DISPOSABLE REFLECTIVE MARKER SPHERES

K100038 · Brainlab AG · HAW · Jul 14, 2010 · Neurology

Device Facts

• Record ID: K100038
• Device Name: DISPOSABLE REFLECTIVE MARKER SPHERES
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jul 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

Device Story

Disposable reflective marker spheres consist of two bonded half-spheres with an integrated screw mechanism, coated in retro-reflective foil. Used in surgical environments; attached to reference arrays and instruments. Function as passive markers for infrared tracking systems to determine spatial positioning of patients and surgical tools within the surgical field. Benefit includes enabling precise navigation and tracking during image-guided surgery.

Clinical Evidence

Bench testing only. Verification of physical properties (impact resistance, retroreflectivity, shelf life) and sterilization/packaging validation performed.

Technological Characteristics

Passive reflective marker spheres; construction includes two bonded half-spheres with screw attachment, coated in retro-reflective foil. Sterile packaging. No electronic components or software.

Indications for Use

Indicated for use in surgical settings to enable infrared tracking systems to detect the position of patients and surgical instruments.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Cranial Image Guided Surgery System (K082060)

Submission Summary (Full Text)

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

# KI00038

JUL 1 4 2010

# 510 (k) Summary Disposable Reflective Marker Spheres

### Manufacturer:

BrainLAB AG Address: Kapellenstrasse 12 Germany Phone:

85622 Feldkirchen [phone] [phone] Fax: Mr. Alexander Schwiersch Mar. 09, 2010

Summary Date:

Contact Person:

### Device Name:

| Trade name: | Disposable Reflective Marker Spheres |
|-----------------------------|--------------------------------------|
| Common/Classification Name: | Disposable Reflective Marker Spheres |
| Regulation number: | 21 CFR 882.4560 |
| Product codes: | HAW, OLO |

#### Predicate Device:

Cranial Image Guided Surgery System K082060

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II

This submission does not change the indications for use for the predicate devices.

#### 1. Intended Use:

Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

#### 2. Device Description:

A disposable reflective marker sphere consists of two bonded half spheres and a screw part that is cut in the lower sphere. An adhesive combines the upper and lower half spheres. The raw sphere is covered with a defined retro-reflective foil.

12
Page of 1

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

### 3. Verification:

To ensure that all specifications of the device have been implemented correctly, following essential requirements have been verified successfully:

- Crucial physical properties of the device (e.g. Impact resistance, homogenous retroreflectivity, shelf life)

- Sterile Packaging

- Sterilization

#### 4. Validation:

4. Validation:
Objective evidence specifications conform with user needs and intended use has Objective onload that acture research, comparison with previously marketed devices and the results of a clinical evaluation.

#### 5. Substantial equivalence:

The Disposable Reflective Marker Spheres have been verified and validated according to BrainLAB's procedures for product design and development. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Cranial Image Guided Surgery System (K082060).

Image /page/1/Picture/9 description: The image shows a fraction of 2/2 over the letter P and the number 3. The fraction is written in a handwritten style, with the numerator and denominator stacked on top of each other. The letter P and the number 3 are written below the fraction, with a horizontal line separating them.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three overlapping figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

BrainLAB AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 85622 Feldkirchen, Gemany

JUL 1 4 2010

Re: K100038

Trade/Device Name: Disposable Reflective Marker Spheres Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: July 02, 2010 Received: July 08, 2010

Dear Mr. Schwiersch:

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

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

Page 2 - Mr. Alexander Schwiersch

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 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 vours.

Mark M. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

长100538 510(k) Number (if known):

Device Name: Disposable Reflective Marker Spheres

Indications For Use:

Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.

Mark M. Melson

(Division Sign-Off) (Division Sign-Only
Division of Surgical, Orthopedic, Division of Survices

K100038

510(k) Number ..

Prescription Use (Per 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)