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

Device Description

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 an orientable arm.

AI/ML Overview

The Quanta System Cyber Tm 150W is a surgical laser instrument intended for various surgical procedures. The submission states that the device is substantially equivalent to predicate devices, focusing on the performance similarities between the 150W model and a 120W predicate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for performance; instead, it relies on demonstrating substantial equivalence to a predicate device (Cyber Surgical Laser Family K090962) through comparative animal testing. The performance is assessed by comparing the effects of a 150W laser to a 120W laser on animal tissue.

Acceptance Criteria (Implied)	Reported Device Performance (Cyber Tm 150W vs. 120W predicate)
Similar lateral coagulation width and axial coagulation depth	"lateral coagulation width and axial coagulation depth do not show any significant difference – therefore the remaining tissue is affected in the same amount"
Similar depth of ablation crater at higher velocities	"depth of the ablation crater: no significant differences when velocities of 5 and 10mm/s were used"
Acceptable ablation depth at lower velocities	"a significant increase of ablation depth at 1mm/s at 150W compared to 120W" (This suggests a different performance at 1mm/s, which the FDA presumably deemed acceptable given the overall substantial equivalence finding.)
Similar carbonization of tissue	"carbonisation of Tm:YAG laser power occurred at 150W in the same manner as could be observed at 120W"
Safe and effective as predicate devices for intended uses	"Quanta System Cyber Tm 150W is as safe and effective as the predicate devices. The Cyber Tm 150W has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device."
No new issues of safety or effectiveness from technological differences	"The minor technological differences between the Cyber Tm 150W and its predicate devices raise no new issues of safety or effectiveness."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document states that "Animal tests were performed." It does not specify the number of animals or the quantity of tissue samples used in these tests.
Data Provenance: The tests were performed on "animal tissue." The country of origin of the data is not specified, but the submitter is Quanta System SpA in Italy. The tests appear to be prospective studies conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not detail the number or qualifications of experts involved in establishing the "ground truth" for the animal tissue studies. The assessment of "significant difference" in coagulation, ablation depth, and carbonization would typically be done by qualified researchers or pathologists, but specifics are not provided.

4. Adjudication method for the test set

The document does not describe the specific adjudication method used for the animal tissue study results. The determination of "significant difference" would imply statistical analysis and potentially expert consensus, but no details are given.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to a standalone evaluation of an algorithm. This device is a physical surgical laser, not an algorithm. Therefore, a standalone algorithm performance study was not performed.

7. The type of ground truth used

The "ground truth" for the animal tissue study was based on direct observation and measurement of the physical effects of the laser on the tissue (lateral coagulation width, axial coagulation depth, depth of ablation crater, carbonization). This would typically involve microscopic and macroscopic pathological examination of the treated tissues.

8. The sample size for the training set

This device is a physical medical device, not a machine learning or AI model that requires a "training set." Therefore, there is no training set in this context.

9. How the ground truth for the training set was established

As there is no training set for this device, how its ground truth was established is not applicable.

Summary

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Title:	510(k) SUMMARYQuanta System Cyber Tm 150W	K102749DEC 10 2010
Submitter:	Quanta System SpAvia IV Novembre,11621058 SolbiateOlona VA / Italy
Contact:	Dr. Isabella CarrerMedical 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 anddermatology
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 systemare intended for use in surgical procedures using open,laparoscopic and endoscopic incision, excision, resection,ablation, vaporization, coagulation and hemostasis ofsoft 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)

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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 -

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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

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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 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.

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

Quanta System Cyber Tm 150W is as safe and effective as the predicate devices. The Cyber Tm 150W has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Cyber Tm 150W and its predicate devices raise no new issues of safety or effectiveness. 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

Substantial Equivalence:

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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

Thus, the Cyber Tm 150W is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Quanta System SPA % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

DEC 1 0 2010

Re: K102749

Trade/Device Name: Quanta System Cyber Tm 150W Regulation Number: 21 CFFR 878.4810 Regulation Name: Lase surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 27, 2010 Received: December 01, 2010

Dear Mr. Job:

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 (Act to not require approval of the Federal Food, Drug,
You may, therefore, market the device, subject to the secure approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of PMA).
general controls provisions of the Act include recorders of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against mistranding and adulteration. Please note: CDRH does not evaluate information related to contract ing and
warranties. We remind vou: bowever, that design is hat 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.

{7}------------------------------------------------

Page 2 – Mr. Mark Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that substantial equivalence detemination does not mean
that FDA has made a determination administers leavith other requirements of the Act or any Federal statutes and regulations administered by other requirements of for comply with all the Act's requirements, including, but not limited to: registration and listing (21)
CFR Part 807); labeling (21 CFR Part 801); modical 10: registration and l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting and listing);
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as and forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, e the election of the of Schild (QS) regulation (21 CFR Part 820); and if applicable, the elect
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 10

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/11/2/2/2/2
the Center for Devices and Radiological Health CDRH/CDRH/Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Offices/ucm 115809.htm for
note the regulation entitled "Misbranding by references of Compliance. Also, please note the regulation entitled than is (CDRH s) Office of Compliance. Also, please
807.97). For questions regarding the reporting of cl 807.97). For question reporting of ference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation ( CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the manner (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A
B
reta

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	Indications for Use Statement
510(k) Number (if known):	K102749

Device Name: Cyber Tm 150W

DEC 1 0 2010

Indications for Use:

2.01um Applications:

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 -

(Division Sign-Off) (Division Sign-Off)
Division of Surgicel, Orthopedic, Orthopedic,
Devices and retive Devices Division of Surgers
and Restorative Devices and Restorative Devices

510(k) Number K1027

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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 -

tissue) including:

(Division Sign-Off)

(Division Sign of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102749

{10}------------------------------------------------

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

Mark A. Milburn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102749

Arthroscopy

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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. -

Prescription Use X Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter

(21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mula A. Millican

(Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surges
and Restorative Devices

K102749

510(k) Number

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.