(66 days)
The GreenLight™ XPS Laser System is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology.
This GreenLight XPS Laser System consists of a console, a fiber optic delivery device, a camera filter and safety glasses that are required in order to use the system. The GreenLight XPS Laser System design and principles of operation are based upon the AMS GreenLight HPS Surgical Laser System & Accessories (K062719) that was successfully introduced to the market in 2006.
The provided text describes a 510(k) premarket notification for the GreenLight™ XPS Laser System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, the requested information regarding acceptance criteria, study details (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) is not explicitly present in the provided document for the GreenLight™ XPS Laser System.
Here's an explanation based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in the format of a clinical trial. For a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to the predicate device.
- Reported Device Performance: The document states that "All necessary bench testing was conducted on the proposed GreenLight XPS Laser System to support a determination of substantial equivalence to the predicate device." However, the specific results of this bench testing or a table of performance metrics are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/not provided. This device relies on "bench testing" to demonstrate substantial equivalence, not a clinical test set in the traditional sense with patient data.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The substantial equivalence determination is based on a comparison to a predicate device and bench testing, not on expert-established ground truth for a test set of data.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical test set data or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- No, an MRMC comparative effectiveness study was not performed or referenced in this 510(k) summary. This type of study is more common for diagnostic devices where human interpretation is involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a laser surgical system, not an algorithm or AI device. It does not have "standalone performance" in the context of an algorithm.
7. The Type of Ground Truth Used:
- The implicit "ground truth" for a 510(k) in this context is the performance and safety profile of the predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719). The new device aims to be substantially equivalent to this established device. Bench testing would assess if the new device's physical and functional characteristics meet established engineering and safety standards, aligning with the predicate.
8. The Sample Size for the Training Set:
- Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The design and development of the device would leverage engineering principles and prior knowledge from the predicate device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.
In summary:
This 510(k) application for the GreenLight™ XPS Laser System focuses on demonstrating substantial equivalence to an existing predicate device (GreenLight HPS™ Surgical Laser System & Accessories K062719) through bench testing. The document explicitly states: "The GreenLight XPS Laser System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed GreenLight XPS Laser System is substantially equivalent to the predicate device."
The types of studies and criteria requested (MRMC, ground truth, training sets, etc.) are typically associated with diagnostic algorithms or devices requiring de novo clearance or PMAs, where clinical performance against a true gold standard needs to be established. For a 510(k) for a surgical laser system, the bar is demonstrating that it's as safe and effective as a device already on the market.
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AMERICAN MEDICAL SYSTEMS, INC.
K092735
GREENLIGHT
510(k) PREMARKET NOTIFICATION
XPS LASER SYSTEM
SECTION 6 510(k) SUMMARY ·
NOV - 9 2009
510(k) Notification K092735
GENERAL INFORMATION
Applicant:
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 U.S.A. Phone: 952-930-6000 Fax: 952-930-6007
Contact Person:
Darlene Crockett-Billig President Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, Ca 94089 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865 Email: dcb@experiengroup.com
Date Prepared: September 18, 2009
Classification: 21 CFR§878.4810
Product Code: GEX
Trade Name: GreenLight™ XPS Laser System
Generic/Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Predicate Device
GreenLight HPS™ Surgical Laser System & Accessories (K062719)
Indications For Use:
The GreenLight" XPS Laser System is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue,
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SECTION 6 510(k) SUMMARY
muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:
General Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condylom'a acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas: lesions of external genitalia: urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia/hypoplasia (BPH).
Product Description
This GreenLight XPS Laser System consists of a console, a fiber optic delivery device, a camera filter and safety glasses that are required in order to use the system. The GreenLight XPS Laser System design and principles of operation are based upon the AMS GreenLight HPS Surgical Laser System & Accessories (K062719) that was successfully introduced to the market in 2006.
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SECTION 6 510(k) SUMMARY
Substantial Equivalence
The GreenLight XPS Laser System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed GreenLight XPS Laser System is substantially equivalent to the predicate device.
Testing in Support of Substantial Equivalence Determination
All necessary bench testing was conducted on the proposed GreenLight XPS Laser System to support a determination of substantial equivalence to the predicate device.
Summary
The GreenLight XPS Laser System is substantially equivalent to the predicate device
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of 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 or other bird-like figure, with its wings spread and head turned to the right. The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV - 9 2009
American Medical Systems, Inc. % Experien Group, LLC Ms. Darlene Crockett-Billig President 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089
Re: K092735
Trade/Device Name: GreenLight™ XPS 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: September 18, 2009 Received: September 21, 2009
Dear Ms. Crockett-Billig:
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.
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. You must
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Page 2 - Ms. Darlene Crockett-Billig
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mikkelsen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AMERICAN MEDICAL SYSTEMS, INC.
GreenLight" XPS Laser System 510(k) PREMARKET NOTIFICATION
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K092735_
Device Name: GreenLight™ XPS Laser System
Indications For Use:
The GreenLight™ XPS Laser System is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:
General Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Prescription Use X 21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
val eviteroise
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SECTION 5 INDICATIONS FOR USE STATEMENT
Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia/hypoplasia (BPH).
Nilkeal for mam
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092735
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.