The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery

Device Description

The Delia Localizer is a head-band based apparatus that aids the surgeon in identifying the optimal location for placing a posterior burr hole for purposes of inserting a posterior ventricular catheter. It mechanically reduces to practice geometric principles that are already used to manually calculate where to position a posterior burr hole. 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 the frontal target point.

AI/ML Overview

The provided text describes a 510(k) summary for the "Caroline Guide and Delia Localizer" integrated system. However, it does not explicitly state specific numerical acceptance criteria or detail a study designed to prove the device meets these criteria in the typical quantitative manner we might expect for medical device performance evaluation.

Instead, the document focuses on:

Substantial Equivalence: The primary goal of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (a ventricular catheter stylette).
Technological Characteristics: It highlights similarities in indications for use, method for advancing the catheter, and patient exposure to materials, while describing how the new device mechanically simplifies existing manual techniques.
Pre-clinical Testing: This testing focused on confirming geometric principles and mechanical accuracy.
Clinical Testing: A clinical trial of the Caroline Guide alone was reported in peer-reviewed literature. More recently, a clinical trial of the combined Delia Localizer and Caroline Guide system was approved, and clinical data on its performance was "now available."

Given this, I will reconstruct the "acceptance criteria" and "study" information based on the emphasis of the 510(k) process, which prioritizes safety and effectiveness demonstrated through substantial equivalence rather than explicit quantitative performance metrics like sensitivity/specificity often seen in AI/diagnostic device submissions.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) notice is primarily framed around the demonstration of substantial equivalence to a predicate device, and ensuring the new technological features do not adversely affect safety or effectiveness. Specific quantitative performance metrics are not provided as acceptance criteria.

Acceptance Criteria (Implied by 510(k) content)	Reported Device Performance (Summary from text)
1. Substantial Equivalence to Predicate Device: Same indications for use, method for advancing catheter, and materials exposure.	Met: The integrated system shares the same indications for use, method for advancing the catheter into the ventricle, and materials exposure to the patient during surgery as the predicate ventricular catheter stylette. The new features mechanically simplify existing manual techniques.
2. Validity of Geometric Principles (Delia Localizer): Accurate embodiment of established geometric principles for burr hole placement.	Met: Pre-clinical testing involved anatomical analysis of CT scans of hydrocephalus patients, confirming the validity of the geometric principles. Testing on cranial phantoms of differing head sizes ensured accurate reduction of principles to practice.
3. Mechanical Accuracy (Caroline Guide): Maintenance of catheter alignment with the frontal target point.	Met: Non-clinical studies confirmed that ventricular catheters passed through the guide tube maintained alignment with the frontal target point as advanced by hand.
4. Safety and Effectiveness (Combined System): New technological features do not adversely affect safety or effectiveness.	Met: Pre-clinical and clinical test data indicate that the new technologic features of the Delia Localizer and Caroline Guide "do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use." Clinical data from a trial using the combined system was available (approved by the University of Iowa Institutional Review Board).

Study Details

The text describes both non-clinical and clinical tests. The primary "study" proving the device meets the substantial equivalence criteria encompasses these findings.

2. Sample size used for the test set and the data provenance:

Delia Localizer (Pre-clinical):
- Test Set: Head CT scans of patients with hydrocephalus (number not specified).
- Provenance: Not explicitly stated, but implies clinical data from patients with hydrocephalus. The cranial phantoms used were for "differing head sizes."
Caroline Guide (Non-clinical):
- Test Set: Not a human sample size, but involved testing with ventricular catheters and the guide tube.
Caroline Guide (Clinical - standalone):
- Test Set: Not explicitly stated, but a clinical trial was conducted at the Universities of Iowa and Washington. This trial was reported in peer-reviewed literature in 1995. This would be prospective data given it was a trial.
Delia Localizer + Caroline Guide (Clinical - combined system):
- Test Set: Clinical data (number of patients not specified) from a new clinical trial approved by the University of Iowa Institutional Review Board. This would be prospective data.
- Provenance: University of Iowa.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the pre-clinical analysis of CT scans, "anatomical analysis" was performed, which implies expert involvement, but the number and qualifications of experts are not specified.
For the clinical trials, it is implied that neurosurgeons were involved in using and evaluating the device, but their number and specific qualifications for establishing 'ground truth' or evaluating outcomes are not detailed in this summary.

