The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Arthroscopy
Gastroenterology
General Surgery, Dermatology, Plastic Surgery and Podiatry
Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications
Powers from 151W to 200W

Device Description

The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH)

AI/ML Overview

The provided text is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the power range for a specific indication. The document does not contain the level of detail typically found in a clinical study report that would establish specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested fields cannot be directly extracted or inferred from this document. However, based on the information provided, here's what can be answered:

Acceptance Criteria and Device Performance:

The document states that the device complies with several voluntary consensus standards, implying that meeting these standards served as acceptance criteria for certain aspects (e.g., electrical safety, electromagnetic compatibility, biocompatibility).

Acceptance Criteria	Reported Device Performance
Compliance with 21 C.F.R. §§ 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products)	Device complies
Compliance with ANSI/AAMI ES1 (Medical Electrical Equipment - Part 1: General Requirements for Safety – Collateral Standard: Essential Performance Requirements of Medical Electrical Equipment and Medical Electrical Systems)	Device complies
Compliance with IEC 601-2-22 (Medical electrical equipment — Part 2-22: Particular requirements for the safety of surgical, cosmetic, therapeutic and diagnostic laser equipment)	Device complies
Compliance with EN 60825-1 (Safety of laser products — Part 1: Equipment classification and requirements)	Device complies
Compliance with ANSI/AAMI/ISO 10993-7 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals)	Device complies
Demonstrated safety and effectiveness for power increase from 150W to 200W for vaporization of the prostate to treat BPH (Substantial Equivalence)	"Published clinical data supplied quantifies ablation rates on a per Watt basis for a 980nm laser versus a 1470nm laser, which together with studies using 200W 980nm lasers on human cadaver prostates and 50W 1470nm lasers on prostates of patients with bladder outlet obstruction along with its predicate devices support the conclusion that the device is safe and effective and substantially equivalent to its predicate devices."

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions "studies using 200W 980nm lasers on human cadaver prostates" and "50W 1470nm lasers on prostates of patients with bladder outlet obstruction." However, specific sample sizes for these studies are not provided.
- Provenance: "human cadaver prostates" and "prostates of patients." The country of origin is not specified but given it's a US FDA submission, US data is implied or preferred, but not explicitly stated.
- Retrospective or prospective: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "published clinical data" and "studies," but doesn't detail the methodology for establishing ground truth within those studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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:
- This device is a surgical laser, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a surgical laser, and its performance is inherently tied to its use by a human in a surgical setting. Therefore, a "standalone algorithm only" performance study is not applicable. The "performance data" refers to the physical effects of the laser (ablation rates).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the ablation studies on prostates, the "ground truth" would likely involve objective measurements of tissue ablation, such as volume of tissue removed, depth of penetration, or other physical/histological evaluations of the treated tissue. The document does not explicitly state the specific type of measurement.
The sample size for the training set:
- The document primarily relies on "published clinical data" and studies on cadaver/patient prostates. There is no mention of a "training set" in the context of an algorithm or AI model, as this is a hardware device.
How the ground truth for the training set was established:
- As there is no "training set" in the context of an AI model for this hardware device, this question is not applicable. The "ground truth" related to the laser's physical performance (e.g., ablation rates) would be established through direct measurement and observation in experiments.

Summary

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JAN 1 3 2012

510(k) Summary Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: July 5, 2011

Name of Device and Name/Address of Sponsor

Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser; Evolve® HPD Dual Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

Surgical laser (21 CFR 878.4810, Product Code GEX)

Predicate Devices

Ceralas 150W 980/ 1470nm Multiwavelength Diode Laser, (K090164) Ceralas 180W 980nm Diode Laser, (K083682) Ceralas 980nm Diode Laser Family, (K100726 & K112324)

Intended Use/Indication for Use

The device is specifically indicated for use as follows:

{1}------------------------------------------------

K112013

Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and II Neck dissection

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy Synovectomy Chondromalacia

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding

Excision and vaporization of colorectal carcinoma

Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection

{2}------------------------------------------------

K 112013

pg 3 of 5

Excision of cutaneous lesions

Hemorrhoidectomy

Appendectomy

Debridement of decubitus ulcers

Hepatobiliary tumors

Mastectomy

Dermabrasion

Laser Assisted Lipolysis

Vaporization and hemostasis of capillary hemangioma

Excision, vaporization and hemostasis of abdominal tumors

Excision, vaporization and hemostasis of rectal pathology

Pilonidal cystectomy

Herniorapphy

Adhesiolysis

Parathyroidectomy

Laparoscopic cholecystectomy

Thyroidectomy

Resection of organs

Debridement of wounds

Photocoagulation of teleangectasia of the legs and face

Photocoagulation of vascular lesions of the face and extremities

Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein

Reflux Associated with Varicose Veins and Varicosities

Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues.

