(117 days)
Not Found
Not Found
No
The summary describes a laser system for lithotripsy and does not mention any AI or ML components or functionalities.
Yes
The device is used for the fragmentation and vaporization of calculi stones in the urinary system, which is a treatment for a medical condition.
No
The device is described as a laser system for fragmentation and vaporization of calculi stones, which is a therapeutic treatment. There is no mention of it being used to identify, detect, or diagnose a condition.
No
The device description explicitly states it is a "Holmium Y AG Laser system," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Urological Laser Lithotripsy stone therapy treatment" and "fragmentation and vaporization of calculi stones in the urinary system." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a laser system used for physical intervention (fragmentation and vaporization), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The CALCULASE Holmium Laser System and Accessories are to be used by qualified surgeons in Urological Laser Lithotripsy stone therapy treatment. It is intended to be used in the fragmentation and vaporization of calculi stones in the urinary system (bladder, urethra, and kidney).
Product codes
GEX
Device Description
Karl Storz CALCULASE Holmium Laser System is a Holmium Y AG Laser system operating at a wavelength of 2080 (2100) nm with impulse energy of 500-1700mJ and pulse frequency of 4-8Hz. The system is suitable for use in noninvasive and invasive Urological Lithotripsy stone therapy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary system (bladder, urethra, and kidney)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons in Urological Laser Lithotripsy stone therapy treatment
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font. The logo is white against a black background.
JAN 2 3 2006
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 Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact: | Paul S. Lee |
| Device Identification: | Common Name:
Holimium (Ho: YAG) Laser
Trade Name: (optional)
Karl Storz CALCULASE Holmium Laser System |
Indication: The CALCULASE Holmium Laser System and Accessories are to be used by qualified surgeons in Urological Laser Lithotripsy stone therapy treatment. It is intended to be used in the fragmentation and vaporization of calculi stones in the urinary system (bladder, urethra, and kidney).
Device Description: Karl Storz CALCULASE Holmium Laser System is a Holmium Y AG Laser system operating at a wavelength of 2080 (2100) nm with impulse energy of 500-1700mJ and pulse frequency of 4-8Hz. The system is suitable for use in noninvasive and invasive Urological Lithotripsy stone therapy procedures.
Substantial Equivalence: The CALCULASE Holmium Laser System is substantially equivalent to the predicate devices since the basic technologies, designs, safety features, and intended uses are similar. The minor differences between the Karl Storz CALCULASE Holmium Laser System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function, or intended use of these devices.
Signed:
Paul Lee
Senior Regulatory Affairs Specialist
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JAN 2 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Drive Culver City, California 90230
Re: K052680
Trade/Device Name: Karl Storz CALCULASE Holmium Lašer System and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 23, 2005
Received: November 9, 2005
Dear Mr. Lee:
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. Isting 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 such 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
2
Page 2 - Mr. Lee
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.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Milken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in large, outlined letters, with a circular design in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is in white against a black background.
510(k) Number (if known): Not yet assigned.
Device Name: Karl Storz CALCULASE Holmium Laser System and Accessories
Indications for Use: The CALCULASE Holmium Laser System and Accessorics are to be used by qualified surgeons in Urological Laser Lithotripsy stone therapy treatment. It is intended to be used in the fragmentation and vaporization of calculi stones in the urinary system (bladder, urethra, and kidney).
Prescription Use:
(Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use:
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
Restorative Division and Neu. 510(k) Number
0000003