The Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.

Device Description

The proposed device is a modification of the INTRABEAM® System with Balloon Applicator, K090584, incorporating a Needle Applicator and guide shafts that are used to open a tract for the positioning of the applicator for irradiation of turnors. The INTRABEAM® System that will be used with the new Needle Applicator accessory was most recently described in K090584. There are no modifications to the INTRABEAM® System hardware or software. The INTRABEAM® Core System consists of the following components: PRS500 Control Console, XRS4 X-ray source, User terminal. Components of the Needle Applicator set are as follows: 1) Inner Sterile Packaging, 2) 5 cm guide shaft, 3) 6 cm guide shaft, 4) Needle Applicator. The physical design of the Needle Applicator consists of a polycarbonate case which fits over the probe of the XRS 4 X-ray source, a stainless steel shaft, and a polyetherimide tip for the Applicator. The guide shafts are stainless steel.

AI/ML Overview

The provided text describes a 510(k) summary for the Carl Zeiss INTRABEAM® System with Needle Applicator. This document focuses on the non-clinical performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study typically associated with AI/ML device approval which would include extensive clinical performance criteria and human reader studies.

Therefore, many of the requested categories related to clinical study design, AI performance, ground truth establishment for a training set, and expert adjudication are not applicable or not explicitly detailed in the provided content. This document primarily addresses the safety and functional performance of the hardware modification (Needle Applicator) to an existing radiation therapy system.

Here's an attempt to populate the requested table and information based on the provided text, indicating "Not Applicable" or "Not Specified" where the information is not present or not relevant to this type of submission.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Sterilization Validation	Compliant with AAMI/ANSI/ISO 11137-1:2006 (development, validation, routine control), AAMI/ANSI/ISO 11137-2:2006 (establishing sterilization dose, VDmax 25 method), and AAMI/ANSI/ISO 11137-3:2006 (dosimetric aspects). Sterilization assurance level 10⁻⁶	Validation performed; Dosimetric release complies. All criteria met.
Performance Testing	1. No adverse effect of sterilization and accelerated aging (equivalent to 5 years) on Needle Applicator functionality. 2. Dosimetry equivalence to the PRS400 with the XRS probe (with sheath). 3. Isotropy of tested units meets criteria.	1. Five samples inspected visually before/after sterilization and accelerated aging. All applicators passed tests, were fully functional, and met engineering specifications. 2. Dose depth curves of Needle Applicators matched those of the bare probe with sheath. 3. Isotropy of tested units met the passing criteria. All criteria met.
Biocompatibility Testing	1. Cytotoxicity (L 929 cell cultures, quantitative proliferation). 2. Chemical Analysis (GC-FID, quantification of organic/inorganic leachables).	1. Needle Applicator and Guide shaft: "No relevant effects observed in comparison to controls." 2. Needle Applicator: "No relevant effects observed in comparison to controls." All criteria met.
Overall Conformity	Fulfills prospectively defined design and performance specifications as basis for substantial equivalence to predicate devices.	Based on the non-clinical testing, the Carl Zeiss INTRABEAM® Needle Applicator is substantially equivalent to the cited predicate devices and fulfills prospectively defined design and performance specifications. This led to a substantial equivalence determination by the FDA in 2012. All key criteria met for regulatory approval based on non-clinical data.

Study Details

Sample size used for the Test Set and Data Provenance:
- Sterilization Validation: Not explicitly stated for specific test runs, but the methodology (VDmax 25) implies a statistically relevant sample size for microbial testing.
- Performance Testing (Functionality/Aging): 5 samples (Needle Applicators) were subjected to visual inspection, sterilization, and accelerated aging.
- Performance Testing (Dosimetry): Not explicitly stated, but "tested units" implies multiple devices.
- Biocompatibility Testing: Not explicitly stated, likely follows standardized protocols requiring specific sample sizes for each test type.
- Data Provenance: The testing was conducted internally by Carl Zeiss Meditec AG, likely in Germany (country of manufacturer) or its affiliates. This is retrospective data for the submission, based on laboratory testing.
Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this submission. The "ground truth" here refers to objective measurements (e.g., sterilization levels, dose depth curves, cytotoxicity assays) against engineering specifications and industry standards, not expert clinical interpretation of medical images or patient data.
Adjudication Method for the test set:
- Not applicable. Performance was assessed against objective, predefined physical and chemical standards, not through adjudication of subjective interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device, and no clinical studies involving human readers or comparative effectiveness were conducted for this submission ("No clinical testing was conducted to support this submission").
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware modification for a radiation therapy system, not an algorithm or AI.
The type of ground truth used:
- Objective physical and chemical measurements/standards:
  - Sterilization Assurance Level (SAL) of 10⁻⁶
  - Engineering specifications for functionality
  - Dosimetry measurements (dose depth curves, isotropy data) compared to bare probe with sheath
  - Standardized biocompatibility test results (cytotoxicity, chemical analysis) compared to controls.
The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of Device and Study Context:

This 510(k) submission (K110590) is for a hardware accessory (Needle Applicator) to an existing X-ray radiation therapy system (INTRABEAM® System). The purpose of the submission is to demonstrate that the new accessory is substantially equivalent to previously cleared predicate devices. The "study" described is a series of non-clinical, laboratory-based tests (sterilization, performance/aging, biocompatibility) designed to ensure the safety, functionality, and compatibility of the Needle Applicator with the existing system and regulatory standards. It does not involve patient data, clinical trials, or AI/ML components, hence many of the specific questions are not relevant in this context.