Examples include:

Vaporization of urethral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia

Vaporization of the prostate to treat benign prostatic (BPH). Note: powers from 151W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue.

Examples include:

Endometrial ablation

Excision or vaporization of condylomata acurninate

Vaporization of cervical intraepithelial neoplasia

{3}------------------------------------------------

K112013 874 af's

Cervical conization Menorrhagia

Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture

Benign and malignant pulmonary obstruction

Endoscopic pulmonary applications

Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery,

debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Powers from 151W to 200W Powers from 151W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

{4}------------------------------------------------

K112013

pg 5 of 5

Technological Characteristics

Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7. Published clinical data supplied quantifies ablation rates on a per Watt basis for a 980nm laser versus a 1470nm laser, which together with studies using 200W 980nm lasers on human cadaver prostates and 50W 1470nm lasers on prostates of patients with bladder outlet obstruction along with its predicate devices support the conclusion that the device is safe and effective and substantially equivalent to its predicate devices.

Substantial Equivalence

The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared Ceralas 150W 980/ 1470mm Diode Laser. The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser has the same intended uses, indications, technological characteristics, and principles of operation as its predicate device. Thus, the Evolve HPD 980/ 1470nm Multiwavelength Diode Laser is substantially equivalent to its predicate devices.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

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

JAN 1 3 2012

Biolitec, Incorporated % Genmarhay BDA Harry Hayes, Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K112013

Trade/Device Name: Evolve HPD 980/1470nm Multiwavelength Diode Laser 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: January 5, 2012 Received: January 10, 2010

Dear Dr. Hayes:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessment to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of prior of ring 2011 - 12:00 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultier. Thease noter Obras set, 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 If your device is elaborition (000 aron). 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 r load be action of a determination that your device complies with other requirements of the Act that I Drivias intatutes and regulations administered by other Federal agencies. You must or any I oderar statute and securements, including, but not limited to: registration and listing (21 compy with an all love (21 CFR Part 801); medical device reporting (reporting of medical CI K Far 607), adoming (21 CFR 803); good manufacturing practice requirements as set

{6}------------------------------------------------

Page 2 - Harry Hayes, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

1cgallanon (21 CFA Part 1007) process 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaulf.htm.

Sincerely yours,

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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pq 1 of 4

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser

Indications for Use:

The device is intended for delivery of laser light to soft tissue in the contact and non The active is included a recedures including via endoscopes. The Evolve HPD contact article attring of 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear. nose and throat and oral surgery (otolaryngology), arthroscopy, m car, nooo and the surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with surger); action approacted Multiwavelength laser is further indicated for laser assisted lipolysis. Bapernelar 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Har, I woo una rizion, ablation, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

Removal of benign lesions from the ear, nose and throat

Excision and vaporization of vocal cord nodules and polyps

Incision and excision of carcinoma in situ

Ablation and vaporization of hyperkeratosis

Excision of carcinoma of the larynx

Laryngeal papillomectomy

Excision and vaporization of herpes simplex I and II

Neck dissection

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include

Menisectomy

Synovectomy

Chondromalacia

Neil R. Ogden for mkn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112013

{8}------------------------------------------------

K.11 2013

1 2 of 4

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding

Excision and vaporization of colorectal carcinoma

Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Laser Assisted Lipolysis Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy (Division Sign-C Herniorapphy Division of Surgical, Orthopedic, Adhesiolysis and Restorative Devices Parathyroidectomy Laparoscopic cholecystectomy 112013 Thyroidectomy 510(k) Number. Resection of organs Debridement of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities I novenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities Treatment of reticular veins and branch varicosities

{9}------------------------------------------------

1/2013 pg 3 of 4

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues.

Examples include: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic hyperplasia (BPH). Note: powers from Vaporization of the procuse to applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acurninate Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include:

hemostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue nitred. in the pulmonary system.

Examples include:

Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications

cision and ablation of soft tissue
Nilk for mam
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Dental Applications

510(k) Number K112013

Indicated for the following applications on intraoral and extraoral soft tissue thatcated or the tonewal gingival and epithelial lining of free gingival). frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy,

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

K 11 2013 Pg 4 of 4

gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery,

debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/ partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Powers from 151W to 200W

x owers from 151 W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)

Neil RPOschelen for mxc

Division of Surnical, Orthopedic, and Restorative Devices

510(k) Number K112013.

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.