(128 days)
Not Found
No
The device description and performance studies focus on the physical properties and retro-reflectivity of marker spheres, with no mention of AI or ML algorithms for image processing or analysis.
No
The device is described as an "accessory to aid in the auto-registration and localization of rigid patient anatomical structures" and consists of "Sterile Reflective Marker Spheres." It does not directly treat or diagnose a disease or condition, but rather assists in image-guided surgical procedures.
No
The device description indicates that the X12's Sterile Reflective Marker Spheres are used as an accessory to aid in auto-registration and localization during image-guided surgical procedures. They are physical markers that reflect light for tracking, not tools for diagnosing medical conditions.
No
The device description explicitly details physical, sterile, reflective marker spheres, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures." This describes a device used during a surgical procedure to assist with navigation and localization within the body.
- Device Description: The device is a physical marker sphere designed to be attached to the patient's anatomy for tracking purposes. It's a mechanical accessory.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is clearly intended for use in vivo (within the living body) as part of a surgical navigation system, not for in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
OLO, HAW
Device Description
X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rigid patient anatomical structures
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)
X12's Sterile Reflective Marker Spheres were tested to verify their retro-reflectivity in comparison to the predicate devices. Both the polar and equatorial views showed retroreflectivity that was equivalent to the predicate devices. A water soak test was conducted to show that the markers maintain there mechanical properties after being soaked in water. A surface abrasion test was performed which showed that the surface durability was substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
PREMARKET NOTIFICATION 510 (K) SUMMARY SEP 2 9 2011
| 1. | Submitters Name: | Dancho Jordanov |
|---|---|---|
| 2. | Address: | X12 Co., Ltd. |
| J&L Center, fl.4, rm.403 | ||
| 46 Lubliana str. | ||
| 1618 Sofia | ||
| Bulgaria | ||
| 3. | Telephone No: | |
| Fax: | +359 878 350 021 | |
| 4. | Date Prepared: | April 28, 2011 |
| 5. | Trade Name: | X12 Sterile Reflective Marker Sphere |
| 6. | Common Name: | Disposable Reflective Marker Sphere |
| 7. | Classification Name: | Neurological Stereotaxic Instrument |
| Orthopedic Stereotaxic Instrument |
X12's Sterile Reflective Marker Spheres are substantially 8. Predicate Devices: equivalent to those legally marketed by BrainLAB AG, Norhern Digital Inc. and ILUMARK GmbH (see table, below). This is based upon their intended use, design and materials of construction.
| Name | Common Name | Product Code | 510(k) Number | Date |
|---|---|---|---|---|
| BrainLAB AG | Disposable Reflective | |||
| Marker Spheres | HAW, OLO | K100038 | July 14, 2010 | |
| Northern Digital | NDI Passive Spheres | HAW | K033621 | January 27, 2004 |
| ILUMARK GmbH | Navigation Marker | HAW, OLO | K103192 | February 7, 2011 |
Device Description: 9.
D
X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the
1
predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.
10. Indications For Use:
Passive Retro-Reflective Markers, disposable, used as an accessory to aid in the autoregistration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
l ] . Performance Testing:
X12's Sterile Reflective Marker Spheres were tested to verify their retro-reflectivity in comparison to the predicate devices. Both the polar and equatorial views showed retroreflectivity that was equivalent to the predicate devices.
A water soak test was conducted to show that the markers maintain there mechanical properties after being soaked in water. A surface abrasion test was performed which showed that the surface durability was substantially equivalent to the predicate devices.
12. Sterilization:
X12's Sterile Reflective Marker Spheres are inserted (6 each), in special "made for sterilization" plastic shells which are sealed in a nitrogen environment in plastic sterilization packets. Each packet is inserted in a box and is gamma sterilized in a carton containing 50 boxes. Each box is printed with pertinent labeling which includes the date of manufacture, expiration date, manufacturer batch and sterilization lot numbers and the manufacturer's name and address, as well as instructions for use.
13. Conclusion:
Based on the available 510 (K) summaries and statements and the information provided here, we conclude that X12's Sterile Reflective Marker Spheres are substantially equivalent to the predicate devices which are legally marketed in the United States under the FDA regulations.
2
Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized bird-like symbol. The text within the border is small and difficult to read, but it appears to follow the curve of the circle. The bird-like symbol consists of three curved lines that resemble the silhouette of a bird in flight. The logo is black and white and has a simple, clean design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MIJ 20993-0002
Pinsco Inc. dba B & L Engineering % Mr. Lee A. Barnes 1901 Carnegie Avenue, Suite Q Santa Ana, California 92705
SEP 29 201
Re: K111443
· Trade/Device Name: X12 Sterile Reflective Marker Sphere Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Requlatory Class: Class II Product Code: OLO, HAW Dated: September 07, 2011 Received: September 12, 2011
Dear Mr. Barnes:
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. Insting 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
3
Page 2 - Mr. Lee A. Barnes
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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.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/Safetv/ReportalProblem/default.htm for the CDRH3'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 N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K111443
Device Name: X12 STERILE REFLECTIVE MARKER SPHERE
Indications for Use:
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
Prescription Use X (Part 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) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K111443
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