(137 days)
No
The device description focuses on electromechanical and ultrasonic principles for stone fragmentation and aspiration, with no mention of AI, ML, or related concepts.
Yes
The device is described as a "dual probe lithotripter" intended for the "fragmentation of urinary tract calculi". Lithotripsy is a medical procedure used to break up kidney stones, which is a therapeutic intervention.
No
The device is intended for the fragmentation of urinary tract calculi, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is an "electromechanical device" with a hand piece, ultrasonic transducer, and probes, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fragmentation of urinary tract calculi in the kidney, ureter and bladder." This describes a therapeutic procedure performed directly on the patient's body to break up stones.
- Device Description: The device description details an electromechanical system that uses ultrasonic waves to fragment and aspirate calculi. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on a sample.
The Cyberwand Dual Probe Lithotripter is a therapeutic medical device used for the treatment of kidney stones.
N/A
Intended Use / Indications for Use
The Cybersonics, Cyberwand Dual Probe Lithotripter is intended to be used for the percutaneous fragmentation and removal of kidney stones.
The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.
Product codes (comma separated list FDA assigned to the subject device)
FFK
Device Description
The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, ureter and bladder
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)
Substantial equivalence has also been demonstrated by stone fragmentation data that the Cybersonics, Cyberwand Dual Probe Lithotripter results in fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against predicate ultrasound lithotripters.
Drill Rate Comparisons (Drill rate data supplied by Indiana University School of Medicine):
- Cyberwand: 10 stones treated, Drill Rate in Seconds (Mean +/- SD) 8.7 +/- 0.9
- Litho Clast Ultra: 10 stones treated, Drill Rate in Seconds (Mean +/- SD) 10.9 +/- 1.0
- Olympus LUS-2: 25 stones treated, Drill Rate in Seconds (Mean +/- SD) 28.8 +/- 2.7
- Circon-ACMI USL-2000: 25 stones treated, Drill Rate in Seconds (Mean +/- SD) 31.7 +/- 8.1
- Karl Storz Calcuson: 15 stones treated, Drill Rate in Seconds (Mean +/- SD) 40.3 +/- 8.1
- Olympus LUS-1: 12 stones treated, Drill Rate in Seconds (Mean +/- SD) 60.5 +/- 13.5
- Richard Wolf Model 2271-004: 10 stones treated, Drill Rate in Seconds (Mean +/- SD) 103.7 +/- 21.6
Key results show that the Cyberwand has a lower drill rate (faster fragmentation) compared to the predicate and other reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
0
Image /page/0/Picture/1 description: The image shows the word "CYBERSONICS" in a simple, sans-serif font. To the left of the word is a stylized graphic, possibly a logo, that resembles a curved line or a letter. The text and graphic are in black and stand out against a white background.
DEC 2 0 2005
510(k) Summary per 807.92(c) for Cybersonics, Inc.
CYBERWAND DUAL PROBE LITHOTRIPTER
SPONSOR
CYBERSONICS, INC.
5368 Kuhl Road Erie, Pennsylvania 16510-4703 USA Phone: 814-899-4220 Fax: 814-899-1410 Contact Person: William A. Stoll Date Prepared: August 01, 2005
DEVICE NAME
Trade/Proprictary Name: Cybersonics, Cyberwand Dual Probe Lithotripter Common/Usual Name: Intracorporeal ultrasonic lithotripter Classification Name: Lithotripter, Ultrasonic Class: 11 (876.4480) 78 FFK
DEVICE EQUIVALENCE
Substantially equivalent to the legally marketed EMS Swiss Lithoclast Ultra.
DEVICE DESCRIPTION
The Cybersonics, Cyberwand Dual Probe Ultrasonic Lithotripsy system is an electromechanical device capable of fragmenting and aspirating calculi. The hand piece consists of an ultrasonic transducer containing the piezo-electronic elements, which are driven by a generator operating at 21 ± 1 kHz. The resulting longitudinal waves are propagated along the ultrasonic dual probe to the target stone. The ultrasonic transducer probes are hollow, permitting simultaneous suction.
INTENDED USE
The Cybersonics, Cyberwand Dual Probe Lithotripter is intended to be used for the percutaneous fragmentation and removal of kidney stones.
