(40 days)
P870018, Supplement 21
Not Found
No
The summary describes a lithotripsy system with a modified shockwave head for increased penetration depth. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is described as being capable of both diagnostic and therapeutic procedures, and its primary use is for the fragmentation of urinary tract stones through extracorporeal shock wave lithotripsy (ESWL), which is a therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter." It also mentions the unit is designed for patient placement in positions which facilitate "urological and diagnostic procedures."
No
The device description clearly states it is a "Shockwave System" and describes modifications to a "shockwave head," indicating it is a hardware device that delivers physical shockwaves for lithotripsy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for therapeutic and diagnostic procedures related to urolithiasis (kidney stones). Specifically, it focuses on the fragmentation of stones using extracorporeal shock wave lithotripsy (ESWL) and facilitating other urological and diagnostic procedures.
- Device Description: The description details a shockwave system designed to physically break down stones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
This device is a therapeutic medical device used for a physical intervention (shockwave lithotripsy) and to aid in other urological procedures.
N/A
Intended Use / Indications for Use
LITHOSTAR Modularis with Shockwave System Coplis is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 LNS, 78 MMZ
Device Description
Siemens LITHOSTAR MODULARIS with Shockwave System Collis is a modification to our predicate device. The shockwave head has been modified to provide an increased penetration depth for a more obese patient population. The penetration depth has been increased from 120mm to 140mm..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney and upper ureter, urinary tract, renal calvceal, renal pelvis, upper ureteral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSTAR MODULARIS with Shockwave System Colls is safe and effective and comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
P870018, Supplement 21
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
§ 876.4890 Urological table and accessories.
(a)
Identification. A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.(b)
Classification. (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
NOV 2 5 2003 LITHOSTAR MODULARIS Special 510(k) Siemens Medical Solutions, Inc.
K033335
Page 1 of 2
SECTION 3 - 510 (K) SUMMARY
Submitter's information
Name
Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway Malvern, PA 19355
Contact Person:
Debbie Peacock Name: Technical Specialist. Requlatory Affairs Title: (610) 448-1773 Phone: Fax: (610) 448-1787 debra.peacock@siemens.com E-mail:
Date summary prepared
10/13/03
Device names
Trade Name
LITHOSTAR MODULARIS with Shockwave System Colus
Common or Classification Name
LITHOSTAR MODULARIS
A. Legally marketed device to which the device is substantially equivalent
The predicate device is the Siemens LITHOSTAR MODULARIS, P870018, Supplement 21.
B. Description of device
Siemens LITHOSTAR MODULARIS with Shockwave System Collis is a modification to our predicate device. The shockwave head has been modified to provide an increased penetration depth for a more obese patient population. The penetration depth has been increased from 120mm to 140mm..
C. Indications for Use
LITHOSTAR MODULARIS with Shockwave System Calle is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calvceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shockwave lithotripsv (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
1
LITHOSTAR MODULARIS Special 510(k) Siemens Medical Solutions, Inc.
K033335
Page 2 of 2
D. Contraindications
Do not use the LITHOSTAR MODULARIS in patients with:
- Confirmed or suspected pregnancy. ●
- Coaqulation abnormalities (as indicated by abnormal prothrombin time, . partial thromboplastin time, or bleeding time) or those currently receiving anticoagulants (including aspirin).
- Arterial calcification or vascular aneurysm in the lithotripter's shockwave . path.
- Urinary tract obstruction distal to the stone. .
- Anatomy which precludes focusing the device at the target stone, such as . severe obesity or excessive spinal curvature.
E. Warnings and Precautions
A listing of Warnings and Precautions are included in labeling.
F. Technological characteristics
The modification has not altered the fundamental technology of the predicate device.
G. Assessment of non-clinical performance data
Device shockwave parameters were measured and documented according to Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shockwave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi..
H. Assessment of clinical performance data
The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSTAR MODULARIS with Shockwave System Colls is safe and effective and comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 2003
Ms. Debra A. Peacock Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K033335
Trade/Device Name: Lithostar Modularis with Shockwave System Colus Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripters, Urological Regulatory Class: II Product Code: 78 LNS Regulation Number: 21 CFR$ 876,4890 Regulation Name: Urological Table and Accessories Regulatory Class: II (Exempt) Product Code: 78 MMZ Dated: November 17, 2003 Received: November 18, 2003
Dear Ms. Peacock:
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 (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.
3
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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under 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 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
4
INDICATIONS FOR USE SECTION 2
510(k) Number (if known): K033335
Device Name: LITHOSTAR MODULARIS WITH SHOCK WAVE SYSTEM Cplus
Indications For Use:
LITHOSTAR Modularis with Shockwave System Coplis is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
(Please do not write below this line - continue on another page if needed)
============================================================================================================================================================================== Concurrence of the CDRH, Office of Device Evaluation (ODE)
V Prescription Use
OR Over-The-Counter Use (Per 21 CFR 801.109)
David A. Lozano
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K033335
CONFIDENTIAL