(203 days)
The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels
The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.
The provided text is a Safety and Effectiveness Summary for an ultrasound transducer, outlining its features and comparing it to a predicate device for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot fulfill the request.
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Safety and Effectiveness Summary LP13 Laparoscopic Diagnostic Ultrasound Transduce Biosound, Inc.
MAR - 1
Safety and Effectiveness Sumr
The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR ¶807.92(a).
807.92(a)(1)
Submitter Information
Wayne Nethercutt Director, Regulatory Affairs 7990 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1793
Facsimile: (317) 841-8616
Contact Person: Wayne Nethercutt
Date: 08-09-95
807.92(a)(2)
Trade Name: LP13 Laparoscopic Transducer
Common Name: Diagnostic Ultrasound Transducers
Classification Name(s): Transducer, Ultrasonic, Diagnostic
892.1570
807.92(a)(3)
Predicate Device(s)
- Aloka UST 5522 7.5 Transducer K925486 .
Biosound, Inc. · An Esante Company 7990 Castleway Drive - Indianapolis, IN 46250 1 317 - 849 1793 > 800 - 428 4374 > FAX 317 - 841-8616
Image /page/0/Picture/19 description: The image shows a document with the word "RECEIVED" stamped on it. Below the word "RECEIVED", the date "11 AUG 85 0322" is stamped. The text "FDA/CDRH/ODE/DHG" is printed on the bottom left corner of the document.
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Safety and Effectiveness Summary LP13 Laparoscopic Diagnostic Ultrasound Transducer Biosound, Inc.
K 953759
P. 2d3
807.92(a)(4)
Device Description
The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.
Specifications
| Intended use | Abdominal, Laparoscopic | |
|---|---|---|
| Operating Modes | B, M, PW, CFM | |
| Operating Frequencies | ||
| B - Mode | 7.5 - 10.0 Mhz | |
| M - Mode | 7.5 - 10.0 Mhz | |
| PW- Mode | 3.5, 4.7 - 7.0 Mhz | |
| CFM - | 3.5, 4.7 - 7.0 Mhz | |
| Movement Range of Transducer | +/- 90° | |
| Cable Length | 3 Meters | |
| Operating Temperature | +5 to +35 C° | |
| Storing Temperature | -5 to +45 C° | |
| Weight | 0.3 Kg | |
| Safety Standard | IEC 601-1 (CEI 62-5) |
The materials comprising the transducer are the same as those described and accepted in K941935. The materials are listed here again for reference:
-
PVC from Putnum Plastics
-
Ultem from General Electric Plastics
-
FDA TRA-Bond Epoxy
Sterilization
Sterilization can be accomplished in the same way as described in K941935 for the LP12 transducer, with Cidex™ solution. Cidex™ solution was cleared by the FDA under K924434. The procedure is described in the operator's manual.
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K953759
P-343
Safety and Effectiveness Summary LP13 Laparoscopic Diagnostic Ultrasound Transducer Biosound, Inc. 807.92(a)(5)
Intended Use(s)
The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels
807.92(a)(6)
Substantial Equivalence
| Characteristic | Esaote LP13 | AlokaUST5522K925486 |
|---|---|---|
| Intended Use | AbdominalLaparoscopic | AbdominalLaparoscopic |
| Technology | Linear Array | LinearArray |
| Operating Modes | B, PW, M, CFM | B, PW, M |
| Diameter | 9.5 mm | 10.0 mm |
| Moveable Transducer | Yes | No |
| Frequencies | 7.5 - 10.0 Mhz | 7.5 Mhz |
| Safety Standard | IEC 601-1 | IEC 601-1 |
Substantial Equivalence Comparison Table
The table above illustrates the equivalence of the compared devices. The LP13 offers and additional mode which enhances its clinical utility. A moveable transducer allows the operator to achieve the best image by achieving an optimum imaging position, a feature not offered by the Aloka device. Based on the about comparison and in light of the minor differences noted, we believe the devices compared above are substantially equivalent
§ 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.