(237 days)
Not Found
No
The summary describes a lithotripter with software control for operating transducers and interfaces for imaging, but there is no mention of AI, ML, or related concepts like image processing for analysis or decision-making. The performance studies focus on standard compliance and physical testing, not AI/ML model validation.
Yes
The device is intended to fragment urinary stones, which is a treatment for a medical condition.
No
The device is described as an Extracorporeal Shock Wave Lithotripter intended to fragment urinary stones, which is a therapeutic function rather than a diagnostic one. While it incorporates imaging interfaces, these are for guiding the treatment, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a Shock Wave Generator, Motorized Floating Treatment Table, and a Control subsystem, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The DUET MAGNA is an Extracorporeal Shock Wave Lithotripter. Its function is to fragment urinary stones within the body using shock waves. This is a therapeutic procedure performed on the patient, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "to fragment urinary stones in the kidney... and upper ureter," which is a treatment, not a diagnostic activity.
Therefore, based on the provided information, the DUET MAGNA is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
Product codes
78 LNS
Device Description
The device is a transportable Electromagnetic Extracorporeal Shock Wave Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem. Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices. The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic imaging, Sonographic imaging
Anatomical Site
Kidney (renal pelvis and renal calyces), upper ureter
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 DUET MAGNA Lithotripter was tested according to the following standards:
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995) .
- IEC 60601-1-1 (2000) .
- IEC 60601-1-2 (2001) .
- IEC 60601-1-3 (1994) .
- IEC 60601-2-7 (1998) .
- IEC 606001-2-36 (1997) .
- IEC 61846 (1998) .
- . IEC 60601-2-38 (1996)
- ANSI/ AAMI/ ISO 10993- 1 (1998) .
- CISPR 11 (1997) + A1 (1999) class B .
- IEC 60601-1-4 (2000) .
- Guidance for the Content of Premarket Notifications (510(k)s) for . Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000
The Duet Magna has been tested and been found to conform, as do the predicate devices, to FDA recognized standards, including electrical safety testing per IEC 60601-1, EMC testing per IEC 60601-1-2, localization accuracy testing and road testing per the lithotripter special control guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.”)
0
K111947 MAR - 1 2012 PG. I OF 3
510(k) SUMMARY
[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]
1. Submitter Information
| Submitter: | | Direx Systems Corporation
960 Turnpike Street
Canton, MA 02021 |
|--------------------------------------|--|----------------------------------------------------------------------|
| Telephone:
Fax:
Contact Person | | (339) 502-6013
(339) 502-6018
Larisa Gershtein
QA Manager |
| Contact Person e-mail address: | | lgershtein@direxusa.com |
| 2. Device | | |
| Trade/Proprietary Name: | | Duet Magna |
| Common/Usual Name: | | Extracorporeal Shock Wave Lithotripter (ESWL) |
| Regulation Number: | | 21 CFR 876.5990 |
| Regulatory Class: | | Class II (special controls) |
| Product code: | | 78 LNS |
| Panel: | | Gastroenterology and Urology |
3. Predicate Devices
| Tripter X - 1 Compact Duet (Direx Systems Corp) (K023535) |
|---|
| Tripter X - 1 Compact Duet (Direx Systems Corp) (K041582) |
| Integra (Direx Systems Corp) K053640) |
4. Intended Use:
The DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
5. Description
The device is a transportable Electromagnetic Extracorporeal Shock Wave
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K111947
PG. 2 OF 3
Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem.
Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices.
The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.
6. Performance Testing
The DUET MAGNA Lithotripter was tested according to the following standards:
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995) .
- IEC 60601-1-1 (2000) .
- IEC 60601-1-2 (2001) .
- IEC 60601-1-3 (1994) .
- IEC 60601-2-7 (1998) .
- IEC 606001-2-36 (1997) .
- IEC 61846 (1998) .
- . IEC 60601-2-38 (1996)
- ANSI/ AAMI/ ISO 10993- 1 (1998) .
- CISPR 11 (1997) + A1 (1999) class B .
- IEC 60601-1-4 (2000) .
- Guidance for the Content of Premarket Notifications (510(k)s) for . Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000
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K111947
PG. 3 of 3
6. Substantial Equivalence
The intended use of Duet Magna is respectively similar to those of the predicate devices. The device is a modification of Tripter Compact Duet and is functionally similar to Tripter Compact Duet, except for shockwave generation that is similar to that of Integra. Furthermore, the Duet Magna has been tested and been found to conform, as do the predicate devices, to FDA recognized standards, including electrical safety testing per IEC 60601-1, EMC testing per IEC 60601-1-2, localization accuracy testing and road testing per the lithotripter special control guidance document. Based on an analysis of similarities and differences, we believe that Duet Magna is substantially equivalent to its predicate devices without raising new safety and/or efficacy issues.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is simple, using a black and white color scheme.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012_
Ms. Larisa Gershtein OA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
Re: K111947
Trade/Device Name: DUET MAGNA Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave Lithotripter Regulatory Class: II Product Code: LNS Dated: January 30, 2012 Received: February 3, 2012
Dear Ms. Gershtein:
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
4
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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerély yours,
Sincerely yours,
Benjamin K. Ticho
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
5
Section 2 Indications For Use Statement
Indications for Use Statement
K111947 510(k) Number (if known):
Device Name: DUET MAGNA
Indications for Use:
DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
Prescription Use - Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K111947 |
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