The Vectra Family of Laser Systems and Accessories are indicated for ablation, vaporization, coagulation, incision/excision of soft tissue in contact or non-contact mode including open surgery and via endoscopes, introducers, trocars, or catheters. The Vectra Family of Laser Systems and Accessories are indicated for use in surgical procedures on skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands in surgical specialties including but not limited to genitourinary surgery, urology (including BPH), gynecology (GYN), gastroenterology, general surgery (including specific treatment of varicose veins, varicosities associated with superficial reflux of the greater saphenous vein, removal of pigmented lesions, photothermolysis of hair follicles), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, podiatry, pulmonary/ thoracic surgery, dentistry and oral surgery (intra/extra oral soft tissue, e.g., removal of diseased soft tissue in the periodontal pocket, and for light activation of bleaching materials for teeth whitening.)

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 device 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, genecology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

Device Description

The Vectra Family of Laser Systems emitting 980nm and 1470 nm wavelengths are substantially equivalent to the Xintec Corporation Vectra Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980nm and 1470nm Diode Laser Systems (East Longmeadow, MA) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.

AI/ML Overview

This document is a 510(k) premarket notification for the Vectra™ Family of Laser Systems and Accessories. It describes the device's intended use and claims substantial equivalence to previously cleared predicate devices. Crucially, this document does not contain an acceptance criteria table, reported device performance metrics, or details of a study demonstrating the device meets performance criteria.

The 510(k) submission process for this type of device (surgical laser) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with specific acceptance criteria in the same way that novel diagnostic AI/ML devices might.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on meeting new, specific algorithmic performance metrics.
Sample size used for the test set and the data provenance: Not applicable as a standalone performance study with a test set for acceptance criteria is not described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a surgical laser, not an AI diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "study":

Acceptance Criteria (Implied by Substantial Equivalence): The implicit "acceptance criteria" for a 510(k) for a device like this is demonstrating substantial equivalence to existing predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate(s).
"Study" (Demonstration of Substantial Equivalence): The document states:
- "There should be no significant differences in laser delivery performance for each of 980nm and 1470nm wavelengths for the Vectra Family of Laser Systems compared to the cleared predicate devices."
- This "performance data" statement, in the context of a 510(k), typically refers to non-clinical testing (e.g., bench testing, engineering comparisons) to confirm that the laser itself performs comparably to the predicate devices in terms of power output, wavelength stability, beam characteristics, safety features, etc. It does not refer to a clinical study with patients to evaluate diagnostic accuracy or a specific clinical outcome with acceptance criteria.

The 510(k) process for this device is centered on the comparison to predicate devices: Biolitec Ceralas 980nm and 1470nm Diode Laser, Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories, and Cynosure Smart Lipo Multiwavelength Laser. The "study" here is the assessment that the new device's technological characteristics and intended uses are similar enough to these predicates that it doesn't require a new, full-scale clinical trial to prove safety and effectiveness.

Summary

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K082230

510K SUMMARY

FEB - 3 2010

Xintec Corporation, dba, Convergent Laser Technologies Vectra™ Family of Laser Systems and Accessories

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

Xintec Corporation, dba, Convergent Laser Technologies 1660 South Loop Road Alameda, CA 94502

Phone:	510-832-2130
Fax:	510-832-1600

Contact Person: Marilyn M. Chou, Ph.D.

January 20, 2010 Date Prepared:

Name of Device and Name/Address of Sponsor:

Vectra™ Family of Laser Systems and Accessories

Xintec Corporation, dba, Convergent Laser Technologies 1660 South Loop Road Alameda, CA 94502

Common or Usual Name:

Surgical Diode Laser Systems and Accessories

Classification Name:

Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX

Predicate Devices:

Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072106; #K072682; #K073063; #K082225; #K083682; #K090164) Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (510(k) #K060114; #K902871; #K910114; #K923599; #K944474; #K944965; #K944704; #K951760; #K992866), and Cynosure Smart Lipo Multiwavelength Laser (K080121)

Intended Use/Indications for Use:

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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, e.g., turbinectomy Excision and vaporization of vocal cord nodules & polyps, e.g., tonselectomy, uvelaplasty Incision and excision of carcinoma in situ, e.g., bronchoscopy 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 and keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy

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Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion 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 Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological, including BPH/prostatic, tissues; examples include:

Vaporization of uretheral 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)

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue: examples include:

Endometrial ablation

Excision or vaporization of condylomata acuminata

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue; examples include: Hemeostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue

Pulmonary Surgery

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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 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, vestibuloplasty, 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux associated with varicose veins and varicosities

Technological Characteristics

Performance Data

There should be no significant differences in laser delivery performance for each of 980nm and 1470nm wavelengths for the Vectra Family of Laser Systems compared to the cleared predicate devices.

Substantial Equivalence

The Vectra Family of Laser Systems are substantially equivalent to Biolitec Ceralas 980nm and 1470nm Diode Laser (510(k)#K024088; #K032863; #K050824; #K071295; #K072106: #K072682: #K073063: #K082225: #K083682; #K090164); Convergent Laser Technologies 980nm Diode Laser and OptiLITE Accessories (510(k) #K060114; #K902871; #K910114: #K923599; #K944474; #K944965; #K944704; #K951760; #K992866); and Cynosure Smart Lipo Multiwavelength Laser (K080121)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Xintec Corporation % Convergent Laser Technologies Marilyn M. Chou, Ph.D. 1660 South Loop Road Alameda, California 94502

FEB - 3 2010

Re: K082230

Trade/Device Name: Vectra" Plus Laser System and Accessories 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 20, 2010 Received: January 22, 2010

Dear Dr. Chou:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Marilyn M. Chou, Ph.D.

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/ResourcesforYou/Industry/default.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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510(k) Number: #K082230

VectraTM Family of Laser Systems and Accessories Device Name:

Intended Use/Indications for Use:

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, e.g., turbinectomy

Excision and vaporization of vocal cord nodules & polyps, e.g., tonselectomy,

uvelaplasty

Incision and excision of carcinoma in situ, e.g., bronchoscopy

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

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

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

Matrixectomy

Excision of neuromas

Excision of periungual and subungual warts

Excision of plantar warts and keloids

Liver resection

Excision of cutaneous lesions

Hemorrhoidectomy

Appendectomy

Debridement of decubitus ulcers

Hepatobiliary tumors

Mastectomy

Dermabrasion

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

Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux

Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological, including BPH/prostatic, tissues. Examples include:

Vaporization of uretheral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia

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

Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:

Endometrial ablation

Excision or vaporization of condylomata acuminata

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue Examples include: Hemeostasis 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 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, tussue retraction for impressions, papillectorny, vestibuloplasty, 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux associated with varicose veins and varicosities

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Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Prescription Use	X
(21 CFR 801.109)

OR	Over-The-Counter Use
----	----------------------

(Division Sign. Officer)

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

510(k) Number K082230

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.