VELA XL
Device Facts
| Record ID | K103654 |
|---|---|
| Device Name | VELA XL |
| Applicant | Starmedtec GmbH |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 6, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Story
The vela® XL is a thulium laser system emitting radiation at approximately 1.9 µm. It consists of a laser unit with a control panel, a foot switch, and an optical application fiber. The device is operated by clinicians in surgical settings (open, laparoscopic, or endoscopic) to perform tissue management (incision, excision, resection, ablation, vaporization, coagulation, and hemostasis). Laser energy is delivered through the fiber to the target tissue. The system provides a surgical tool for various medical specialties, enabling precise tissue interaction to achieve clinical outcomes like tumor removal, lithotripsy, or hemostasis. It is a prescription-only device.
Clinical Evidence
Bench testing only. No clinical data required.
Technological Characteristics
Thulium laser system; wavelength ~1.9 µm; fiber optic delivery. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC 62366. Software complies with IEC 62304. Regulatory class II.
Indications for Use
Indicated for surgical incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft and hard tissue across multiple specialties including urology (e.g., BPH, tumors, lithotripsy), gastroenterology, thoracic/pulmonary, gynecology, ENT, dermatology, plastic surgery, general surgery, and arthroscopy/orthopedic surgery (including spinal).
Regulatory Classification
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.
Predicate Devices
- Lisa Laser Products – Revolix 120 Laser System (K070476)
Submission Summary (Full Text)
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APR - 6 2011
Image /page/0/Picture/2 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol inside, followed by the word "starmedtec" in black text. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font size.
103654
510(k) summary of safety and effectiveness information according 21 CFR Part 807.87(h)
- 1. General Information:
- a. Applicant:
StarMedTec GmbH Kreuzstrasse 22 82319 Starnberg Germany +49815126861-0 (phone) +49815126861-35 (fax)
b. Contact: Gregor Weidemann November 16, 2010 Date Prepared: C.
- 2. Names:
- a. Device Name:
- vela® XL
- b. Common Name: Classification Name: C.
- d. Product code:
vela® XL Laser instrument, surgical, powered GEX
- 3. Predicate Device:
Lisa Laser Products – Revolix 120 Laser System (510(k) Number: K070476)
- 4. Product Description:
The vela® XL is thulium laser system, which emits laser radiation with a wavelength of approximately 1.9 µm. The laser power transfers an optical application fiber. The indications are dissection, ablation, resection and coagulation of tissue. The laser system consists of:
- laser system including control panel (user interface) -
- foot switch -
- application fiber
- 5. Indications for use:
The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including:
Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery
### Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coaqulation and hemostasis) including:
- Strictures of urethra and ureter -
- Bladder Neck Incisions (BNI) -
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Image /page/1/Picture/1 description: The image shows the logo for "starmedtec" with the tagline "innovative solutions." To the left of the company name is a black square containing a white target symbol. A horizontal line separates the company name from the tagline. The text is in a simple, sans-serif font.
1103654
- Ablation and resecetion of Bladder Tumors, Uretheral Tumors and Ureteral -Tumors
- Ablation of Benian Prostatic Hyperplasia (BPH) -
- Transurethral incision of prostate (TUIP) -
- Holmium Laser Resection of the prostate (HoLRP) -
- -Holmium Laser Enucleation of the prostate (HoLEP)
- Holmium Laser Ablation of the prostate (HoLap) -
- -Condvlomas
- ﮮ Lesions or external genitalia
#### Gastroenterology
Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy -
- -Polyps
- Biopsy -
- Gall Bladder Calculi (Lithotripsy) -
- Biliary/Bile duct calculi (Lithotripsy) -
- -Ulcers
- Gastric ulcers -
- Duodenal ulcers -
- ー Non bleeding ulcers
- Pancreatitis -
- Hemorrhoids -
- Cholecystectomy -
- Benign and malignant neoplasm -
- -Angiodysplasia
- Colorectal cancer -
- -Telangiectasias
- Telangiectasias of Osler-Weber-Renu disease -
- Vascular malformation -
- Gastritis ー
- Esophagitis -
- -Esophageal ulcers
- Varices -
- Colitis -
- Mallory-Weiss tear -
- Gastric Erosions …
#### Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
- Laryngeal lesions ー
- Airway obstructions including carcinoma l
- Polyps and granuloma -
- Palliation of obstructing carcinoma of the tracheobroncial tree -
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Image /page/2/Picture/38 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol inside, followed by the word "starmedtec" in a bold, sans-serif font. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller, lighter font. The phrase is underlined by a thin black line.
