(86 days)
Not Found
No
The summary describes a surgical laser system with standard components and controls. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is a surgical laser intended for medical procedures, specifically to treat benign prostatic hypertrophy (BPH) through endoscopic holmium laser resection of the prostate (HoLRP), which is a therapeutic intervention.
No
The device is a surgical laser intended for treatment, specifically for endoscopic holmium laser resection of the prostate (HoLRP) and other soft tissue ablation, vaporization, excision, incision, and coagulation procedures. It does not perform any diagnostic functions.
No
The device description explicitly lists multiple hardware components, including a laser console, fiber port, control and display panels, footswitch, handswitch, remote control unit, and delivery device systems and accessories. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical laser used for procedures like resection, ablation, vaporization, excision, incision, and coagulation of soft tissue. These are all in vivo procedures performed directly on the patient's body.
- Device Description: The description details components of a surgical laser system, not equipment used for testing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples in vitro. This device is a surgical tool used in vivo.
N/A
Intended Use / Indications for Use
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and the delivery systems and accessories that are used with them to deliver Ho:YAG and Ho:YAG/Nd:YAG laser energy are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:
- Ho:YAG urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgery; and general surgery; and
- Nd:YAG urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH).
The modified and the currently marketed Coherent VersaPulse Select Single Wavelengt (Ho:YAG) and Dual Wavelength (Ho:YAC/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for tr ign prostatic hypertrophy (BPH).
Product codes
GEX
Device Description
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are comprised of the following main components:
- a laser console
- a fiber port (for delivery systems)
- control and display panels
- footswitch and handswitch delivery controls
- a remote control unit
- a variety of delivery device systems and accessories
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, prostate
Indicated Patient Age Range
Not Found
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)
Clinical data was provided to demonstrate that the Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective, when indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
Clinical study results demonstrated that the modified and predicate Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518
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.
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Attachment 10 510(k) Summary Statement for the Modified Coherent VersaPulse Select Ho:YAG Single Wavelength and Ho:YAG/Nd:YAG Dual Wavelength Surgical Lasers
I. General Information
Coherent Medical Group Submitter: 3270 West Bayshore Road Palo Alto, CA 94303 Anne C. Worden Contact Person: February 20, 1998 Summary Preparation Date:
- II. Names
Device Names: Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Accessories.
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).
III. Predicate Devices
• Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518)
IV. Product Description
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are comprised of the following main components:
- · a laser console
- · a fiber port (for delivery systems)
- · control and display panels
- · footswitch and handswitch delivery controls
- · a remote control unit
- · a variety of delivery device systems and accessories
V. Indications for Use
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and the delivery systems and accessories that are used with them to deliver Ho:YAG and Ho:YAG/Nd:YAG laser energy are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:
1
- urology; urinary lithotripsy; arthroscopy; discectomy; endonasal · Ho:YAG surgery; gynecological surgery; and general surgery; and
- urology; general surgery; gastroenterology; thoracic and pulmonary • Nd:YAG surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH).
VI. Rationale for Substantial Equivalence
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and their delivery device accessories share the same indications for use, similar design features (including control system, wavelengths, beam quality, laser configuration, active medium, cooling system, and controls and displays), functional features (including power, repetition rate, energy, spot sizes and treatment areas), and therefore are substantially equivalent to the Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and their delivery device accessories (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518).
VII. Safety and Effectiveness Information
Clinical data was provided to demonstrate that the Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective, when indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
VIII. Conclusion
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers were found to be substantially equivalent to the currently marketed and predicate VersaPulse Select surgical lasers. The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers share the same indications for use, design features, and similar functional features as, and thus are substantially equivalent to the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers.
Clinical study results demonstrated that the modified and predicate Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Ms. Anne C. Worden ·Sr. Manager, Regulatory Affairs Coherent® Medical Group 3270 West Bayshore Road Post Office Box 10122 94303-0810 Palo Alto, California
K980685 Re: Modified Versapulse Select Ho:YAG/ND:YAG Trade Name: Lasers Regulatory Class: II GEX Product Code: February 20, 1998 Dated: Received: February 23, 1998
Dear Ms. Worden:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 II (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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Rand and Drug Administration (FDA) will verify such assamptions. Failure to comply with the GMP regulation may result in regulatery In addition, FDA may publish further announcements action. 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.
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Page 2 - Ms. Worden
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) 594-4595. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witton, Ph.D.
a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known):_____________________________________________________________________________________________________________________________________________________ Device Name : Modified Coherent VersaPulse Select Single Wavelength Ho:YAG & Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers & Delivery Devices
Indications For Use:
The modified and the currently marketed Coherent VersaPulse Select Single Wavelengt
(Ho:YAG) and Dual Wavelength (Ho:YAC/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for tr ign prostatic hypertrophy (BPH).
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980685 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use (Optional Format 1-2-96) |
tication, 510(k) for the Modifi Ise Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers Attachment