(82 days)
Soltive Laser System(K183647)
No
The summary describes a laser system with standard components and software for controlling settings. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device explicitly describes its functions as "incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue" for various medical conditions, which are therapeutic interventions. Additionally, the performance studies mention compliance with "IEC 60601-2-22:2019 Medical Electrical Equipment -Part 2-22: Particular Requirements For Basic Safety And Essential Performance of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," directly identifying it as therapeutic equipment.
No
The device is described as a "Thulium Fiber Laser" intended for surgical procedures such as incision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are therapeutic actions, not diagnostic ones. Although it mentions compliance with "IEC 60601-2-22:2019 Medical Electrical Equipment -Part 2-22: Particular Requirements For Basic Safety And Essential Performance of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," this standard covers various types of laser equipment, and the specific intended uses listed for this device are purely therapeutic.
No
The device description explicitly states it is a "laser system" with physical components like a laser, power electronics, optical delivery system, control electronics, cooling system, and a footswitch. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's soft tissue and calculi using a laser. This is a therapeutic and surgical device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The device description details a laser system that delivers energy via an optical fiber for surgical applications. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Thulium Fiber Laser described is a surgical laser system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.
Urology
- · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- · Laser Resection of the Prostrate (LRP)
- · Laser Enucleation of the Prostate (LEP)
- · Laser Ablation of the Prostate (LAP)
- · Transurethral Incision of the Prostate (TUIP)
- · Condylomas
- · Urethral strictures
- · Lesions of external genitalia
- · Bladder neck incisions (BNI)
- · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- · Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
- · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- · Endoscopic fragmentation of renal calculi
- · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- · Angiodysplasia
- · Polyps
- · Colorectal cancer
- · Biopsy
- · Telangiectasias
- •Gall Bladder calculi
- · Telangiectasias of the Osler-Weber-Renu disease
- · Biliary/Bile duct calculi
- · Vascular Malformation
- · Ulcers
- · Gastritis
- · Gastric ulcers
- · Esophagitis
- · Duodenal ulcers
- · Esophageal ulcers
- Non Bleeding Ulcers
- Varices
- Pancreatitis
- Colitis
- Haemorrhoids
- Mallory-Weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 um with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber.
The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The Subject device performs testing in accordance with the following recognized consensus standards
- Risk analysis activities, in compliance with the requirements of ISO 14971: 2019 Medical . devices - Application of Risk Management to Medical Devices.
- Electrical and laser safety and electromagnetic compatibility tests, in compliance with: .
- IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment Part 1: General O Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014+A1:2020, Medical Electrical Equipment Part 1-2: General o Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-2-22:2019 Medical Electrical Equipment -Part 2-22: Particular Requirements For Basic Safety And Essential Performance of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
- IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and o requirements.
- IEC 60601-1-6:2010+A1:2013+A2:2020 Medical Electrical Equipment Part 1-6: o General Requirements for Basic Safety and Essential Performance-collateral standard: Usability.
- IEC 62366-1:2015/AMD1:2020 Medical devices Part 1: Application of usability o engineering to medical devices
- Software verification and validations, in compliance with FDA "Content of Premarket Submissions ● for Device Software Functions" (issue on 2023). The tests verified that the subject Thulium Fiber Laser performs according to its specifications.
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 Dust (K210142)
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.
Soltive Laser System(K183647)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services seal. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 17, 2024
Allengers Global Healthcare Private Limited Harpreet Singh Director-Technical Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road District- Mohali Derabassi. Punjab 140507 India
Re: K242987
Trade/Device Name: Thulium Fiber Laser (FiberLAZE+, FiberLAZE) 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 19, 2024 Received: September 26, 2024
Dear Harpreet Singh:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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.
TANISHA L Digitally signed by Date: 2024.12.17 HITHE S 21:57:32 -05'00' Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
Indications for Use (Describe)
Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.
