(109 days)
The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.
Medispec Ltd.'s Econolith™ EM1000 system is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.
The EM1000 device includes a shock wave generator which is based on an Electromagnetic shock wave head and is to be used in conjunction with a multi axes Motorized Treatment Table, a C-Arm X-ray/fluoroscope imaging unit, an ECG monitor, and an anesthesia apparatus, which may be supplied by the user. The device also contains the necessary interface for optional Ultrasonic imaging devices. The EM1000 includes the following components for patient handling, positioning and shock wave generation:
- Shockwave Generator
- Electromagnetic Shock wave head,
- High-Voltage System.
- Water System,
- Treatment Table Control,
- ECG System.
- Control and Timing Circuitry, and
- Front Panel Controls
The provided text describes a 510(k) premarket notification for the Medispec Econolith™ EM1000, an Extracorporeal Shock Wave Lithotripter (ESWL). This document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for an AI diagnostic might.
No specific acceptance criteria values or a detailed study proving the device meets them are provided. The submission relies on establishing substantial equivalence to existing devices and compliance with FDA guidance and performance standards.
Here's an analysis based on the provided text, addressing the requested points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "All specifications are in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards." However, it does not list these specific criteria or the EM1000's performance against them.
2. Sample Size for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission for a medical device (lithotripter), not an AI diagnostic algorithm. There is no mention of a "test set" in the context of evaluating an algorithm's performance on data. The evaluation for this device would typically involve bench testing, engineering specifications, and a comparison to predicate devices, not data-driven performance metrics on a specific dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is not an AI diagnostic, there is no "ground truth" established by experts on a test set in the sense of image interpretation or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging systems or AI software, often comparing human reader performance with and without AI assistance. This document describes a physical medical device (lithotripter) and does not involve human readers interpreting data.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical lithotripter system, not a standalone algorithm. Its operation inherently involves a human operator (e.g., a urologist) and other medical equipment.
7. Type of Ground Truth Used
Not applicable in the context of an AI diagnostic. For this medical device, the "ground truth" would relate to its engineering specifications, safety, and effectiveness in fragmenting stones, which would be evaluated through pre-clinical testing (e.g., in vitro stone fragmentation studies, animal studies) and clinical experience with predicate devices, rather than a diagnostic 'ground truth'. The document confirms the device's "Intended Use" as "non-invasive fragmentation of upper urinary tract stones."
8. Sample Size for the Training Set
Not applicable. As this is not an AI diagnostic, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/0 description: The image shows a logo for "MEDISPEC". The logo features a stylized letter "M" above the company name. The "M" is composed of several parallel lines, giving it a textured appearance. The company name "MEDISPEC" is written in a bold, sans-serif font.
MEDISPEC LTD 20401 Observation Drive, Suite 102 Germantown, MD 20876 USA Tel: (301) 944-1575 Toll Free: (888) 6-Medispec Fax: (301) 972-6098 E-mail: info@medispec.com
KO63504 AG. 1 OF 2
MAR 0 3 2007
510(K) SUMMARY
[21 CFR section 807.92]
Applicant's Name and Address
Medispec Ltd. 12850 Middlebrook Road, Suite 1 Germantown, MD 20874 Contact: Anil Dhingra, Vice President and COO Phone: 301-944-1575 Fax: 301-972-6098
. .
Date of Summary
March 2, 2007
Device Trade Name
Econolith™ EM1000
Device Generic Name
Extracorporeal Shock Wave Lithotripter
川川
Classification Name
Class II - Lithotripter, Extracorporeal Shock Wave (Urological) [21 CFR Section 876.5990] / Product Code - LNS
Intended Use
The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.
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KO63504 PG. 2 OF 2
MEDISPEC LTD
Predicate Device(s)
Siemens Lithostar Lithotripter-1870018, Dornier Compact Delta - P840008/S56, and Medispec Econolith™ E3000 - K040461
Device Description
Medispec Ltd.'s Econolith™ EM1000 system is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.
The EM1000 device includes a shock wave generator which is based on an Electromagnetic shock wave head and is to be used in conjunction with a multi axes Motorized Treatment Table, a C-Arm X-ray/fluoroscope imaging unit, an ECG monitor, and an anesthesia apparatus, which may be supplied by the user. The device also contains the necessary interface for optional Ultrasonic imaging devices. The EM1000 includes the following components for patient handling, positioning and shock wave generation:
- Shockwave Generator
- Electromagnetic Shock wave head,
- 트 High-Voltage System.
- 트 Water System,
- 트 Treatment Table Control,
- 이 ECG System.
- 트 Control and Timing Circuitry, and
- l Front Panel Controls
Substantial Equivalence
The Econolith™ EM1000 is substantially equivalent to the Seimens Lithostar Lithotrioter (approved under PMA# P870018), the Dornier Compact Delta (approved under PMA# P8400008/S56), and Medispec Econolith™ E3000 (cleared under K040461). The EM1000 is found to be substantially equivalent to these devices in respect to the intended use, principle of operations, ancillary equipment, and technological specifications.
Technological Characteristics
All specifications are in compliance with FDA Guidance for the Content of Premarket Notifications (510(k)) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, August 2000 and all applicable performance standards.
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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 stylized eagle with three curved lines representing its wings and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
0 9 2007
Ms. Sheryl D. Skinner Manager of Regulatory Affairs Medispec Ltd. 12850 Middlebrook Road, Suite 1 GERMANTOWN MD 20874
K063504 Re:
Trade/Device Name: Econolith™ EM1000 Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: March 2, 2007 Received: March 2, 2007
Dear Ms. Skinner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". Three stars are below the word "Centennial". The text "A Century of Public Health" surrounds the logo.
Protecting and Promoting Public Health
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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); good manufacturing practice requirements as set forth in 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K063504 510(k) Number (if known):
Device Name: Econolith™ EM1000
Indications For Use: The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUING ON ANOTHER PAGE IF NEEDED)
AD/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lyman
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.”)