(315 days)
Not Found
No
The description focuses on image-guided stereotactic assistance, 3D reconstruction, planning tools, and manual instrument advancement. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data to perform tasks. The performance studies focus on accuracy, usability, and safety through bench tests, clinical experience, and patient/animal studies, not on the performance of an AI/ML model.
No.
The device is a stereotactic accessory intended to assist in the planning and manual advancement of instruments during CT-guided percutaneous procedures, not to directly treat a condition or disease.
No
The device is described as a stereotactic accessory intended to assist in the planning and manual advancement of instruments during CT-guided percutaneous procedures. Its functions are related to guidance, positioning, and monitoring during an interventional procedure, not primarily to diagnose a patient's condition or disease.
No
The device description explicitly states that MAXIO™ consists of a stereotactic device and its accessories, software loaded on a computer, and a respiratory gating system, indicating it includes hardware components beyond just software.
Based on the provided information, the MAXIO™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- MAXIO™'s Intended Use: The intended use of MAXIO™ is to assist in the planning and manual advancement of instruments during Computed Tomography (CT) guided percutaneous procedures. These are procedures performed directly on the patient's body, guided by imaging.
- Device Description: The device description reinforces this by describing MAXIO™ as a stereotactic accessory to a CT system for spatial positioning and orientation of instruments during these in-vivo procedures.
- Lack of Specimen Analysis: There is no mention of MAXIO™ analyzing any specimens derived from the human body. Its function is to guide instruments within the body based on imaging data.
Therefore, MAXIO™ falls under the category of a surgical or interventional guidance system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.
MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided perculaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
Product codes
JAK
Device Description
MAXIO™ is an image-guided, physician controlled stereotactic accessory to a Computed Tomography (CT) system, intended for the stereotactic spatial positioning and orientation of an end effector and instrument guide to assist in manual advancement of one or more instruments such as rigid straight needles and probes during CT guided percutaneous procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
MAXIO™ System provides pre-operative planning assistance to the physician by creating a reconstructed 3D image model of received CT data and by visually representing the planned instrument path and position(s) of one or more instruments on the model, along with performance data provided by the instrument manufacturer or as specified by the user.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory for levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement. MAXIOTM is intended to be used by physicians trained for CT procedures.
MAXIO" consists of a stereotactic device and its accessories, software loaded on a computer, and a respiratory gating system. The accessories include a patient immobilizer and skin-markers. MAXIO™ System uses single use sterile disposables viz, end effector, instrument guide and drapes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
thorax, abdomen and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained for CT procedures
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
Bench tests performed using static phantom in accordance with Perfint's Quality Management System demonstrate that the accuracy targets of the MAXIO™ system were met and the system is suitable for its intended use.
Segmentation and Registration accuracy were demonstrated through adequate bench testing and also through clinical experience of qualified users.
Usability studies with qualified users were conducted in accordance with HE75 AAMI / ANSI HE75:2009, Human factors engineering - Design of medical devices.
Device Safety tests were performed in accordance with IEC 60601-1, 31d edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
· EMI / EMC testing performed in accordance with IEC 60601-1-2, 36 edition, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility.
The laser pointer used for verification of registration complies with 21CFR1040.10 and 1040.11 - Performance standards for light-emitting products.
Biocompatiblity testing of all disposables that might come in contact with the patient directly or indirectly have been tested in accordance with ISO 10993-1- Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Disposables that are supplied sterile meet all the relevant/applicable IEC and FDA standards of sterilization, packaging and shelf life.
Ability of a physician to adequately intervene to pull back an instrument or to release the instrument for the stereotactic arm in case of gross patient movement during needle insertion has been tested at Memorial Sloan Kettering Cancer Center.
Effectiveness of skin marker / laser alignment to detect patient movement and the correlation between skin marker and anatomy to establish anatomical accuracy was verified under a CRO supervised study performed by Perfint Engineers on 14 patients at Global Hospitals, Chennai India
170 CT Guided Interventions performed by users of MAXIO outside of the USA has been analysed and report included to demonstrate accuracy and repeatability of MAXIO stereotactic performance under clinically relevant and worst case conditions
A 20 patient, 40 tumor liver ablation study performed at the University of Malaya Medical Center, Kuala Lumpur demonstrates accurate needle placement using MAXIO for CT guided Tumor ablations
An animal study performed at Memorial Sloan Kettering Cancer Center demonstrates that the accuracy of needle placement with MAXIO assistance is comparable to freehand placement by experts however fewer needle manipulations, check-scans.
A 35 needle placement study using MAXIO™ on 6 animal liver targets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests performed using static phantom, Accuracy targets of MAXIO™ system were met.
