(27 days)
Not Found
No
The summary describes a traditional lithotripsy device with X-ray imaging and image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for the fragmentation of urinary tract stones, which is a therapeutic procedure.
Yes
The device description states that the Gemini 220 XP is designed for both "extracorporeal shock wave lithotripsy ('ESWL') and for diagnostic and therapeutic procedures usual in Urology." It also mentions "The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures," indicating its capability for imaging for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a basic unit, patient table, control desk, X-ray C-arm, therapy arm, shock wave source, and X-ray unit. While it includes software for image processing and control, it is fundamentally a hardware-based system.
Based on the provided information, the Gemini 220 XP is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the fragmentation of urinary tract stones. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a urological workstation designed for extracorporeal shock wave lithotripsy (ESWL) and other urological procedures. It involves generating shock waves and using X-ray imaging to target stones within the body.
- Nature of the Procedure: ESWL is a non-invasive medical procedure that uses external shock waves to break up stones inside the body. This is a treatment, not a diagnostic test performed on samples taken from the body.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Gemini 220 XP does not perform this function. It is a therapeutic device used for treating a medical condition within the patient's body.
N/A
Intended Use / Indications for Use
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal pelvic stones, and upper ureteral stones.
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Product codes (comma separated list FDA assigned to the subject device)
LNS
Device Description
The Gemini 220 XP is a modular urological work station designed for extracorporeal shock wave lithoripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.
The Gemini 220 XP is composed of the following modules:
- Basic Unit with integrated X-rav C-arm and Therapy Arm for Shockwave Treatment; .
- Patient Table: .
- Control Desk User Interface: and ●
The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures.
The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
The Gemini 220 XP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithoriosy and urological procedures. It is the same as in the predicate device.
Mentions image processing
The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
urinary tract, renal pelvic, upper ureteral, renal calyceal, kidney
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)
The company has complied with all of the requirements described in FDA 's Guidance for the Content of Premarket Notifications (510k's) for Extrucorporeal Shock Wave Lithoripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.
The device is in compliance with the following standards:
- IEC 60601-1:2007 Electrical safety of medical devices
- IEC60601-1-2:2007 Electromagnetic compatibility
- IEC 60601-1-3:2008 Radiation protection
- IEC 60601-1-6:2008 Usability
- IEC 60601-2-7 Safety of high-voltage generators of diagnostic X-ray generator
- IEC 60601-2-28 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
- IEC 60601-2-36:1997 Extracorporeally induced Lithotripsy
- IEC 60601-2-32:1995 Safety of X-ray equipment
- ISO 13485:2003+AC:2007 Quality management system
- IEC 61846 Ultrasonics - Pressure pulse lithotripters characteristic of fields
In summary, during the design and verification testing, the acoustic output of the EMSE, the electrical safety of the system and any electromagnetic compatibility issues were fully addressed by demonstrating compliance with the appropriate standards. There were no unanticipated risks identified. Lastly, the device manual was reviewed and approved as part of the design control process. It contains all necessary warnings, cautions and instructions to mitigate potential injuries.
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.
Dornier Gemini Lithotripter (K121656), Dornier Doli S XP Lithotripter (K011873)
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.
Not Found
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
§ 876.5990 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.”)
0
510(k) SUMMARY Gemini 220 XP Lithotripter
770-514-6163
770-514-6291
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Phone: Dornier MedTech America Fax: 1155 Roberts Blvd. Date Prepared: September 19, 2013 Kennesaw. GA 30144
Contact Person: John Hoffer
Phone: 770-514-6163
Name of Device and Name/Address of Sponsor
Gemini 220 XP 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Shock Wave Lithotripter
Classification Name
According to 21 C.F.R. $ 876.5990. FDA has classified extracorporeal shock wave lithotripters as Class II devices with special controls. The Product Code for these lithotripters is LNS.
Predicate Devices
Dornier Gemini Lithotripter (K121656) Dornier Doli S XP Lithotripter (K011873)
Purpose of the Special 510(k) Notice
The Gemini 220 XP is a modification to Dornier's Gemini Lithotripter (K121656).
Intended Use
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal pelvic stones, and upper ureteral stones.
Device Description
The Gemini 220 XP is a modular urological work station designed for extracorporeal shock wave lithoripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.
The Gemini 220 XP is composed of the following modules:
- Basic Unit with integrated X-rav C-arm and Therapy Arm for Shockwave Treatment; .
- Patient Table: .
- Control Desk User Interface: and ●
The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures.
The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
The Gemini 220 XP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithoriosy and urological procedures. It is the same as in the predicate device.
SEP 2 3 2013
1
The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
Performance Data
The company has complied with all of the requirements described in FDA 's Guidance for the Content of Premarket Notifications (510k's) for Extrucorporeal Shock Wave Lithoripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.
The device is in compliance with the following standards:
| • IEC 60601-1:2007 | Electrical safety of medical devices |
|---|---|
| • IEC60601-1-2:2007 | Electromagnetic compatibility |
| • IEC 60601-1-3:2008 | Radiation protection |
| • IEC 60601-1-6:2008 | Usability |
| • IEC 60601-2-7 | Safety of high-voltage generators of diagnostic X-ray generator |
| • IEC 60601-2-28 | Particular requirements for the safety of X-ray source assemblies |
| and X-ray tube assemblies for medical diagnosis | |
| • IEC 60601-2-36:1997 | Extracorporeally induced Lithotripsy |
| • IEC 60601-2-32:1995 | Safety of X-ray equipment |
| • ISO 13485:2003+AC:2007 | Quality management system |
| • IEC 61846 | Ultrasonics - Pressure pulse lithotripters characteristic of fields |
In summary, during the design and verification testing, the acoustic output of the EMSE, the electrical safety of the system and any electromagnetic compatibility issues were fully addressed by demonstrating compliance with the appropriate standards. There were no unanticipated risks identified. Lastly, the device manual was reviewed and approved as part of the design control process. It contains all necessary warnings, cautions and instructions to mitigate potential injuries.
Substantial Equivalence
The Gemini 220 XP has similar technological characteristics as the predicate FDA-cleared Gemini Lithotripper (K 121656), to which it is a modification. The Gemini are extracorporeal shock wave lithotripters used for fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones. The technology to perform this function involves use of an electromagnetic shock wave emitter ("EMSE"). In the case of the subject device, the identical shock wave source is used as in the cleared predicate product, the Doli S XP (K011183). The other primary elements of the Gemini 220 XP, i.c., the patient able and the X-ray unit, are the same to that of the Gemini (K 121656). They perform the same function and operate in the same manner during the procedures involved in the fragmenting of urological stones.
From a clinical perspective and comparing design specifications. the Gemini 220 XP and the predicate devices are substantially equivalent and have the same intended use.
Dornier Medical Systems, Inc. believes the minor differences do not raise any concerns regarding the overall safety or effectiveness. Thus, the Gemini 220 XP is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
Food and Drug Administrution 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2013
Dornier MedTech America, Inc. % John S. Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd., Suite 100 Kennesaw. GA 30144
Re: K132672
Trade/Device Name: Gemini 220 XP Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: August 26, 2013 Received: August 27, 2013
Dear John S. Hoffer,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and I ou musi compry many; labeling (21 CFR Part 801); medical device reporting (reporting of
3
Page 2 - John S. Hoffer
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
hun://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K132672 510(k) Number (if known):_
Device Name: Gemini 220 XP
Indications for Use:
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Prescription Use _ × (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)