The MultiPulse TM+1470 Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including:

Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, Plastic Surgery, General Surgery and Arthroscopy.

Urology

Open and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH) Transurethral incision of the prostate (TUIP) Laser Resection of the Prostate (HoLRP) Laser Enucleation of the Prostate (HoLEP) Laser Ablation of the Prostate (HoLAP) Condylomas

Lesions of external genitalia

Gastroenterology

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

Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasia Telangiectasia of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis):

Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix

ENT

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

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy

General surgery

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

Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy 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

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue):

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery

Device Description

The MultiPulse Tm+1470 laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode. The device is a combination of a Thulium:YAG laser that emits a wavelength of 1940 nm and a near infrared diode laser module that emits a wavelength of 1470 nm. The laser power up to 150 Watts is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.

AI/ML Overview

This looks like a 510(k) summary for a medical device, which is focused on demonstrating "substantial equivalence" to a predicate device rather than proving a new device meets specific, quantitative acceptance criteria through a dedicated study in the way a novel diagnostic or AI device would.

Therefore, many of the requested categories about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context. The document explicitly states "Clinical Performance Data: None".

However, I can extract the relevant information from the provided text based on the 510(k) process.

Here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: For a 510(k) submission like this, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily achieved by showing similar indications for use, safety, and technological characteristics. The performance is then judged against the predicate's established safety and effectiveness.
Reported Device Performance:
- Indications for Use: Surgical procedures involving incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue across various specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, and Arthroscopy).
- Technological Characteristics:
  - Combination of a Thulium:YAG laser (1940 nm wavelength) and a near infrared diode laser module (1470 nm wavelength).
  - Laser power up to 150 Watts.
  - Operates in CW or pulsed mode.
  - Transmitted through different optical fibers.
  - Device components: optical bench, power supply, water cooling unit, control electronic.
  - Operation via touch screen and foot switch.
- Safety and Effectiveness: "Laboratory testing was conducted to validate and verify that the MultiPulse Tm+1470 met all design specifications and was substantially equivalent to the predicate device."

Criterion (for Substantial Equivalence to Predicate)	MultiPulse Tm+1470 Performance / Feature
Indications for Use	Surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
Technological Characteristics	Combination of Thulium:YAG (1940 nm) and near infrared diode (1470 nm) laser. Power up to 150W. CW/pulsed mode. Fiber optic delivery.
Safety and Effectiveness	Met all design specifications; deemed substantially equivalent to predicate device via nonclinical testing.
Predicate Device (Quanta System Cyber Tm 150W)	Similar indications for use, safety compliance, design features, functional features. The MultiPulse has an additional shiftable 1470 nm diode laser module.
Predicate Device (Evolve HPD 980/1470nm Multiwavelength Diode Laser)	Similar indications for use and safety compliance, similar design and functional features. The Evolve device also offers an additional wavelength with coagulative effect.

2. Sample size used for the test set and the data provenance

Not Applicable (N/A) in the context of this 510(k) submission. The submission relies on nonclinical (laboratory) testing to demonstrate substantial equivalence, not a clinical "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No expert-established ground truth from a clinical test set was required or provided for this 510(k). The evaluation is based on engineering and performance specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not relevant as there was no clinical test set requiring expert adjudication.

5. 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

N/A. This device is a laser surgical instrument, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies. The submission explicitly states "Clinical Performance Data: None."

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

N/A. This device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A. Since no clinical performance data was submitted, there was no "ground truth" derived from patient outcomes, expert consensus, or pathology for evaluation of the device in a clinical setting. The "ground truth" for the nonclinical testing would be the engineering specifications and performance standards.

8. The sample size for the training set

N/A. There is no "training set" in the context of this 510(k) premarket notification for a laser surgical instrument. This is not an AI or machine learning device.

9. How the ground truth for the training set was established

N/A. As there is no training set mentioned, this question is not applicable.

