The Empower H65 laser system 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, Discectomy, Gynaecology, ENT and General Surgery.

Device Description

The Empower H65 laser system and its fiber optic delivery system. The device is a modified version of the Litho 60 (K172025) with some technical modifications.

AI/ML Overview

The provided text is a 510(k) summary for the Empower H65 laser system. It describes the device, its intended use, modifications, and testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain information regarding traditional acceptance criteria, performance metrics, or study details (like sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies) typically found in an AI/ML medical device submission.

The document states: "There are no mandatory performance standards for this device." and focuses on demonstrating compliance with electrical safety, electromagnetic compatibility, and general laser safety standards. The performance testing section specifically refers to:

IEC 60601-1:2012, ed 3.1 (Basic Safety And Essential Performance)
IEC 60601-1-2 Edition 4: 2014 (Electromagnetic Compatibility)
IEC 60601-2-22: 2012-10 ed 3.1 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
IEC 60825-1 Ed. 3.0 (2014) (Safety of laser products)
Software verification and validation testing (as per FDA guidance for software in medical devices)

Since the prompt asks for specific details related to acceptance criteria and study design for demonstrating performance, and the provided document focuses on regulatory compliance and safety standards rather than clinical performance metrics, the answer will reflect the absence of this information in the input.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Compliance with IEC 60601-1:2012, ed 3.1	Passed
Compliance with IEC 60601-1-2 Edition 4: 2014	Passed
Compliance with IEC 60601-2-22: 2012-10 ed 3.1	Passed
Compliance with IEC 60825-1 Ed. 3.0 (2014)	Passed
Software Verification and Validation	Successfully passed, documentation provided as recommended

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is related to hardware and software performance according to electrical and safety standards, not a clinical test set with patient data.

3. 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)

This information is not applicable and not provided. The "ground truth" concept is relevant for AI/ML diagnostic or prognostic devices, which this laser system is not. The testing focused on technical performance against engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not described here.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is relevant for AI-assisted diagnostic tools, not for a surgical laser system designed for direct therapeutic intervention. The device is a surgical instrument, not an AI diagnostic assistant.

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

This is not applicable as the Empower H65 is a laser surgical instrument, a hardware device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. The concept of "ground truth" as it applies to clinical data for device performance evaluation is outside the scope of the substantial equivalence claim presented in this 510(k) summary for a surgical laser.

8. The sample size for the training set

This information is not applicable as the Empower H65 is a hardware device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the Empower H65 is a hardware device, not an AI/ML algorithm that requires a training set and ground truth establishment in that context.

Summary

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March 15, 2018

quanta system spa Francesco Dell'antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 It

Re: K180423

Trade/Device Name: Empower H65 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: February 12, 2018 Received: February 16, 2018

Dear Francesco Dell'antonio:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180423

Device Name Empower H65

Urology

Open and endoscopic surgery (incision, excision, 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
· dehvdrate 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, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
Polyps
Biopsy
· Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
· Gastric ulcers
· Duodenal ulcers

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• 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-SI 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, excision, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

· Endonasal/sinus Surgery
· Partial turbinectomy
· Polypectomy
Dacryocystorhinostomy

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• Frontal Sinusotomy

· Ethmoidectomy
Maxillary antrostomy
· Functional endoscopic sinus surgery

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 of partial resection of internal organs, tumors and lesions
Bionsv

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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5. 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy, 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	February 12th 2018
Device Name:	Empower H65
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for Submission:	Device modifications
Legally Marketed Device	Litho 60 (K172025) – Quanta System SPALumenis Pulse 120h (K140388) – Lumenis LTD

The modified device Empower H65 is derived from the legally marketed (unmodified) device Litho 60 (K172025).

Performance Standards:

There are no mandatory performance standards for this device.

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Description of the modifications:

This Special 510(k) of Empower H65 is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to some technical modifications.

The modified device has the same intended use of the unmodified device. Moreover, the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.

Intended Use/Indications for Use

Empower H65 has the same intended use of the unmodified device, as follows:

The Empower H65 laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Urology

Open and endoscopic surgery (incision, excision, 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 urethral, 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.

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Gastroenterology

Open and endoscopic Gastroenterology surgery (incision, excision, 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

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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-SI lumbar discs, . including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology

Open and laparoscopic gynaecological surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, 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

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:

Appendectomy
Skin incision
Excision of external and internal lesions
Complete of partial resection of internal organs, tumors and lesions ●
. Biopsy

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Performace testing

Empower H65 was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:

। IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-IEC 60601-1-2 Edition 4: 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: 2012-10 ed 3.1, 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 Ed. 3.0 (2014) Safety of laser products – Part 1: Equipment classification and requirements
-Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Empower H65 passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.

Comparison with predicate device:

The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Holmium laser sources.

Summary

The modified device Empower H65 is substantially equivalent to its identified predicate device.

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.