The Auriga QI 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 tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Device Description

The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, 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 510(k) summary for the Auriga QI laser system does not include acceptance criteria or a study that evaluates the device's performance against such criteria. The document explicitly states:

"No clinical information is required."

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Auriga XL, K111475) through laboratory testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Here's a breakdown of why each specific point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not provided. The document mentions "all design specifications" were met through laboratory testing, but no specific performance metrics or acceptance criteria are listed.
Sample size used for the test set and the data provenance: Not provided. Only "laboratory testing" is mentioned, without details on sample sizes or data origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical study requiring expert ground truth for a test set.
Adjudication method for the test set: Not applicable for the same reason as above.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic or interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical data or ground truth establishment is described for performance evaluation.
The sample size for the training set: Not applicable for a traditional medical device submission that does not involve machine learning or AI.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K 121570

510(k) Auriga Ql Summary (Section 5)

starmedtec

JAN 1 6 2013

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)

Gregor Weidemann

May 24, 2012

Auriga Ql

b. Contact:
c. Date Prepared:
1. Names:
- a. Device Name:
- b. Common Name:
- C. Classification Name:
- ರ Product code:

Auriga QI Laser instrument, surgical, powered GEX

1. Predicate Device:
  StarMedTec GmbH - Auriga XL (510(k) Number: K111475)
Product Description: 4.
The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, 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:

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, coagulation and hemostasis) including:

Strictures of urethra and ureter ।
1 -Bladder Neck Incisions (BNI)

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for starmedtec. The logo has the word "starmedtec" in bold, black letters. Below the word is the phrase "innovative solutions" in a smaller, lighter font. To the left of the word is a black square with a white circle and crosshair in the center.

510(k) Auriga Ql Summary (Section 5)

Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors
Ablation of Benign Prostatic Hyperplasia (BPH) l
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) 1
Condylomas -
Lesions or external genitalia -
Lithotripsy -
Percutaneous Urinary Lithotripsy ー
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragmentation of kidney calculi -
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

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) ー
Ulcers ー
Gastric ulcers -
Duodenal ulcers -
Non bleeding ulcers —
Pancreatitis -
Hemorrhoids -
Cholecystectomy -
Benign and malignant neoplasm -
-Angiodysplasia
Colorectal cancer ﻴﻨ
Telangiectasias -
Telangiectasias of Osler-Weber-Renu disease -
Vascular malformation -
Gastritis -
Esophaqitis -
Esophageal ulcers -
-Varices
Colitis -
Mallory-Weiss tear -
Gastric Erosions -

{2}------------------------------------------------

510(k) Auriga Ql Summary (Section 5)

Arthroscopy

Arthroscopy/Orthopedic surqery (excision, ablation and coagulation of soft and crtilaginous tissue) in small and large joints of the body excluding the spine but including:

starmedtec

vative solutions

Ligament and tendon Release ၊
Contouring and sculpting of articular surfaces |
Capsulectomie in the knee
Chondreoplasty in the knee
Debridement of inflamed synovial tissue -
Chondromalacia ablation -
Chondtromalcia and tears -
-Plica removal
I Meniscectomy
Loose body debridement -
Lateral retineacular release

Ablation of soft, cartilaginous and bony tissue in minimal invasive spinal surgery including

Percutaneous laser disc decompression/discectomy of the L4-5 and L5-S1 ! lumbar discs, including forminoplasty
Percutaneous cervical disc decompression/discectomy l
Percutaneous thoracic disc decompression/discectomy

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Gynaecology

Open and endoscopic/laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis).

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue and cartilage) including:

Endonasal / sinus surgery
Partial turbinectomy
Polypectomy
Dacryocystorhinostomy -
Frontal sinustomy -
Ethmoidectomy -
Maxillary antrostomy ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Functional endoscopic sinus surgery

{3}------------------------------------------------

Image /page/3/Picture/0 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 bold font on the right. Below the word "starmedtec" is a line, and below that is the phrase "innovative solutions" in a smaller font.

