial equivalence" serves as the validation.
8. The sample size for the training set
- Not applicable. This document describes the clearance of an ultrasound imaging system, not an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML algorithm is mentioned.
In summary, the "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to a legally marketed predicate device (SonoAce 600 Diagnostic Ultrasound System, K000030) and adherence to a list of relevant safety and performance standards. No human clinical trial data or performance metrics from a test set were required or presented in this 510(k) summary.
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510(K) Summary
JUL - 3 2007
This summary of 510(k) safety and effectives information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ Ko71156
Submitter / Distributor:
Sounmed, Inc. 6800 N.W. 77th Court Miami, FI 33166 Establishment Registration # 3004483577
Telephone: 305-477-0986 Fax: 305-477-5351
-
Contact Person: .
Jhoana Lores Email: jhoana@sounmed.com -
Manufacturer: .
Xuzhou Kaixin Electronic Instrument Co., LTD Kaixin Mansion C-01, Economic Development Zone 221004 Xuzhou, Jiangsu REPUBLIC OF CHINA -
Date Prepared: .
April 20, 2007
Name of the device:
- Sounmed SD-2000 Plus Portable Ultrasound scanner Trade/Proprietary Name: . and Transducers.
- Ultrasonic Imaging Systems and Transducers. . Common Name:
- . Classification:
Regulatory Class: II
FR Number Product Code 90-IYO 892.1560 Ultrasonic pulsed echo imaging system Diagnostic ultrasonic transducer 892.1570 90-ITX
Legally Marketed Predicate Device:
SonoAce 600 Diagnostic Ultrasound System. K000030
{1}------------------------------------------------
Device Description:
The Sounmed SD-2000 Plus (KX2000G) is a black and white mobile diagnostic ultrasound imaging system. This device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. Operating Modes of SD-2000 Plus (KX2000G) are B, B/B, B/M, and M .
The Sounmed SD-2000 Plus (KX2000G) supports a selection of Linear and Convex probes for wide variety of application. It is an ultrasound scanner, which provides high resolution, high penetration, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz.
All transducers used with SD the SD-2000 Plus ultrasonic diagnostic imaging system are track 1
Statement of Intended Use:
- . Fetal-OB/GYN
- . Abdominal
- . Small Organs (breast, thyroid, testicle)
- Trans-Vaqinal .
- . Trans-Rectal
Typical examinations performed using the system are:
- . General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
- . Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- . First, second and third trimester pregnancy studies.
- . Prostate, bladder and rectum visualization.
Comparison of Technological Characteristics:
The Sounmed SD-2000 Plus (KX2000G) ultrasonic imaging system with added transducers operates identical to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images.
{2}------------------------------------------------
Applicable Standards:
The Sounmed SD-2000 Plus (KX2000G) Portable Ultrasound Device with added transducers conforms to the following standards:
EN60601-1, Medical electrical equipment. General requirements for safety
EN60601-1-2, Medical electrical equipment. General requirements for safety. Collateral standard. Electromagnetic compatibility.
EN60601-1-4, Medical electrical equipment. General requirements for safety. Collateral standard. General requirements for programmable electric.
EN60601-2-37, Medical electrical equipment. Particular requirements for the safety of ultrasonic diagnostic and monitoring equipment.
EN61157, Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
EN980, medical device labeling standard for CE mark compliance
ISO 14971, Medical devices - Application of risk management to medical devices
ISO 13485:2003, Medical devices - Quality management systems
ISO 9001:2000, Quality management systems
CE Mark 93/42/EEC
Clinical Tests:
Not Required
Conclusion:
The conclusions drawn from testing of the The Sounmed SD-2000 Plus (KX2000G) ultrasonic imaging system with added transducers demonstrates that the device is as safe, as effective as well as the legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2007
Ms. Jhoana Lores Regulatory Affairs Soundmed, Inc. 6800 NW 77th Court MIAMI FL 33166
Re: K071156
Trade Name: Soundmed SD-2000 Plus Portable Ultrasound Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: April 23, 2007 Received: April 26, 2007
Dear Ms. Lores:
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 Soundmed SD-2000 Plus Portable Ultrasound Scanner, as described in your premarket notification:
Transducer Model Number
3.5MHz Convex Array (3.5C60A2) 6.5MHz Endocavity (6.5C13B2) 7.5MHz Linear Array (7.5L40B2)
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
{4}------------------------------------------------
Page 2 - Ms. Lores
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 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 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 Andrew Kang at (240) 276-3666.
