ASAP MUITISCOPE

K121261 · Asap Endoscopic Products GmbH · HRX · Jan 8, 2013 · Orthopedic

Device Facts

• Record ID: K121261
• Device Name: ASAP MUITISCOPE
• Applicant: Asap Endoscopic Products GmbH
• Product Code: HRX · Orthopedic
• Decision Date: Jan 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discec tomy, and foraminotomy.

Device Story

The asap multiscope is a rigid or semiflex-type multi-channel endoscope used for minimally invasive spinal surgery. It utilizes a rod lens system to transmit light and images from the operative site to an external video system. The device features a working channel for instruments and irrigation/suction channels. It is used by surgeons in clinical settings to perform procedures such as nucleotomy, discectomy, and foraminotomy. The device is inserted through standard working sheaths (cannulas). By providing direct visualization, it assists the surgeon in navigating internal structures, potentially reducing tissue trauma compared to open surgery. The device is compatible with standard endoscopic cameras and light systems via a snap coupler or smart lock connector.

Clinical Evidence

Bench testing only. Performance testing was conducted according to IEC 60601-2-18 (Medical Electrical Equipment - Particular Requirements for the Safety of Endoscopic Equipment). No clinical data provided.

Technological Characteristics

Rigid or semiflex-type multi-channel endoscope; surgical steel construction; rod lens optical system; working channel and irrigation/suction channels; snap coupler/smart lock connector for external camera/light source; non-sterile, validated for steam sterilization; compliant with IEC 60601-2-18.

Indications for Use

Indicated for patients requiring visualization of internal anatomy via cannulated incision for diagnostic and surgical procedures including arthroplasty, nucleotomy, discectomy, and foraminotomy.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Joimax Tessys Multiscope (K051827)
• Arthro Kinetics Endoscopic Spine System (K061246)
• maxMorespine Endoscope (K083552)

Submission Summary (Full Text)

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## K121261

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### General Information

### 5.1 Applicant:

asap endoscopic products GmbH Stöckmatten 19 79224 Umkirch / Germany

Phone: [phone] +49.7665.947 7311 Fax: Email: [e-mail] Contact Person : Horst Baholzer

### 5.2 Device Identification

Trade name: asap multiscope

Common name: Spinal Endoscope

Classification Name: Arthroscope and Accessoires (21 CFR 888.1100; Product Code HRX)

### 5.3 Predicate Devices

K051827: Joimax Tessys Multiscope

K061246: Arthro Kinetics Endoscopic Spine System

K083552: maxMorespine Endoscope

#### 5.4 Description of Device

The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists of an outer and an inner tube of surgical steel. The light-carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod lens system, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.

### 5.5 Indications for Use

The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discec tomy, and foraminotomy.

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## ETOS & C VAL

### 5.6 Technological Characteristics

The asap multiscope is a multi-channel endoscope used to visualize the operative site and provided with a working channel and irrigation channel(s). It is a rigid or semiflex-type endoscope consisting of three basic components through which light is projected into the operation site and a video image is produced on an external video . The asap multiscope has a snap coupler or smart lock connector enabling replacement of the eyepiece by a standard camera.

### Performance Data 5.7

Specifications and intended use of the asap multiscope are the same as those of the predicate devices. There are no significant differences between the asap multiscope and the predicates in design or usage conditions. Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility.

The device will be sold non-sterile for steam sterilization by the user. The recommended cleaning and sterilization processes have been validated.

Performance testing was conducted according to the applicable sections of standard IEC 60601-2-18. Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment.

### 5.8 Conclusions

The information provided in this 510(k) submission provides reasonable assurance that the asap multiscope is safe and effective and that it is substantially equivalent to the predicate devices with respect to intended use and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## 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

ASAP Endoscopic Products GMBH % Business Support International Ms. Angelika Scherp Regulatory Affairs Consultant Amstel 320-I Amsterdam, Netherlands 1017AP

Re: K121261

Trade/Device Name: asap multiscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 02, 2012 Received: November 05, 2012

Dear Ms. Scherp:

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

January 8, 2013

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 [phone] or [phone] 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

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510(k): asap multiscopes

Indications for Use

510(k) Number (if known): K121261

Device Name: asap multiscopes

Indications for Use:

The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, and foraminotomy.

Prescription Use __ X

ANDY

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2013.01.07 13:29:56 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number __ K121261