(331 days)
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.
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.
The provided document describes the Lite-Med LM-9200 ELMA Lithotripter, an Extracorporeal Shock Wave Lithotripter (ESWL) for fragmenting kidney and ureteral stones.
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria for clinical performance are not explicitly stated as numerical targets in the provided text. Instead, the study reports an "overall success rate" against which its performance is implicitly measured, and also highlights safety and compliance with standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall clinical success in stone fragmentation | 85% success rate |
| Safety and high evaluation for device function | Patients treated are safe and have high evaluations for device function. No device malfunction incidence reported. |
| Compliance with relevant medical device safety standards | IEC 60601-2-36, IEC 61846, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, ISO 13485, ISO 14971 |
| Adequacy of user's manual | User's manual is adequate for operation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 40 patients (30 male, 10 female)
- Data Provenance: Not explicitly stated, but the company is based in Taipei City, Taiwan. The clinical investigations were performed at 2 sites, implying prospective data collection for the purpose of this application.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document refers to "experiences of physicians" but does not specify the number of experts used to establish a formal "ground truth" for the test set, nor their specific qualifications (e.g., years of experience). The assessment of device function and safety, as well as the success rate, would presumably be based on clinical evaluations by the treating physicians at the two sites.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the success rate or safety outcomes. Clinical outcomes were reported, implying a direct assessment by the treating physicians without an explicit external adjudication panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the LM-9200 ELMA Lithotripter alone.
6. Standalone Performance Study
Yes, a standalone study was performed. The clinical investigation directly assessed the performance of the LM-9200 ELMA Lithotripter without human-in-the-loop assistance for the primary function of stone fragmentation. The clinical success rate of 85% for stone fragmentation and the safety profile were assessed based on the device's use.
7. Type of Ground Truth Used
The ground truth appears to be based on clinical outcomes as assessed by treating physicians. The "overall success rate" would be defined by the clinical fragmentation of kidney and ureteral stones, likely confirmed through imaging or other medical follow-ups. Safety was also assessed based on clinical observations and patient evaluations.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. The device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the concept of a training set as typically applied to machine learning models is not relevant here.
9. How the Ground Truth for the Training Set Was Established
As noted above, the device is a physical lithotripter, not an AI/ML algorithm. Thus, there is no "training set" or ground truth establishment method for a training set in this context. The physical and technological characteristics of the device were established through measurements based on standards like IEC 61846.
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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 |
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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.
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| 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 targetlocation(mm) -z-axis | 3 | 3 | 3 |
| Distance between the focus and targetlocation(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.
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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 forextracorporeally induced lithotripsy |
|---|---|
| IEC 61846 | Ultrasonics - Pressure pulse lithotripters - Characteristics offields (1998) |
| IEC 60601-1-1 | Medical Electrical Equipment - Part 1 General Requirements forSafety" with Amend 1 and 2 |
| IEC 60601-1-2 | Medical Electrical Equipment - Part 1 General Requirements forSafety-2. Collateral Standard: ElectromagneticCompatibility-Requirements and Tests |
| IEC 60601-1-4 | Medical Electrical Equipment - Part 1 General Requirements forSafety-4. Collateral Standard: Programmable Electrical MedicalSystems |
| ISO 13485 | Medical Devices - Quality Management Systems -Requirements for Regulatory Purposes |
| ISO 14971 | Medical Devices -- Application of Risk Management to MedicalDevices |
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.
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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
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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
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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
§ 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.”)