MultiPulse HoPLUS

K161257 · Asclepion Laser Technologies GmbH · GEX · Mar 31, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161257
• Device Name: MultiPulse HoPLUS
• Applicant: Asclepion Laser Technologies GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiPulse HoPLUS Laser system and its fiber 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, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Device Story

MultiPulse HoPLUS is a Class IV, pulsed, solid-state Holmium-YAG laser system (2100 nm). It delivers laser energy up to 140 Watts via flexible quartz/quartz optical fibers (reusable or single-use) to target tissue. Operated by physicians in OR or clinical settings, the system is controlled via a user interface panel and a dual-pedal footswitch. The laser energy performs incision, excision, resection, ablation, vaporization, coagulation, and hemostasis. By enabling precise tissue interaction, the device facilitates various endoscopic and open surgical procedures, including lithotripsy and disc decompression, potentially reducing invasiveness compared to traditional surgical methods.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance data, including verification and validation of software, fiber, and laser components, and final test reports.

Technological Characteristics

Class IV Ho:YAG laser; 2100 nm wavelength; 140W average power; 0.25-6 Joule energy range; 150-1700 μs pulse duration; 5-100 Hz repetition rate. Delivery via flexible quartz/quartz fibers. Power supply: 400V 50Hz/16A 3-phase. Weight: 285 kg. Includes dual-pedal footswitch and control panel interface.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, resection, ablation, vaporization, coagulation, hemostasis) in urology, gastroenterology, arthroscopy, pulmonary, gynecology, ENT, dermatology, plastic surgery, and general surgery. Includes lithotripsy for urinary calculi (cystine, calcium oxalate, monohydrate, dehydrate) and spinal disc decompression.

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

• Multipulse Holmium Plus Model 1910 (K131987)
• Lumenis Pulse 120H (K140388)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.

Public Health Service

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

March 31, 2017

Asclepion Laser Technologies Gmbh Antje Katzer RA Manager Bruesseler Str. 10 Jena, 07747 DE

Re: K161257

Trade/Device Name: MultiPulse HoPlus 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: October 4, 2016 Received: October 6, 2016

Dear 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 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

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

For 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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ndications for Use

Form Approved: OMB No. 0810-0120 Expiration Date: January 31, 2017 See PPRA Statement below

# 510(k) Number (if known

עוד מערב העיר המשפט המערכת המערכת המערכת המערכת המשפט המשפעיי שלו המע

## Device Name

MultiPulse HoPLUS

# Indications for Use (Describe

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### Urology

Building is and but notision, excition, excition, solation, solution, cossultation and personalism and personalisment Urethral Strictures

- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Turno
- Ablation of Benign Prostatic Hypertrophy (BHP)
- Transurethral incision of the prostate (TUIP)
- Holmium Laser Resection of the Prostate (HoLRP
- Holmium Laser Enucleation of the Prostate (HoL
- Holmiurm laser Ablation of the Prostate (HoLAP
- Condylomas
- Lesions of external genitalia
- ithotripsy and Percutaneous Urinary Lithotripsy
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- Biopsy
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- Gall Bladder calculi
- Biliary/Bile duct calculi
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- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weisss tear
- Gastric Erosions

## Arthroscopy

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- Ligament and tendom Release
- Contouring and sculpting of articular surfaces
- Capsulectorny in the Knee
- Chondreoplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- Chondromalacia and tears
- Plica Removal
- Meniscectorny
- Loose Body Debridement
- Lateral retineacular release
- Abinal of soft, cating suisent lamining in suise Spinst Surgery including
- Percutaneous Cervical Disc Decompression/Discectorny Percursus Laser Disc Decompression of the L-F- and L-F-S and under discs, including Formingly
- Percutaneous Thoracic Disc Decompression/Discectory

## Pulmonary

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- Endonasal/sinus Surgery
- Partial turbinectomy
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- Functional endoscopic sinus surgery

# Dermatology and Plastic Surgery

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- Basal Cell Carcinomas
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## · Plantar warts

- Lesions of skin and subcutancous tissue
- Port Wine Stains
- · Papillomas

# General Surgery

hemostasis) including: and and

- · Appendectorny
- Skin incision
- Excision of external lessions
- Complete or partial resection of internal organs, turnors and lesion
- Biopsy

