(66 days)
No
The summary describes a standard Holmium laser system with software control for device functions and user selections, but there is no mention of AI or ML capabilities, image processing, or data sets for training/testing.
Yes
The IEC 60601-2-22: 2007+A1:2012 standard specifically mentions "Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," and this device performs surgical procedures listed in its intended use, which are inherently therapeutic.
No.
The document describes the Holmium Medical Laser as a surgical device used for procedures like incision, resection, ablation, vaporization, coagulation, and haemostasis across various medical specialties. These are all surgical procedures, not diagnostic ones.
No
The device description explicitly states that the device is a "Holmium laser family" device with physical components including a laser source, power electronics, optical delivery system, control electronics, and cooling system. While it mentions "Specific software controls the device functions," the device is clearly a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for various procedures involving the manipulation of soft tissue and calculi within the body. This is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description details a laser source, power electronics, optical delivery system, control electronics, and cooling system. These are components of a surgical laser, not a device designed to analyze samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to directly interact with tissue and calculi.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The Holmium Medical Laser and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynecology, ENT, Pulmonary Surgery and General Surgery.
Urology
Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
- Ablation of Benign Prostatic Hypertrophy (BPH),
- Transurethral incision of the prostate (TUIP)
- Holmium Laser Resection of the Prostrate (HoLRP)
- Holmium Laser Enucleation of the Prostate (HoLEP)
- Holmium laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
- Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
- monohydrate and calcium oxalate
- dehydrate stones.
- Endoscopic fragmentation of kidney 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
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitas
- Haemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
- Ligament and tendon Release
- Contouring and sculpting of articular surfaces
- Capsulectomy in the Knee
- Chondreplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- Chondromalacia and tears
- Plica Removal
- Meniscectomy
- Loose Body Debridement
- Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
- Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
Pulmonary Surgery
Open and endoscopic pulmonary surgery (cutting, vaporization, incision and coagulation of soft tissue)
General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- Appendectomy
- Skin incision
- Excision of external and internal lesions
- Complete or partial resection of internal organs, turnors and lesions
- Biopsy
Product codes
GEX
Device Description
The devices belonging to Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. Specific software controls the device functions and allows the user selections. 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
Soft tissue, cartilaginous tissue, bony tissue including:
Urethral, Bladder Neck, Bladder, Uretheral, Ureteral, Benign Prostatic Hypertrophy (BPH), Prostate, external genitalia, ureteral, bladder, renal, kidney, Appendectomy, Polyps, Gall Bladder, Biliary/Bile duct, Ulcers (Gastric, Duodenal, Non Bleeding, Esophageal), Pancreatitas, Haemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal, Telangiectasias, Vascular Malformation, Gastritis, Esophagitis, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions, Ligament, tendon, articular surfaces, Capsule (Knee), Chondral (Knee), synovial tissue, disc (L4-5, L5-S1 lumbar, Cervical, Thoracic), Plica, Meniscus, external and internal lesions, internal organs.
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+ CORR.1:2006+CORR. 2:2007 +AM1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-2-22: 2007+A1:2012 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 requirements.
- Software verification and validations, in compliance with FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (issue on 2005). The tests verified that the subject Holmium Medical Laser performs according to its specifications.
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.
0
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August 18, 2023
Allengers Global Healthcare Private Limited Harpreet Singh Director-Technical Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road Derabassi, District- Mohali, Punjab 140507 India
Re: K231718
Trade/Device Name: Holmium Medical Laser 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 5, 2023 Received: June 13, 2023
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 (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 (QS) 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.
Digitally signed by Tanish Tanisha L. 0ate: 2023.08.18 15:22:10 Hithe -S
Tanisha Hithe, MS, MHS 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) K231718
Device Name
Holmium Medical Laser
The Holmium Medical Laser and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynecology, ENT, Pulmonary Surgery and General Surgery.
Urology
Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Urethral Strictures
- · Bladder Neck Incisions (BNI)
- · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
- · Ablation of Benign Prostatic Hypertrophy (BPH),
- · Transurethral incision of the prostate (TUIP)
- · Holmium Laser Resection of the Prostrate (HoLRP)
- · Holmium Laser Enucleation of the Prostate (HoLEP)
- · Holmium laser Ablation of the Prostate (HoLAP)
- · Condylomas
- · Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,
- monohydrate and calcium oxalate
- · dehydrate stones.
