The laser is used to create laser energy for the destruction of calculi and/or for soft tissue treatments such as the cutting of tissue and the opening of stenosis and strictures during endoscopic urological applications.

Device Description

The KARL STORZ Calculase II is a Ho-YAG desktop laser that emits a mid-infrared beam at the wavelength of 2080nm with pulse energy of 500-2000mJ and pulse frequency of 4 – 15Hz. The laser energy is transmitted into the tissue via an optical fiber, with the maximum limit of the laser energy set at 20W.

The laser energy generated by Calculase II enables the optimal lithotripsy of all calculus compositions in the human body and soft tissue treatment such as the ablation of strictures and stenosis, for example.

Calculase II is a desktop unit designed to be mobile so that it can be easily transported and placed on top of a desk or cart and positioned within the treatment room by using special, retractable handles located on the both sides of the desktop units. All controls and displays required for operating the unit (On/off switching key, fiber connection port, power setting. etc.) are located on the front of the device in a user-friendly control panel and easy-to-read LED displays, which make the unit safe and easy to operate by the users. The 1-pedal footswitch allows the users to release the laser to the intended area during use.

The Calculase II Holmium Laser system uses a flexible laser fiber, inserted into an endoscope (flexible, semi-rigid and rigid) through the urethra or percutaneously to fragment and vaporize the calculi stone located in the bladder, urethra, or kidney. With the proper energy level setting, it can also perform soft tissue treatments such as ablation of strictures and stenosis. For lithotripsy, proper energy level should be set depending on the fiber diameter, hardness of stone, and location of the stone.

The laser emission is activated by a footswitch pedal, which allows the operator to be "hands-free" for specific target fragmentation. With the fiber placed lightly against the stone or soft tissue in the contact procedure, pulses of energy are used to fragment and vaporize the stone or ablate strictures and stenosis.

As the laser beam is concentrated on the target area, the surrounding tissue can relax, cool and dissipate the heat in between the short bursts. This way the target tissue sustains cumulative thermal effect with maximum protection of the surrounding area.

AI/ML Overview

This document describes the Karl Storz Calculase II, a powered laser surgical instrument (Ho-YAG desktop laser) used for the destruction of calculi and soft tissue treatments in endoscopic urological applications. The information provided is for regulatory submission (K140964) to the FDA to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Stated or Implied)	Reported Device Performance (Calculase II)
Laser Type	Ho-YAG desktop laser	Ho-YAG desktop laser
Wavelength	2080nm	2080nm
Max Energy Output	Not explicitly stated an "acceptance criteria" but compared to predicate 30W.	20W
Pulse Energy Range	Not explicitly stated an "acceptance criteria" but compared to predicate 200-4000mJ.	500 – 2000 mJ
Pulse Frequency Range	Not explicitly stated an "acceptance criteria" but compared to predicate 4 – 20Hz.	4 – 15 Hz
Pulse Duration Range	Not explicitly stated an "acceptance criteria" but compared to predicate 200 – 500 μs.	100 – 500 μs
Safety and Effectiveness	As safe and effective as legally marketed devices (predicate).	Bench testing demonstrates meeting design specifications and substantial equivalence.
Standards Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1	Tested according to these standards.
Functional Performance	Enables optimal lithotripsy and soft tissue ablation	Demonstrated in bench tests, meeting design specifications.
Usability/Operation	User-friendly control panel, easy-to-read LED displays, 1-pedal footswitch.	Device described as having these features for safe and easy operation.

Note on Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to a predicate device (AURIGA QI (K121570)). Therefore, the "acceptance criteria" are largely implied by the predicate device's characteristics and the Calculase II's design specifications. The key acceptance criterion is that the Calculase II meets its own stated specifications and is as safe and effective as the predicate, despite minor differences in technical parameters.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The primary testing described is non-clinical bench testing of the device's performance, not human clinical trials or analysis of patient data.
Data Provenance: The data comes from the manufacturer's (Karl Storz Endoscopy-America, Inc.) internal bench testing. The country of origin for this testing is not explicitly stated but is implicitly associated with the manufacturer. The data is prospective in the sense that the tests were conducted specifically for this regulatory submission to evaluate the device's performance against its specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable as the study described is technical bench testing of device specifications, not a study involving expert assessment of medical data (like images or patient outcomes). Ground truth for device functionality is established through engineering and quality control procedures, adherence to technical specifications, and compliance with recognized standards.

