(92 days)
The Econolith™ E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
Medispec Ltd.'s Econolith™ E3000 uses shock waves generated outside the patient's body to fragment urinary calculi within either the kidney or upper ureter. The device consists of an electrony draulic shock wave generator, control panel, and motorized patient table. Although the device does not provide imaging or monitoring functions, it does contain dedicated interfaces for the requisite fluoroscopic imaging and ECG monitoring.
The shock wave generator is a self-contained unit which includes an underwater electrode, a control system, and a high voltage power supply system.
The treatment table is specifically designed for use with the Econolith™ Lithotripter. The table can position the patient in multi-dimensions and also provides access to the patient's lumbar region through removable inserts.
The provided document is a 510(k) summary for the Medispec Ltd. Econolith™ E3000, an Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the format requested.
Therefore, the document does not contain the detailed clinical study information required to fill out a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or adjudication methods for a standalone study designed to prove the device meets specific performance metrics.
The document primarily states that the device's "Technological Characteristics" 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." This implies that the device was evaluated against existing standards and guidance, but the specifics of that evaluation (e.g., breakdown of performance metrics, sample sizes, and ground truth establishment) are not provided in this summary.
Based on the provided text, I cannot complete the requested information for a clinical study proving the device meets specific acceptance criteria.
The document's purpose is to show substantial equivalence, not to detail the results of a primary clinical study establishing performance against new acceptance criteria.
Information that can be extracted from the provided text, but does not directly answer the requested questions:
- Intended Use/Indications for Use: Non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
- Predicate Device: HealthTronic's Lithotron Lithotripsy System (P970019).
- Basis for Substantial Equivalence: Similar intended use, principle of operations, ancillary equipment, and technological specifications.
- Regulatory Guidance: 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.
Conclusion: The provided 510(k) summary does not contain the detailed performance study information typically associated with establishing acceptance criteria and proving a device meets them through empirical data. It serves as a regulatory document demonstrating equivalence to an already approved device.
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MEDISPEC LTD 12850 Middlebrook Road, Suite 1 Germantown, MD 20874 USA Tel: (301) 944-1575 Toll Froc: (888) 6-Medispec Fax: (301) 972-6098 E-mail: medispec@aol.com
510(K) SUMMARY [21 CFR section 807.92]
Applicant's Name and Address
Medispec Ltd. 12850 Middlebrook Road, Suite 1 Germantown, MD 20874 Contact: Sheryl D. Skinner Phone: 301-944-1575 Fax: 301-972-6098
Date of Summary
February 19, 2004
Device Trade Name
Econolith™ E3000
Device Generic Name
Extracorporeal Shock Wave Lithotripter
Classification Name
Class II - Lithotripter, Extracorporeal Shock Wave (Urological) [21 CFR Section 876.5990] / Product Code - LNS
Intended Use
The Econolith™ E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.
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Image /page/1/Picture/0 description: The image shows a logo for a company called "MEDISPEC LTD". The logo consists of a stylized, handwritten-style symbol above the company name. The symbol appears to be two overlapping letters, possibly "M"s, rendered in a bold, calligraphic font. The company name, "MEDISPEC LTD", is printed in a bold, sans-serif font below the symbol.
Image /page/1/Picture/1 description: The image shows a handwritten text that appears to be a note or a label. The text is written in cursive and seems to contain two lines. The first line appears to read "Kotoriel", while the second line is less clear but seems to say "fage 3k". The handwriting is somewhat messy, making it difficult to decipher the exact words.
Predicate Device
HealthTronic's LithoTron Lithotripsy System (P970019)
Device Description
Medispec Ltd.'s Econolith™ E3000 uses shock waves generated outside the patient's body to fragment urinary calculi within either the kidney or upper ureter. The device consists of an electrony draulic shock wave generator, control panel, and motorized patient table. Although the device does not provide imaging or monitoring functions, it does contain dedicated interfaces for the requisite fluoroscopic imaging and ECG monitoring.
The shock wave generator is a self-contained unit which includes an underwater electrode, a control system, and a high voltage power supply system.
The treatment table is specifically designed for use with the Econolith™ Lithotripter. The table can position the patient in multi-dimensions and also provides access to the patient's lumbar region through removable inserts.
Substantial Equivalence
The Econolith™ E3000 is substantially equivalent to the HealthTronics Lithotron (cleared under PMA# P970019). Both devices are found to be substantially equivalent 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Anil Dhingra VP and COO Medispec Ltd. 12850 Middlebrook Rd., Suite 1 GERMANTOWN MD 20874
Re: K040461
Trade/Device Name: Econolith™ E3000, Model 3000 (SW-6) Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shockwave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: May 4, 2004 Received: May 4, 2004
Dear Mr, Dhingra:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your boodeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to donimer to provise to may as a sified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrerey mains 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 (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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to oegni marteeting your antial equivalence of your device to a legally premarket notification. The FDA inding of sacchanial equivalians of 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 If you desire specific advice for your device on our as a subnumber at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 10f questions on the promotion =................................................................................................................................ Other of Compliance at (301) 524-1057. I 2007.97) you may obtain. Other general by reference to premarket nonitation (21 of Act may be obtained from the Division of Stratl intornation on your responsionities under the station of its toll-free number (800) 638-2041 or Manufacturers, International and Collisanter Filter Frida.gov/cdrh/dsma/dsmamain.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
Page 2
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Econolith TM E3000
Indications For Use: The Econolith™ E3000 is indicated for use in non-invasive findications For Ose. "The Economia
fragmentation of upper urinary tract stones between 5 and 20 mm in size.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUING ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off) Division of Reproductive, Abdon inal. and Radiological Devices 510(k) Number.
Page 1 of 1
§ 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.”)