(57 days)
The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of bladder calculi.
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of bladder 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.
This document describes the 510(k) submission for the Karl Storz Calcusplit Pneumatic Lithotriptor. The device is a pneumatic lithotriptor designed for the fragmentation of bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., fragmentation time, stone clearance rate). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated safety no worse than the EMS Swiss Lithoclast. |
| Effectiveness no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated effectiveness no worse than the EMS Swiss Lithoclast. |
| Same intended use as predicate | The Calcusplit has the same intended use as the predicate Swiss Lithoclast (pneumatic fragmentation of bladder calculi). |
| Same technological characteristics as predicate | 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. |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench testing of probe endurance and tissue effects." It does not specify the sample size for this bench testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information is provided regarding experts or ground truth establishment for a test set. The evaluation relies on direct comparison to the predicate device's established safety and effectiveness.
4. Adjudication method for the test set:
Not applicable. There is no mention of a test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The evaluation method described is bench testing and comparison to a predicate device, not a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a pneumatic lithotriptor, not an AI algorithm. Its performance is inherent to its mechanical function.
7. The type of ground truth used:
The "ground truth" for the device's performance is established by the safety and effectiveness of the legally marketed predicate device (EMS Swiss Lithoclast Lithotriptor). The Karl Storz Calcusplit's performance is deemed acceptable if it is "no worse than" the predicate. A literature search also supported the general safety and effectiveness of Pneumatic Lithotripsy.
8. The sample size for the training set:
Not applicable. This device is a mechanical medical instrument, not an AI system that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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AUG 18 1003
K 992114 Pg. 1 of 2
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 LithotriptorTrade Name: (optional) |
Karl Storz Calcusplit The Karl Storz Calcusplit system is intended for use by qualified surgeons and Indication:
provides for the pneumatic fragmentation of bladder 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
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Image /page/1/Picture/0 description: The image shows a black and white photo of a document. The document contains the text 'K 992114' and 'Jag 2008 r'. There is also a logo for Karl Storz Endoskope in the upper right corner of the image. The document appears to be a record or label of some kind.
for the EMS Swiss Lithoclast Lithotriptor. A literature search demonstrated that Pneumatic Lithotripsy (PL) is a safe and effective means of fragmenting urinary stones.
Signed: Surry Summing
Kevin Kennan Senior Regulatory Affairs Specialist
Date: June 18, 1999
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230
Re: K992114 Calcusplit Lithotriptor Dated: June 18, 1999 Received: June 22, 1999 Requlatory 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 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 531 through 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz. M.D. Acting 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):
K 992114
Device Name: Calcusplit Lithotriptor
Indications for Use: These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of bladder calculi.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
(Per 21 CFR 801.109)
OR Over-The-Counter Use:
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992114
§ 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.”