(73 days)
The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of renal and lower ureteral calculi.
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of lower ureter and renal calculi.
The Karl Storz Calcusplit is a pneumatic lithotriptor designed for the pneumatic fragmentation of urinary calculi. The Calcusplit system uses pneumatic energy converted to mechanical energy to disintegrate calculi. The force of the mechanical energy provided by this device is sufficient to fragment calculi of most sizes and composition.
The provided text is a 510(k) summary for the Karl Storz Calcusplit Pneumatic Lithotriptor. This document focuses on demonstrating substantial equivalence to a predicate device (EMS Swiss Lithoclast) rather than establishing novel safety and effectiveness criteria as would be done for a new device. Therefore, the information provided is not structured in a way that directly addresses typical "acceptance criteria" for a new AI/medical imaging device and the study proving it meets those.
However, I will extract the relevant information and interpret it within the given framework, noting where the information is not directly applicable or is inferred.
Here's an analysis based on your request, with the understanding that this document describes a device substantially equivalent to another device and not a novel AI/imaging device with specific performance metrics against a defined acceptance criterion.
Acceptance Criteria and Device Performance for Karl Storz Calcusplit Pneumatic Lithotriptor
The document describes a comparative study against a predicate device, not a study setting de novo acceptance criteria. The "acceptance criteria" here are effectively "no worse than the predicate device" in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Clinical Trial and Bench Testing) |
|---|---|
| Safety: No worse than the EMS Swiss Lithoclast Lithotriptor regarding tissue effects and overall safety. | Bench testing demonstrated that safety was "no worse than" the predicate. Clinical trial demonstrated safety was "no worse than" the predicate. |
| Effectiveness: No worse than the EMS Swiss Lithoclast Lithotriptor in the pneumatic fragmentation of renal and lower ureteral calculi. | Bench testing demonstrated that effectiveness was "no worse than" the predicate (e.g., probe endurance). Clinical trial demonstrated effectiveness in fragmenting lower ureter and renal stones was "no worse than" the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "an unmasked and self-controlled multi-center clinical trial." However, it does not specify the sample size for this clinical trial.
- Data Provenance: The document does not explicitly state the country of origin. It does mention "multi-center," implying data from multiple sites, likely within the country where the FDA submission was made (USA), but this is not confirmed. The trial was prospective, as described by "clinical trial was also conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable in this context. The study is a clinical trial evaluating the performance of a physical medical device (a lithotriptor) in fragmenting stones in human patients. The "ground truth" of whether a stone was fragmented, and the safety outcomes, would be determined by clinical observation, imaging studies, and patient outcomes, likely assessed by the surgeons performing the procedures and other clinical staff, rather than a panel of independent experts establishing a "ground truth" for a test set in the way it's done for AI models (e.g., image annotation).
4. Adjudication Method for the Test Set
Not applicable in the typical sense for an AI/imaging device evaluating a test set. Clinical trial outcomes (e.g., successful stone fragmentation, adverse events) were likely assessed by investigators at each site according to the study protocol. The phrase "unmasked and self-controlled" refers to the trial design, not an adjudication method for a test set of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Readers with vs. without AI Assistance)
Not applicable. This is not an AI or imaging device where human readers interact with AI. It is a pneumatic lithotriptor used by surgeons.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. This is a physical surgical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this clinical trial would be based on clinical outcomes (e.g., successful fragmentation of calculi, complete clearance, residual fragments, complications) as assessed by the treating surgeons and subsequent evaluations (e.g., post-procedure imaging, patient follow-up). The specific methodology for determining successful fragmentation or safety outcomes would have been detailed in the clinical trial protocol (which is not provided here).
8. Sample Size for the Training Set
Not applicable. This device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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JUN 1 5 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Pneumatic Lithotriptor |
Trade Name: (optional) Karl Storz Calcusplit
Indication: The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of renal and lower ureteral calculi.
Predicate: EMS Swiss Lithoclast Lithotriptor
Device Description: The Karl Storz Calcusplit is a pneumatic lithotriptor designed for the pneumatic fragmentation of urinary calculi. The Calcusplit system uses pneumatic energy converted to mechanical energy to disintegrate calculi. The force of the mechanical energy provided by this device is sufficient to fragment calculi of most sizes and composition.
Substantial Equivalence: The Karl Storz Calcusplit is substantially equivalent to the EMS Swiss Lithoclast currently marketed by Boston Scientific Corporation (K951531 and K963285); the Karl Storz Calcusplit has the same intended use as the predicate Swiss Lithoclast and has the same technological characteristics as the predicate Swiss Lithoclast. Both the Calcusplit and the Lithoclast systems use compressed air and direct contact, rigid probes to fragment urinary tract stones under direct vision endoscopic control.
Bench testing of probe endurance and tissue effects was conducted and demonstrated that the safety and effectiveness of the Calcusplit system was no worse than the safety and efficacy for the EMS Swiss Lithotriptor. An unmasked and self-controlled multi-center
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clinical trial of the Calcusplit system for fragmentation of lower ureter and renal stones was also conducted. The study demonstrated that the safety and effectiveness of the Calcusplit system in fragmenting lower ureter (ureteroscopic approach) and renal stones (percutaneous approach) was no worse than the safety and efficacy for the EMS Swiss Lithoclast Lithotriptor.
Signed:
Kevin Kennan
Senior Regulatory Affairs Specialist
Date: March 31, 1998
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Štorz Endoscopy 600 Corporate Pointe Culver City, CA 90230-7600
Re: K981233
Calcusplit Lithotriptor and Accessories Dated: March 31, 1998 Received: April 3, 1998 Regulatory Class: III 21 CFR 876.4480/Procode: 78 FFK
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director. Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Not yet assigned
Device Name: Calcusplit Lithotriptor
Indications for Use: These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of lower ureter and renal calculi.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daler R. Rolling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
OR Over-The-Counter Use:
510(k) Number K981233
Prescription Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”