(80 days)
The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. 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, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
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
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts an 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
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 homeostasis 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
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:
Endometrial ablation
Excision or vaporization of condylomata acuminate
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 and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectorny, implant recovery, gingivoplasty, 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, papillectorny, vestibulopasty, 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.
The Vectra™ Laser System and Accessories is substantially equivalent to the Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser Systems (East Longmeadow, MA)) previously cleared for marketing under applicable 510(k) pre-market notification regulations.
Table I summarizes device specifications of the Vectra Laser Systems compared to the Xintec Corporation Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser System (East Longmeadow, MA)) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.
The provided text describes a 510(k) summary for the Vectra™ Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is established by showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.
Therefore, the input document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them in the context of clinical performance metrics like sensitivity, specificity, accuracy, etc. The document primarily compares the technical specifications and intended uses of the Vectra™ Laser System to existing predicate devices.
Specifically, the following points cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No such clinical performance criteria or results are reported. The provided table (Table I) compares technical specifications (wavelength, maximum output power, operating modes, etc.) to predicate devices, not clinical performance acceptance criteria.
- Sample size used for the test set and the data provenance: No test set (clinical or otherwise for performance evaluation) is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical performance study is described.
- 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 is a laser system, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 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.
{0}------------------------------------------------
7 2006 APR
510(k) Summary Vectra™ Laser System and Accessories
Xintec Corporation, dba, Submitter's Name: Convergent Laser Technologies, 1660 S. Loop Road Alameda, CA 94502 510-832-2130 Phone Number: 510-832-1600 Fax Number: Marilyn M. Chou, Ph.D. Contact Person: February 23, 2006 Date Prepared: Vectra™ Laser System and Accessories Name of Device: Xintec Corporation, dba, Sponsor: Convergent Laser Technologies, 1660 S. Loop Road Alameda, CA 94502 Diode laser Classification: Ceralas Diode 980 nm Laser System (Model 100) Predicate Device:
Intended Use/Indications for Use:
The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. 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, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
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
KO 60114
{1}------------------------------------------------
1060 4
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 an 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 Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy Herniorapphy Adhesiolysis
{2}------------------------------------------------
406011-
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 homeostasis 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
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:
Endometrial ablation Excision or vaporization of condylomata acuminate 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
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a series of the number 1 and the number 2. There are many instances of the number 1, and only one instance of the number 2. The numbers are arranged in a single line.
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, operculectorny, implant recovery, gingivoplasty, 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, papillectorny, vestibulopasty, 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.
Technical Characteristics
The Vectra™ Laser System and Accessories is substantially equivalent to the Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser Systems (East Longmeadow, MA)) previously cleared for marketing under applicable 510(k) pre-market notification regulations.
Table I summarizes device specifications of the Vectra Laser Systems compared to the Xintec Corporation Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser System (East Longmeadow, MA)) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.
Table I: DEVICE DESCRIPTION AND EQUIVALENCE INFORMATION
Specifications
| Vectra™ | Optica ™510K# K901710 | Odyssey™510K# 951910 | Ceralas510L#K050824 | |
|---|---|---|---|---|
| Wavelength | 980nm± 10% | 1064nm± 10% | 2100nm± 10% | 980nm |
| MaximumOutput Power | 10/20/30W; 60W;80W; 100W; 120W | 60W; 80W;100W; 120W | 15W; 30W; 45W;60W; 80W | 15W; 25W;50W; 100W |
{4}------------------------------------------------
| Operating Modes | Continuous orpulsed | Quasi-Pulsed | Pulse | Continuous orpulsed |
|---|---|---|---|---|
| Aiming Beam | Green | Red | Green | Red |
| Laser Activation | Footswitch | Footswitch | Footswitch | Footswitch |
| Cooling | Air-cooled | Air-cooled | Air-cooled | Air-cooled |
| Weight | ~200 lbs | 250 lbs | 175 lbs | 50 lbs |
| PowerRequirement | 110/220VAC | 110/220VAC | 110/220VAC | 110/220VAC |
Note: These prototype specifications are subject to modifications for the final production models.
.
{5}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Xintec Corporation, dba c/o Marilyn M. Chou, Ph.D. Convergent Laser Technologies 1660 South Loop Road Alameda, CA 94502
Re: K060114
Trade/Device Name: Vectra™ Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: February 23, 2006 Received: February 24, 2006
Dear Dr. Chou:
This letter corrects our substantially equivalent letter of April 7, 2006.
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 (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.
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.
{6}------------------------------------------------
Page 2 - Marilyn M. Chou, Ph.D.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
O'Malli
Bram D. Zuekerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): K#060114
Device Name: Vectra™ Laser System
Indications for Use:
The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. The device is gencrally 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, neurosurgery (pcripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
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 car, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
Removal of benign lesions from the car, 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 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 an 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, fa and dermabrasion. Examples include:
Matrixectomv Excision of neuromas
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
KOGOJI4 510(k) Number
{8}------------------------------------------------
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 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 homeostasis 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
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:
Endometrial ablation
Excision or vaporization of condylomata acuminate Vaporization of cervical intraepithelial neoplasia Cervical conization
Menorrhagia
elgndl
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number_ KOSDI14
{9}------------------------------------------------
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 tissuc
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, biopsv, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgerv, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions. papillectomy, vestibulopasty, excision of lesions, exposure of unerupted/partially erupted tecth, 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.
, },
ﺪ
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence Afice of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number KO6014
§ 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.