(253 days)
No
The summary describes a laser system for BPH treatment with no mention of AI/ML in the device description, intended use, or performance studies. The software is mentioned but only in the context of standard software verification and validation, not AI/ML specific processes.
Yes
The device is intended for the surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP), which directly treats a medical condition.
No
Explanation: The device is intended for surgical treatment (photoselective vaporization) of benign prostatic hyperplasia, which is a therapeutic rather than diagnostic function. It is a laser system used to treat a condition, not to identify or characterize it.
No
The device description explicitly states it is a "semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser" and lists hardware components like a "semiconductor-pumped controller, Laser internal circulating cooling system, electronic control system and footswitch." It also mentions electrical safety, laser safety, and EMC testing, which are associated with hardware. While software is mentioned, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP)." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical green laser system" used with laser fibers. This is a therapeutic device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The information provided clearly indicates this is a surgical device used for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
Product codes
GEX
Device Description
The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.
The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance testing was conducted on surgical green laser system according to IEC 60825-1:2014. Additionally, optical pulse and RF Wireless performance tests were conducted. Electrical safety, laser safety and EMC testing were conducted on the device. The device complies with the ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012, 2012 and A2:2010/(R) 2012 (Consolidated Text), and C1:2009/(R) IEC 60601-2-22:2007(third edition) + A1:2012 for safety, and the IEC 60601-1-2:2014 standard for EMC. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern. Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification. The non-clinical data support the safety of the device and the performance testing report demonstrate that surgical green laser system should perform as intended in the specified application conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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June 4, 2021
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 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K202828
Trade/Device Name: Surgical Green 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: II Product Code: GEX Dated: April 25, 2021 Received: April 30, 2021
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202828
Device Name Surgical Green Laser System
Indications for Use (Describe)
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
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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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- SUBMITTER
Realton (Suzhou) Medical Technology Co., Ltd. 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, P.R.China Phone: +86-512-62868599
- SUBMITTER
| Primary Contact | Olivia Meng |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| 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 | May 31, 2021 |
| 2. DEVICE | |
| Device Name: | Surgical Green Laser System |
| Common/Usual Name: | Surgical Green Laser System |
| Classification Name: | Laser Surgical Instrument For Use In General And Plastic |
| Surgery And In Dermatology | |
| Model: | PVP-120, PVP-140, PVP-160, PVP-180 |
| Regulation number: | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX Powered Laser Surgical Instrument |
-
- PREDICATE DEVICE
GreenLight XPS Laser System (K092735)
- PREDICATE DEVICE
-
- DEVICE DESCRIPTION
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The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.
The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.
5. INDICATIONS FOR USE
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photo-selective vaporization of the prostate (PVP).
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.
| Subject device | Predicate device | Discussion of difference | |
|---|---|---|---|
| Device name | Surgical green laser system | GreenLight XPS Laser System | NA |
| K number | K202828 | K092735 | NA |
| Manufacturer | Realton (Suzhou) Medical Technology | ||
| Co., Ltd. | American Medical Systems, Inc. | NA | |
| Indications for Use | The surgical green laser system is | ||
| intended for surgical treatment of | |||
| benign prostatic hyperplasia (BPH) | |||
| through photo-selective vaporization | |||
| of the prostate (PVP). | The GreenLight TM 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, | Similar |
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| 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. | |
| 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 |
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| hyperplasia/hypoplasia (BPH). | |||
|---|---|---|---|