4. Adjudication Method for the Test Set

Ajudication Method: Not applicable. As this is non-clinical bench testing, there is no "adjudication" in the sense of reconciling multiple expert opinions on a medical diagnosis or outcome. The "adjudication" of performance is done by comparing achieved technical parameters to predefined design specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an active medical instrument operated by a human, not an algorithm. Performance is evaluated on the device's physical and functional capabilities, not on an algorithm's standalone accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is based on:
- Engineering Design Specifications: The predetermined technical parameters (e.g., maximum energy output, pulse energy range, frequency range, pulse duration range) the device was designed to achieve.
- International Standards: Compliance with electrical safety and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Functional Verification: The ability of the device to perform its stated functions (lithotripsy, soft tissue ablation) as intended.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware-based medical instrument and does not involve AI or machine learning algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 3, 2014

Karl Storz Endoscopy-America, Inc. Winkie Wong Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo. CA 90245-5017

Re: K140964

Trade/Device Name: Calculase II Regulation Number: 21 CFR§ 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: April 11, 2014 Received: April 17, 2014

Dear Winkie Wong,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140964

Device Name Calculase II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

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, Inc2151 E. Grand AvenueEl Segundo, CA 90245
Contact:	Winkie WongRegulatory Affairs Specialist424-218-8379424-218-8519
Date of Preparation:	April 11, 2014
Device Identification:	Trade Name: Calculase IICommon Name: Powered Laser Surgical InstrumentClassification Name: Powered Laser Surgical Instrument
Product Code:	GEX
Regulation:	CFR 878.4810
Predicate Device(s):	AURIGA QI (K121570)
Device Description:	The KARL STORZ Calculase II is a Ho-YAG desktop laserthat emits a mid-infrared beam at the wavelength of 2080nmwith pulse energy of 500-2000mJ and pulse frequency of 4 –15Hz. The laser energy is transmitted into the tissue via anoptical fiber, with the maximum limit of the laser energy set at20W.The laser energy generated by Calculase II enables the optimallithotripsy of all calculus compositions in the human body andsoft tissue treatment such as the ablation of strictures andstenosis, for example.
	Calculase II is a desktop unit designed to be mobile so that itcan be easily transported and placed on top of a desk or cartand positioned within the treatment room by using special,retractable handles located on the both sides of the desktopunits. All controls and displays required for operating the unit(On/off switching key, fiber connection port, power setting.etc.) are located on the front of the device in a user-friendlycontrol panel and easy-to-read LED displays, which make theunit safe and easy to operate by the users. The 1-pedalfootswitch allows the users to release the laser to the intendedarea during use.
	The Calculase II Holmium Laser system uses a flexible laserfiber, inserted into an endoscope (flexible, semi-rigid and rigid)through the urethra or percutaneously to fragment and vaporizethe calculi stone located in the bladder, urethra, or kidney.With the proper energy level setting, it can also perform softtissue treatments such as ablation of strictures and stenosis.For lithotripsy, proper energy level should be set depending onthe fiber diameter, hardness of stone, and location of the stone.
	The laser emission is activated by a footswitch pedal, whichallows the operator to be "hands-free" for specific targetfragmentation. With the fiber placed lightly against the stoneor soft tissue in the contact procedure, pulses of energy areused to fragment and vaporize the stone or ablate strictures andstenosis.
	As the laser beam is concentrated on the target area, thesurrounding tissue can relax, cool and dissipate the heat inbetween the short bursts. This way the target tissue sustainscumulative thermal effect with maximum protection of thesurrounding area.
Indications For Use:	The laser is used to create laser energy for the destruction ofcalculi and/or for soft tissue treatments such as the cutting oftissue and the opening of stenosis and strictures duringendoscopic urological applications
TechnologicalCharacteristics:	The predicate and subject devices are both Holmium LaserSystem that emit laser energy at the wavelength of 2080nm.However, due to the limitation of the indications of the subjectdevice compared to the predicate, they have minor differencesin the technological characteristics. These differences are:
	The subject device has a maximum energy output as●
	20W, whereas the predicate has the maximumenergy output as 30W; a difference of 10W inmaximum energy.The range for pulse duration for the subject deviceis 100 – 500 μs, whereas the predicate device'srange for pulse duration is 200 – 500 μs; adifference of 100µs in the lower limit for pulseduration. The ranges for the frequency and pulse energy forthe subject device are 4 – 15 Hz and 500 – 2000 mJ,respectively, whereas the predicate device has theranges for the frequency and pulse energy are 4 – 20Hz and 200 – 4000 mJ, respectively; a difference of5 Hz in the upper limit of the frequency range, 300mJ in the lower limit and 2000 mJ in the upper limitof the pulse energy's range. The bench test data for the Calculase II Holmium Laser Systemdemonstrates that the design characteristics used as the basisfor the comparison have been met. The results show that thesubject device has met all its specifications. The performancevalidation test report, System Test Record, is provided insection 021_Performance Testing of this submission.Combining the minor difference in specifications with thelimited indication of use in the Calculase II compared to thepredicate device, Auriga QI, Calculase II does not raise newissues of safety and effectiveness and the devices aresubstantially equivalent for urological application.
Non-ClinicalPerformance Data:	Calculase II is tested according to the following standard:IEC 60601-1 IEC 60601-1-2 IEC 60601-2-22 IEC 60825-1 Additional bench testing for performance verification andvalidation purposes:Max Output Pulse Duration
	Pulse Energy
	The bench testing performed verified and validated that theCalculase II has met all its design specification and issubstantially equivalent to the predicate device, AURIGA QI,for urological procedures.
ClinicalPerformance Data:	No clinical information is required for this submission
Conclusion:	The Karl Storz's Calculase II is substantially equivalent to itspredicate devices. The non-clinical testing demonstrates thatthe device is as safe and effective as the legally marketeddevices.

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Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.