: ●

510(k) Auriga Ql Summary (Section 5)

Dermatology and Plastic Surgery

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, mucosal tissue, fatty tissue and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas -
Lesion of skin and subcutaneous tissue -
Skin tags 1
Plantar warts ﺳﮯ
-Lesions of skin and subcutaneous tissue
Port wine stains -
-Papillomas

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy -
Biopsv -
-Skin incision
Excision of external tumours and lesions -
Complete or partial resection of internal organs, turnours, lesions -
1. Performance testing:

The Auriga QI is tested according to following standards:

ISO 14971:2006 IEC 60601-1:2005 (DIN EN 60601-1:2006) IEC 60601-1-2:2007 (DIN EN 60601-1-2:2007-12) IEC 60601-1-6:2006 (DIN EN 60601-1-6:2007) / IEC 62366:2007 (DIN EN 62366:2008) IEC 60601-2-22:2005 IEC 60825-1:2007 (DIN EN 60825-1:2007) IEC 62304:2006 (DIN EN 62366:2006) 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 Auriga QI met all design specifications and is substantially equivalent to the predicate device. Clinical data: No clinical information is required.

Conclusion:

The Auriga QI is as effective and safe as the predicate device. The Auriga QI is substantially equivalent to the cited legally marketed predicate device.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2013

StarMedTec GmbH % Mr. Gregor Weidemann Director, Regulatory Affairs Kreuzstrasse 22 Starnberg, Germany 82319

Re: K121570

Trade/Device Name: Auriga QI 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: December 18, 2012 Received: December 21, 2012

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 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

{5}------------------------------------------------

Page 2 - Mr. Gregor Weidemann

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/ucm l 15809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

Device Name:

Auriga Ql

1. Indications for use:
  The Auriga QI 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 tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy,

Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General 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)

Neil R Ogden 2013.01.15 16:25:29 -05'00'

(Division Sign-Off) for mxm
Division of Surgical Devices
510(k) Number K121570

(1) - 1982 - 1998) 1:4. . : : +++ . . : = = = = = = : . . . . . . . . . . .

starmedtec

nnovative solutions

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

starmedtec
innovative solutions

Dermatology and Plastic Surgery

Basal Cell Carcinomas ー
Lesion of skin and subcutaneous tissue -
Skin tags
Plantar warts
Lesions of skin and subcutaneous tissue
Port wine stains
Papillomas l

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy -
Biopsy -
Skin incision -
Excision of external tumours and lesions =
Complete or partial resection of internal organs, tumours, lesions ー

Prescription Use ਮ (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)

Neil R Ogden
2013.01.15 16:28:34 -05'00'

(Division Sign-Off)	for mrm
Division of Surgical Devices
510(k) Number	K121570

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

11:48:43

Gastroenterology

Open and endoscopic gastroenterological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy l
Polyos -
Biopsy -
-Gall Bladder Calculi (Lithotripsy)
Biliary/Bile duct calculi (Lithotripsy) -
Ulcers ﺳ
Gastric ulcers -
Duodenal ulcers -
Non bleeding ulcers -
Pancreatitis -
Hemorrhoids -
Cholecystectomy -
Benign and malignant neoplasm ﺮﺕ
Angiodysplasia -
-Colorectal cancer
Telangiectasias -
Telangiectasias of Osler-Weber-Renu disease -
Vascular malformation -
Gastritis -
Esophagitis -
Esophageal ulcers -
Varices -
Colitis -
Mallory-Weiss tear -
Gastric Erosions

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)

Neil R Ogden 2013.01.15 16:26:53 -05'00'

(Division Sign-Off)	for mam
Division of Surgical Devices
510(k) Number	K121570

{9}------------------------------------------------

starmedtec innovative solutions

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 Ogden 2013.01.15 16:29:10 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number

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.