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

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Asclepion Laser Technologies GmbH · Brüsseler Str. 10 · 07747 Jena · Germany

#### SPECIAL 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MultiPulse HoPlus

This Special 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS is submitted in accordance with the requirements of 21 CFR 807.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH<br>Bruesseler Str. 10<br>07747 Jena, Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer<br>Product Management and<br>International Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |
| Preparation Date: | March 29, 2017 |
| Device Name: | MultiPulse HoPLUS |
| Common Name: | Surgical Holmium-Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology<br>GEX<br>21 CFR 878.4810 |
| Equivalent Devices: | MultiPulse HoPLUS K131987 Asclepion Laser Technologies<br>Lumenis Pulse 120 K140388 Lumenis |
| Device Description: | The MultiPulse HoPLUS Laser system and its fiber optic delivery<br>system is a laser Class IV, pulsed, solid state Holmium-YAG, which<br>emits laser radiation with a wavelength of approximately 2100 nm with<br>a pulse with between 150-1700 microseconds. The laser power up to<br>140 Watts is transmitted to the tissue through different optical fibers. |

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The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories Intended Use: The MultiPulse HoPLUS Laser system and its fiber 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, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

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 (BHP)
Transurethral incision of the prostate (TUIP)

Holmium Laser Resection of the Prostrate (HoLRP)

Holmium Laser Enucleation of the Prostate (HoLEP)

Holmium laser Ablation of the Prostate (HoLAP)

Condylomas

Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

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

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

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Arthroscopy / Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal 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-SI lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

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

Gynecology

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

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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

Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, ablation, vaporization,

coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

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#### Summary of Technical Characteristics

| | Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device |
|--------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Name<br>510(k) | MultiPulse HoPLUS<br>Model 1911 | Multipulse Holmium Plus<br>Model 1910<br>K131987 | Lumenis Pulse 120H<br>K140388 |
| Indications | Incision, excision, resection,<br>ablation, vaporisation,<br>coagulation and hemostasis<br>in medical specialties | Incision, excision, resection,<br>ablation, vaporisation,<br>coagulation and hemostasis in<br>medical specialties | Incision, excision, vaporization,<br>ablation and coagulation in<br>medical specialties |
| Device Type | Ho :YAG | Ho :YAG | Ho :YAG |
| Delivery | Different flexible<br>Quartz/Quartz fibers<br>Reusable and single use | Different flexible<br>Quartz/Quartz fibers<br>Reusable and single use | Different flexible Quartz/Quartz<br>fibers<br>Reusable and single use |
| Wavelength | 2100 nm | 2100 nm | 2100 nm |
| Average Power | 140 Watt | 110 Watt | 120 Watt |
| Energy range | 0,25 - 6 Joule | 0,3 - 3,5 Joule | 0,2 - 6 Joule |
| Pulse Duration | 150 - 1700 μs | 200-800 μs | adjustable |
| Repetition Rate | 5 - 100 Hz | Up to 75 Hz | 5 - 80 Hz |
| Power supply | 400 V 50 Hz/16 A 3-phase | 230V 50Hz/32A monophase | 230V 50Hz/<46 A monophase |
| Weight | 285 kg | 240 kg | 245 kg |
| Dual pedal<br>footswitch | Yes | Yes | Yes |

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Comparison to: The MultiPulse HoPLUS, model 1911, surgical laser and delivery devices share the same intended use, similar design features, functional features, and therefore, is substantially equivalent to the Asclepion MultiPulse HoPLUS, model 1910. The Multipulse HoPlus is also substantial equivalent in terms of indications for use to the Lumenis Pulse 120H system with similar parameters and the same intended use.

Non-clinical Performance Data: Verification and Validation activities. These activities comprises the verification and validation of the software, the verification of the device, the verification of the fiber, the verification of the laser, an Investigation Report and the Final Test Report. These investigations lead to the conclusion, that the device is as safe and effective as the predicates and no additional risks occur.

Clinical Performance Data: None

- Conclusion: The Multipulse HoPLUS, model 1911, as a modification of the MultiPulse HoPLUS, model 1910, is substantially equivalent to the cited legally marked predicate devices.