Segmentation and Registration accuracy demonstrated through bench testing and clinical experience.
Usability studies with qualified users conducted in accordance with HE75 AAMI / ANSI HE75:2009.
Safety tests performed in accordance with IEC 60601-1, 3rd edition.
EMI / EMC testing performed in accordance with IEC 60601-1-2, 3rd edition.
Laser pointer complies with 21CFR1040.10 and 1040.11.
Biocompatibility testing of disposables in accordance with ISO 10993-1.
Disposables meet relevant IEC and FDA standards for sterilization, packaging and shelf life.
Memorial Sloan Kettering Cancer Center: Ability of physician to intervene to pull back instrument or release from stereotactic arm tested.
CRO supervised study by Perfint Engineers on 14 patients at Global Hospitals, Chennai India: Effectiveness of skin marker / laser alignment to detect patient movement and correlate with anatomy verified.
170 CT Guided Interventions (outside USA): Accuracy and repeatability of MAXIO stereotactic performance demonstrated.
20 patient, 40 tumor liver ablation study at University of Malaya Medical Center, Kuala Lumpur: Accurate needle placement using MAXIO for CT guided Tumor ablations demonstrated.
Animal study at Memorial Sloan Kettering Cancer Center: Accuracy of needle placement with MAXIO assistance comparable to freehand placement by experts, with fewer needle manipulations and check-scans.
35 needle placement study on 6 animal liver targets: Demonstrated accuracy and repeatability across various clinically relevant conditions.
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.
ig4 Image Guided System (K060903), PinPoint (K974513)
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K132108
Page 1 of 7
510(k) Summary
- Perfint Healthcare, Pvt. Ltd., 1. Manufacturer/Applicant Name: No. 16, III Floor Address: South West Boag Road Tamil Nadu. Chennai 600017 India Phone number: +91 44-4550-6412
-
- Contact person: Phone number: Fax number:
Fax number:
Contact:
-
- Trade name: Common name: Classification name: Classification: Product Code:
-
Date prepared:
-
Substantial equivalence claimed to:
ig4 Image Guided System (K060903) PinPoint (K974513)
Computed tomography x-ray system 21 CFR Part 892.17.50 Class II
6. Device Description
MAXIO™ is an image-guided, physician controlled stereotactic accessory to a Computed Tomography (CT) system, intended for the stereotactic spatial positioning and orientation of an end effector and instrument guide to assist in manual advancement of one or more instruments such as rigid straight needles and probes during CT guided percutaneous procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
+91 44-2434-5911
(267)675-4611
(267)675-4601
CT stereotactic accessory
MAXIO™
May 14, 2014
JAK
Nandakumar Subburaman, CEO
Janice Hogan (Hogan Lovells US LLP)
MAXIOTM System provides pre-operative planning assistance to the physician by creating a reconstructed 3D image model of received CT data and by visually representing the planned instrument path and position(s) of one or more instruments on the model, along with performance data provided by the instrument manufacturer or as specified by the user.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory for levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during
MAY 1 9 2014
1
planning and instrument placement. MAXIOTM is intended to be used by physicians trained for CT procedures.
MAXIO" consists of a stereotactic device and its accessories, software loaded on a computer, and a respiratory gating system. The accessories include a patient immobilizer and skin-markers. MAXIO™ System uses single use sterile disposables viz, end effector, instrument guide and drapes.
7. Intended Use
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.
MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided percutaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
8. Substantial equivalence
MAXIO™ has been shown to be substantially equivalent to ig4 Image Guided System (K060903) for providing planning assistance by visually representing the targeted path and position(s) for one or more instruments along with data provided by the instrument manufacturer, on an image based model of the target organ and for providing verification assistance by overlaying or registering images during and after image guided procedures.
MAXIO™ has been shown to be substantially equivalent to PinPoint (K974513), which provides a multi axis electromechanical arm for the spatial positioning and orientation of an instrument guide to assist in manual advancement of instruments through the guide for image guided interventional procedures.
A comparison of technological characteristics of MAXIO™ with its predicates is shown in Annexure to 510K summary on Pg.15.
2
9. Performance Data
Bench tests performed using static phantom in accordance with Perfint's Quality Management System demonstrate that the accuracy targets of the MAXIO™ system were met and the system is suitable for its intended use.
Segmentation and Registration accuracy were demonstrated through adequate bench testing and also through clinical experience of qualified users.
Usability studies with qualified users were conducted in accordance with HE75 AAMI / ANSI HE75:2009, Human factors engineering - Design of medical devices.
Device Safety tests were performed in accordance with IEC 60601-1, 31d edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
· EMI / EMC testing performed in accordance with IEC 60601-1-2, 36 edition, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility.