K103654
#### Gynaecology
Open and endoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coaqulation and hemostasis):
- Intra-uterine treatment of sub mucous fibroids -
- Benign endometrial polyps and uterine septum by incision, excision and or ー vessel coagulation
- Soft tissue excision procedures such as excisional conisation of the cervix -
#### ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coaqulation and hemostasis) including:
- Endonasal / sinus surgery —
- -Partial turbinectomy
- -Polypectomy
- Dacryocystorhinostomy —
- -Frontal sinustomy
- -Ethmoidectomy
- Maxillary antrostomy -
- Functional endoscopic sinus surgery -
- Lesions or tumours (oral, nasal, glossal, pharyngeal or laryngeal) -
- Tonsillectomy -
- -Adenoidectomy
#### Dermatology and Plastic Surgery
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue (hard tissue) including:
- Basal Cell Carcinomas -
- Lesion of skin and subcutaneous tissue -
- -Skin tags
- -Plantar warts
#### General Surgery
Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystectomy 1
- Lysis of adhesion -
- Appendectomy ー
- Biopsv -
- -Skin incision
- Tissue dissection -
- Excision of external tumours and lesions -
- Complete or partial resection of internal organs, tumours, lesions -
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Image /page/3/Picture/1 description: The image shows the logo for starmedtec, which is written in lowercase letters. Below the company name is the phrase "innovative solutions". The number K103654 is written in a large font below the logo.
- Mastectomy i
- Hepatectomy
- Pancreatectomy -
- Splenectomy -
- Thyroidectomy —
- Parathyroidectomy -
- Herniorrhaphy -
- Tonsillectomy -
- Lymphadenectomy -
- -Partial nephrectomy
- Pilonidal Cystectomy -
- Resection of lipoma -
- Debridement of decubitus ulcer -
- Hemorrhoids …
- Debridement of statis ulcer -
#### Arthroscopy
Arthroscopic/orthopaedic surgery (excision, ablation, and coagulation of soft and cartilaginous (hard) tissue):
Ablation of soft and cartilaginous (hard) tissue in minimal invasive spinal surgery including
- Percutaneous laser disc decompression/disectomy —
- Foraminoplasty -
- Ablation and coagulation of soft vascular and non vascular tissue in minimally --invasive spinal surgery
- 6. Performance testing:
The vela® XL is tested according to following standards:
IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-2:2005 IEC 60601-1-4: 1996 (First Ed.) + Am.1: 1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts 1 (1991) and 2 (1995)60601-1-6 IEC 60601-2-22:2005 IEC 60825-1:2007 IEC 62366:2007 IEC 62304:2007 The device also complies with European Medical Device 93/42/EEC + Amendment 2007/47/EC
- 7. Performance data
Laboratory testing was conducted to verify and validate that the vela® XL met all design specifications and is substantially equivalent to the predicate device. Clinical data: No clinical information is required.
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Image /page/4/Picture/1 description: The image shows the logo for "starmedtec" with the tagline "innovative solutions." The logo consists of a black square with a white target symbol on the left, and the company name in black text on the right. Below the company name is the tagline in a smaller font.
K103654
- 8. Conclusion:
The vela® XL is as effective and save as the predicate device. The vela® XL is substantially equivalent to the cited legally marked predicate device.
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Image /page/5/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 symbol resembling an eagle or bird with three stylized wing segments.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
StarMedTec GmbH % Mr. Gregor Weidemann Kreuzstraß22 82319 Starnberg Germany
APR - 6 2011
Re: K103654 Trade/Device Name: vela XL 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: March 7, 2011 Received: March 9, 2011
Dear Mr. Weidemann:
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 - Mr. Gregor Weidemann
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 Pan 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.html 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.
Aing B. Rete
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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Image /page/7/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol inside, followed by the word "starmedtec" in a sans-serif font. Below the word is a line, and below the line is the phrase "innovative solutions" in a smaller font.
K103654
pg 1 of 6
### Indications for Use
510(k) Number (if known): n.a.
Device Name: vela XL
Indications For Use:
The vela XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including:
Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) 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 of CD Device Evaluation (ODE)
> (Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103654
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### 510(k) vela XL Indication for Use Statement (section 4)
Image /page/8/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black letters on the right. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font.
