(15 days)
K002929, P840008 / S65
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses solely on the intended use for stone fragmentation.
Yes
The device is indicated for fragmentation of urinary tract stones, which is a therapeutic intervention aimed at treating a medical condition.
No
The provided text for "Intended Use / Indications for Use" states that the device is "indicated for fragmentation of urinary tract stones," which is a treatment, not a diagnosis.
No
The device is a lithotripter, which is a hardware device used for fragmenting stones. The 510(k) summary describes a physical medical device, not a software-only one.
No, the Dornier Lithotripter 140 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Dornier Lithotripter 140 is used to treat a condition within the body. Its intended use is the fragmentation of urinary tract stones inside the patient.
The device description and intended use clearly indicate it's a therapeutic device used directly on the patient, not a diagnostic device used on samples.
N/A
Intended Use / Indications for Use
The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.
Product codes
78 LNS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (renal calyceal, renal pelvic, upper ureteral)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K002929, P840008 / S65
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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JUN 2 2 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medical Systems, Inc.'s Dornier Lithotripter 140
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Dornier Lithotripter 140 ("Doli 140")is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following:) Dornier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier Medical Systems, Inc.
1155 Roberts Boulevard
| Kennesaw, GA 30144 | Phone: | 770-426-1315 |
|---|---|---|
| Facsimile: | 770-514-6288 | |
| Date Prepared: | June 5, 2001 | |
| Contact Person: Suzanne Courtney | Phone: | 770-514-6206 |
| Fax: | 770-514-6288 |
Name of Device and Name/Address of Sponsor
Dornier Lithotripter 140 ("Doli 140") Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
According to 21 CFR § 876.5990, FDA has classified extracorporeal shock wave lithotripters as Class II device with special controls. The Product Code for these lithotripters is 78 LNS..
Predicate Devices
Dornier Compact Alpha Lithotripter (K002929) Dornier Compact Delta Lithotripter (P840008 / S65)
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Intended Use
K011773
page 2 of 2
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The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices, Dornier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65).
Dornier Medical Systems, Inc. believes the minor differences of the Dornier Lithotripter 140 ("Doli 140") and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.
- This information was prepared for the sole purpose of compliance Advisory: with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2001
Ms. Suzanne Courtney Manager, Regulatory and Quality Affairs Dornier Medical Systems, Incorporated 1155 Roberts Boulevard KENNESAW GA 30144
Re: K011773 Dornier Lithotripter 140 ("Doli 140") Dated: June 5, 2001 Received: June 7, 2001 Regulatory Class: II 21 CFR §876.5990/Procode: 78 LNS
Dear Ms. Courtney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section 310(x) notherions of mich evelosure) to legally marketed predicate devices device is substantially equivality tot the mactions 16, 1976, the enactment date of the Medical Device Amendments, or to devices marketed in mierslate commeted provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will and provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general on pro research practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval) it may be subject If your device is classifica (so above nate viass affecting your device can be found in the Code of Federal Regulations, To Such additional controls. Existing major regulated determination assumes compliance with the Current Good Manufacturing ITIE ZT, Paris 800 0 693. A Subsianty of Trailent Georgianion (QS) for Medical Devices: General regulation (21 CFR Partic Practice requirements, as set four in the Quality Dread Nog Administration (FDA) will Verify such as anyances and 820) and that, timough periodic QS mspecions, the Programs, In addition, FDA may publish further announcements to comply will the Unit Togulation may road. In regencies to your premarket notification submission does not concerning your device in the rederal Register. I 1660 notes under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his letter will and would to begally marketed predicated predicate 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 and additionally 809.10 for in vitro II you desire specific advice tor your de radition of (301) 594-4639. 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" (21CFR 807.97). Other general information on your entified, "Misoraliung of telefice to premation "(Ereires of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours
Nancy C Brogdon
Nancy C. Brogdon
Brogdon Nancy C Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble a human figure.
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
Koi 1773
Device Name:
Dornier Lithotripter 140
Indications for Use:
The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract The Domic Laronplor Tron ( S. ) ( ) = ) = s, renal pelvic stones, and upper ureteral stones.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| or | |
| Over-the-Counter Use |
Qirrd a. Lygom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K011773