(372 days)
Not Found
No
The description focuses on the physical properties and function of the laser system and delivery devices, with no mention of AI or ML capabilities.
Yes
The device is intended for use in cutting, coagulating, and vaporizing prostatic tissues during the treatment of benign prostatic hyperplasia (BPH), which indicates a therapeutic purpose.
No
The device description clearly states its intended use is for "cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH)", indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly details hardware components including laser systems (Nd: YAG and KTP), crystals, and angled delivery devices (fibers and connectors). There is no mention of the device being solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH)". This describes a surgical procedure performed directly on the patient's tissue.
- Device Description: The device description details a surgical laser system that emits light energy to interact with tissue. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to diagnose a condition. IVD devices are specifically designed for this type of in vitro analysis.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Benign Prostatic Hyperplasia (BPH) - treatment for benign prostatic hyperplasia, intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic yolumes of 60cc or less. Ablation and hemostasis are performed with Nd: YAG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
Product codes
GEX
Device Description
The Laserscope KTP/Nd: YAG Surgical Laser Systems lasing medium is an yttrium aluminum garnet (YAG rod) that has been doped with a small amount of the element neodymium (Nd). In this system, the electrons of the Nd atoms become excited and release photons of a characteristic wavelength. The light energy that is emitted from this source has a wavelength of 1064 nm which is in the infrared portion of the spectrum.
The KTP/532 laser utilizes the same lasing medium as the Nd: Y AG laser. In this system, the infrared beam produced by Nd: Y AG source is passed through a second crystal made from potassium titanyl phosphate (KTP), The KTP crystal converts some of the infrared light in the green portion of the spectrum. The wavelength of this light is 532 nm. The process that converts the infrared light to the visible ereen light requires two photons of infrared light to produce one photon of green light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: YAG beam. Thus, KTP is not a laser crystal, rather it is a frequency doubling crystal.
Laserscope's line of Angled Delivery Devices have side-firing capabilities for use in contact and non-contact procedures. The devices come in a variety of configurations (length, fiber core diameters, coaxial capability, etc.). The devices are available with either a Laserscope proprietary SmartConnector or a standard SMA-905 connector, facilitating use with either Laserscope or SMA-905 compatible lasers. The SmartConnector versions can transmit both the 532 and 1064 wavelengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostatic tissues
Indicated Patient Age Range
men 50 years of age or older
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K912538, K933880, K920589, K924644
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 17 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE KTP/Nd: YAG SURGICAL LASER SYSTEM AND ANGLED DELIVERY DEVICES FOR THE TREATMENT OF BPH
REGULATORY AUTHORITY
Safe Medical Device Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134 Phone: 408 943-0636 FAX: 408-943-1454
DEVICE TRADE NAME:
800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices (ADD Family Product Line)
DEVICE COMMON NAME:
Laser Instrument, Surgical, Powered Laser Fiberoptic
DEVICE DESCRIPTION:
The Laserscope KTP/Nd: YAG Surgical Laser Systems lasing medium is an yttrium aluminum garnet (YAG rod) that has been doped with a small amount of the element neodymium (Nd). In this system, the electrons of the Nd atoms become excited and release photons of a characteristic wavelength. The light energy that is emitted from this source has a wavelength of 1064 nm which is in the infrared portion of the spectrum.
The KTP/532 laser utilizes the same lasing medium as the Nd: YAG laser. In this system, the infrared beam produced by Nd: Y AG source is passed through a second crystal made from potassium titanyl phosphate (KTP), The KTP crystal converts some of the infrared light in the green portion of the spectrum. The wavelength of this light is 532 nm. The process that converts the infrared light to the visible ereen light requires two photons of infrared light to produce one photon of green light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: YAG beam. Thus, KTP is not a laser crystal, rather it is a frequency doubling crystal.
Laserscope's line of Angled Delivery Devices have side-firing capabilities for use in contact and non-contact procedures. The devices come in a variety of configurations (length, fiber core diameters, coaxial capability, etc.). The devices are available with either a Laserscope proprietary SmartConnector or a standard SMA-905 connector, facilitating use with either Laserscope or SMA-905 compatible lasers. The SmartConnector versions can transmit both the 532 and 1064 wavelengths.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
Laserscope KTP/Nd: Y AG Surgical Laser Systems have been specifically classified as Class II medical devices by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels. Laser fiberoptics have not been classified.
PERFORMANCE STANDARDS:
The Laserscope KTP/Nd: YAG Surgical Laser Systems conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATIONS FOR USE STATEMENT:
KTP/532 with Nd:YAG/1064:
Benign Prostatic Hyperplasia (BPH) - treatment for benign prostatic hyperplasia, intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic yolumes of 60cc or less. Ablation and hemostasis are performed with Nd: YAG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
COMPARISON WITH PREDICATE DEVICE:
The Laserscope KTP/Nd: YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent to the devices cleared under K912538, K933880, K920589 and K924644.
The risks and benefits for the Laserscope KTP/Nd: Y AG Surgical Laser Systems and Angled Delivery Devices are comparable to the predicate devices when used for similar clinical applications.
Since the Laserscope KTP/Nd: YAG Surgical Laser Systems and Angled Delivery Devices are substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe they clearly meet the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Mr. Paul H. Hardiman Manager Regulatory Affairs/Clinical Affairs Laserscope 3052 Orchard Drive San Jose, California 95134-2011
Re: K972575
Trade Name: 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices (ADD Family Product Line) Regulatory Class: II Product Code: GEX Dated: April 10. 1998 Received: April 14, 1998
Dear Mr. Hardiman:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542
3
Page 2 - Mr. Paul H. Hardiman
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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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人1727i
INDICATIONS FOR USE STATEMENT
510(k) Number:
None assigned as of this time
Device Name:
800 Series Surgical Laser Systems and Accessories
Indications for Use:
The 800 Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd: Y AG wavelength (1064 nm). Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/9 description: The image shows a black and white drawing of a symbol. The symbol is a square with an X inside of it. A line extends from the bottom left corner of the square.
Prescription Use (per 21 CFR 801.109)
0
Over-the-Counter Use
Dioollo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982575
5
f7771111
INDICATIONS FOR USE STATEMENT
510(k) Number:
None assigned as of this time
Device Name:
Orion Series Surgical Laser Systems and Accessories
Indications for Use:
The Orion Series Surgical Laser Systems and Accessories are intended for use in cutting, coagulating and vaporizing prostatic tissues during treatment of benign prostatic hyperplasia (BPH) in men 50 years of age or older with prostatic volumes of 60cc or less. Ablation and hemostasis are performed with Nd: YAG wavelength (1064 nm). -Vaporization is performed with the KTP wavelength (532 nm). Specific indications include: laser prostatectomy, visual laser ablation of the prostate (VLAP), obstructive voiding symptoms, obstructive prostatic adenoma, prostatic enlargement, prostatic adenoma and bladder outlet obstruction due to BPH. The device is not intended to treat prostate cancer.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/9 description: The image shows a hand-drawn symbol that resembles a star or asterisk. The symbol is composed of a square with an 'x' through it, and a vertical line extending downwards from the square. The lines are thick and black, and the symbol appears to be drawn with a marker or pen. The symbol is simple and abstract.
Prescription Use (per 21 CFR 801.109)
□
Over-the-Counter Use
bicolefa