The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (Evolve Dual) (and its delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

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 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.

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
Urology
Gynecology
Neurosurgery
Cardiac Surgery
Pulmonary Surgery
Dental Applications

Device Description

The Biolitec Medical Device, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same identical components as the cleared Biolitec, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (K112013).

AI/ML Overview

The provided document is a 510(k) summary for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser. It explicitly states that the device is determined to be substantially equivalent to a predicate device (K112013).

In the context of 510(k) submissions, the acceptance criteria for a new device are typically met by demonstrating that it is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or highly similar technological characteristics, intended use, indications for use, and principles of operation, and by demonstrating compliance with relevant voluntary consensus standards.

Therefore, the "study that proves the device meets the acceptance criteria" in this case is the substantial equivalence determination by the FDA, based on a comparison to the predicate device and compliance with established standards. There is no clinical study, comparative effectiveness study, or standalone algorithm performance study described in these documents that would provide information on sensitivity, specificity, or other performance metrics typically associated with AI/software devices.

Here's the breakdown of why certain requested information cannot be provided from this document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied by Substantial Equivalence): The device must be "as safe and effective" as the predicate device (Evolve HPD 980/ 1470nm Multiwavelength Diode Laser, K112013). This implicitly means it must perform within the same safety and effectiveness parameters as the predicate.
- Reported Device Performance: The document states, "The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared predicate device." and "The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser has the identical same intended uses, indications, technological characteristics, and principles of operation as its predicate device." No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or other clinical outcomes) are provided for either device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided: No test set or clinical study data is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to a predicate device through technological and intended use comparisons, and compliance with recognized standards.
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)
- Not applicable / Not provided: No test set or ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: No test set or adjudication process is described.
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
- No: No MRMC study was done, nor is this device an AI-assisted device. The device is a multiwavelength diode laser for general surgical applications.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical device (laser), not an algorithm or software. Therefore, a standalone performance assessment in the sense of an algorithm is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided: No ground truth used for a performance study is described as no performance study was conducted for this 510(k). The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
The sample size for the training set
- Not applicable / Not provided: This is not a machine learning or AI device. No training set is involved.
How the ground truth for the training set was established
- Not applicable / Not provided: No training set is involved.

In summary, this 510(k) submission for the Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser is based on demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary consensus standards. It does not involve performance studies in the context of diagnostic or AI devices, and therefore, most of the requested information regarding independent performance testing, sample sizes, and ground truth is not present in the provided text.

Summary

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1x12023

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

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

Biolitec Medical Devices, 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: January 23, 2012

Name of Device and Name/Address of Sponsor

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

Classification Name

Surgical laser, GEX

Predicate Devices

Evolve HPD 980/ 1470nm Multiwavelength Diode Laser, (K112013)

Intended Use/Indication for Use

Technological Characteristics

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Ki20231
2 of 2

Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. 88 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 60601-1; IEC 60601-2-22; EN 60825-1, and ANSIVAAMISO 10993-7.

Substantial Equivalence

The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared predicate device.

The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser has the identical 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 device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Public Health Service

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

APR 2 4 2012

Biolitec Medical Devices, Inc. % Harry Hayes, Ph.D. Regulatory Consultant 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K120231

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: II Product Code: GEX Dated: January 23, 2011 Received: January 25, 2011

Dear Dr. Hayes:

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 practice, labeling, 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

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Page 2 - Harry Hayes, Ph.D

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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

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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

for 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): K \ a O23 (

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

Indications for Use:

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.

The device is specifically indicated for use as follows:

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

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

120231 510(k) Number.

GBDA/ BioMD-EvolveHPDDual-012312-11 ·

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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

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

GBDA/ BioMD-EvolveHPDDual-012312-11

Page 195

K12 0231

(Division Sign-Off)

510(k) Number_

Division of Surgical, Orthopedic,

and Restorative Devices

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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 15 ] W 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

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 2. JRPOck

in the pulmonary system.

Examples include:

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

Restorative Devices

510(k) Number K120231

Division of Surgical, Orthopedic,

(Division Sign-Off)

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,

GBDA/ BioMD-EvolveHPDDual-012312-11

Page 196

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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).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ ਵ (Per 21 C.F.R. 801.109)

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

Nil R.P. Ogale fr m
Digital Signature

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

510(k) Number K120231

GBDA/ BioMD-EvolveHPDDual-012312-11

Page 197

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.