(28 days)
The Modified Lumenis VersaPulse PowerSuite Holmium (Ho:YAG) Surgical Lasers and Delivery Devices and Accessories - Lumenis Pulse 120H is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The Lumenis Pulse 120H System and the currently marketed VersaPulse PowerSuite Holmium Surgical Lasers with Delivery Devices and Accessories are indicated for use in the performance of specific surgical applications as follows: Urology - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the . prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) - . Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: - bladder; - superficial and invasive bladder, urethral and ureteral tumors; o - condylomas; o - lesions of external genitalia; o - ureteral and penile hemangioma; - o ureteral strictures; - bladder neck obstructions o - Urinary Lithotripsy including: - endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) o calculi. including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; - treatment of distal impacted fragments of steinstrasse when guide wires cannot o be passed. Arthroscopy - Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in . various small and large joints of the body, excluding the spine, including: - meniscectomy; o - plica removal; o - ligament and tendon release; o - contouring and sculpting of articular surfaces; o - debridement of inflamed synovial tissue (synovectomy); o - loose body debridement; o - chondromalacia and tears; o - lateral retinecular release; o - capsulectomy in the knee; o - chondroplasty in the knee; o - o chondrornalacia ablation. - . Discectorny including: - percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral o spine; open and arthroscopic spine procedures; foraminotomy. General Surgery - Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, . and coagulation of soft tissue) including: - cholecystectomy; o - lysis of adhesions; - appendectomy; o - biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; o - skin incision: o - tissue dissection; 0 - excision of external tumors and lesions; o - complete or partial resection of internal organs, tumors and lesions; o - mastectomy; o - hepatectomy; o - pancreatectomy; o - o splenectomy; - thyroidectomy; o - parathyroidectomy; - herniorrhaphy; o - tonsillectomy; o - lymphadenectomy; o - partial nephrectomy; o - pilonidal cystectomy; o - resection of lipoma; o - debridement of decubitus ulcer; o - hemorrhoids; o - debridement of statis ulcer; o - biopsy. o ENT Surgery - Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and . coagulation of soft tissue and cartilage) including: - partial turbinectomy; o - ethmoidectomy; o - polypectomy; o - maxillary antrostomy; o - frontal sinusotomy; o - sphenoidotomy; o - dacryocystorhinostomy (DCR); o - functional endoscopic sinus surgery (FESS). o Gynecological Surgery - Open and laparoscopic gynecological surgery (ablation, vaporization, incision, . excision, and coagulation of soft tissue). Gasteroenterology Surgery - Open and endoscopic gasteroenterology surgery (ablation, vaporization, incision, . excision, resection, coagulation and hemostasis, including: - gall bladder calculi; - biliary/bile duct calculi; o - benign and malignant neoplasm; o - polyps; o - colitis; o - ulcers; - angiodysplasia; o - hemorrhoids; o - o varices; o esophagitis; o esophagcal ulcer; o Mallory-Weiss tear; o gastric ulcer; o duodenal ulcer; o non-bleeding ulcer; o gastric erosions; o colorectal cancer; o gastritis; o bleeding tumors; o pancreatitis: o vascular malformations; o telangiectasias; o telangiectasias of the Osler-Weber-Renu disease. Pulmonary Surgery - Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision . excision and coagulation of soft tissue. Dermatology and Plastic Surgery - Incision, excision, resection, ablation, coagualation, hemostasis and vaporization of . soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dennatologic and aesthetic surgical procedures, including: - scars: o - tattoo removal; - vascular lesions; o - port wine stains; 0 - hemangioma; o - telangiectasia of the face and leg; o - o rosacea; - corns; o - papillomas; o - basal cell carcinomas; o - lesions of skin and subcutaneous tissue; o - plantar warts; o - periungual and subungual warts; o - debridement of decubitus ulcer; - skin tag vaporization. o
The Lumenis Pulse 120H System, which is the subject of this submission, is a single wavelength holmium (Ho:YAG) laser, being a new member in the VersaPulse PowerSuite family of holmium lasers manufactured by Lumenis Ltd. The subject device is a modification of the previously cleared Lumenis laser system, the VersaPulse PowerSuite 100 Watt (VPPS100, most recently cleared under K011703), also a member of the same product family. The modified subject Lumenis Pulse 120H system relies on the same fundamental underlying technology of the cited predicate system, as well as of all Lumenis holmium lasers used in clinical practice. The subject device modifications involve both hardware (HW) and software (SW) elements, whereas the functional capabilities of the laser system remain unaltered in both the modified and cleared systems. The Lumenis Pulse 120H additionally includes an integrated suction pump in order to increase user convenience in procedures where aspiration of surgical debris is common practice, which represents a minor subject product change in relation to the predicate. The subject Lumenis Pulse 120H system is a solid state Single Wavelength (Holmium) surgical laser, being comprised of the following functional HW components: - . Laser Console - Dual pedal Footswitch . - Variety of Fiber Optic Delivery Devices (fibers) and accessories t The Lumenis Pulse 120H system is operated and controlled via proprietary SW. The SW comprises embedded SW in the main and peripheral processors, and Graphical User Interface (GUI) application running on a Personnel Computer (PC).
