(29 days)
Not Found
No
The description focuses on the laser technology and its surgical applications, with no mention of AI or ML components in the device description, intended use, or performance studies.
Yes
The device is intended for use in various surgical procedures, which are therapeutic interventions aimed at treating medical conditions.
No
Explanation: The device is a surgical laser system intended for use in open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue. Its purpose is therapeutic intervention, not diagnosis.
No
The device description clearly lists hardware components such as a laser console, control and display panel, fiber port, foot switch, and fiber optic delivery devices, in addition to operating software.
Based on the provided information, the VersaPulse P20 Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue." This describes a device used on the patient's body for treatment, not a device used to test samples from the body in a laboratory setting.
- Device Description: The description details a surgical laser system with components like a laser console, fiber port, foot switch, and fiber optic delivery devices. These are typical components of a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the VersaPulse P20 Laser System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VersaPulse P20 Laser System is intended for use in surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue.
The VersaPulse P20 Ho:YAG (2.1 μm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Arthroscopy, Urinary lithotripsy, Gynecological surgery, Gastroenterological surgery, Urology, ENT surgery, General surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VersaPulse P20 Laser System is a desktop 20 Watt surgical Holmium laser and is an improved model configuration of the 20 Watt VersaPulse PowerSuite Holmium Surgical Laser, [510 (k) K011703].
Main functional components :
- A Laser console.
- Control and display panel
- A fiber port for Laser delivery systems
- A covered foot switch
- Operating software
- A variety of fiber optic delivery devices with accessories.
The system uses the same type of laser delivery devices as the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence of the VersaPulse P20 Laser System has been conducted.
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.
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
K 10028
FEB 2 4 2010
Attachment 6 - 510(k) Summary of Safety and Effectiveness - VersaPulse P20 Laser System
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
SUBMITTER INFORMATION: 6.1.
| Submitter's Name: | Lumenis, Inc. |
|---|---|
| Address: | 3959 West 1820 South |
| Salt Lake City, UT 84104 | |
| Contact: | Douglas Stante |
| Phone: | 801-656-2620 |
| Fax: | 801-565-2627 |
| Date of Preparation: | January 20, 2010 |
6.2. DEVICE NAME:
| Trade Name(s): | VersaPulse P20 Laser System |
|---|---|
| Common/Usual Name: | powered laser surgical instrument |
| Classification Names: | 79 GEX |
| CFR Reference: | 21 CFR 878.4810 Laser surgical instrument for use in |
| general and plastic surgery and in dermatology |
6.3. PREDICATE DEVICE:
The predicate device is the Holmium 20 Watt VersaPulse PowerSuite (Ho:Yag) and Dual Wavelength (Ho: Yag/ Nd: Yag) Surgical Lasers, K011703, August 29, 2001.
1
6.4. DEVICE DESCRIPTION:
The VersaPulse P20 Laser System is a desktop 20 Watt surgical Holmium laser and is an improved model configuration of the 20 Watt VersaPulse PowerSuite Holmium Surgical Laser, [510 (k) K011703].
Main functional components :
- A Laser console .
- . Control and display panel
- A fiber port for Laser delivery systems
- . A covered foot switch
- Operating software
- A variety of fiber optic delivery devices with accessories .
The system uses the same type of laser delivery devices as the predicate.
6.5. INTENDED USE:
The VersaPulse P20 Laser System is intended for use in surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue.
TECHNOLOGICAL CHARACTERISTICS SUMMARY & SUBSTANTIAL EQUIVALENCE 6.6. STATEMENT:
The subject device, the VersaPulse P20 Laser System, has the same intended use, general design and same fundamental scientific technology as the Lumenis predicate device.
6.7. PERFORMANCE DATA SUMMARY:
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence of the VersaPulse P20 Laser System has been conducted.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly meant to evoke a sense of care and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB 2 4 2010
Lumenis, Inc. % Mr. Douglas Stante Global Director Regulatory and Quality Systems Compliance 3959 West 1820 South Salt Lake City, Utah 84104
Re: K100228
Trade/Device Name: VersaPulse P20 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: January 25, 2010 Received: February 01, 2010
Dear Mr. Stante:
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 iddications 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 contractuality warranties. We remind you; however, that device labeling must be truthful and not mist leading,
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 it the 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 aft the Act
3
Page 2 - Mr. Douglas Stante
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); 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 53.1-542 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/CDRHQffices/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.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2 - Indications for Use Statement
| 510(k) Number (if known) | K 100 228 |
|---|---|
| Device Name | VersaPulse P20 |
| Indications for Use | The VersaPulse P20 Ho:YAG (2.1 μm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: ArthroscopyUrinary lithotripsyGynecological surgeryGastroenterological surgeryUrologyENT surgeryGeneral surgery |
| Prescription Use (Per 21 CFR 801. 109) | X OR Over-The-Counter Use_________________ |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100228
ﻳﺔ، ﻓ
·
ﻟﺴﻴﺔ
・・・
:28
:: :
። .