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.

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.

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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that prove MAXIO™ meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance (Study Finding)
Accuracy Targets	Met (demonstrated through bench tests using static phantom)
Segmentation Accuracy	Demonstrated (through adequate bench testing and clinical experience)
Registration Accuracy	Demonstrated (through adequate bench testing and clinical experience)
Usability	Conducted in accordance with HE75 AAMI / ANSI HE75:2009 (Human factors engineering)
Safety (Electrical)	Performed in accordance with IEC 60601-1, 3rd edition
Safety (EMI/EMC)	Performed in accordance with IEC 60601-1-2, 3rd edition
Laser Pointer Compliance	Complies with 21CFR1040.10 and 1040.11
Biocompatibility of Disposables	Tested in accordance with ISO 10993-1
Sterilization, Packaging, Shelf Life (Disposables)	Meet all relevant/applicable IEC and FDA standards
Ability to intervene (patient movement)	Tested (at Memorial Sloan Kettering Cancer Center)
Effectiveness of skin marker/laser alignment for patient movement	Verified (under a CRO supervised study)
Correlation between skin marker and anatomy for anatomical accuracy	Verified (under a CRO supervised study)
Accuracy and Repeatability (stereotactic performance)	Demonstrated (through analysis of 170 CT Guided Interventions, a 20-patient liver ablation study, and an animal study)
Accurate needle placement (liver ablation)	Demonstrated (in a 20-patient liver ablation study)
Accuracy of needle placement (comparable to expert freehand)	Demonstrated (in an animal study)
Reduced needle manipulations, check-scans (compared to expert freehand)	Demonstrated (in an animal study)

2. Sample Size Used for the Test Set and Data Provenance

170 CT Guided Interventions:
- Sample Size: 170 needle placements
- Provenance: Outside of the USA (retrospective analysis of interventions performed by users of MAXIO™)
20-Patient Liver Ablation Study:
- Sample Size: 20 patients, 40 tumors
- Provenance: University of Malaya Medical Center, Kuala Lumpur (likely prospective)
CRO-supervised study on skin marker/laser alignment:
- Sample Size: 14 patients
- Provenance: Global Hospitals, Chennai, India (likely prospective)
Animal Study (needle placement accuracy):
- Sample Size: 6 animal liver targets, 35 needle placements
- Provenance: Memorial Sloan Kettering Cancer Center (likely prospective)
Bench Tests: Used static phantom, not human or animal data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for any of the studies mentioned. It generally refers to "qualified users" or "physicians trained for CT procedures." For the animal study, it mentions comparison to "freehand placement by experts," implying expert involvement but not quantifying or qualifying them.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? The document mentions an animal study where "the accuracy of needle placement with MAXIO assistance is comparable to freehand placement by experts however fewer needle manipulations, check-scans." This implies a comparison between human performance (experts doing freehand) and human performance with AI assistance (MAXIO™ assistance).
Effect size of how much human readers improve with AI vs. without AI assistance: The document states "fewer needle manipulations, check-scans" with MAXIO™ assistance compared to expert freehand. It doesn't provide a quantitative "effect size" or specific percentage of improvement, but rather a qualitative benefit in procedural efficiency.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The accuracy targets, segmentation accuracy, and registration accuracy were demonstrated through "bench tests" using a "static phantom." This portion of the evaluation appears to be a standalone assessment of the device's capabilities without human intervention, focusing on its technical precision.

7. Type of Ground Truth Used

Bench Tests (Accuracy, Segmentation, Registration): Likely based on precisely known measurements from a static phantom and potentially expert-defined benchmarks or measurements for segmentation/registration.
Clinical/Animal Studies:
- Needle Placement Accuracy: Most likely determined by subsequent imaging (e.g., CT scans) to verify the actual needle tip position relative to the planned target, along with clinical outcomes or observations during the procedure. The "accurate needle placement using MAXIO for CT guided Tumor ablations" in the 20-patient study points to this.
- Patient Movement Detection/Correlation: Verified through direct observation, measuring shifts, and comparing skin marker data to anatomical movement in CT scans.
- Needle Manipulations/Check-scans: Direct observation and recording during the procedures.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The studies described are primarily for validation of the device's performance.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, there's no information on how its ground truth was established.