Urologv
- · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- · Laser Resection of the Prostrate (LRP)
- · Laser Enucleation of the Prostate (LEP)
- · Laser Ablation of the Prostate (LAP)
- · Transurethral Incision of the Prostate (TUIP)
- · Condylomas
- · Urethral strictures
- · Lesions of external genitalia
- · Bladder neck incisions (BNI)
- · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- · Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
- · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- · Endoscopic fragmentation of renal calculi
- · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- · Angiodysplasia
- · Polyps
- · Colorectal cancer
- · Biopsy
- · Telangiectasias
- •Gall Bladder calculi
- · Telangiectasias of the Osler-Weber-Renu disease
- · Biliary/Bile duct calculi
- · Vascular Malformation
- · Ulcers
- · Gastritis
- · Gastric ulcers
- · Esophagitis
- · Duodenal ulcers
- · Esophageal ulcers
4
- Non Bleeding Ulcers
- Varices
- Pancreatitis
- Colitis
- Haemorrhoids
- Mallory-Weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
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) |
|---|---|
| ---------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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5
510(k) SUMMARY
(K242987)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
| Applicant /Manufacturer
Name and Address | Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road, Derabassi,
District- Mohali, 140507, Punjab (India)
+911762-272600 |
| --------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
|---|
Harpreet Singh
Address: Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road, Derabassi, District- Mohali, 140507, Punjab (India) 510(K) Contact person Contact Number: +919876615337 Email ID: ra@allengersglobal.com:director@allengersglobal.com
- Date Prepared 15 September,2024 Thulium Fiber Laser Device/Trade Name FiberLAZE+, FiberLAZE Models Names Class II Regulation Class Laser Surgical Instrument For Use In General And Plastic Surgery And Regulation Name In Dermatology Regulation Number 21 CFR 878.4810 Product Code GEX Panel General and Plastic Surgery Predicate Device Fiber Dust (K210142) -Quanta system SpA Reference Device Soltive Laser System(K183647)-Olympus Surgical Technologies America
6
Device Description
Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 um with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber.
The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.
Accessories
The device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use.
Intended Use/ Indications for Use:
Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in the following indications: Urology, Lithotripsy,Gastroenterological surgery and Gynecological Surgery.
Urology
- Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] ●
- Laser Resection of the Prostrate (LRP) .
- Laser Enucleation of the Prostate (LEP) ●
- Laser Ablation of the Prostate (LAP) .
- Transurethral Incision of the Prostate (TUIP) .
- Condylomas
- Urethral strictures ●
- Lesions of external genitalia ●
- Bladder neck incisions (BNI) ●
- Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors ●
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy .
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
- . Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- . Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
7
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- Appendectomy .
- Angiodysplasia .
- Polyps ●
- Colorectal cancer ●
- Biopsy .
- Telangiectasias ●
- •Gall Bladder calculi ●
- Telangiectasias of the Osler-Weber-Renu disease
- Biliary/Bile duct calculi .
- Vascular Malformation .
- Ulcers ●
- Gastritis ●
- Gastric ulcers .
- Esophagitis ●
- Duodenal ulcers .
- Esophageal ulcers ●
- Non Bleeding Ulcers ●
- Varices .
- Pancreatitis ●
- Colitis ●
- Haemorrhoids .
- Mallory-Weiss tear .
- Cholecystectomy .
- Gastric Erosions ●
- . Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
8
Comparison with predicate device
The subject device technological characteristics and indication for use are same to the predicate device.
Other differences between the subject device and predicate device not raise new types of question regarding the subject device's safety and efficacy.
Summary of Technical Characteristic
| Feature | Subject Device
Allengers Global Healthcare Pvt.
Ltd. | Subject Device
Allengers Global Healthcare Pvt.
Ltd. | Predicate Device
Quanta System SpA | Justification
for differences |
|--------------------------|------------------------------------------------------------|------------------------------------------------------------|---------------------------------------|----------------------------------|
| Manufacturer | | | | |
| Models | FiberLAZE+ | FiberLAZE | Fiber Dust | NA |
| 510(k) | K242987 | | Fiber Dust (K210142) | NA |
| Manufacturer | Allengers Global Healthcare Pvt.
Ltd. | | Quanta System SpA | NA |
| Device Name | Thulium Fiber Laser | | Fiber Dust | NA |
| Laser Medium | Thulium Laser | | Thulium Laser | Same |
| Wavelength | 1.94 µm | | 1.94 µm | Same |
| Emission | Pulsed/CW | | Pulsed/CW | Same |
| Pulse Duration | 0.1 to 15ms | | 0.1 to 15ms | Same |
| Pulse Frequency | 1 to 2500 Hz | 1 to 1600 Hz | 1 to 2500 Hz | Similar |
| Pulse Energy | 0.02 to 6J | | 0.02 to 6J | Same |
| Maximum
Average Power | 60 W | 35W | 60 W | Similar |
| Delivery System | Optical Fiber | | Optical Fiber | Same |
| Type | DPSS | | DPSS | Same |
| Power | Power