1
BASIS FOR SUBSTANTIAL EQUIVALENCE
Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the Electro Medical Systems SA Swiss LithoClast Ultra (K012445), and Karl Storz Electro Medical Systems oripter (K973251) which have been cleared for the Calcuson Oftrasonic Ention por (emoval of kidney stones. Information on these perculancous fragmentation and removal of this submission. The Cyberwand Dual Probe systems can be found in section 11 or this succifications as compared with the predicate devices. Substantial equivalence has also been demonstrated by stone predicate devices. Duostantal equivalention of that the Cybersonics, Cyberwand Dual Probe Lithotripter results in fragmentation of a variety of standard artificial stone I 1000 Enthoulpter results in 1988
materials (ranging from soft to hard) when tested against predicate ultrasound lithotripters.
| | Storz
Calcuson | Olympus
LUS-2 | EMS
LithoClast
Ultra | Cybersonics
Cyberwand |
|----------------------------------------------|-------------------|------------------|----------------------------|--------------------------|
| Comparison of Technological Characteristics | | | | |
| Operating
Frequency | 25--26kHz | 23.5kHz | 24--26kHz | 20--22kHz |
| Utilities | 120--240 Vac | 120--240 Vac | 120--240 Vac | 120--240Vac |
| Autoclavable
probes and hand
piece | Yes | Yes | Yes | Yes |
| Probes threaded
for assembly | Yes | Yes | Yes | Yes |
| Probe length
( standard ) | 400 mm | 400 mm | 400 mm | 400 mm |
| Probe OD ≤
3.75mm | Yes | Yes | Yes | Yes |
| Ultrasonic Probe
tip excursion
≤100 µm | Yes | Yes | Yes | Yes |
| Detachable hand
piece | Yes | Yes | Yes | Yes |
| Handpiece with
rear suction
connection | Yes | Yes | Yes | Yes |
| Piezo stack with
Titanium horn | Yes | Yes | Yes | Yes |
| Detachable
footswitch | Yes | Yes | Yes | Yes |
| Table Top
Generator | Yes | Yes | Yes | Yes |
| Applied Part BF | Yes | Yes | Yes | Yes |
5368 Kuhl Road • Erie, Pennsylvania 16510-4703 • TEL (814) 899-4220 • FAX (814) 899-1410
2
| Drill Rate Comparisons
| Drill rate data supplied by Indiana University School of Medicine | |||||
|---|---|---|---|---|---|
| Instrument | Stones Treated | Drill Rate in Seconds | |||
| (Mean +/- SD) | |||||
| Cyberwand | 10 | 8.7 +/- 0.9 | |||
| Litho Clast Ultra | 10 | 10.9 +/- 1.0 | |||
| Olympus LUS-2 | 25 | 28.8 +/- 2.7 | |||
| Circon-ACMI USL-2000 | 25 | 31.7 +/- 8.1 | |||
| Karl Storz Calcuson | 15 | 40.3 +/- 8.1 | |||
| Olympus LUS-1 | 12 | 60.5 +/- 13.5 | |||
| Richard Wolf Model 2271-004 | 10 | 103.7 +/- 21.6 |
CONCLUSION
Cybersonics Cyberwand Dual Probe Lithotripter is substantially equivalent to the legally Cybersonics Cyberwand Daal Proov wand is as safe, as effective and performs as well or better than the predicate devices.
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "Department of Health & Human Services" around the edge. Inside the circle is a stylized image of a bird or other winged creature. The image is in black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2005
Mr. William A. Stoll Manager of Quality Assurance & Regulatory Affairs Cybersonics, Inc. 5368 Kuhl Road ERIE PA 16510
Re: K052135
Trade/Device Name: Cyberwand Dual Probe Lithotripter Regulation Number: 21 CFR §876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: November 29, 2005 Received: November 30, 2005
Dear Mr. Stoll
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your socurer 5 retty prehentially equivalent (for the indications for use stated in above and nave decomments ad predicate devices marketed in interstate commerce prior to the enclosure) to tegany manectod production of the Medical Devices that have been May 20, 1770, the chanance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accordation while pro noval application (PMA). You may, therefore, market the do not require approval of a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general volual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (300 as 10) hitting major regulations affecting your Approval), it thay of subject to secured Regulations, Title 21, Parts 800 to 898. In addition, FDA uevice can be round in the concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advisou mai 1 DA s 135dailed of a see complies with other requirements of the Act of the Act of the FDA has made a decemination mad your as router Federal agencies. You must comply with all the Federal statues and regulations administration and listing (21 CFR Part 807); labeling Act s requirements, metading but hot minted to reguirements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 5 I (k) This letter will allow you lo begin matketing your actives of your device of your device of your device to a legally
premarket notification. The FDA finding of substantial e premarket notification. The IDA finding of substantial equildine of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring regulation () ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general intonnation on your respections and its toll-free number (800) Division of Binan National of Street address 056-2041 of (2019/01/2019/2017/industry/support/index.html.
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
5
Indications for Use
510(k) Number (if known): K052135
Device Name: Cybersonics – Cyberwand Dual Probe Lithotripter
Indications for Use:
The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary The Cyberwand Daily and bladder.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jennie A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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(Posted November 13, 2003)