(76 days)
No
The description focuses on the mechanical, electrical, and imaging components of the device for shock wave lithotripsy and urological procedures. There is no mention of AI or ML in the device description, intended use, or performance studies. The image processing mentioned is standard for X-ray systems and DICOM compatibility.
Yes
The device is indicated for the fragmentation of urinary tract stones, which is a therapeutic intervention.
Yes
The device is described as a "modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology." This explicit mention of "diagnostic procedures" indicates its diagnostic capability.
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, X-ray unit, and camera. While it includes software for image processing and control, it is fundamentally a hardware-based system.
Based on the provided information, the Gemini XXP-HP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is the fragmentation of urinary tract stones within the patient's body using extracorporeal shock wave lithotripsy (ESWL). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device is a urological workstation designed for ESWL and other urological procedures. It involves physical interaction with the patient (shock waves, imaging).
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The Gemini XXP-HP is a medical device used for a therapeutic procedure (lithotripsy) and diagnostic imaging (X-ray) performed in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Product codes
LNS
Device Description
The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.
The Gemini XXP-HP is composed of the following modules:
- Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwaye Treatment: .
- Patient Table;
- Control Desk User Interface. 0
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 XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. It is the same as in the predicate device.
The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.
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 stones, renal calyceal stones, renal pelvic stones, upper ureteral stones.
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)
According to the recommendations of the special control quidance document, a confirmatory clinical study was performed using the Gemini XXP-HP to confirm the usability, safety, and effectiveness of this modified lithotripter. As compared to the conventional EMSE (penetration depth 150mm), both mean number of shockwaves and mean energy level were slightly lower with the subject device. Overall treatment results were comparable with a slight advantage for the Gemini XXP-HP:
The complication rate was extremely low. Beside expected pain, no further complications were observed. No shock wave-induced hematoma or shock wave related complications were encountered.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.”)
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined lines that form a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
Dornier Medtech America, Inc. John Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd Kennesaw, GA 30144
Re: K151298 Trade/Device Name: Gemini XXP-HP Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: May 18, 2015 Received: May 19, 2015
Dear John 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, listing 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 either 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Dornier Gemini XXP-HP
Indications for Use (Describe)
The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
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510(k) SUMMARY Gemini XXP-HP Lithotripter
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier MedTech America | Phone: 770-514-6163 |
|---|---|
| 1155 Roberts Blvd. | Fax: 770-514-6291 |
| Kennesaw, GA 30144 | Date Prepared: May 14, 2015 |
Contact Person: John Hoffer Phone: 770-514-6163
Name of Device and Name/Address of Sponsor
Gemini 220 XXP-HP 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 Device
Dornier Gemini 220 XP Lithotripter (K132672)
Reference Devices
Storz Modulith SLX-F2 180 (K072788) Siemens Lithoskop/Pulso (K070665)
Purpose of the 510(k) Notice
The Gemini XXP-HP is a modification to Dornier's Gemini 220 XP Lithotripter (K132672) to allow the use of an alternate EMSE source and to reintroduce the camera (Opticouple) feature to view the patient to bellows coupling interface.
Intended Use
The Gemini XXP-HP is indicated for the fragmentation of urinary tract stones, i.e., renal calvceal stones, renal pelvic stones, and upper ureteral stones.
Device Description
The Gemini XXP-HP is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.
4
The Gemini XXP-HP is composed of the following modules:
- Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwaye Treatment: .
- Patient Table;
- Control Desk User Interface. 0
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 XXP-HP's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. It is the same as in the predicate device.
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 (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi (i.e., the special control quidance document).
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
- · 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. Additionally, verification and validation testing of the modified system software was successfully completed. 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.
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Clinical Data
According to the recommendations of the special control quidance document, a confirmatory clinical study was performed using the Gemini XXP-HP to confirm the usability, safety, and effectiveness of this modified lithotripter. As compared to the conventional EMSE (penetration depth 150mm), both mean number of shockwaves and mean energy level were slightly lower with the subject device. Overall treatment results were comparable with a slight advantage for the Gemini XXP-HP:
The complication rate was extremely low. Beside expected pain, no further complications were observed. No shock wave-induced hematoma or shock wave related complications were encountered.
Substantial Equivalence
The Gemini XXP-HP has the same technological characteristics as the predicate Dornier Gemini 220 XP Lithotripter (K132672), to which it is a modification. The Gemini XXP-HP and the predicate 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"). This basic technology is identical in the subject device and the Dornier predicate. In the case of the shock wave source parameters, the characteristics of the subject device are substantially equivalent to those for the Storz Modulith SLX-F2 180 (K072788) and the Siemens Lithoskop/Pulso (K070665). The other primary elements of the Gemini XXP-HP, i.e., the patient table and the X-ray unit, are the same to that of the Dornier predicate. They perform the same function and operate in the same manner during the procedures involved in the fragmenting of urological stones. The Gemini XXP-HP also includes a camera to view in real time the integrity of the patient to bellows coupling interface. The camera feature is directly comparable to that of the Dornier Model HM3 lithotripter, which was previously approved (P840008 S18) prior to the downclassification of lithotripters to class II.
From a clinical perspective and comparing design specifications, the Gemini XXP-HP and the predicate devices are substantially equivalent and have the same intended use. The minor differences between the subject and predicate device do not raise any concerns regarding the overall safety or effectiveness. Thus, the Gemini XXP-HP is substantially equivalent to its predicate device.