The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. a pationing and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Device Description

The Encompass™ SRS Immobilization System is a highly advanced, non-invasive immobilization solution designed for precisely targeted brain, head and neck treatments. The Encompass™ SRS Immobilization System consists of a posterior support of either a Fibreplast™ thermoplastic mask, or a Moldcare cushion which rests on a contoured surface. The Encompass™ SRS Immobilization System features the IntegraBite™, which reduces motion allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The Integrated Shim System™ enables quick and seamless 0.5 mm height adjustments of the thermoplastic mask for a fully customizable patient setup. The Encompass™ SRS Immobilization System is designed to optimize workflow efficiencies and improve patient outcomes.

AI/ML Overview

The provided text describes the Encompass™ SRS Immobilization System and its performance studies to support its substantial equivalence to a predicate device. However, it does not explicitly define "acceptance criteria" in the way one might expect for a diagnostic or AI-driven medical device (e.g., sensitivity, specificity thresholds). Instead, the performance studies assess immobilization and workflow.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, I will infer them from the "verification, validation and safety requirements" and the "conclusions" of the studies.

Acceptance Criteria (Inferred)	Reported Device Performance
Immobilization Performance (Sub-millimeter stability)	- Resting Conditions: Provides submillimeter stability under resting conditions, both with and without IntegraBite™.
Immobilization Performance (Intrafractionation Motion)	- Clinical Intrafractionation: Intrafractionation motion demonstrated to be less than 1mm/1°.
Workflow Efficiency (Mask Formation Time)	- Masks could be formed in under 5 minutes.
Workflow Efficiency (Total Mask Making Touch Time)	- Total touch time during the mask making workflow was 20 minutes or less.
Hardware Specifications Verification	- Verification of hardware specifications completed.
Ease of Use/Ergonomics	- Ease of use/ergonomics assessments completed. improved ergonomics are listed as a new feature.
Load Rating (IEC 60601-1 Ed. 3)	- Load rating per IEC 60601-1 Ed. 3 verified.
Aluminum Equivalence	- Verification of aluminum equivalence completed.
Deflection Requirements (IEC 60976)	- Verification of deflection requirements per IEC 60976 completed.
MRI Safety & Compatibility with Optical Tracking Systems	- Verification of MRI Safety and compatibility with optical tracking systems completed.
Compliance with Risk Management (ISO 14971:2007)	- Risk management ensured via a risk analysis in compliance with ISO 14971:2007, with identified hazards controlled via measures in development, testing, and product labeling. Adheres to recognized industry practices and standards, such as IEC 60601-1 for safety and performance risks.

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

Sample Size for Test Set:
- Motion Studies: Healthy volunteers (number not specified).
- Intrafractionation Studies: Not specified, but conducted "at a clinical site."
- Workflow Studies: Not specified.
Data Provenance: The text does not explicitly state the country of origin. The motion studies were conducted on "healthy volunteers," implying a prospective study. The intrafractionation studies were conducted "at a clinical site," also suggesting prospective data collection.

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

There is no mention of experts establishing ground truth in the context of diagnostic accuracy for this immobilization system. The "ground truth" for immobilization performance appears to be directly measured via tracking systems. For workflow studies, the assessment is observational.

4. Adjudication Method for the Test Set

Not applicable. The performance studies described involve direct measurement of physical parameters (motion, time), not subjective interpretation requiring adjudication among experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an immobilization system, not a diagnostic imaging interpretation tool where human readers and AI would be compared. The study focused on the physical performance of the device itself.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done

Not applicable. The device is a physical immobilization system, not an algorithm. Its performance is inherent in its design and physical properties, tested in conjunction with human interaction (mask formation, patient use).

7. The Type of Ground Truth Used

Motion Studies: Direct measurement of motion using tracking systems.
Intrafractionation Studies: Direct measurement of intrafractionation motion, likely using external tracking or imaging.
Workflow Studies: Timed observations of the mask-making process.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

December 4, 2015

Qfix % Ms. Nadia Sookdeo Harhen Regulatory Affairs Manager 440 Church Road AVONDALE PA 19311

Re: K152321

Trade/Device Name: Encompass™ SRS Immobilization System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 30, 2015 Received: December 1, 2015

Dear Ms. Harhen:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152321

Device Name

Encompass™ SRS Immobilization System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

