(87 days)
No
The description focuses on the physical characteristics and function of a fiber optic delivery device for a laser system, with no mention of AI or ML capabilities.
Yes
The device is described as a fiber optic delivery device used for surgical procedures like incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, which are all therapeutic actions.
No
Explanation: The "Intended Use / Indications for Use" section states that Fiber One is a "fiber optic delivery device" intended for use with a laser system for "surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue." This description indicates it is a therapeutic or surgical device, not a diagnostic one.
No
The device description clearly states "Fiber One is a fiber optic delivery device" and describes physical components like a "side firing mechanism" and being "liquid cooled." It is a hardware device used to deliver laser energy.
Based on the provided information, the Fiber One device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use." These indications involve surgical procedures on soft tissue, including vaporization of the prostate. This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The description details how the device delivers laser energy to tissue for surgical purposes (incision/excision, vaporization, ablation, hemostasis, coagulation). This is consistent with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are designed to perform tests on samples to aid in diagnosis, monitoring, or screening.
In summary, the Fiber One is a surgical delivery device used in conjunction with a laser system for therapeutic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Fiber One is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Fiber One is a fiber optic delivery device that is supplied as a sterile, single-use device. Fiber One is intended for use with the GreenLight XPS Laser System for its FDA cleared indications for use. It can access the tissue in multiple planes. Fiber One is a liquid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Specifically mentioned: prostate for benign prostatic hyperplasia (BPH).
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)
All necessary bench and animal testing was conducted on Fiber One to support a determination of substantial equivalence to the predicate device.
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.
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.
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SECTION 5 510(k) SUMMARY (CONT.)
KIOD746 510(k) Notification K
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: March 15, 2010
DEVICE INFORMATION
Fiber One is a fiber optic delivery device that is supplied as a sterile, single-use device. Fiber One is intended for use with the GreenLight XPS Laser System for its FDA cleared indications for use. It can access the tissue in multiple planes. Fiber One is a liquid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
Classification:
21 CFR8878.4810
Product Code: GEX
Trade Name: Fiber One
Generic/Common Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology
JUN 1 1 2010
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SECTION 5 510(k) SUMMARY (CONT.)
PREDICATE DEVICE
Fiber One is substantially equivalent to the 2090 Fiber (K062719). The 2090 Fiber is a fiber optic delivery device that was cleared as an accessory with the GreenLight HPS Surgical Laser System & Accessories (K062719) that is currently being used with the GreenLight XPS Laser System (K092735).
INTENDED USE
Fiber One features a side firing mechanism delivering up to 180W of 532nm light to tissue. Fiber One can be used 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.
Fiber One will deliver 532nm laser energy from a compatible laser console (GreenLight XPS Laser System) to tissue during surgical procedures, including photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH).
INDICATIONS FOR USE
Fiber One is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for Fiber One are substantially equivalent to the indications for use of the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, the Fiber One is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench and animal testing was conducted on Fiber One to support a determination of substantial equivalence to the predicate device.
SUMMARY
Fiber One is substantially equivalent to the predicate device, the 2090 Fiber (K062719).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenuc Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems, Inc. % Experien Group, LLC Ms. Darlene Crockett-Billig President 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089
JUN 1 1 2010
Re: K100746
Trade/Device Name: Fiber One 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: May 13, 2010 Received: May 14, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
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
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Page 2 - Ms. Darlene Crockett-Billig
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 (OS) 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/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark M. Millerson
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.
Fiber One 510(k) Premarket Notification
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K (2014 b
Device Name: Fiber One
Indications For Use:
Indications For Use.
Fiber One is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.
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)
Neil R.P. Ogden for mixm
(Division Sign-Off (Division Sign-cal, Orthopedic, and Restorative Devices
510(k) Number. K100746
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