(406 days)
The MultiPulse TM+1470 Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including:
Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, Plastic Surgery, General Surgery and Arthroscopy.
Urology
Open and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH) Transurethral incision of the prostate (TUIP) Laser Resection of the Prostate (HoLRP) Laser Enucleation of the Prostate (HoLEP) Laser Ablation of the Prostate (HoLAP) Condylomas
Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasia Telangiectasia of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis):
Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy
General surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue):
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery
The MultiPulse Tm+1470 laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode. The device is a combination of a Thulium:YAG laser that emits a wavelength of 1940 nm and a near infrared diode laser module that emits a wavelength of 1470 nm. The laser power up to 150 Watts is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.
This looks like a 510(k) summary for a medical device, which is focused on demonstrating "substantial equivalence" to a predicate device rather than proving a new device meets specific, quantitative acceptance criteria through a dedicated study in the way a novel diagnostic or AI device would.
Therefore, many of the requested categories about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context. The document explicitly states "Clinical Performance Data: None".
However, I can extract the relevant information from the provided text based on the 510(k) process.
Here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: For a 510(k) submission like this, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily achieved by showing similar indications for use, safety, and technological characteristics. The performance is then judged against the predicate's established safety and effectiveness.
- Reported Device Performance:
- Indications for Use: Surgical procedures involving incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue across various specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, and Arthroscopy).
- Technological Characteristics:
- Combination of a Thulium:YAG laser (1940 nm wavelength) and a near infrared diode laser module (1470 nm wavelength).
- Laser power up to 150 Watts.
- Operates in CW or pulsed mode.
- Transmitted through different optical fibers.
- Device components: optical bench, power supply, water cooling unit, control electronic.
- Operation via touch screen and foot switch.
- Safety and Effectiveness: "Laboratory testing was conducted to validate and verify that the MultiPulse Tm+1470 met all design specifications and was substantially equivalent to the predicate device."
| Criterion (for Substantial Equivalence to Predicate) | MultiPulse Tm+1470 Performance / Feature |
|---|---|
| Indications for Use | Surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy. |
| Technological Characteristics | Combination of Thulium:YAG (1940 nm) and near infrared diode (1470 nm) laser. Power up to 150W. CW/pulsed mode. Fiber optic delivery. |
| Safety and Effectiveness | Met all design specifications; deemed substantially equivalent to predicate device via nonclinical testing. |
| Predicate Device (Quanta System Cyber Tm 150W) | Similar indications for use, safety compliance, design features, functional features. The MultiPulse has an additional shiftable 1470 nm diode laser module. |
| Predicate Device (Evolve HPD 980/1470nm Multiwavelength Diode Laser) | Similar indications for use and safety compliance, similar design and functional features. The Evolve device also offers an additional wavelength with coagulative effect. |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) in the context of this 510(k) submission. The submission relies on nonclinical (laboratory) testing to demonstrate substantial equivalence, not a clinical "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. No expert-established ground truth from a clinical test set was required or provided for this 510(k). The evaluation is based on engineering and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not relevant as there was no clinical test set requiring expert adjudication.
5. 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
- N/A. This device is a laser surgical instrument, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies. The submission explicitly states "Clinical Performance Data: None."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. Since no clinical performance data was submitted, there was no "ground truth" derived from patient outcomes, expert consensus, or pathology for evaluation of the device in a clinical setting. The "ground truth" for the nonclinical testing would be the engineering specifications and performance standards.
8. The sample size for the training set
- N/A. There is no "training set" in the context of this 510(k) premarket notification for a laser surgical instrument. This is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A. As there is no training set mentioned, this question is not applicable.
§ 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.