(148 days)
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Not Found
No
The summary describes a lithotripsy device with standard components (shock wave generator, imaging systems, control console) and mentions no features or studies related to AI/ML.
Yes
The device's intended use is to "fragment urinary stones," which is a treatment action.
No
The "Intended Use" states the device is "intended to fragment urinary stones," which describes a therapeutic purpose, not a diagnostic one. While it uses imaging (X-ray, ultrasound) for localization, this is to facilitate treatment, not to diagnose a condition.
No
The device description clearly lists multiple hardware components including a shock wave generator, control console, X-ray, ultrasound imaging system, and treatment table.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Piezolith 3000 is used to directly treat a condition within the human body. It fragments urinary stones using shock waves.
The description clearly indicates that the device is a therapeutic device used for a medical procedure performed directly on a patient, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Piezolith 3000 is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Product codes (comma separated list FDA assigned to the subject device)
LNS
Device Description
The Piezolith 3000 is comprised of the following principal components: (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; (2) a control console; (3) an X-ray; (4) ultrasound imaging system for localization; and (5) a treatment table.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray; ultrasound
Anatomical Site
kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The company performed shock wave characterization measurements, localization accuracy measurements, and road testing. In addition, the Piezolith 3000 system was tested according to and conforms with the following voluntary consensus standards: (1) IEC 60601-1: 1988 with Amdt 1, 1991 and Amdt 2, 1995 "Medical electrical equipment," (2) IEC 60601-1-1: 1992 with Amdt 1, 1995 "Medical electrical equipment; Part 1: General requirements for safety," (3) IEC 60601-1-2: 1993 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests; 62A/336/FDIS", (4) CISPR 11: 1990 "Limits and Methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment," (5) IEC 60601-2-36: 1997 "Medical electrical equipment: Part 2 Particular requirement for the safety of equipment for extracorporeally induced lithotripsy," and (6) as reference for the measurements: IEC 61846: 1998 "Ultrasonic - Pressure pulse lithotripters -Characteristics of field." In addition, clinical data demonstrated that the device is substantially equivalent to its predicate devices. In all instances, the Piezolith 3000 functioned as intended and performed as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”)
0
510(k) SUMMARY
UMS's Piezolith 3000 Lithotripter
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
United Medical Systems One Technology Drive, Third Floor Westborough, MA 01581 Tel: (800) 516-9425 Fax: (508) 870-0682 Registration Number: 1226692
Contact Person: Jorgen Madsen
Date Prepared: September 17, 2003
Name of Device and Name/Address of Sponsor
Piezolith 3000 Lithotripter
United Medical Systems One Technology Drive, Third Floor Westborough, MA 01581
Common or Usual Name
Extracorporeal Shock Wave Lithotripter
Classification Name
Extracorporeal Shock Wave Lithotripter
Predicate Devices
Richard Wolf Piezolith E.P.L. Lithotripter, Model 2300 Dornier Compact S Dornier Compact Delta Siemens Modularis Litho Storz Modulith SLX Storz Modulith SLK
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1032958 PG. 2 OF 2
Intended Use / Indications for Use
The Piezolith 3000 is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Technological Characteristics
The Piezolith 3000 is comprised of the following principal components: (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; (2) a control console; (3) an X-ray; (4) ultrasound imaging system for localization; and (5) a treatment table.
Substantial Equivalence
The Piezolith 3000 is substantially equivalent to the other currently marketed lithotripters which are referenced above. The Piezolith 3000 and its predicate devices are all extracorporeal shock wave lithotripters. Thus, the Piezolith 3000 raises no new issues of safety or effectiveness.
Performance Data
The company performed shock wave characterization measurements, localization accuracy measurements, and road testing. In addition, the Piezolith 3000 system was tested according to and conforms with the following voluntary consensus standards: (1) IEC 60601-1: 1988 with Amdt 1, 1991 and Amdt 2, 1995 "Medical electrical equipment," (2) IEC 60601-1-1: 1992 with Amdt 1, 1995 "Medical electrical equipment; Part 1: General requirements for safety," (3) IEC 60601-1-2: 1993 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests; 62A/336/FDIS", (4) CISPR 11: 1990 "Limits and Methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment," (5) IEC 60601-2-36: 1997 "Medical electrical equipment: Part 2 Particular requirement for the safety of equipment for extracorporeally induced lithotripsy," and (6) as reference for the measurements: IEC 61846: 1998 "Ultrasonic - Pressure pulse lithotripters -Characteristics of field." In addition, clinical data demonstrated that the device is substantially equivalent to its predicate devices. In all instances, the Piezolith 3000 functioned as intended and performed as expected.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2004
United Medical Systems, Inc. c/o Jeffrey K. Shapiro Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004-1109
Re: K032958
Trade/Device Name: Piezolith 3000 Lithotripter Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporcal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: December 17, 2003 Received: December 17, 2003
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 (sec 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 (OS) regulation (2) 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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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notheadon. The PDA miams cassification 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 advice of your do too of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (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, for questions on the promote the regulation entitled, "Misbranding Other of Complance at (301) 37 1 185 (21CFR Part 807.97) you may obtain. Other general by relection on your responsibilities under the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Colless http://www.fda.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
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Indications for Use
| ్ 10(k) Number (if known): K032958 | |
|---|---|
| -------------------------------------- | -- |
United Medical Systems, Inc. Piezolith 3000 Device Name: Lithotripter
The Piezolith 3000 is intended to fragment Indications for Use: urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Division Sign. Occ.
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Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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