I. General Information

Establishment	Anholt Technologies, Inc. DBA Qfix440 Church RoadAvondale, PA 19311 USA
Date Prepared	August 14, 2015
Manufacturer	Qfix440 Church RoadAvondale, PA 19311 USARegistration Number: 2247992
Contact Person	Mrs. Nadia HarhenRegulatory Affairs Manager
	Qfix440 Church RoadAvondale, PA 19311 USAPhone: (610) 268-0585Fax: 610-268-0588
Device Name	Encompass™ SRS Immobilization System
Common Names:	Thermoplastic (moldable), patient positioning device
Classification Name:	Medical charged-particle radiation therapy system
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.5050
Classification:	Class II
Product Code:	Primary: IYE, Secondary: LHN, JAI, JAK, LNH, KPS, OUO

100 - 100

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

Indications for Use

The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of treatment, enabling radiation therapy.

Device Description

Performance Standards and Testing

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product however testing and analysis has been conducted to show that the verification, validation and safety requirements have been met. Performance, safety, labeling, usage, and consumable requirements were all part of verification and validation for the Encompass™ SRS Immobilization System. This analysis includes:

Verification of hardware specifications -
-Timed workflow studies
ー Ease of use/ergonomics assessments
Load rating per IEC 60601-1 Ed. 3 -
ー Verification of aluminum equivalence
Verification of deflection requirements per IEC 60976 ー
・ Verification of MRI Safety, compatibility with optical tracking systems

No clinical studies were completed to support the subject device and the substantial equivalence argument however, analysis of positioning accuracy and immobilization studies were conducted to support the efficacy and safety features the Encompass™ SRS Immobilization System offers. Motion studies were conducted on healthy volunteers by tracking forced and resting motion with the Encompass mask for 15 minutes. It was concluded that the subject device with and without Integrabite™ provides submillimeter stability under resting conditions. Intrafactionation studies were also conducted at a clinical site, which established that the intrafractionation motion was less than 1mm/1°. Workflow studies. It was concluded that masks could be formed in under 5 minutes with a total touch time during the mask making workflow of 20 minutes or less.

Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

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Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in development, testing and product labeling. To minimize risks, Qfix adheres to recognized and established industry practices and standards, such as IEC 60601-1, to minimize safety and performance risks. Furthermore, the operators and end users of the device are healthcare professionals familiar with and responsible for the treatment of radiation therapy.

Predicate information

The subject device, Encompass™ SRS Immobilization System, includes all of the device properties belonging to the predicate device, the AccuFix Radiolucent Patient Immobilization System. The predicate device information follows:

Predicate Device Name	FDA ClearanceNumber and Date	Productcode	Manufacturer
AccuFix Radiolucent PatientImmobilization System	K032156, clearedSeptember 2, 2003	IYE	WFR/AQUAPLASTCORP (Qfix)

This predicate has not been subject to a design-related recall. There is no reference device for this premarket notification.

Comparison to Predicate Device

The subject device, Encompass™ SRS !mmobilization System, offers the following new features with respect to the predicate device, AccuFix Radiolucent Patient Immobilization System (Cleared with K032156, September 2, 2003).

New Shimming which is integrated into the system .
Improved Ergonomics .
. Improved Immobilization
. New optional IntegraBite™
. Utilizes variable perf Fibreplastic, with new coating (predicate device utilizes both Aquaplast and Fibreplast Thermoplastics). Note that the mask can be open or closed view.

Substantial Equivalence

The predicate device, AccuFix Radiolucent Patient Immobilization System is designed to be used with Aquaplast™ or Fibreplast™ Thermoplastic (K935067) masks to immobilize, position and reposition patients undergoing radiation therapy utilizing a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table with a specific focus on the head/neck. This system was modified to expand the portfolio offering to the Encompass™ SRS Immobilization System which has a specific focus on superior immobilization and integrated patient shimming as it pertains to the head/neck regions.

The subject device is the Encompass™ SRS Immobilization System, consists of a rigid support device and a thermoplastic consumable, where the device can either be one of three options: a kVue insert, an Encompass™ standalone device or an MRI version of the Encompass™ device.

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The superior immobilization and integrated patient shimming attributes of the Encompass™ SRS Immobilization System give the subject device greater capabilities than the predicate device, especially as it pertains user ergonomics and immobilization. However, the Encompass™ SRS Immobilization System is an extension of the functionalities of the predicate.

The conclusions from the non-clinical data suggest that the features are of similar technological characteristics with respect to the predicate device and bear an equivalent safety and performance profile as that of the predicate device

Therefore, Qfix is of the opinion that Encompass™ SRS Immobilization System does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed AccuFix Radiolucent Patient Immobilization System (K032156).

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.