Statement of indications for use:
The Caroline Guide is indicated for use by neurosurgeons for posterior ventricular catheter placement for patients who are:

Adults or children
Have enlarged ventricles
Have no intracranial mass legions or any structural abnormalities other than hydrocephalus
Have no general contraindications to surgery

Device Description

The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and a frontal target point.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Accuracy: Maintain alignment of the ventricular catheter with the frontal target point as it is advanced through the guide tube.	Met: "The mechanical accuracy of the Caroline Guide was tested in non-clinical studies by passing ventricular catheters through the guide tube and confirming that the catheters maintain alignment with the frontal target point as they were advanced by hand."
Material Durability: Withstand repeated decontamination, cleaning, and sterilization cycles without adverse effects.	Met: "Pre-clinical testing demonstrated that the materials used in the construction of the Caroline Guide will withstand repeated decontamination, cleaning and sterilization cycles without adverse effects."
Safety and Effectiveness in Pediatric Patients: No complications when used in pediatric patients.	Met: "No complications have been noted as a result of use of the Caroline Guide in pediatric patients."
Safety and Effectiveness (Overall): New technologic features do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use.	Met: "These pre-clinical and clinical test data indicate that the new technologic features of the modified Caroline Guide do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use."

Study Information

Here's the detailed study information based on the provided text, noting that the document primarily describes pre-clinical (non-clinical) and clinical test data from a previous study rather than a new de novo study for this specific submission:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size.
- Data Provenance: The clinical trial "involved both pediatric and adult patients" at the Universities of Iowa and Washington. Non-commercial prototypes were also "used routinely in adult and pediatric cases" at these universities and Children's Hospital, Washington University (St. Louis). This suggests a retrospective analysis of previously collected data and ongoing experience, rather than a new prospective trial for this specific K98/809 submission. The countries of origin are the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The text mentions "neurosurgeons" as the intended users and participants in the clinical use, but doesn't detail their specific role in establishing "ground truth" for the assessment of device performance from the earlier referenced trials.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated.
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:
- No. This device is a mechanical guide, not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for mechanical aspects. The "non-clinical tests" evaluated the device's mechanical accuracy (maintaining alignment) and material durability in a standalone manner, without human intervention during the actual "test" phase for these specific criteria.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes/Observation: For the clinical aspect, ground truth was based on the absence of complications in pediatric patients during actual use and the overall safety and effectiveness observed in the referenced clinical trial and subsequent routine use.
- Direct Measurement/Observation: For mechanical accuracy, it involved confirming catheter alignment. For material durability, it involved observing the material's condition after cleaning/sterilization cycles.
The sample size for the training set:
- Not applicable/Not explicitly stated. This is a mechanical device, not a machine learning algorithm requiring a "training set" in the conventional sense. The "training" essentially occurred through the previous design, testing, and clinical use of commercial and prototype versions of the device.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, the concept of establishing ground truth for a "training set" does not apply. The functional requirements and design were likely based on neurosurgical principles and previous device experience.

Summary

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AUG 1 4 1998

K98/809

BB TAM

/ 300/нуоз/

SOLUTIONS SURGICAL

510(k) Summary (as required by section 807.92c)

Submitters name, address, phone and fax:

Chief Medical Officer Surgical Solutions, L.L.C. 2550 Bluffwood Circle Iowa City, IA 52245

Name of contact person:

Matthew A. Howard III, MD Chief Medical Officer

Date of summary preparation:

May 21, 1998

Proprietary and (common) name:

Caroline Guide (Posterior Ventricular Catheter Guide)

Classification:

Stereotaxis Instrument, Regulatory class: II, Product code HAW 882.4560

Legally marketed device to which equivalence is being claimed:

Caroline Guide (K973277)

Description of the device:

The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and a frontal target point.

The intended use:

The Caroline Guide is intended for use by neurosurgeons during posterior ventricular catheter placement procedures.

Surgical Solutions, L.L.C.

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Summary of the technological characteristics of the new device compared to the predicate device:

The modified Caroline Guide and original Caroline Guide (predicate device) have the following characteristics in common:

1. same indications for use (except patient age)
1. Same method for advancing the catheter into the ventricle
1. same materials exposure to the patient during surgery

Description of non-clinical tests:

The mechanical accuracy of the Caroline Guide was tested in non-clinical studies by passing vent ricular catheters through the guide tube and confirming that the catheters maintain alignment with the frontal target point as they were advanced by hand. Pre-clinical testing demonstrated that the materials used in the construction of the Caroline Guide will withstand repeated decontamination, cleaning and sterilization cycles without adverse effects.

Discussion of clinical tests:

The Caroline Guide was tested in a clinical trial at the Universities of Iowa and Washington, involving both pediatric and adult patients. The trial results were reported in the peer reviewed scientific literature (Appendix F) in 1995. Non-commercial Caroline Guide prototypes have been used routinely in adult and pediatric cases since that time at the aforementioned university hospitals, as well as, at Children's Hospital, Washington University (St. Louis). No complications have been noted as a result of use of the Caroline Guide in pediatric patients.

In 1997, an "adult patient only" Caroline Guide received FDA 510(k) approval. This device is sold in conjunction with an adult burr hole localizer (the Delia Localizer). The Delia Localizer is not suitable for use in children. The modified Caroline Guide described in this submission is suitable for use in either adult (with the Delia Localizer) or pediatric (without the Delia Localizer) patients.

Conclusions drawn from the non-clinical and clinical tests:

These pre-clinical and clinical test data indicate that the new technologic features of the modified Caroline Guide do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an inner symbol. The inner symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 1998

Matthew A. Howard, III, MD Chief Medical Officer Surgical Solution, L.L.C. 2550 Bluffwood Circle Iowa City, Iowa 52245

Re: K981809 Trade Name: Caroline Guide Regulatory Class: II Product Code: HAW Dated: May 21, 1998 Received: May 21, 1998

Dear Dr. Howard:

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 - Dr. Matthew A. Howard

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 vours,

Mark M. Milburnson

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 nt

K981809 510(k) Number (if known):

Caroline Guide Device Name:_

Indications For Use:

Statement of indications for use:

The Caroline Guide is indicated for use by neurosurgeons for posterior ventricular catheter placement forpatients who are:

1. Adults or children
Have enlarged ventricles 2)
Have no intracranial mass legions or any structural abnormalities 3) other than hydrocephalus
Have no general contraindications to surgery 4)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millikan

for
cmw

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981809

Prescriptionالاق (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

SK-68

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).