(79 days)
K934915/S1
K934915/S1
No
The document describes a general-purpose ultrasound system cleared in 1994 and its transducer, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "general purpose diagnostic ultrasound system" used for providing "diagnostically useful images" and "detecting normal and abnormal conditions," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device is "capable of providing diagnostically useful images" and that the images are "useful to physicians in detecting normal and abnormal conditions." Additionally, the "Device Description" explicitly calls it a "general purpose diagnostic ultrasound system."
No
The device description explicitly states that it consists of a transducer, electronic and mechanical hardware, software controls, and digital components comprising the ultrasound system console. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a diagnostic ultrasound system that provides images of anatomy and pathology within the human body. It uses ultrasonic pulsed echo imaging to visualize internal structures.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. It directly images structures within the body.
Therefore, the L7 when used with the Aspen ultrasound system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The L7 when used with Aspen ultrasound system is capable of providing diagnostically useful images of anatomy and pathology in the major bone, joint, and muscle groups of the human body. Specific anatomy and pathology in the neck, shoulders, arms, elbows, wrist, hand, hips and pelvis, legs, knees, ankles and feet can be imaged. The images obtained depict anatomical structures and regions of increased and reduced blood flow which are useful to physicians in detecting normal and abnormal conditions in these regions of the body.
Product codes
90 IYN, 90 ITX
Device Description
The Aspen model ultrasound system and L7 transducer is a general purpose diagnostic ultrasound system that received marketing clearance via 510(k) K934915/S1 on October 21, 1994. For the musculoskeletal indication for use described above, the device consists of the L7, a 128 element, 3-10 Mhz broadband, 38 mm flat linear array transducer and electronic and mechanical hardware, software controls, and digital components comprising the ultrasound system console.
The maximum acoustic outputs for any musculoskeletal L7 operating mode are I sera 3 = 86 mW/cm2 and I spp.3 = 124 W/cm2. The L7 may be used for musculoskeletal imaging in the following operating modes: B mode, M mode. Color Doppler mode, and Pulsed Wave Doppler mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed echo imaging system
Anatomical Site
major bone, joint, and muscle groups of the human body. neck, shoulders, arms, elbows, wrist, hand, hips and pelvis, legs, knees, ankles and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were conducted to verify system performance in all imaging modes. Clinical data was submitted to the Food and Drug Administration as part of our 510(k) notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K934915/S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
I. GENERAL INFORMATION
NOV - 5 19
K973079
Ultrasonic pulsed echo imaging system and ultrasonic transducer Device generic name: Aspen ultrasound system and L7 transducer Device trade name: Acuson Corporation Applicants name: 1220 Charleston Road Mountain View, CA 94043 Unknown at this time 510(k) No .: August 15, 1997 Date of 510(k) submission:
II. INDICATIONS FOR USE
The L7 when used with Aspen ultrasound system is capable of providing diagnostically useful images of anatomy and pathology in the major bone, joint, and muscle groups of the human body. Specific anatomy and pathology in the neck, shoulders, arms, elbows, wrist, hand, hips and pelvis, legs, knees, ankles and feet can be imaged. The images obtained depict anatomical structures and regions of increased and reduced blood flow which are useful to physicians in detecting normal and abnormal conditions in these regions of the body.
III. DEVICE DESCRIPTION
The Aspen model ultrasound system and L7 transducer is a general purpose diagnostic ultrasound system that received marketing clearance via 510(k) K934915/S1 on October 21, 1994. For the musculoskeletal indication for use described above, the device consists of the L7, a 128 element, 3-10 Mhz broadband, 38 mm flat linear array transducer and electronic and mechanical hardware, software controls, and digital components comprising the ultrasound system console.
The maximum acoustic outputs for any musculoskeletal L7 operating mode are I sera 3 = 86 mW/cm2 and I spp.3 = 124 W/cm2. The L7 may be used for musculoskeletal imaging in the following operating modes: B mode, M mode. Color Doppler mode, and Pulsed Wave Doppler mode.
IV. WARNINGS AND PRECAUTIONS
The addition of the musculoskeletal indication for use did not result in the addition of new warnings or precautions to the user manuals.
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V. POTENTIAL ADVERSE EFFECTS
Addition of the musculoskeletal indication for use did not introduce any new potential hazards to Address of the Aspen/L7 system. Since the introduction of the Aspen system in October, 1996, no adverse health effects to the patient and user population have been confirmed.
VI. BIOCOMPATIBILITY
No material changes to the L7 were necessary to add the musculoskeletal indication for use. Biocompatibility data for all Acuson transducer materials contacting patients is on file.
VII. IMAGING PERFORMANCE
Clinical studies were conducted to verify system performance in all imaging modes. Clinical data was submitted to the Food and Drug Administration as part of our 510(k) notification.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1997
William E. Welch Regulatory Affairs Manager ACUSON Corp. 1220 Charleston Road P.O. Box 7393 Mountain View, CA 94039-7393 Re: K973079 ACUSON Model L7 Transducer for Model 2001 (Aspen) Ultrasound System Dated: October 20, 1997 Received: October 21, 1997 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1570/Procode: 90 ITX
a province of the considered to the
Dear Mr. Welch:
We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Model 2001 (Aspen) Ultrasound System, as described in your premarket notification:
Transducer Model Number
ACUSON Model L7
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." 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.
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Page 2 - Mr. William Welch
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Degen
illian Yin. Ph.D. 6 Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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ATTACHMENTAA ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Ultrasound Device Indications Statement
Ultrasound System: - Aspen
Transducer: L7
| Clinical
Applications | A | B | PWD | CWD | Color
Doppler | Power
(Ampl.)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------------------------|---|---|-----|-----|------------------|-----------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | x | x | x | x | x | x | | * | |
| Intra-operative
- abdominal
- cardiac | x | x | x | x | x | x | | * | |
| Intra-operative
Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ - Thyroid
- Breast
- Testicle | x | x | x | x | x | x | | * | |
| Neonatal Cephalic | x | x | x | x | x | x | | * | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | x | x | x | x | x | x | | * | |
| Trans-esophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Luminal | | | | | | | | | |
| Peripheral Vascular | x | x | x | x | x | x | | * | |
| Laparoscopic | | | | | | | | | |
| Musculo-Skeletal
Conventional | x | x | x | x | x | x | | * | |
| Musculo-Skeletal
Superficial | x | x | x | x | x | x | | * | |
| Other (Specify) | | | | | | | | | |
Additional Comments:
- Combinations: B+M, B+PWD, B+Color Doppler, B+PWD+Color Doppler, B+Power Doppler, B+PWD+Power Doppler,
Simid A. Syper
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973079
Prescription Use (Per 21 CFR 801.109)
Acuson Corporation