(85 days)
Not Found
No
The description focuses on the physical characteristics and function of a fiber optic delivery device, with no mention of AI or ML capabilities.
Yes
The device is described as a "fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use," which includes "photoselective vaporization of the prostate for benign prostatic hyperplasia (BPH)". This indicates it is used to deliver therapy for a medical condition.
No
The device is a fiber optic delivery device used for laser treatment, not for diagnosing medical conditions. It aids in delivering laser power for procedures like photoselective vaporization of the prostate.
No
The device is described as a "fiber optic delivery device" and a "liguid cooled delivery device," indicating it is a physical hardware component used with a laser system, not software.
Based on the provided information, this 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." This describes a device used during a medical procedure to deliver energy to tissue, not a device used to test samples (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description focuses on its physical characteristics, how it delivers laser power, and its compatibility with a laser system. This aligns with a surgical or therapeutic device, not a diagnostic one.
- Anatomical Site: The anatomical sites listed are where the laser energy is applied in vivo (within the body), not where samples are collected for in vitro testing.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver laser energy for therapeutic purposes.
N/A
Intended Use / Indications for Use
INTENDED USE
The Model Number 0010-2400 features a side firing mechanism delivering up to 180W of 532nm light to tissue. Model Number 0010-2400 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.
Model Number 0010-2400 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
Model Number 0010-2400 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
Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid 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
soft tissue, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue. muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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)
All necessary bench testing was conducted on the Model Number 0010-2400 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.
Fiber One (K100746)
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
AMERICAN MEDICAL SYSTEMS
Model Number 0010-2400 SPECIAL 510(K)
SECTION 7 510(K) SUMMARY [21 CFR 807.92]
510(k) Notification K120870
SUBMITTER'S NAME AND ADDRESS
Doreen Nakamura Senior Regulatory Affairs Specialist American Medical Systems Innovation Center - Silicon Valley 3070 Orchard Drive San Jose, CA 95134 U.S.A. Phone: 408-445-3441 Fax: 408-943-9630 Email: Doreen.Nakamura@AmericanMedicalSystems.com
DATE SUMMARY WAS PREPARED
June 14, 2012
DEVICE TRADE/PROPRIETARY NAME GreenLight MoXyTM Fiber Optic
DEVICE COMMON/ USUAL NAMES Laser surgical instrument for use in general and plastic surgery and in dermatology
DEVICE CLASSIFICATION NAMES Powered Laser Surgical Instrument
PRODUCT CODE GEX
CLASSIFICATION
Class II- 21 CFR8878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology
PREDICATE DEVICE
Fiber One (K100746) cleared June 11, 2010.
JUN 1 5 2012
1
SECTION 7 510(K) SUMMARY [21 CFR 807.92]
DEVICE INFORMATION
Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.
INTENDED USE
The Model Number 0010-2400 features a side firing mechanism delivering up to 180W of 532nm light to tissue. Model Number 0010-2400 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.
Model Number 0010-2400 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
Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™XPS Laser System for its FDA cleared indications for use.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE The Model Number 0010-2400 modification is deemed equivalent and there are no changes to the device intended use and/or device functional scientific technology.
| Model 0010-2400 | Fiber One | |
|---|---|---|
| 510(k) Number | K120870 | K100746 |
| Regulation Number | 21 CFR§878.4810 | 21 CFR§878.4810 |
| Regulation Name | Laser surgical instrument for use | |
| in general and plastic surgery and | ||
| in dermatology | Laser surgical instrument for use in | |
| general and plastic surgery and in | ||
| dermatology | ||
| Classification | Class II | Class II |
| Product Code | GEX | GEX |
2
SECTION 7 510(K) SUMMARY [21 CFR 807.92]
| Model 0010-2400 | Fiber One | |
|---|---|---|
| Laser System | ||
| Compatibility | GreenLight XPS Laser System | GreenLight XPS Laser System |
| Endoscope/Cystoscope | ||
| Compatibility | 22 to 24 Fr continuous flow | 22 to 24 Fr continuous flow |
| Saline flow | ≥0.3mL/sec | ≥0.3mL/sec |
| Fiber and Cap | ||
| Assembly Outer | ||
| Diameter | Concurrence of CDRH, Office af Devise Evaluation (ODE) ( moder |
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number. K120870. 22