This document is a 510(k) summary for a modified surgical laser, the Lumenis Pulse 120H. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the way an AI/ML clinical validation study would.
Instead, the provided text details the performance testing conducted to demonstrate that the modified device performs in accordance with its requirements and specifications, and that it is as safe and effective as its predicate device. This is a common approach for 510(k) submissions for device modifications that do not fundamentally change the technology or intended use.
Therefore, many of your requested fields related to clinical efficacy studies for AI will be N/A (Not Applicable) based on the provided text.
Here's a breakdown of the requested information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Risk Analysis | Performed. Results indicated the device performs in accordance with its requirements and specifications, in similarity to its predicate device, raising no new safety and/or effectiveness issues. |
| Electrical and Laser Safety and Electromagnetic Compatibility (EMC) Testing | Performed. Results indicated the device performs in accordance with its requirements and specifications, in similarity to its predicate device, raising no new safety and/or effectiveness issues. |
| Software Verification and Validation | Performed. Results indicated the device performs in accordance with its requirements and specifications, in similarity to its predicate device, raising no new safety and/or effectiveness issues. |
| Ability to withstand variant operation, storage and transportation conditions | Performed. Results indicated the device performs in accordance with its requirements and specifications, in similarity to its predicate device, raising no new safety and/or effectiveness issues. |
| System Testing (e.g., footswitch, emission indicator, emergency button, ON/OFF button) | Performed. Results indicated the device performs in accordance with its requirements and specifications, in similarity to its predicate device, raising no new safety and/or effectiveness issues. |
| Safety and Effectiveness Equivalence to Predicate Device | Based on all performance testing, the Lumenis Pulse 120H is believed to be as safe and effective for its intended use as its predicate and is substantially equivalent without raising any new safety and/or effectiveness issues. The modifications involve hardware (HW) and software (SW) elements, but the functional capabilities remain unaltered. The addition of an integrated suction pump for user convenience is a minor change. |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of patient data or clinical cases. The "test set" here refers to the rigorous engineering and regulatory testing of the device itself.
- Data Provenance: N/A as it's not a clinical data-driven study in the sense of patient images/records. The testing would have been conducted by the manufacturer (Lumenis Ltd. in Israel) or designated testing facilities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This is not a study requiring expert clinical ground truth assessment (like for AI image analysis). The "ground truth" for these engineering and regulatory tests typically refers to industry standards, regulatory requirements, and the established specifications of the predicate device. Experts involved would be engineers, safety specialists, and quality control personnel.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in clinical assessments, which is not applicable here. Performance against technical specifications is usually evaluated directly.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a modification of a surgical laser, not an AI/ML diagnostic or assistive device for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a surgical laser, always used with a human in the loop (a surgeon). The "standalone" testing refers to the device itself meeting its specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the engineering and safety tests, the "ground truth" implicitly refers to:
- Relevant international and national safety standards (e.g., electrical safety, laser safety).
- Internal design specifications and performance requirements.
- The performance characteristics of the predicate device (establishing substantial equivalence).
- For the engineering and safety tests, the "ground truth" implicitly refers to:
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The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set of data.
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How the ground truth for the training set was established
- N/A. Not an AI/ML device.
§ 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.