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.

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..

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "LITHOSTAR MODULARIS with Shockwave System Collis." This device is a modification of a previously approved lithotripter, designed to increase penetration depth for obese patients.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

The document states that the device is "safe and effective and comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21)." This implies that the acceptance criteria are met if the modified device performs equivalently to the predicate device in terms of safety and effectiveness for its stated indications for use.

Acceptance Criteria	Reported Device Performance
Safety	"safe"
Effectiveness	"effective"
Comparability to Predicate Device	"comparable to the currently approved LITHOSTAR MODULARIS (P870018, Supplement 21)."

Study Details

The document mentions "The confirmatory clinical study," indicating that a clinical study was performed. However, it provides very limited details about this study.

Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions a "confirmatory clinical study" but does not detail how ground truth was established within this study, nor does it refer to experts establishing ground truth for a test set in the context of an AI/algorithm-driven device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- The document does not mention or suggest that an MRMC comparative effectiveness study was performed. The device described is an extracorporeal shockwave lithotripter, not an AI-assisted diagnostic or interpretation tool. The comparison is between the new device and a predicate device for stone fragmentation, not between human readers with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument (lithotripter) used for therapeutic procedures, not a diagnostic algorithm. Therefore, "standalone algorithm performance" is not relevant to this device's evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document states "The confirmatory clinical study suggests that treatment of urinary tract stones with the LITHOSTAR MODULARIS with Shockwave System Colls is safe and effective." This implies that the ground truth for "effectiveness" would likely be based on outcomes data related to stone fragmentation and clearance, and "safety" based on documented adverse events. However, specific metrics or methods for establishing this ground truth are not detailed.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "training set" concept is relevant to machine learning models, not physical medical devices like a lithotripter.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

In summary, the provided information is for a conventional medical device (lithotripter) modification, not an AI/ML-driven device. Therefore, many of the requested details pertaining to AI/ML evaluation (like training sets, expert adjudication for algorithms, MRMC studies for AI, etc.) are not present in the document. The evaluation focuses on the physical and clinical performance of the modified device compared to its predicate.

Summary

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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

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.

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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).

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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.

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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

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INDICATIONS FOR USE SECTION 2

510(k) Number (if known): K033335
Device Name: LITHOSTAR MODULARIS WITH SHOCK WAVE SYSTEM Cplus

Indications For Use:

(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

Regulation Number and Section

§ 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.