(406 days)
Not Found
No
The document describes a laser system for surgical procedures and does not mention any AI or ML components in the device description or performance studies.
Yes
The device is described as a laser system intended for surgical procedures, including incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue across various medical specialties. These actions directly contribute to the treatment of diseases, injuries, or conditions, which aligns with the definition of a therapeutic device.
No
The device is described as a surgical laser system intended for use in various surgical procedures involving incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are all therapeutic and interventional procedures, not diagnostic ones.
No
The device description clearly states it is a laser system with hardware components including an optical bench, power supply, water cooling unit, and control electronic. It is operated by a touch screen and foot switch, indicating physical interaction with hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the MultiPulse TM+1470 Laser system is used for surgical procedures directly on soft tissue within the human body (incision, excision, resection, ablation, vaporization, coagulation, and haemostasis).
- The device description focuses on the laser technology and its application in surgery. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a surgical laser system, not an IVD.
N/A
Intended Use / Indications for 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 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
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, Bladder, Ureter, Prostate, external genitalia, Appendix, Colon, Gallbladder, Biliary/Bile duct, Stomach, Duodenum, Pancreas, Rectum, Intestines, Esophagus, Cervix, Uterus, Sinuses, Nose, Oral cavity, Pharynx, Larynx, Tonsils, Adenoids, Skin, Soft tissue, all internal organs, Breast, Liver, Spleen, Thyroid, Parathyroid, Lymph nodes, Kidney, Spine, Cartilage, Arteries, Veins
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
1
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
2
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)
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
FORM FDA 3881 (1/14)
3
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
4
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
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5
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 GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|---------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.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 plastic
surgery
79-GEX
21 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.
6
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 |
7
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:
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, 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
8
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