(193 days)
The Delta™ 2000 Series Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The DELTA lithotripter utilizes well known spark gap technology. To generate a shock wave utilizing this method, an electrical discharge is created between two electrodes submerged in water. This sudden discharge of the enormous amount of energy lasts less than 1 microsecond. During this time an evaporation of water surrounding the gap between the electrodes occurs. The evaporation causes an instant expansion of vapor which produces a shock wave. In an extracorporeal lithotripter, the two wire electrodes are embedded in a plastic tube filled with insulating material. On one end of the tube the tips of the wire are bent towards each other with a small gap between them. A source of electrical energy is connected to each wire on the other end of this tubular structure. This electrode assembly is placed inside an ellipsoidal reflector in such a way that the gap between the two conductors coincides with the first focal point of the reflector. The reflector is filled with water and covered with a thin elastic membrane. After discharging the energy, reflected shock waves are transmitted to the second focal point through noncompressible medium, such as water in the reflector and in human tissue. The energy generated at the first focal point is recaptured at the second focal point of the ellipsoidal reflector with only minimal losses. When the second focal point is positioned on the treatment area such as the kidney stone inside the body, the repeated impact of the shock waves on the stone, at various energy levels, causes its disintegration.
This document describes a 510(k) premarket notification for the "Delta™ 2000" Series Lithotripter, seeking substantial equivalence to a predicate device. This is primarily a regulatory submission, not a study report that details specific acceptance criteria and performance data in the structured way requested. Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here is the information that can be extracted, along with explanations for what cannot be provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., stone fragmentation rate, success rate, energy delivery accuracy) nor independent "reported device performance" against such criteria. The basis of acceptance is substantial equivalence to a predicate device (EDAP Technomed Sonolith Praktis, K003529).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Indications for Use (fragment urinary stones in kidney/ureter) | SAME as predicate device |
| Where used (Hospitals) | SAME as predicate device |
| Standards compliance (UL-2601, IEC 60601, IEC 60601-2-36, IEC 61846, IEC 60601-1-2 for EMC) | SAME as predicate device |
| Technology (Extracorporeal shock wave, spark) | SAME as predicate device |
| Power Source (120 VAC 50-60~ 15 amp outlet) | SAME as predicate device |
| Overall safety and effectiveness | "Testing, certifications, and clinical experience demonstrates that the device is equivalent to the EDAP Technomed Sonolith Praktis, K003529" and "meets the requirements of Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters..." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified. The document states "clinical experience demonstrates that the device is equivalent," but it does not provide details about a specific clinical study with a defined test set sample size.
- Data Provenance: Not specified. It refers to "clinical experience" generally, without indicating country of origin, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This is a medical device approval document based on substantial equivalence, not an AI/diagnostic algorithm study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
- Not applicable for the same reason as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device, nor does the document describe an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not a standalone algorithm.
7. The Type of Ground Truth Used:
- The concept of "ground truth" as typically used in AI/diagnostic evaluation is not directly applicable here. The "truth" for this device's approval is its substantial equivalence to an already legally marketed predicate device, based on comparable characteristics, standards compliance, and overall safety and effectiveness ("clinical experience").