The laser pointer used for verification of registration complies with 21CFR1040.10 and 1040.11 - Performance standards for light-emitting products.
Biocompatiblity testing of all disposables that might come in contact with the patient directly or indirectly have been tested in accordance with ISO 10993-1- Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Disposables that are supplied sterile meet all the relevant/applicable IEC and FDA standards of sterilization, packaging and shelf life.
Ability of a physician to adequately intervene to pull back an instrument or to release the instrument for the stereotactic arm in case of gross patient movement during needle insertion has been tested at Memorial Sloan Kettering Cancer Center.
Effectiveness of skin marker / laser alignment to detect patient movement and the correlation between skin marker and anatomy to establish anatomical accuracy was verified under a CRO supervised study performed by Perfint Engineers on 14 patients at Global Hospitals, Chennai India
3
170 CT Guided Interventions performed by users of MAXIO outside of the USA has been analysed and report included to demonstrate accuracy and repeatability of MAXIO stereotactic performance under clinically relevant and worst case conditions
A 20 patient, 40 tumor liver ablation study performed at the University of Malaya Medical Center, Kuala Lumpur demonstrates accurate needle placement using MAXIO for CT guided Tumor ablations
An animal study performed at Memorial Sloan Kettering Cancer Center demonstrates that the accuracy of needle placement with MAXIO assistance is comparable to freehand placement by experts however fewer needle manipulations, check-scans
10.Conclusion
Information provided in this 510K notification demonstrate that the MAXIO™ is substantially equivalent to ig4 Image Guide System (K060903) for planning and verification assistance and to PinPoint (K974513) for assistance in manual advancement of instruments, for CT guided percutaneous interventional procedures. The indications for use and technological characteristics of the MAXIO™ System are similar to those of its predicates ig4 Image Guide System (K060903) and PinPoint (K974513).The differences from the Predicates do not raise any new questions of safety and effectiveness as confirmed by the Performance testing results.
4
Annexure to 510K summary
| Device | |||
|---|---|---|---|
| Technological | |||
| Characteristics | MAXIO™ | PinPoint | ig4 Image Guided System |
| K132108 | K974513 | K060903 | |
| Stereotactic | |||
| device | Physician controlled multi- | ||
| axis electromechanical arm | Physician controlled multi-axis | ||
| electromechanical arm | Physician controlled | ||
| electromagnetic tracking | |||
| system | |||
| Image type | DICOM CT images ( If | ||
| received from more than | |||
| one series, then registered) | DICOM CT images | DICOM CT images ( If | |
| received from more than one | |||
| series, then registered) | |||
| Image models | 2D / MPR/ 3D Volume / | ||
| Segmented views | 2D / MPR views | 2D / MPR/ 3D Volume / | |
| Segmented views | |||
| Type of | |||
| instruments | |||
| supported | Rigid, straight | ||
| Interventional instruments | |||
| such as needles, probes for | |||
| biopsy, ablation and | |||
| drainage. | Interventional instruments for | ||
| biopsies. drainage. bone | |||
| pinnings, brachytherapy, bone | |||
| and spine interventions | Interventional instruments | ||
| such as biopsy needles. | |||
| ablation needle, aspiration | |||
| needles | |||
| Pre-Operative | |||
| Planning | Physician created | ||
| trajectory on image models | Physician created trajectory on | ||
| image models | Physician created trajectory on | ||
| image models | |||
| Instrument | |||
| performance | |||
| display | Manufacturer and user | ||
| defined instrument | |||
| performance such as | |||
| ablation size | None | Manufacturer and user defined | |
| instrument performance such | |||
| as ablation size | |||
| CT- Device | |||
| registration | Docking relative to CT on | ||
| floor | Docking relative to CT on | ||
| Gantry | Electromagnetic registration | ||
| Verification of | |||
| registration | Laser pointer directed on | ||
| pre-identified points on | |||
| patient, CT (compliant | |||
| with 21CFR 1040) | Laser pointer directed on pre- | ||
| identified points on patient | EM probe directed on pre- | ||
| identified points on patient | |||
| Assistance for | |||
| instrument | |||
| advancement | Arm aligns an end-effector | ||
| to plan, using motors. | |||
| Instrument then manually | |||
| advanced through the | |||
| guide gripped by the end- | |||
| effector. | Arm manually assisted to align | ||
| an instrument guide to the | |||
| plan. Instrument then manually | |||
| advanced through the guide | |||
| gripped by the end-effector. | EM tracked instrument aligned | ||
| manually to plan and then | |||
| manually advanced through the | |||
| guide. | |||
| Intraoperative | |||
| verification | Image registration to | ||
| compare current position | |||
| to plan | Not available | Instrument tracking to compare | |
| current position to plan | |||
| Post-procedure | |||
| verification | · Post procedure CT image | ||
| Image registration or | |||
| overlay | Post procedure CT image | Post procedure CT image | |
| No. of probes | |||
| supported for a | |||
| procedure | Multiple instruments. | ||
