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 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

AI/ML Overview

The provided document is a 510(k) summary for the StarMedTec vela® XL laser system. It details the device's intended uses and provides information about performance testing. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness from a multi-reader, multi-case study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific accuracy thresholds, rates of success for procedures). Instead, the performance testing described focuses on compliance with established standards and substantial equivalence to a predicate device.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Safety and Effectiveness	Substantial equivalence to predicate device (Lisa Laser Products – Revolix 120 Laser System, K070476) for various surgical procedures (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue).	"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."
Design Specifications	Met all design specifications.	"Laboratory testing was conducted to verify and validate that the vela® XL met all design specifications..."
Standards Compliance	Compliance with specified international and European standards.	"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."
Clinical Data	No clinical information required for submission.	"No clinical information is required."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical information is required." This means there was no clinical "test set" of patients or cases used for performance evaluation in the context of this 510(k) submission. The evaluation was based on laboratory testing and comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical test set was required or used for performance evaluation in this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was required or used for performance evaluation in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC comparative effectiveness study was reported in this document. The submission states that "No clinical information is required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The vela® XL is a laser surgical instrument, an active device used by a human practitioner. It's not an "algorithm only" device in the sense of AI-driven diagnostic software. Its performance is intrinsically linked to its operation by a human user during surgical procedures. The performance evaluation focuses on the device's technical specifications and safety rather than independent algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by demonstrating its compliance with technical standards and its substantial equivalence to an already legally marketed predicate device (Lisa Laser Products – Revolix 120 Laser System, K070476). This relies on:

Engineering and laboratory test data confirming design specifications.
Regulatory assessment of the similarities and differences between the new device and the predicate device, with respect to indications for use, technological characteristics, and safety/effectiveness profiles.

8. The Sample Size for the Training Set

Not applicable. As this is a medical device approval based on substantial equivalence and laboratory testing, there is no "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in this context.

Summary

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APR - 6 2011

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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.

1. Names:
- a. Device Name:
vela® XL
b. Common Name: Classification Name: C.
d. Product code:

vela® XL Laser instrument, surgical, powered GEX

1. Predicate Device:
  Lisa Laser Products – Revolix 120 Laser System (510(k) Number: K070476)
1. 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
1. Indications for use:

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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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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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
1. 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

1. 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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K103654

1. 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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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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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

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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

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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

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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

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

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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

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.