(188 days)
Not Found
No
The description focuses on physical properties and performance related to tracking systems, with no mention of AI/ML.
No
The device is a reflective marker sphere used for tracking patient and instrument positions during surgery, not for treating a disease or condition. Its function is limited to enabling infrared tracking systems.
No
The device description indicates that these are passive reflective markers used for tracking, not for diagnosing medical conditions.
No
The device description explicitly details physical components (reflective marker spheres, bonded half spheres, screw part, adhesive, retro-reflective foil) and performance studies focus on physical properties and packaging, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field." This is a surgical navigation/tracking function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The description details a physical marker used for tracking, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device's function is purely related to surgical guidance and tracking.
N/A
Intended Use / Indications for 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.
Product codes
HAW, OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
0
KI00038
JUL 1 4 2010
510 (k) Summary Disposable Reflective Marker Spheres
Manufacturer:
BrainLAB AG Address: Kapellenstrasse 12 Germany Phone:
85622 Feldkirchen +49 89 99 15 68 0 +49 89 99 15 68 33 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.
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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:
- 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 (800) 638-2041 or (301) 796-7100 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
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)