| Planning assistance | |||
| software alerts for possible | |||
| arm - instrument, | |||
| instrument - instrument | |||
| interference | Single instrument | Multiple instruments, user | |
| takes care of possible | |||
| instrument - instrument | |||
| interference | |||
| Management of | |||
| respiratory | |||
| motion | Respiratory Motion control | ||
| using Breath-Hold for | |||
| Interventional Radiology | No solution described | Respiration tracking system | |
| using EM tracking. | |||
| Device | |||
| Technological | |||
| Characteristics | MAXIO™ | PinPoint | ig4 Image Guided System |
| K132108 | K974513 | K060903 | |
| Management of | |||
| patient | |||
| movement | CT belt and optional | ||
| patient immobilization bed | CT belt | CT belt | |
| Instrument | |||
| release during | |||
| procedure | Instantaneous removal by | ||
| clinician with no | |||
| additional device action. | |||
| Alternatively, through foot | |||
| switch control or | |||
| emergency button. | Instantaneous removal by | ||
| clinician with no additional | |||
| device action. | Instantaneous removal by | ||
| clinician with no additional | |||
| device action. |
A comparison of technological characteristics of MAXIO™ with its predicates is shown below.
:
.
:
.
.
5
Discussion of differences:
Mounting the device to the floor mat using InstaReg in MAXIO™ achieves the same purpose of bringing the arm repeatedly to the same point as permanently fixing the arm to the CT Gantry in predicate PinPoint (K9745). Floor mounting and Ceiling mounting are commonly employed docking techniques in the industry and this dissimilarity does not raise additional safety and effectiveness issues.
Using motors to move the axes of an electromechanical arm, as done in MAXIO™, is a well established practice in the motion control industry. Alternatively the axes can be moved manually as in the predicate PinPoint (K974513).
MAXIO™ uses a well established collision avoidance algorithm to prevent arm - instrument and instrument - instrument interference, in addition to the physician assessing any possible interference prior to placement and arm pullback.
For procedure planning, MAXIO™ provides the physician the ability to plan needle placement on current CT images and on registered images from multiple series. Predicates ig4 (K060903) and Pinpoint (K974513) to allow planning only on current CT images. The registration feature offered by MAXIO™ is a well understood and commonly deployed technique in image guided procedures. In addition MAXIO™ registration accuracy has been bench tested and found acceptable.
For verification, MAXIO™ and its predicates ig4 (K060903) and Pinpoint (K974513) provide physicians the ability to visualize instrument(s) or targets using current CT images. In addition MAXIO™ provides intra-operative CT image registration with plan images to verify instrument position, whereas ig4 (K060903) uses electromagnetically tracked instruments to verify instrument position. MAXIO™ provides similar registration of post-procedure CT images to
6
K132108
Page 7 of 7
compare the treated organ with plan. The registration feature offered by MAXIO™ is a well understood and commonly deployed technique in image guided procedures. In addition MAXIO™'s registration accuracy has been bench tested and found acceptable.
In addition all disposables that may come in contact with the patient or the user, directly or indirectly, have been tested in accordance to the US standards prior to commercial marketing of the device.
In addition, MAXIO™ has been bench tested to demonstrate that it meets the performance requirements for its intended use. Additionally, the following data demonstrates that MAXIO™'s stereotactic navigation is accurate and repeatable across various clinically relevant conditions:
- An analysis of 170 needle placements performed using MAXIO™ outside of the USA. .
- A 20 patient study using MAXIO™ for liver ablation. .
- A 35 needle placement study using MAXIO™ on 6 animal liver targets. .
Therefore it has been concluded that the MAXIO™ is substantially equivalent to its predicates ig4 Image Guided System (K060903) and PinPoint (K974513) for its intended use.
7
Image /page/7/Picture/1 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 symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2014
Perfint Healthcare Pvt. Ltd. % Ms. Janice M. Hogan, Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor PHILADELPHIA PA 19103
Re: K132108
Trade/Device Name: MAXIOTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 15, 2014 Received: May 15, 2014
Dear Ms. Hogan:
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-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.
8
Page 2-Ms. Janice Hogan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 80)), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 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" (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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
:
. ' .
Sincerely yours,
Michael D. O'Hara
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known) K132108
Device Name MAXIOTM
Indications for Use (Describe)
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.
MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided perculaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
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