- · Endoscopic fragmentation of kidney 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
- Polyps
- · Biopsy
- · Gall Bladder calculi
- · Biliary/Bile duct calculi
- · Ulcers
- · Gastric ulcers
- · Duodenal ulcers
- · Non Bleeding Ulcers
- · Pancreatitas
- · Haemorrhoids
- · Cholecystectomy
- · Benign and Malignant Neoplasm
- · Angiodysplasia
- · Colorectal cancer
3
· Telangiectasias
- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- · Gastritis
- · Esophagitis
- · Esophageal ulcers
- Varices
- · Colitis
- · Mallory-Weiss tear
- · Gastric Erosions
Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
- · Ligament and tendon Release
- · Contouring and sculpting of articular surfaces
- · Capsulectomy in the Knee
- · Chondreplasty in the Knee
- · Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- · Chondromalacia and tears
- · Plica Removal
- · Meniscectomy
- · Loose Body Debridement
- · Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy
Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:
- · Endonasal/sinus Surgery
- · Partial turbinectomy
- · Polypectomy
- · Dacryocystorhinostomy
- · Frontal Sinusotomy
- · Ethmoidectomy
- · Maxillary antrostomy
- · Functional endoscopic sinus surgery
Pulmonary Surgery
Open and endoscopic pulmonary surgery (cutting, vaporization, incision and coagulation of soft tissue)
General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
4
· Skin incision
- · Excision of external and internal lesions
- · Complete or partial resection of internal organs, turnors and lesions
- · Biopsy
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5
SECTION 5
510(k) Summary K231718
6
510(k) SUMMARY
(K231718)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
| Applicant /Manufacturer
Name and Address | Allengers Global Healthcare Private Limited
Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road, Derabassi,
District- Mohali, 140507, Punjab (India) | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | +911762-272600 | | |
| 510(K) Contact person | Harpreet Singh
Address: Room No.5, Khasra no. 79, Bhankarpur, Mubarakpur Road,
Derabassi, District- Mohali, 140507, Punjab (India)
Contact Number: +919876615337
Email ID: harpreet.singh@allengers.net | | |
| Date Prepared | 5th May, 2023 | | |
| Device/Trade Name | Holmium Medical Laser | | |
| Models Names | BLAZE-prime, BLAZE | | |
| Regulation Class | Class II | | |
| Regulation Name | Laser Surgical Instrument For Use In General And Plastic Surgery And
In Dermatology | | |
| Regulation Number | 21 CFR 878.4810 | | |
| Product Code | GEX | | |
| Panel | General and Plastic Surgery | | |
| Predicate Devices | Cyber Ho 100 (K192600)-Quanta system spa | | |
| Reference Devices | Empower H65(K180423), Litho(K163009)- Quanta system spa
Lumenis Pulse 120H (K170121)-Lumenis Ltd. | | |
7
Device Description
The devices belonging to Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. Specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.
| Feature | Subject Device | | Predicate Device | Justification
for
differences |
|--------------------------|----------------------------------------------|----------------|-----------------------------------|-------------------------------------|
| Manufacturer | Allengers Global Healthcare Pvt.
Ltd. | | Quanta System SPA | |
| Models | BLAZE-prime
(100W,65W) | BLAZE
(35W) | Cyber Ho 100 | |
| 510(k) | K231718 | | K192600 | |
| Manufacturer | Allengers Global Healthcare Pvt.
Ltd. | | Quanta System SPA | |
| Device/Trade
Name | Holmium Medical Laser | | Cyber Ho 100 | |
| Laser Medium | Pulsed Holmium laser (CTH:YAG) | | Pulsed Holmium laser
(CTH:YAG) | Same |
| Wavelength | 2100nm | | 2100nm | Same |
| Emission | Pulsed | | Pulsed | Same |
| Pulse Duration | 95- 1500μs | | 50 - 1100 μs | Similar |
| Pulse Frequency | 3-80HZ (100W)
3-60HZ (65W) | 3-30HZ | 3-80 Hz | Same |
| Pulse Energy | 0.1J to 5J | | Upto 5J | Same |
| Maximum
Average Power | Up to 100 W
(100W)
Up to 65 W
(65W) | Up to 35 W | Up to 105W | Similar |
| Delivery System | Optical Fiber | | Optical Fiber | Same |
| Aiming Beam | | | | |
| Type | DPSS | | DPSS | Same |
| Power | Power