(545 days)
Not Found
No
The summary describes a laser system for soft tissue ablation and coagulation, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for various surgical procedures for ablation, vaporization, coagulation, incision/excision of soft tissue, and tissue modification in a wide range of medical specialties. These are therapeutic interventions aimed at treating or alleviating medical conditions.
No
The device is indicated for ablation, vaporization, coagulation, incision/excision of soft tissue for surgical procedures, not for diagnostic purposes.
No
The device description explicitly states it is a "Laser System" and mentions wavelengths (980nm and 1470nm), indicating it is a hardware device that emits laser light for surgical procedures. There is no mention of it being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the Vectra Family of Laser Systems clearly state that it is used for surgical procedures on soft tissue within the body (in vivo). It is used for ablation, vaporization, coagulation, incision/excision, and delivery of laser light directly to the tissue.
The device is a surgical laser system, not a device for testing samples taken from the body.
N/A
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 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.
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, and Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, ear, nose, throat, oral cavity, joint tissues, upper and lower gastrointestinal tracts, skin, abdominal, rectal, fat or muscle tissue, liver, cutaneous, hemorrhoids, appendix, decubitus ulcers, hepatobiliary tumors, breast, capillary hemangioma, abdominal tumors, rectal pathology, pilonidal cyst, hernias, adhesions, parathyroid, gallbladder, thyroid, organs, wounds, teleangectasia of the legs and face, vascular lesions of the face and extremities, greater saphenous vein, reticular veins, branch varicosities, urological tissues, prostate, uretheral tumors, urethral stricture, bladder neck, external genitalia, gynecological tissue, endometrium, condylomata acuminata, cervical intraepithelial neoplasia, cervix, peripheral nervous system, cardiac tissue, pulmonary system, tracheobronchial, intraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024088, K032863, K050824, K071295, K072106, K072682, K073063, K082225, K083682, K090164, K060114, K902871, K910114, K923599, K944474, K944965, K944704, K951760, K992866, K080121
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
1
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.
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
2
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
3
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
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.
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)
4
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
5
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
6
510(k) Number: #K082230
VectraTM Family of Laser Systems and Accessories Device Name:
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.)
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 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.
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
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
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
9
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | X |
|---|---|
| (21 CFR 801.109) |
| OR | Over-The-Counter Use |
|---|---|
| ---- | ---------------------- |
1
(Division Sign. Officer)
(Division Sign-()ff)
Division of Surgical, Orthopedic, Orthopedic,
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K082230