Sincerely yours,
Nancy C Brogdon
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}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number : Device Name :
Sounmed SD-2000 Plus Portable Ultrasound Scanner
Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: Intended Use:
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | ColorVelocityImaging | Combined(B-M) | Other(specify |
| Ophtalmic | |||||||||
| Fetal | N | N | N | ||||||
| Abdominal | N | N | N | ||||||
| Intraoperative (specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | N | N | N | Note 1 | |||||
| Neonatal Cephalic | N | N | N | ||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Trasesophageal | |||||||||
| Transrectal | N | N | N | ||||||
| Transvaginal | N | N | N | ||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | N | N | ||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | N | N | N | ||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Note 1: Small Organ: breast, thyroid, testes.
Additional Comments:
(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 Division of Reproductive. Abo and Radiological Devices 510(k) Number
Page 1 of 4
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Diagnostic Ultrasound Indications for Use Form 07115
510(k) Number : Device Name : Transducer:
Sounmed SD-2000 Plus Portable Ultrasound scanner 3.5Mhz Convex Array Probe Model : 3.5C60A2
ర
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ABMPWDCWDColor DopplerColor Velocity ImagingCombined (B - M)Other (specify)OphtalmicFetalNNNAbdominalNNNIntraoperative (specify)IntraoperativeNeurologicalPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicCardiacTrasesophagealTransrectalTransvaginalTransurethralIntravascularPeripheral VascularLaparoscopicMusculo-skeletalConventionalMusculo-skeletalSuperficialOther (specify) | A | B | M | PWD | CWD | Color Doppler | Color Velocity Imaging | Combined (B - M) | Other (specify) | Ophtalmic | Fetal | N | N | N | Abdominal | N | N | N | Intraoperative (specify) | Intraoperative | Neurological | Pediatric | Small Organ (specify) | Neonatal Cephalic | Adult Cephalic | Cardiac | Trasesophageal | Transrectal | Transvaginal | Transurethral | Intravascular | Peripheral Vascular | Laparoscopic | Musculo-skeletal | Conventional | Musculo-skeletal | Superficial | Other (specify) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| A | B | M | PWD | CWD | Color Doppler | Color Velocity Imaging | Combined (B - M) | Other (specify) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ophtalmic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fetal | N | N | N | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abdominal | N | N | N | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intraoperative (specify) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intraoperative | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Neurological | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pediatric | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Small Organ (specify) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Neonatal Cephalic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Adult Cephalic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cardiac | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Trasesophageal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Transrectal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Transvaginal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Transurethral | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Intravascular | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Peripheral Vascular | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Laparoscopic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Musculo-skeletal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Conventional | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Musculo-skeletal | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Superficial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(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, Abdom and Radiological Devices 510(k) Number _
Page 2 of 4
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number : Device Name : Transducer:
07115 6 Sounmed SD-2000 Plus Portable Ultrasound scanner 6.5 Mhz Endocavity Probe model: 6.5C13B2
| Intended Use: | Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | ColorVelocityImaging | Combined(B + M) | Other(specify |
| Ophtalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Trasesophageal | |||||||||
| Transrectal | N | N | N | ||||||
| Transvaginal | N | N | N | ||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | |||||||||
| Conventional | |||||||||
| Musculo-skeletal | |||||||||
| Superficial | |||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(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 __
{8}------------------------------------------------
510(k) Number : Device Name : Transducer:
Diagnostic Ultrasound Indications for Use Form unmed SD-2000 Plus Portable Ultrasound scanner
| 7.5Mhz Linear Array Probe Model: | 7.5L40B2 |
|---|---|
| ---------------------------------- | ---------- |
| Intended Use: | Diagnostic ultrasound imaging or fluid flowd analyisis of the human body as follows: |
|---|---|
| --------------- | -------------------------------------------------------------------------------------- |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Color Velocity Imaging | Combined (B + M) | Other (specify) | |
| Ophtalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative (specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | N | N | N | ||||||
| Neonatal Cephalic | N | N | N | ||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Trasesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | N | N | Note 1 | |||||
| Laparoscopic | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Note 1: Small Organ: breast, thyroid, testes.
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Page 4 of 4
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.