Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware components and laser technology, with no mention of AI or ML.

Therapeutic

Yes
The prompt states that the device is intended for various surgical procedures involving "incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue," which are all therapeutic actions.

Diagnostic

No

The intended use description explicitly states the device is for "surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue," which are all therapeutic functions. There is no mention of diagnostic capabilities such as imaging, analysis, or detection of medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines numerous hardware components including a rack, cooling units, laser source, power supply, laser head, optical bench, power meter, optical fibers, emergency button, key-switch, status led, footswitch connector, metal door, magneto-thermal switch, line cable, safety interlock connector, and a touch-screen PC. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for surgical procedures involving incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are all procedures performed on the patient's body.
Device Description: The description details a laser system designed for delivering energy to tissue. This is consistent with a surgical device, not a device used to examine samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cyber Tm 150W and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.and Arthroscopy

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures -
Bladder Neck Incisions (BNI) ー
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
Tumors. -
Ablation of Benign Prostatic Hypertrophy (BHP). -
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostrate (HoLRP) -
Laser Enuculeation 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 -
Telangiectasias -
Telangiectasias of the Osler-Weber-Renu disease -
Vascular Malformation -
Gastritis -
Esophagitis -
-Esophageal ulcers
Varices I
Colitis
Mallory-Weiss tear
Gastric Erosions

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, 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, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including

Endonasal/sinus Surgery -
Partial turbinectomy -
Polypectomy -
Dacrvocystorhinostomy
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 ﮯ
Parathvroidectomy a
Herniorrhaphy .
Tonsillectomy -
Lymphadenectomy -
Partial Nephrectomy ﮯ
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer
Hemorrhoids
Debridement of Statis Ulcer
Biopsy

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

Ablation of soft and cartilaginous tissue in Minimal Invasive -Spinal
Surgery including -
Percutaneous Laser Disc Decompression/Discectomy -
-Foraminoplasty
Ablation and coagulation of soft vascular and non vascular tissue in
minimally invasive spinal surgery. -

Product codes

GEX

Device Description

The Cyber Tm 150W is a surgical laser instrument for use in general surgery and dermatology. The Cyber Tm 150W is:
Models: Cyber Tm
Wavelength: 2.01μm
Laser Power: 150W

Cyber Tm is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy

The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed.

The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01pm wavelength with power adjustable from 5 to 150W.

An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600pm) and bare fibers (200, 365, 400, 550, 600, 800 and 1000um) are available for both laser source.

The emergency red push button , the key-switch and the operation status led are housed in the front part of the system.

The footswitch connector is housed in the back side of the system. A metal door closes the lower rack.

On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chiller outlet grids cooling .

The device is controlled by a touch-screen PC mounted on a orientable arm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urethral, Bladder, Uretheral (Tumors), Ureteral (Tumors), Prostate (BHP, TUIP, HoLRP, HoLEP, HoLAP), external genitalia, Appendix, Polyps (Gastroenterology), Gall Bladder, Biliary/Bile duct, Ulcers (Gastric, Duodenal, Non Bleeding, Esophageal), Pancreas, Hemorrhoids, Cholecyst, Benign and Malignant Neoplasm (Gastroenterology), Angiodysplasia, Colorectal, Osler-Weber-Renu disease, Vascular Malformation (Gastroenterology), Stomach, Esophagus, Varices, Colon, Mallory-Weiss tear, Gastric Erosions, uterine, Cervix, nose, sinuses, pharynx, larynx, tonsils, adenoids, Abdominal Cavity (Lysis of adhesion), Skin, various soft tissues and internal organs for excision and resection (including breast, liver, pancreas, spleen, thyroid, parathyroid, hernia, lymph nodes, kidney), Pilonidal Cyst, Lipoma, Decubitus Ulcer, Statis Ulcer, soft and cartilaginous tissue of the spine.

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)

Animal tests were performed to demonstrate the Performance Data consistent and predictable ablation and coagulation of different tissues used in the study.

From a clinical point of view, comparing 120W vs 150W application on animal tissue it has been showed that:

lateral coagulation width and axial coagulation depth do not show any significant difference – therefore the remaining tissue is affected in the same amount
depth of the ablation crater: no significant differences when velocities of 5 and 10mm/s were used, while a significant increase of ablation depth at 1mm/s at 150W compared to 120W
carbonisation of Tm:YAG laser power occurred at 150W in the same manner as could be observed at 120W

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.

K090962

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

| Title: | 510(k) SUMMARY
Quanta System Cyber Tm 150W | K102749
DEC 10 2010 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Submitter: | Quanta System SpA
via IV Novembre,116
21058 Solbiate
Olona VA / Italy | |
| Contact: | Dr. Isabella Carrer
Medical Division Manager | |
| Date Prepared: | October 5, 2009 | |
| Device Trade Name: | Quanta System Cyber Tm 150W | |
| Common Name: | Laser surgical instrument for use in general surgery and
dermatology | |
| Classification Name: | Instrument, surgical, powered, laser | |
| Predicate Devices: | - Quanta System Cyber Surgical Laser Family
(K090962); | |
| Intended Use / | 2.01μm Applications: | |
| Indications for Use: | The Cyber Tm 150W and its fiber optic delivery system
are intended for use in surgical procedures using open,
laparoscopic and endoscopic incision, excision, resection,
ablation, vaporization, coagulation and hemostasis of
soft tissue in use in medical specialties including:
Urology, Gastroenterology, Thoracic and Pulmonary,
Gynecology, ENT, Dermatology, Plastic Surgery,
General Surgery.and Arthroscopy | |
| | Urology | |
| | Open and endoscopic surgery (incision, excision, | |

resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures
-Bladder Neck Incisions (BNI)

1

Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
Tumors. -
Ablation of Benign Prostatic -Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostrate -(HoLRP)
Laser Enuculeation of the Prostate -(HoLEP)
Laser Ablation of the -Prostate(HoLAP)
Condylomas a
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 -
Telangiectasias -
Telangiectasias of the Osler-Weber--Renu disease
Vascular Malformation -
Gastritis -
Esophagitis -
Esophageal ulcers -
Varices -
Colitis
Mallory-Weiss tear -
Gastric Erosions

2

Gynecology

Open and laparoscopic gynecological surgery (incision. excision, resection.

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, resection, 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 1
Biopsv -
Skin incision -
Tissue dissection -

3

Excision of external tumors and lesions
Complete or partial resection of internal organs, tumors and lesions
Mastectomy -
Hepatectomy -
Pancreatectomy -
Splenectomy -
Thyroidectomy -
Parathyroidectomy -
Herniorrhaphv -
Tonsillectomy .
Lymphadenectomy -
Partial Nephrectomy -
Pilonidal Cystectomy ﺳ
Resection of lipoma -
Debridement of Decubitus Ulcer -
Hemorrhoids
Debridement of Statis Ulcer -
Biopsy -

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal
Surgery including -
Percutaneous Laser Disc -Decompression/Discectomy
Foraminoplasty -
Ablation and coagulation of soft vascular and non vascular tissue in
minimally invasive spinal surgery.

The Cyber Tm 150W is a surgical laser instrument for use in general surgery and dermatology. The Cyber Tm 150W is:

Technological
Characteristics:

Models	Wavelength	Laser Power
Cyber Tm	2.01μm	150W

Cyber Tm is intended for use in surgical procedures using open, laparoscopic and

4

endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy