(331 days)
No
The device description and performance studies focus on the mechanical and physical aspects of shockwave lithotripsy and do not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is indicated for the fragmentation of kidney stones and ureteral stones, which are medical conditions, and thus it is used to treat or alleviate a disease or injury.
No
The device is a therapeutic device for fragmenting kidney and ureteral stones using extracorporeal shock wave lithotripsy (ESWL). While it may use imaging (X-ray and ultrasound) for guidance, its primary function is treatment, not diagnosis.
No
The device description explicitly details hardware components such as a Shockwave Generator, operator interface/touch panel, water circulation subsystem, treatment table, C-arm X-ray fluoroscope, and ultrasound imaging unit. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lite-Med LM-9200ELMA Lithotripter is a therapeutic device. It uses shock waves to physically break up kidney and ureteral stones within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the fragmentation of stones, which is a treatment, not a diagnostic process.
- Device Description: The description details the mechanism of generating and focusing shock waves for therapeutic purposes.
- Imaging Modality: While it uses imaging (X-ray and ultrasound) for guidance, these are used to locate the stones for treatment, not to analyze biological samples.
Therefore, based on the provided information, the Lite-Med LM-9200ELMA Lithotripter is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lite-Med LM-9200ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.
Product codes
78 LNS
Device Description
The Lite-Med LM-9200 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9200 ELMA device consists of a Shockwave Generator, an operator interface/touch panel, and a water circulation subsystem. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic ficld which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
For the ESWL operation to be fully functional, two or three optional subsystems are needed. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved electrically in all three axes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
C-arm X-ray fluoroscope, ultrasound imaging
Anatomical Site
kidney, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical investigations are performed at 2 sites with 1 and 2 weeks follow-up to support this application. Totally 40 (30 male, and 10 female) patients with stones were treated. The stones sizes treated were between 5 mm and 18 mm. None of the patients received general anesthesia. The overall success rate of the investigations is measured as 85%.
The experiences of physicians have shown that patients treated by the LM-9200 ELMA are safe and having high evaluations for the device function. And the user's manual is adequate for the operation of LM-9200 ELMA. The incidence of device malfunction does not happen in these clinical investigations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall success rate of the investigations is measured as 85%.
Predicate Device(s)
Dornier Compact Alpha Lithotripter (K002929), Siemens Lithoskop (K070665), Medispec Econolith EM1000 (K063504)
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
Section 5. 510(k) Summary and the same of the same of the same
510k Number: K103217 PG. I ord
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
LITE-MED LM-9200 ELMA Lithotripter
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 LM-9200 ELMA is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices like Dornier Compact Alpha Lithotripter (K002929), Siemens Lithoskop (K070665) and Medispec Econolith EM1000 (K063504).
Applicant/Manufacturer Information
Lite-Med Inc. 9th Floor, 49, Dongxing Road, Xinyi District Taipei City,Taiwan,110 TAIWAN Contact Person: Walt Hsu Tel: +886-2-2915-4183 Fax: +886-2-2911-1780
Device Identification
| Proprietary Trade Name: | LM-9200 ELMA |
|---|---|
| Generic Device Name: | Extracorporeal Shockwave Lithotripter |
| Product Code: | 78 LNS |
| Regulatory Class: | Class II with special controls |
| Regulation Number: | 21 CFR 876.5990 |
1
KJ03217 PG. ZOF A
Intended Use
The Lite-Med LM-9200ELMA Lithotripter is indicated for lingmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.
Substantial Equivalence
The Lite-Med LM-9200ELMA Lithotripter is substantially equivalent to the following currently marketed devices:
Dornier Compact Alpha Lithotripter
Siemens Lithoskop
Medispec Econolith EM1000
Device Description
The Lite-Med LM-9200 ELMA is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, flexibility and affordability. The standard LM-9200 ELMA device consists of a Shockwave Generator, an operator interface/touch panel, and a water circulation subsystem. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance coil, generating a magnetic ficld which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shockwaves and cooling of the generator.
For the ESWL operation to be fully functional, two or three optional subsystems are needed. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved electrically in all three axes.