Summary

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Image /page/0/Picture/1 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 three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 30, 2015

Asclepion Laser Technologies GmbH Antje Katzer Regulatory Affairs Manager Brüsseler Straße 10 07747 Jena Germany

Re: K133891

Trade/Device Name: Multipulse Tm+1470 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 27, 2015 Received: January 29, 2015

Dear Ms. Antje Katzer:

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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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 Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

for

Sincerely yours, Jennifer R. Stevenson -A

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133891

Device Name

Multipulse Tm+1470

Indications for Use (Describe)

Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, Plastic Surgery, General Surgery and Arthroscopy.

Urology

Lesions of external genitalia

Gastroenterology

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

FORM FDA 3881 (1/14)

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Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis):

ENT

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

General surgery

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

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Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue):

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY . .

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510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH K133891

MultiPulse Tm +1470

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MultiPulse Tm+1470 is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

Applicant:	ASCLEPION LASER TECHNOLOGIES GmbHBruesseler Str. 1007747 Jena, Germany
Contact Person:	Mrs. Antje KatzerProduct Management andInternational Regulatory Affairs
Phone:Fax:e-mail:	+49 3641 77 00 309+49 3641 77 00 302antje.katzer@asclepion.com
Preparation Date:	December 10, 2013
Device Name:	MultiPulse Tm +1470
Common Name:	MultiPulse Tm +1470
Classification Name:	Laser surgical instrument for use in general and plasticsurgery79-GEX21 CFR 878.4810
Equivalent Devices:	Evolve HPD 980/1470 Multiwavelength Diode Laser K120231

K102749 Quanta System Cyber Tm 150 Watt

Device Description: The MultiPulse Tm+1470 laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode. The device is a combination of a Thulium:YAG laser that emits a wavelength of 1940 nm and a near infrared diode laser module that emits a wavelength of 1470 nm. The laser power up to 150 Watts is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.

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Intended Use: The Multipulse Tm +1470 Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BPH), Transurethral incision of the prostate (TUIP) Laser Resection of the Prostate Laser Enucleation of the Prostate Laser Ablation of the Prostate Condyloma Lesions of external genitalia

Gastroenterology

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

Appendectomy	Angiodysplasia
Polyps	Colorectal cancer
Biopsy	Telangiectasia
Gall Bladder calculi	Telangiectasia of the Osler-Weber-
Biliary/Bile duct calculi	Renu disease
Ulcers	Vascular Malformation
Gastric ulcers	Gastritis
Duodenal ulcers	Esophagitis
Non Bleeding Ulcers	Esophageal ulcers
Pancreatitis	Varices
Hemorrhoids	Colitis
Cholecystectomy	Mallory-Weiss tear
Benign and Malignant	Gastric Erosions
Neoplasma

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Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including:

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including:

Percutaneous Laser Disc Decompression/Discectomy

Foraminoplasty

Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue:

ENT

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

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors (oral, nasal, glossal, pharyngeal and laryngeal) Tonsillectomy Adenoidectomy

General surgery

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

Cholecystectomy Lysis of adhesion Appendectomy Biopsy

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Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer

Substantial Equivalence

The MultiPulse Tm+1470 laser system shares the same indications for use and safety compliance, similar design features, functional features, and therefore is substantially equivalent to the predicate device, the Quanta System Cyber Tm 150W. The only difference in the specification/characteristic of the MultiPulse Tm+1470 laser system and its predicate Quanta System Cyber Tm 150W is the additional shiftable near diode laser module of 1470 nm. This module can enhance Thulium laser treatment by adding a coagulation effect in cases where hemostasis is desirable. The MultiPulse Tm+1470 laser system shares the same indications for use and safety compliance, similar design features, functional features, and therefore is substantially equivalent to the predicate device, the Evolve HPD 980/1470nm Multiwavelength Diode Laser. As the MultiPulse Tm+1470, the Evolve device can be operated with an additional wavelength with coagulative effect.

Nonclinical Performance Data:

Laboratory testing was conducted to validate and verify that the MultiPulse Tm+1470 met all design specifications and was substantially equivalent to the predicate device.

Clinical Performance Data: None

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.