Summary

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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
1. Contact person: Phone number: Fax number:

Fax number:

Contact:

1. 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

+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)

MAY 1 9 2014

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planning and instrument placement. MAXIOTM is intended to be used by physicians trained for CT procedures.

7. Intended Use

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.

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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

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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.

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Annexure to 510K summary

	Device
TechnologicalCharacteristics	MAXIO™	PinPoint	ig4 Image Guided System
	K132108	K974513	K060903
Stereotacticdevice	Physician controlled multi-axis electromechanical arm	Physician controlled multi-axiselectromechanical arm	Physician controlledelectromagnetic trackingsystem
Image type	DICOM CT images ( Ifreceived from more thanone series, then registered)	DICOM CT images	DICOM CT images ( Ifreceived from more than oneseries, then registered)
Image models	2D / MPR/ 3D Volume /Segmented views	2D / MPR views	2D / MPR/ 3D Volume /Segmented views
Type ofinstrumentssupported	Rigid, straightInterventional instrumentssuch as needles, probes forbiopsy, ablation anddrainage.	Interventional instruments forbiopsies. drainage. bonepinnings, brachytherapy, boneand spine interventions	Interventional instrumentssuch as biopsy needles.ablation needle, aspirationneedles
Pre-OperativePlanning	Physician createdtrajectory on image models	Physician created trajectory onimage models	Physician created trajectory onimage models
Instrumentperformancedisplay	Manufacturer and userdefined instrumentperformance such asablation size	None	Manufacturer and user definedinstrument performance suchas ablation size
CT- Deviceregistration	Docking relative to CT onfloor	Docking relative to CT onGantry	Electromagnetic registration
Verification ofregistration	Laser pointer directed onpre-identified points onpatient, CT (compliantwith 21CFR 1040)	Laser pointer directed on pre-identified points on patient	EM probe directed on pre-identified points on patient
Assistance forinstrumentadvancement	Arm aligns an end-effectorto plan, using motors.Instrument then manuallyadvanced through theguide gripped by the end-effector.	Arm manually assisted to alignan instrument guide to theplan. Instrument then manuallyadvanced through the guidegripped by the end-effector.	EM tracked instrument alignedmanually to plan and thenmanually advanced through theguide.
Intraoperativeverification	Image registration tocompare current positionto plan	Not available	Instrument tracking to comparecurrent position to plan
Post-procedureverification	· Post procedure CT imageImage registration oroverlay	Post procedure CT image	Post procedure CT image
No. of probessupported for aprocedure	Multiple instruments.Planning assistancesoftware alerts for possiblearm - instrument,instrument - instrumentinterference	Single instrument	Multiple instruments, usertakes care of possibleinstrument - instrumentinterference
Management ofrespiratorymotion	Respiratory Motion controlusing Breath-Hold forInterventional Radiology	No solution described	Respiration tracking systemusing EM tracking.
	Device
TechnologicalCharacteristics	MAXIO™	PinPoint	ig4 Image Guided System
	K132108	K974513	K060903
Management ofpatientmovement	CT belt and optionalpatient immobilization bed	CT belt	CT belt
Instrumentrelease duringprocedure	Instantaneous removal byclinician with noadditional device action.Alternatively, through footswitch control oremergency button.	Instantaneous removal byclinician with no additionaldevice action.	Instantaneous removal byclinician with no additionaldevice action.

A comparison of technological characteristics of MAXIO™ with its predicates is shown below.

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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

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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.

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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.

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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

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Indications for Use

510(k) Number (if known) K132108

Device Name MAXIOTM

Indications for Use (Describe)

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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Regulation Number and Section

§ 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.