The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for use in:

· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)

· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

Device Description

Prior to use the ViewPoint tools must be sterilized. Testing has been completed to validate the use of the Sterrad 100 system for this process. The Guide Block (Non-Trackable and Trackable) and the Trackable Awl are three additional tools now available for the ViewPoint. The Guide Blocks guide and track the trajectory of a biopsy needle during a procedure. The Trackable Awl is a standard awl that has been adapted to include infrared emitting diodes so that the tip of the awl can be tracked similar to the standard ViewPoint Y-probe.

AI/ML Overview

The provided text describes the ViewPoint Tools - Sterrad, an Image Assisted Surgery Device. The submission is a 510(k) for new tools (Guide Blocks and Trackable Awl) and a new sterilization technique (Sterrad 100 system) for the previously cleared ViewPoint system. The document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's diagnostic performance for its intended use.

Here's the breakdown of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily aims to demonstrate that the new ViewPoint tools (Guide Blocks and Trackable Awl) and the new sterilization technique (Sterrad 100 system) are substantially equivalent to previously cleared predicate devices and sterilization methods. The acceptance criteria are implicit in proving this equivalence, particularly regarding the existing accuracy specifications of the ViewPoint system.

Parameter	Acceptance Criteria (from Predicate Device)	Reported Device Performance (ViewPoint - Sterrad)
Tools	Y-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable)	Y-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable), Guide Block (Non-Trackable and Trackable), Trackable Awl (New tools claimed equivalent)
Material Considerations	Combination of metal and non-metal, IREDs sensitive to heat.	Same.
Lumens	Dead-end lumen in LEMO Connector for trackable tools; single-channel stainless steel lumen for drill guides.	Same.
Use limits	None specified for predicate.	Same (None).
Accuracy (Y-probe)	Repeatability/Resolution: 1mm; Distance measurement: $\pm$ 0.75 mm; 3D Localization: $\leq$ 1.57 mm; Fourth Fiducial Checkpoint: $<$ 5.0 mm	Same (Implied: the new tools/sterilization do not degrade the existing accuracy).
Sterilization Technique	Ethylene Oxide	Sterrad (New technique claimed equivalent in effectiveness and non-impact on tool function/accuracy).
Intended Use	As device for presurgical planning and intra-operative orientation/reference.	Same.
Indications for Use	Intra-cranial and Spinal surgical procedures.	Same.

Study Proving Acceptance Criteria:

The "study" described is a demonstration of substantial equivalence to predicate devices (K963221 and K970604). This is a regulatory pathway, not a traditional clinical accuracy or effectiveness study. The primary focus is on showing that the modifications (new tools and sterilization method) do not raise new questions of safety or effectiveness and perform as well as the legally marketed predicate devices.

The document states: "The use of the Sterrad 100 system adequately sterilizes the ViewPoint tools for intraoperative procedures and does not affect the accuracy or function of the tools. The Guide Blocks and the Trackable Awl described in this submission are equivalent to the tools described in the 510(k) submissions K963221 and K970604. This equivalence is demonstrated in the following table."

This suggests that:

Sterilization Validation: Testing was completed to validate the use of the Sterrad 100 system for this process. This implies a sterilization validation study was performed to ensure the Sterrad 100 achieves sterility and does not negatively impact the tools' accuracy or function.
Tool Equivalence: The new tools (Guide Blocks and Trackable Awl) are stated to be "equivalent" to the predicate tools, implying design and performance similarity where applicable, and that their addition does not change the overall system's fundamental performance characteristics (like accuracy).

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" in the context of a clinical performance study with a patient cohort. The submission is focused on demonstrating equivalence through technical comparisons and sterilization validation. For the sterilization validation, the sample size would refer to the number of devices or cycles tested, but this detail is not provided.
Data Provenance: Not applicable in the context of a clinical test set. The data originates from internal company testing (for sterilization validation and tool comparison) and references previously cleared predicate device characteristics.

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

This is not applicable as the submission is not a clinical effectiveness study requiring expert interpretation of results for ground truth establishment. The ground truth for tool accuracy parameters would be established by engineering measurements and metrology standards. For sterilization, ground truth is microbiological sterility testing.

