(98 days)
Not Found
No
The summary describes a passive fiber optic delivery device for a laser system and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is described as a fiber optic delivery device intended for surgical incision/excision, ablation, hemostasis, and coagulation of soft tissue, including vaporization of prostatic hyperplasia, all of which are direct medical treatments, classifying it as therapeutic.
No
The device is described as a fiber optic delivery device for surgical procedures like incision/excision, ablation, hemostasis, and coagulation of soft tissue, indicating its therapeutic function rather than diagnostic.
No
The device description clearly states it is a "single-use sterile medical laser fiber" made of "fused quartz" with a "special connector" and different "output structures." This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that this device is a fiber optic delivery device intended for use with a laser system to deliver laser energy directly to tissue during surgical procedures. It is used for surgical incision/excision, ablation, hemostasis, and coagulation of soft tissue.
- Lack of Specimen Analysis: There is no mention of the device being used to collect, prepare, or analyze any specimens taken from the body. Its function is to deliver energy for direct tissue modification.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostatic hyperplasia (BPH).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The single-use sterile medical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. The optical fiber material is fused quartz, and its core diameter is 760 µm. One end of the optical fiber is a special connector, which can be connected to the medical laser surgery system. The output structure of the other end of the optical fiber can be divided into side-firing type and front-firing type: W760SF-30, B760SF-30, G760SF-30 and P760SF-30 are side-firing types, W760F-30, B760FF-30, G760FF-30 and P760FF-30 are front-firing types.
The product is sterilized by EO. It is a disposable medical device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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)
Biocompatibility testing
The biocompatibility evaluation for single-use sterile medical laser fiber was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
Performance testing
Performance testing was conducted on single-use sterile medical laser fiber. Technical parameters about dimension, optical performance and mechanical strength were evaluated in the performance testing. In addition, the shelf life was evaluated. All of the tested parameters met the predefined acceptance criteria.
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.
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December 15, 2020
Realton (Suzhou) Medical Technology Co., Ltd % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No. 26 Oinglan Street, Panvu District Guangzhou, Guangdong 510006, China
Re: K202601
Trade/Device Name: Single-use sterile medical laser fiber 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: November 26, 2020 Received: November 30, 2020
Dear Olivia Meng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202601
Device Name Single-use sterile medical laser fiber
Indications for Use (Describe)
The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostatic hyperplasia (BPH).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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Page 1 of 5
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- SUBMITTER
Realton (Suzhou) Medical Technology Co., Ltd.
- SUBMITTER
601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, P.R.China Phone: +86-512-62868599
| Primary Contact | Olivia Meng |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| 8-9th Floor, R&D Building, No. 26 Qinglan Street, Panyu | |
| District, Guangzhou, CHN 510006 Guangdong | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Mingzhu Liu |
| Person: | Quality Manager |
| Realton (Suzhou) Medical Technology Co., Ltd. | |
| Tel: (+86)-512-62868599 | |
| Date prepared | December 11, 2020 |
| 2. DEVICE | |
| Device Name: | Single-use sterile medical laser fiber |
| Common/Usual Name: | Single-use sterile medical laser fiber |
| Model: | W760SF-30, B760SF-30, G760SF-30, P760SF-30, W760F- |
| 30, B760FF-30, G760FF-30 and P760FF-30 | |
| Regulation number | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX (Powered Laser Surgical Instrument) |
| Regulation Name: | Laser Surgical Instrument for Use in General and Plastic Surgery and In |
| Dermatology |
PREDICATE DEVICE 3.
K120870 GreenLight MoXyTM Fiber Optic
-
- DEVICE DESCRIPTION
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The single-use sterile medical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. The optical fiber material is fused quartz, and its core diameter is 760 µm. One end of the optical fiber is a special connector, which can be connected to the medical laser surgery system. The output structure of the other end of the optical fiber can be divided into side-firing type and front-firing type: W760SF-30, B760SF-30, G760SF-30 and P760SF-30 are side-firing types, W760F-30, B760FF-30, G760FF-30 and P760FF-30 are front-firing types.
The product is sterilized by EO. It is a disposable medical device.
| Item | Specification |
|---|---|
| Overall Length | 300 cm |
| Core Diameter | 0.76 mm |
| Applicable wave lengths | 532 nm |
| Minimum transmission efficiency | 80 % |
| Maximum transmission power | 180 W |
| Tensile strength | 10 N |
| Minimum bending working radius | 500 mm |
| Light output angle (side-firing types) | 70°± 20° |
| Connector | SMA-905 |
The specification of the single- use sterile medical laser fiber is as followed:
5. INDICATIONS FOR USE
The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use.