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
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APR 2 9 2002
PAGE / UF 2
EXHIBIT 2 510(k) Summary of Safety and Effectiveness E.S.W.L. Products, Inc. 1542 Barclay Blvd. Buffalo Grove, IL 60089 USA Tel 1+847-419-6844 Fax 1+847-419-6881 Contact: Christopher Nowacki, President
October 17, 2001
-
- Identification of the Device: Proprietary-Trade Name: "Delta™ 2000" Series Lithotripter. Classification Name/Product Code: 78 LNS Common/Usual Name: Extracorporeal Shock Wave Lithotripter
- Indications for Use (intended use) The Delta™ 2000 Series Lithotripter is intended 3. to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
-
- Description of the Device: The DELTA lithotripter utilizes well known spark gap technology. To generate a shock wave utilizing this method, an electrical discharge is created between two electrodes submerged in water. This sudden discharge of the enormous amount of energy lasts less than 1 microsecond. During this time an evaporation of water surrounding the gap between the electrodes occurs. The evaporation causes an instant expansion of vapor which produces a shock wave. In an extracorporeal lithotripter, the two wire electrodes are embedded in a plastic tube filled with insulating material. On one end of the tube the tips of the wire are bent towards each other with a small gap between them. A source of electrical energy is connected to each wire on the other end of this tubular structure. This electrode assembly is placed inside an ellipsoidal reflector in such a way that the gap between the two conductors coincides with the first focal point of the reflector. The reflector is filled with water and covered with a thin elastic membrane. After discharging the energy, reflected shock waves are transmitted to the second focal point through noncompressible medium, such as water in the reflector and in human tissue. The energy generated at the first focal point is recaptured at the second focal point of the ellipsoidal reflector with only minimal losses. When the second focal point is positioned on the treatment area such as the kidney stone inside the body, the repeated impact of the shock waves on the stone, at various energy levels, causes its disintegration.
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PAGE 2 OF 2
| Comparison Areas | EDAP Technomed Sonolith | "Delta™ 2000" Series |
|---|---|---|
| Praktis, K003529 | Lithotripter | |
| Indications for use | Intended to fragment urinarystones in the kidney (renalpelvis and renal calyces) andureter (upper, middle, andlower ureter). | SAME |
| Where used | Hospitals | SAME |
| Standards compliance | a. UL-2601 and IEC 60601b. IEC 60601-2-36, "Medicalelectrical equipment - Part 2:Particular requirements for thesafety of equipment forextracorporeally inducedlithotripsy" (1997).c. IEC 61846, "Ultrasonics -Pressure pulse lithotripters -Characteristics of fields" (1998).d. EMC: Compliance with IEC60601-1-2 will be maintained,except during the triggering andgeneration cycle of thePRESSURE PULSE release | SAME |
| Technology | Extracorporeal shock wave,spark. | SAME. |
| Power Source | 120 VAC 50-60~ 15 ampoutlet | SAME |
-
- Safety and Effectiveness, comparison to predicate device:
- Conclusion: In all material respects, the "Delta™ 2000" Series Lithotripter is 6. substantially equivalent to one or more products of similar description. Testing, certifications, and clinical experience demonstrates that the device is equivalent to the EDAP Technomed Sonolith Praktis, K003529, currently on the market. The "Delta™ 2000" Series Lithotripter meets the requirements of Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, Document issued on August 9, 2000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Rockville MD 20850
E.S.W.L. Products, Inc. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates, Inc. P.O. Box 7007 DEERFIELD IL 60015
Re: K013471
Trade/Device Name: Delta™ 2000 Series Extracorporeal Lithotripter Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: February 20, 2002 Received: February 21, 2002
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 re(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars actment date of the Medical Device Amendments, or to conniter co pror to may 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been receasined in assee approval of a premarket approval application (PMA). and Cosmetic (110-) that to novice, subject to the general controls provisions of the Act. The r ou may, aference, manner of the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 It may be subject to additional come of the 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 I loase of advised that I Dris issum that your device complies with other requirements of the Act that I DA has made a dolorimiations administered by other Federal agencies. You must of any I ederal statures than ogenements, including, but not limited to: registration and listing comply with an the Hel Frequirement Bart 801); good manufacturing practice requirements as set (21 CFR Part 007), advening (21 CFR Part 820); and if applicable, the electronic forth in the quant) by events (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 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 If you desire specific ac at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by rolerence to premiumed the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy 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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10. Indications for Use
K013471 510((k) Number________________________________________________________________________________________________________________________________________________________________
The Delta™ 2000 Series of Extracorporeal Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | |
|---|---|
| ------------------ | -- |
OR
| Over the Counter Use | |
|---|---|
| (Per 21 CFR 801.109) |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013471 |
|---|---|
| --------------- | --------- |
8
§ 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.”)