Summary

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KI10580

510(k) Summary for

APR 1 3 2012

Carl Zeiss Meditec AG INTRABEAM® System Needle Applicator per 21 CFR 807.92

1. SUBMITTER/510(K) HOLDER

Manufacturer: Carl Zeiss Meditec AG Carl-Zeiss-Strasse 22 D-73447 Oberkochen Germany

Contact Person: Judith A. Brimacombe, MA Director, Regulatory/Clinical Affairs Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, CA 94568 Phone: (925) 557-4616 FAX: (925) 557-4259

2. DEVICE NAME

Proprietary Name: Carl Zeiss INTRABEAM® System with Needle Applicator Common/Usual Name: X-ray radiation therapy system Classification Name: System, Therapeutic, X-ray, (21 CFR 892.5900) Product Code: IAD

3. PREDICATE DEVICES

. Photon Radiosurgery System PRS 400 System, K980526
INTRABEAM® System with Balloon Applicator, most recently cleared in K090584 .

4. DEVICE DESCRIPTION

Physical Description

The INTRABEAM® System that will be used with the new Needle Applicator accessory was most recently described in K090584. There are no modifications to the INTRABEAM® System hardware or software. The INTRABEAM® Core System

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consists of the following components:

. PRS500 Control Console
. XRS4 X-ray source
. User terminal

Components of the Needle Applicator set are as follows:

1. Inner Sterile Packaging
1. 5 cm guide shaft
1. 6 cm guide shaft
1. Needle Applicator

How the Device Functions

The XRS 4 X-ray source generates X-rays according to the parameters set for the required treatment on the PRS500 Control Console. The Needle Applicator allows radiation treatment to be delivered directly to the target (e.g. an intracranial turnor).

Scientific Concepts that form the Basis for the Device

X-ray irradiation of tumors is a widely used treatment option in a variety of applications. The INTRABEAM® System delivers a controlled X-ray dose.

Significant Physical and Performance Characteristics of the Device, such as Device Design, Material Used, and Physical Properties

The physical design of the Needle Applicator consists of a polycarbonate case which fits over the probe of the XRS 4 X-ray source, a stainless steel shaft, and a polyetherimide tip for the Applicator. The guide shafts are stainless steel.

5. INTENDED USE

The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.

6. Summary of Technological Characteristics Compared to the\Predicate DEVICE

Carl Zeiss Meditec AG claims substantial equivalence of the INTRABEAM® System with Needle Applicator to the cited predicate device based on the intended use, design, fundamental technology, and operation characteristics.

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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The testing summarized below supports the claim of substantial equivalence to the cited predicate by indicating that the Needle Applicator is a sterile device which performs as designed after sterilization and is safe for its intended use as is the predicate device.

Sterilization Validation

Sterilization validation of the Needle Applicator was performed in compliance with AAMI/ANSI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Dose setting is performed in accordance with AAMI / ANSI/ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, VDmax 25 method. Dosimetric release complies with AAMI/ANSI/ISO 11137-3:2006. Sterilization of health care products - Radiation - Part 3: Guidance on Dosimetric Aspects. The sterilization assurance level is 10 .

Performance Testing

The testing of the dosimetry of sterilized and aged INTRABEAM® Needle Applicator was performed to demonstrate that sterilization and accelerated aging exert no adverse effect on the INTRABEAM® Needle Applicator. Five samples were inspected visually before and after sterilization and accelerated aging. The functionality of Needle Applicators subjected to sterilization and accelerated aging equivalent to five years was tested by Carl Zeiss Meditec AG. All applicators passed the tests, were fully functional, and met the requirements of the engineering specifications.

Dosimetry testing of the PRS400 with the XRS probe (with sheath) compared to the INTRABEAM® System with Needle Applicator was conducted to demonstrate equivalence. The testing consists primarily of isotropy (radiation characteristics) and transfer functions (using a water phantom) using the same protocol used for past aging studies. The dose depth curves of the Needle Applicators tested matched those of the bare probe with sheath. The isotropy of the tested units met the criteria for passing the test.

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Biocompatibility Testing Table 5-2. Biocompatibility Testing Performed on the

Material	Test	Comments	Result
NeedleApplicator	Cytotoxicity ENISO 10993-5	L 929 cell cultures, quantitativedetermination of cell proliferation	No relevant effects observedin comparison to controls
Guide shaft	Cytotoxicity ENISO 10993-5	L 929 cell cultures, quantitativedetermination of cell proliferation	No relevant effects observedin comparison to controls
NeedleApplicator	Chemical AnalysisEN ISO 10993-18	GC-FID, quantification of organicand inorganic leachables	No relevant effects observedin comparison to controls

Final Device Components

Based on the information and supporting documentation provided in the premarket notification, the Carl Zeiss INTRABEAM® Needle Applicator is substantially equivalent to the cited predicate devices. Testing demonstrates that the Carl Zeiss INTRABEAM® Needle Applicator fulfills prospectively defined design and performance specifications.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical testing was conducted to support this submission.

9. SUMMARY OF OTHER INFORMATION

No other information is provided.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the information and supporting documentation provided in the premarket notification, the Carl Zeiss INTRABEAM® System with Needle Applicator is substantially equivalent to the cited predicate device. Testing demonstrates that the Carl Zeiss INTRABEAM® with Needle Applicator fulfills prospectively defined design and performance specifications.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Carl Zeiss Meditec AG Ms. Judith A. Brimacombe. MA Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive DUBLIN CA 94568

APR 1 3 2012

Re: K110590

Trade/Device Name: Carl Zeiss INTRABEAM® System with Needle Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: March 2, 2012 Received: March 5, 2012

Dear Ms. Brimacombe:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ヒル0590

Carl Zeiss INTRABEAM® System with Needle Applicator Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Carl Zeiss Surgical GmbH, Traditional 510(k) INTRABEAM® System with Needle Applicator

510K

CONFIDENTIAL Page 4-1

Regulation Number and Section

§ 892.5900 X-ray radiation therapy system.

(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.