| Contraindications | Similar | ||
| Patients who are suspected of having | |||
| prostate cancer or patients who are | |||
| not suitable for laser surgery and | |||
| critically ill patients in other | |||
| departments. Including the following | |||
| but not limited to: | |||
| The patient's medical history | |||
| contraindicates anesthesia Places where tissues (especially | |||
| tumors) are calcified For hemostasis of blood vessels | |||
| over 2 mm in diameter Out of control bleeding disorders | |||
| and coagulopathy Acute urinary tract infection Severe urethral stricture Patients with prostate cancer | The use of the Laser System is contraindicated for patients: | ||
| Whose general medical condition contraindicates surgical intervention Where appropriate anesthesia is contraindicated by patient history Where tissue (especially tumors) has calcified For hemostatis of vessels over approximately two millimeters in diameter Where laser therapy is not considered the treatment of choice Uncontrolled bleeding disorders and coagulopathy Prostate cancer Acute urinary tract infection (UTI) Severe urethral stricture The GreenLight XPS Laser System 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 makes passage of instruments difficult or dangerous. Care should be taken to avoid injury to urethral tissue. | |||
| Composition | The surgical green laser system | ||
| consists of a semiconductor-pumped | The laser system consists of a console, which generates the green laser light and a fiber optic delivery device that transmits laser light from the | Similar | |
| controller, Laser internal circulating | |||
| cooling system, electronic control | |||
| system and footswitch. | console to the patient. | ||
| The console is a diode-pumped Solid State Laser | |||
| utilizing Nd:YAG laser gain medium and | |||
| Acousto-Optic Q Switch. | |||
| Laser type | Solid state, frequency doubled, | ||
| Nd:YAG laser | Solid state, frequency doubled, Nd:YAG laser | Same | |
| Output mode | Multimode | Multimode | Same |
| Main wavelength (nm) | 532 | 532 | Same |
| Maximum delivered | |||
| power | PVP-120: 120 W | ||
| PVP-140: 140 W | |||
| PVP-160: 160 W | |||
| PVP-180: 180 W | 180W | Similar | |
| Mode of operation | Adjustable | Adjustable | Same |
| Maximum aiming beam | |||
| power | 5 mW | 5 mW | Same |
| Cooling type | Internal circulating | Internal circulating | Same |
| Cooling liquid | Deionized water | Distilled or deionized water | Similar |
| Operation temperature | 10° C - 30° C | 10° C - 30° C | Same |
| Relative humidity | 30%- 90% | 10%- 90% | Similar |
| Compatible device | Single-use sterile medical laser fiber | ||
| (model: W760SF-30, B760SF-30, | |||
| G760SF-30, P760SF-30, W760F-30, | |||
| B760FF-30, G760FF-30, P760FF-30) | |||
| manufactured by Realton (Suzhou) | |||
| Medical Technology Co., Ltd. | |||
| Laser protective Eyewear | |||
| Endoscope | GreenLight Moxy™ Fiber Optic | ||
| Laser protective eyewear | |||
| Endoscope | Similar | ||
| Optical operating | Pulse mode | Pulse mode | Same |
| modes | |||
| Compatible fibers optical beam area at 2mm | 0.48mm² | 0.48mm² | Same |
| Compatible fibers applicable wavelength | 532nm | 532nm | Same |
| Compatible fibers Maximum optical transmission power | 180W | 180W | Same |
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The subject device and the predicate device are similar in the indications, composition and maximum delivered power. These differences do not raise different questions of safety and effectiveness. The technological differences can be evaluated through the performance testing provided.
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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 7.
The following performance data were provided in support of the substantial equivalence determination.
Performance testing
Performance testing was conducted on surgical green laser system according to IEC 60825-1:2014. Additionally, optical pulse and RF Wireless performance tests were conducted.
Electrical safety, laser safety, and electromagnetic compatibility (EMC)
Electrical safety, laser safety and EMC testing were conducted on the device. The device complies with the ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012, 2012 and A2:2010/(R) 2012 (Consolidated Text), and C1:2009/(R) IEC 60601-2-22:2007(third edition) + A1:2012 for safety, and the IEC 60601-1-2:2014 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
CONCLUSION 8.
The proposed device is substantially equivalent to the predicate device, GreenLight XPS Laser System, in the laser type, output mode, main wavelength, mode of operation, maximum aiming beam power, cooling type, operation temperature and relative humidity and compatible device. The non-clinical data support the safety of the device and the performance testing report demonstrate that surgical green laser system should perform as intended in the specified application conditions.
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From the results of non-clinical data including the performance testing described, Realton (Suzhou) concludes that surgical green laser system is as safe and as effective as the predicate device.