(145 days)
The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The Piezolith 3000 Triple Focus consists of (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X·ray imaging is used) mounted to a swivel slide on C-arm (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.
The provided text describes a 510(k) premarket notification for the Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against those criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics is not explicitly available in the provided document sections.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device functions as intended without posing new safety risks compared to predicate devices. | "In all instances, the Piezolith 3000 Triple-Focus functioned as intended and the results observed were as expected." |
| Effectiveness: Device effectively fragments urinary stones in the kidney and ureter, comparable to predicate devices. | "Bench and clinical testing was performed using the Piezolith 3000 Triple Focus." The device is claimed to be "as safe and effective as the Piezolith 3000 (K032958), the Karl Storz Modulith Lithotripter (K010340, K012482, K011700), and the Direx Systems Corporation Integra (K053640, K062147)." |
| Compliance with Standards: Device meets relevant electrical, medical device, and lithotripsy standards. | "the modified device was tested according to the following standards: IEC 60601-1 (1988) (including Amendment 1(1991) and Amendment 2 (1995)); IEC 60601-1-1 (2000) with Amendment 1, 1995; IEC 60601-1-2 (2001); IEC 60601-2-36 (1997); IEC 61846 (1998)." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and clinical testing" but does not specify the sample size for any clinical test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described is a comparison against predicate devices and adherence to standards rather than an independent expert-validated ground truth study.
4. Adjudication Method for the Test Set
This information is not provided as no specific "test set" requiring expert adjudication is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, an MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned in the document. This is a medical device (lithotripter), not an AI diagnostic tool that assists human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm-only device. It's a physical medical device. The "performance data" refers to the device's physical capabilities and operational characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance demonstration is primarily:
- Performance against predicate devices: The Piezolith 3000 Triple Focus is deemed "substantially equivalent" in safety and effectiveness to existing, legally marketed lithotripters. This implies that the accepted performance of previous devices serves as a benchmark.
- Compliance with recognized standards: The device met specific IEC standards related to medical electrical equipment and lithotripters.
- Functionality as intended: General statement about the device functioning as expected.
No specific, independent "expert consensus, pathology, or outcomes data" is detailed as being used for a distinct "ground truth" to validate the device's primary efficacy in the context of this 510(k) summary.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Piezolith 3000 Triple Focus is a physical medical device, not a machine learning model that undergoes "training" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as above.
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510(k) SUMMARY
K072538 PAGE | VF 2
United Medical Systems (DE), Inc.'s Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
United Medical Systems (DE), Inc. 1500 West Park Drive Suite 390 Westborough, MA 01581 Phone: (508) 870-6565 Fax: (508) 870-0682
Contact Person: Joseph Pelletiere, Director of Operations
Date Prepared: September 6, 2007
Name of Device and Name/Address of Sponsor
Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System
United Medical Systems (DE), Inc. 1500 West Park Drive Suite 390 Westborough, MA 01581
Common or Usual Name/Classification Name
Extracorporeal Shock Wave Lithotripsy System/ Urological Lithotripter
Predicate Devices
United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147)
Intended Use / Indications for Use
The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Technological Characteristics
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The Piezolith 3000 Triple Focus consists of (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X·ray imaging is used) mounted to a swivel slide on C-arm (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.
Performance Data
Bench and clinical testing was performed using the Piezolith 3000 Triple Focus. In addition, the modified device was tested according to the following standards: IEC 60601-1 (1988) (including Amendment 1(1991) and Amendment 2 (1995)); IEC 60601-1-1 (2000) with Amendment 1, 1995; IEC 60601-1-2 (2001); IEC 60601-2-36 (1997); IEC 61846 (1998). In all instances, the Piezolith 3000 Triple-Focus functioned as intended and the results observed were as expected.
Substantial Equivalence
The Piezolith 3000 Triple Focus is as safe and effective as the Piezolith 3000 (K032958), the Karl Storz Modulith Lithotripter (K010340, K012482, K011700), and the Direx Systems Corporation Integra (K053640, K062147). The Piezolith 3000 Triple Focus has the same intended uses/indications for use, and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the Piezolith 3000 Triple Focus and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Piezolith 3000 Triple-Focus is as safe and effective as the predicate devices. Thus, the Piezolith 3000 Triple Focus is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JAN 30 2008
United Medical Systems, Inc. c/o Mr. Jeffrey K. Shapiro Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 WASHINGTON DC 20005
Re: K072538 Trade/Device Name: Piezolith 3000 Triple-Focus Extracorporeal Shock Wave Lithotripsy System Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: January 23, 2008 Received: January 23, 2008
Dear Mr. Shapiro:
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.
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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 (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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/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 Statement
K072538 510(k) Number (if known):
Device Name: Piezolith 3000 Triple Focus Lithotripter
Indications for Use:
The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Prescription Use __ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Braxton
Page ____ of_
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K072538
§ 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.”)