4. Adjudication Method for the Test Set

Not applicable as there is no human-read test set requiring adjudication in this 510(k) submission.

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

No, an MRMC comparative effectiveness study was not done or described in this document. The submission focuses on device equivalence, not clinical effectiveness studies with human readers.

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

This device is an Image Assisted Surgery Device, implying a human-in-the-loop system. The concept of "standalone" performance for an algorithm without human intervention generally applies to diagnostic AI systems, which is not the primary focus of this submission. The accuracy parameters (e.g., repeatability, 3D localization) relate to the device itself, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For Accuracy: The ground truth for the stated accuracy parameters (e.g., 3D Localization $\leq$ 1.57 mm) would be based on engineering measurement standards and metrology, verified through controlled laboratory testing.
For Sterilization: The ground truth for adequate sterilization would be established through microbiological testing (e.g., sterility testing, bioburden reduction validation) following recognized sterilization standards.
For Equivalence of Tools: The ground truth for equivalence (e.g., material considerations, lumens, form, and fit) is via design specifications, material certifications, and comparative technical analysis against the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device submission that involves a training set.

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

Not applicable. As above, there is no AI/ML training set.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers 9, 8, 3, 7, 6, and 4. The characters are written in a dark, bold font, and they appear to be slightly slanted.

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1.	General Information
	Classification: Class IIImage Assisted Surgery Device
	Common/Usual Name: Image Assisted Surgery Device Option
	Proprietary Name: ViewPoint Tools - Sterrad
	Establishment Registration: Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965
	Performance Standards: No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic Act.

Intended Uses 2.

The ViewPoint is indicated for use in:

· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)

· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

3. Device Description

PICKER INTERNATIONAL, INC. (STERRAD) 10/22/98 I - 1

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4. Safety and Effectiveness

The use of the Sterrad 100 system adequately sterilizes the ViewPoint tools for intraoperative procedures and does not affect the accuracy or function of the tools. The Guide Blocks and the Trackable Awl described in this submission are equivalent to the tools described in the 510(k) submissions K963221 and K970604. This equivalence is demonstrated in the following table.

Parameter	ViewPoint - Sterrad	Predicate Devices
Tools	• Y-Probe with various tips• Cable• Head Tracker• Spine Tracker• Drill Guide (Non-Trackable and Trackable)• Guide Block (Non-Trackable and Trackable)• Trackable Awl	• Y-Probe with various tips• Cable• Head Tracker• Spine Tracker• Drill Guide (Non-Trackable and Trackable)
Material Considerations	Same.	Combination of metal and non-metal materials. IREDs on trackable tools are sensitive to heat.
Lumens	Same.	Trackable tools have a dead-end lumen in the LEMO Connector. The drill guides have a single-channel stainless steel lumen.
Use limits	Same.	None.
Accuracy (Y-probe)	Same.	Repeatability/Resolution: 1mmDistance measurement: $\pm$ 0.75 mm3D Localization: $\leq$ 1.57 mmFourth Fiducial Checkpoint: $<$ 5.0 mm
Sterilization Technique	Sterrad	Ethylene Oxide
Intended Use	Same.	The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures

Substantial Equivalence Table

PICKER INTERNATIONAL, INC. (STERRAD)

10/22/98

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Parameter	ViewPoint - Sterrad	Predicate Devices
Indications for Use	Same.	The ViewPoint is indicated for use in:• Intra-cranial surgical proceduresinvolving space occupying lesions ormalformations (including soft tissue,vascular and osseous)• Spinal surgical procedures involvingspinal stabilization, neuraldecompression, or resection of spinal

PICKER INTERNATIONAL, INC. (STERRAD)

10/22/98

、

I - 3

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 8 1999

Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

Re: K983764 Trade Name: ViewPoint Tools - Sterrad Regulatory Class: II Product Code: HAW Dated: April 8, 1999 Received: April 9, 1999

Dear Dr. Keeler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Elaine K. Keeler, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

983764

ViewPoint - Sterrad Sterilization Device Name:

Indications for Use:

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for use in:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pcsell

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K983764

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).