(86 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses solely on the device's intended use as a lithotripter.
Yes
The device is indicated for the non-invasive disintegration of kidney and upper ureteral stones, which is a therapeutic intervention aimed at treating a medical condition.
No
The device, a lithotripter, is indicated for the disintegration of kidney and ureteral stones, which is a treatment/therapeutic function, not a diagnostic one.
No
The device is described as an "Extracorporeal Shock Wave Lithotripter," which is a type of medical device that uses physical shock waves to break up stones. This inherently involves hardware components to generate and deliver the shock waves, making it a hardware-based device, not software-only.
Based on the provided information, the Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter 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 the device is a "Lithotripter" used for the "non-invasive disintegration of kidney... and upper ureteral stones." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Indicators: The provided text does not mention any analysis of biological samples, detection of biomarkers, or any other activities typically associated with IVD devices.
Therefore, the Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the disintegration of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.
Product codes
78 LNS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
kidney (renal pelvis and renal calyceal) and upper ureteral
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)
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Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Genemed, Inc. c/o Mr. David Balzer Official Correspondent Bio Medical Technology, Inc 660 Main Street South #7 WOODBURY CT 06798
RE: K042427
Trade/Device Name: Genestone Exel (XL) Lithotripter Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shockwave Lithotripter Regulatory Class: II (special controls) Product Code: 78 LNS Dated: November 22, 2004 Received: November 24, 2004
Dear Mr. Balzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levicwed your bocurent be rest probably equivalent (for the indications for use stated in above and nave decemined at a levices marketed in interstate commerce prior to the closure) to tegally mantoled problem of the Medical Device Amendments, or to devices that have been May 20, 1770, the cillectified acto of the Federal Food, Drug, and Cosmetic Act (Act) that icclassified in acconcultion with approval application (PMA). You may, therefore, market the do not required on a premaines approvisions of the Act. The general controls provisions of the Act uevice, subject to the general controls, 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 classined (600 as ) additional controls. Existing major regulations affecting your Apploval), it thay be subject to same at Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round in ouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease oc advised mate 1 27 i istual your device complies with other requirements of the Act or any FDA has made a decemination and your as your as rederal agencies. You must comply with all the r colors statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, moduling, but not a more a morements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to oegin ubstantial equivalence of your device to a legally marketed nonicate device results in a classification for 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 spoolite ac ne of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on of folor to premained to promised 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.
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
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STATEMENT of INDICATIONS for USE
510(k) NUMBER (IF KNOWN): K042427
DEVICE NAME: Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter
INDICATIONS for USE:
The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in The Gellessons Exor (AD) Extraot Fidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.
(Please do not write under this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | Nancy C broydon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042427 |