# K 10365
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Strictures of Urethra and Ureter
- Bladder Neck Incisions (BNI) ー
- Ablation and resecetion of Bladder Tumors, Uretheral Tumors and -Ureteral Tumors
- Ablation of Benign Prostatic Hyperplasia (BPH) -
- Transurethral incision of prostate (TUIP) -
- Holmium Laser Resection of the prostate (HoLRP) -
- Holmium Laser Enucleation of the prostate (HoLEP)
- Holmium Laser Ablation of the prostate (HoLap) -
- Bladder/Renal Calculi (Lithotripsy) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Condylomas -
- Lesions or external genitalia
#### Gastroenterology
Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy -
- Gall Bladder Calculi (Lithotripsy) -
- Biliary/Bile duct Calculi (Lithotripsy ﺴﯩ
- Ulcers
- Gastric ulcers
- Duodenal ulcers
Prescription Use X (Part 21 CFR 801 Subpart D) 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 of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103654
{9}------------------------------------------------
### 510(k) vela XL Indication for Use Statement (section 4)
starmedtec
K103654 pg
- Non bleeding ulcers -
- Pancreatitis -
- Hemorrhoids -
- Cholecystectomy ー
- Benign and malignant neoplasm -
- Angiodysplasia -
- Colorectal cancer -
- Telangiectasias -
- Telangiectasias of Osler-Weber-Renu disease -
- Vascular malformation ー
- Gastritis -
- Esophagitis -
- Esophageal ulcers -
- Varices -
- Colitis --
- Mallory-Weiss tear ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- Gastric Erosions
#### Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
- Laryngeal lesions l
- Airway obstructions including carcinoma
- Polyps and granuloma
- Palliation of obstructing carcinoma of the tracheobroncial tree
Prescription Use X (Part 21 CFR 801 Subpart D) 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 of CDRH, Office of Device Evaluation (ODE)
NehRP Dyke for nxm
Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103654
{10}------------------------------------------------
### 510(k) vela XL Indication for Use Statement (section 4)
Image /page/10/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol inside, followed by the word "starmedtec" in a simple, sans-serif font. Below the word "starmedtec" is the phrase "innovative solutions" in a smaller font.
K103654
pg 4 of 6
#### Gynaecology
Open and endoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis):
- Intra-uterine treatment of sub mucous fibroids -
- Benign endometrial polyps and uterine septum by incision, excision and or vessel coagulation
- Soft tissue excision procedures such as excisional conisation of the | cervix
#### ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Endonasal / sinus surgery
- Partial turbinectomy -
- Polypectomy -
- Dacryocystorhinostomy -
- Frontal sinustomy -
- Ethmoidectomy -
- Maxillary antrostomy -
- Functional endoscopic sinus surgery -
- Lesions or tumours (oral, nasal, glossal, pharyngeal or laryngeal) ー
- Tonsillectomy -
- Adenoidectomy -
#### Dermatology and Plastic Surgery
Prescription Use (Part 21 CFR 801 Subpart D) 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 of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Dable for
vision of Surgical, Orthopedic. Restorative Devi
510(k) Number K103654
{11}------------------------------------------------
### 510(k) vela® XL Indication for Use Statement (section 4)
Image /page/11/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in a sans-serif font on the right. Below the word "starmedtec" is the phrase "innovative solutions" with a line above it.
K103654 pg 5 of 6
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, muscosal tissue, fatty tissue and cartilaginous tissue (hard tissue) including:
- Basal Cell Carcinomas -
- Lesion of skin and subcutaneous tissue -
- Skin tags -
- Plantar warts -
#### General Surgery
Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystectomy ー
- Lysis of adhesion |
- -Appendectomy
- Biopsy -
- Skin incision -
- -Tissue dissection
- Excision of external tumours and lesions -
- Complete or partial resection of internal organs, tumours, lesions -
- Mastectomy -
- = Hepatectomy
- -Pancreatectomy
- Splenectomy -
- -Thyroidectomy
- ﺳﮯ Parathyroidectomy
- Herniorrhaphy -
- Tonsillectomy -
- Lymphadenectomy
Prescription Use × (Part 21 CFR 801 Subpart D) 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 of CDRH, Office of Device Evaluation (ODE)
Neil RP. Ooster for maxim
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103654
{12}------------------------------------------------
### 510(k) vela® XL Indication for Use Statement (section 4)
Image /page/12/Picture/1 description: The image shows the logo for starmedtec. The logo consists of a black square with a white target symbol on the left, and the word "starmedtec" in black font on the right. Below the word "starmedtec" is the phrase "innovative solutions".
- Partial nephrectomy -
- Pilonidal Cystectomy --
- Resection of lipoma -
- Debridement of decubitus ulcer -
- Hemorrhoids -
- Debridement of statis ulcer -
#### Arthroscopy
Arthroscopic/orthopaedic surgery (excision, ablation, and coagulation of soft and cartilaginous (hard) tissue):
Ablation of soft and cartilaginous (hard) tissue in minimal invasive spinal surgery including
- Percutaneous laser disc decompression/disectomy -
- -Foraminoplasty
- Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery
Prescription Use × (Part 21 CFR 801 Subpart D) 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 of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K103654