The product 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.
The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostate for benign prostatic hyperplasia (BPH).
The indications for use statement for the subject device is same as the predicate device.
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Page 3 of 5
| Specification | Subject device | Predicate device | Discussion
of
difference |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Device name | Single-use Sterile Medical Laser Fiber | GreenLight MoXy™ Fiber Optic | NA |
| Manufacturer | Realton (Suzhou) Medical Technology
Co., Ltd. | American Medical Systems | NA |
| 510
(k)
number | NA | K120870 | NA |
| Product code | GEX | GEX | Same |
| Intended use | The device is a fiber optic delivery device
intended for use with the laser system
for its FDA cleared indications for use.
The product 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.
The product will deliver 532 nm laser
energy from a compatible laser console
(Surgical Green Laser System) to tissue
during surgical procedures, including
photo-selective vaporization of the
prostate for benign prostatic hyperplasia
(BPH). | 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.
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
532 nm 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). | Same |
| Contraindica-
tions | The fiber is contraindicated in the
presence of severe urethral strictures;
however, the system can be used in the
treatment of urethral strictures with
proper cautions. A severe stricture is any
stricture with visible narrowing via
urethrography or ultrasonography, with
near total obstruction that make passage
of instruments difficult or dangerous. | The fiber is contraindicated in the
presence of severe urethral strictures;
however, the system can be used in
the treatment of urethral strictures
with proper cautions. A severe
stricture is any stricture with visible
narrowing via urethrography or
ultrasonography, with near total
obstruction that make passage of
instruments difficult or dangerous. | Same |
| Prescription or
OTC | Prescription | Prescription | Same |
| Components | The device is mainly composed of four
parts: fiber connect part (cap for
connector, connector), fiber
transmission part, fiber handle and
treatment part (Side-firing type: bare | The device is mainly composed of
metal cap, laser firing point, outer
flow tubing, control knob, fiber
handle, inlet flow tubing and
connector, etc. | Similar |
| | indicator and fiber cap; front-firing type:
bare fiber and laser firing point). | | |
| Type | Front-firing and side-firing | Side-firing | Similar |
| Material
of
fiber | Fused quartz | Fused quartz | Same |
| Fiber core size | 0.76 mm | 0.75 mm | Similar |
| Catheter
length | 300 cm | 305 cm | Similar |
| Operation
length | 34.5 cm | 36 cm | Similar |
| Power density
at 2 mm | @180W=326 W/mm2
@120W=218 W/mm2 | @180W=326 W/mm2
@120W=218 W/mm2 | Same |
| Applicable
wave lengths | 532 nm | 532nm | Same |
| Maximum
transmission
power | 180 W | 180 W | Same |
| Total amount
of energy
transferred | 643 KJ | 643 KJ | Same |
| Connector | SMA-905 standard optical connector | Optical Connector | Different |
| Laser systems
compatibility | Surgical Green Laser System | GreenLight™ XPS Laser System | Different |
| Endoscope/Cy
stoscope
compatibility | 24 Fr continuous flow | 22 to 24 Fr continuous flow | Similar |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
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Page 4 of 5
The indications for use and technological characteristics of the subject and predicate devices are comparable. The subject device and the predicate device differ in some technical specifications such as components, connector and compatible laser systems. However, these differences do not raise different questions of safety and effectiveness.
7. SUMMARY OF NON-CLINICAL TESTING
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for single-use sterile medical laser fiber was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation
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of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity
- Sensitization ●
- Irritation
- Systemic toxicity
Performance testing
Performance testing was conducted on single-use sterile medical laser fiber. Technical parameters about dimension, optical performance and mechanical strength were evaluated in the performance testing. In addition, the shelf life was evaluated. All of the tested parameters met the predefined acceptance criteria.
8. CONCLUSION
The indications for use statement for the subject device is the same as that of the predicate. The differences between the subject device and its predicate device do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that single-use sterile medical laser fiber should perform as intended in the specified application conditions.
From the results of non-clinical data including the performance testing described, Realton (Suzhou) concludes that the subject device single-use sterile medical laser fiber is substantially equivalent to the predicate device.