Technological Characteristics
The shock wave characteristics are reported below by taking the guideline described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithorripters - Characteristics of fields" (1998) into consideration. PVDF film type hydrophones are used in the measurements. The details of the measurements/calculations are given in relevant part of 510(k) application. The results are found similar to the predicate device characteristics.
2
| Parameter | min(16kv) | typical(18kv) | max(20kv) |
|---|---|---|---|
| Peak-positive acoustic pressure(MPa) | 17.7 | 29.2 | 35.6 |
| Peak-negative acoustic pressure(MPa) | 3.2 | 3.5 | 3.2 |
| Rise time (ns) | 400 | 200 | 100 |
| Compressional pulse duration(ns) | 400 | 400 | 360 |
| Maximum focal width(mm) | 7 | 7.5 | 8 |
| Orthogonal focal width(mm) | 7 | 7.5 | 8 |
| Focal extent(mm) | 106 | 125 | 120 |
| Focal volume(mm3) | 2720 | 3682 | 4021 |
| Distance between the focus and target | |||
| location(mm) -z-axis | 3 | 3 | 3 |
| Distance between the focus and target | |||
| location(mm) -x/y-axis | 2 | 2 | 2 |
| Derived focal acoustic pulse energy(mJ) | 3.08 | 5.25 | 7.62 |
| Derived acoustic pulse energy(mJ) | |||
| (R=12mm) | 5.93 | 9.81 | 13.31 |
Clinical Study
The clinical investigations are performed at 2 sites with 1 and 2 weeks follow-up to support this application. Totally 40 (30 male, and 10 female) patients with stones were treated. The stones sizes treated were between 5 mm and 18 mm. None of the patients received general anesthesia. The overall success rate of the investigations is measured as 85%.
The experiences of physicians have shown that patients treated by the LM-9200 ELMA are safe and having high evaluations for the device function. And the user's manual is adequate for the operation of LM-9200 ELMA. The incidence of device malfunction does not happen in these clinical investigations.
3
Safety and Performance Studies
The LM-9200 ELMA is designed in accordance with the product safety and performance requirements established in the following standards :
| IEC 60601-2-36 | Particular Requirements for safety of equipment for
extracorporeally induced lithotripsy |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 61846 | Ultrasonics - Pressure pulse lithotripters - Characteristics of
fields (1998) |
| IEC 60601-1-1 | Medical Electrical Equipment - Part 1 General Requirements for
Safety" with Amend 1 and 2 |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1 General Requirements for
Safety-2. Collateral Standard: Electromagnetic
Compatibility-Requirements and Tests |
| IEC 60601-1-4 | Medical Electrical Equipment - Part 1 General Requirements for
Safety-4. Collateral Standard: Programmable Electrical Medical
Systems |
| ISO 13485 | Medical Devices - Quality Management Systems -
Requirements for Regulatory Purposes |
| ISO 14971 | Medical Devices -- Application of Risk Management to Medical
Devices |
Conclusion
From a clinical perspective and comparing design specifications, the LM-9200 ELMA is substantially equivalent to the predicate devices. The LM-9200 ELMA meets the FDA requirements stated in "Guidance for the Content of Premarket Notifications 510(k)s for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi" issued on Aug. 9, 2000. Lite-Med Inc. believes the minor differences of the LM-9200 ELMA and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Walt Hsu President and CEO Lite-Med Inc. 940 Floor, 49. Dongxing Road. Xinyi District TAIPEI CITY 110 TAIWAN R.O.C.
Re: K103217
SEP 2 8 2011
Trade/Device Name: LM-9200 ELMA Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: H Product Code: LNS Dated: September 23, 2011 Received: September 26, 2011
Dear Mr. Hsu:
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 (Spècial 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 of medical device-related
5
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/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.
Sincerely yours,
Herbert Leuner MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement Section 4.
Indications for Use
510(k) Number (if known): K103217 LM-9200 ELMA Device Name: Indications for Use:
The Lite-Med LM-9200ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.
Prescription Use AND/OR · (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Valer Leun
ctive, Gastro-Renal, and