4. Adjudication method for the test set:

Not specified. The 510(k) summary does not provide details on adjudication methods for either the pre-clinical or clinical studies.

5. 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, an MRMC study was not done. This device is a mechanical surgical guide, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply. The comparison is between manual surgical techniques and mechanically guided techniques. The summary states that the new device "mechanically reduces to practice geometric principles that are already used to manually calculate."

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

Yes, in essence. The pre-clinical tests for the Delia Localizer (validity of geometric principles, accuracy on phantoms) and the non-clinical tests for the Caroline Guide (mechanical accuracy with catheters) can be considered "standalone" evaluations of the device's mechanical function, prior to or separate from human-in-the-loop clinical use.

7. The type of ground truth used:

Delia Localizer (Pre-clinical): Established geometric principles related to burr hole placement, confirmed by "anatomical analysis of head CT scans" and testing against physical cranial phantoms.
Caroline Guide (Non-clinical): Mechanical alignment with a "frontal target point."
Clinical Trials (Caroline Guide alone and combined system): Clinical performance, which for a surgical guidance device typically involves outcomes like successful catheter placement, reduction in complications, accuracy of placement, and patient safety. The specific metrics are not detailed but would be expert-assessed clinical outcomes.

8. The sample size for the training set:

Not applicable in the typical sense of machine learning. This device is mechanical, not an AI/ML algorithm that requires a "training set." The development of the device would have been基于engineering principles and anatomical knowledge rather than data training.

9. How the ground truth for the training set was established:

Not applicable as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design principles was established through anatomical and geometric understanding, surgical practice, and pre-clinical verification.

Summary

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K973277

Image /page/0/Picture/1 description: The image shows a logo for Surgical Solutions Inc. The logo features two stylized letter 'S' stacked on top of each other on the left side. To the right of the 'S' letters, the words 'urgical' and 'olutions' are stacked on top of each other. Below the word 'olutions' is the word 'Inc.'.

NOV 1 7 1997

2550 Bluffwood Circle lowa City, lowa USA (319) 337-6882

510(k) Summary

(as required by section 807.92c)

Submitters name, address, phone and fax:

Surgical Solutions Inc. 2550 Bluffwood Circ. Iowa City, IA 52245 phone: 319 337-6882 fax: 319 354-7308

Name of contact person:

Matthew A. Howard III, MD President and CEO

Date of summary preperation:

September 1, 1997

Proprietary name:

Caroline Guide and Delia Localizer (to be sold together as an integrated system)

Common name:

Posterior Ventricular Catheter Guide (Caroline Guide) and Posterior Burr Hole Localizer (Delia Localizer)

Classification name:

Accessories to shunt system implantaton instruments, regulation number 21 CFR 882.4545 (per FDA correspondance, see Appendix D)

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Legally marketed device to which equivalence is being claimed:

Ventricular catheter stylette (pre-amendment device)

Discription 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 the frontal target point.

The intended use:

The Delia Localizer and Caroline Guide are intended to be used as an integrated system by neurosurgeons during posterior ventricular catheter placement procedures.

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

The Delia Localizer and Caroline Guide integrated system have the following characteristics in common with the predicate device (catheter stylette)

1. same indications for use
1. same method for advancing the catheter into the ventricle
1. same materials exposure to the patient during surgery.

The Delia Localizer makes use of intersecting sighting devices to simplify a commonly used manual measuring technique and indicate where to locate a posterior burr hole. Surgeons using the predicate device and standard catheter placement techniques rely on manual measurements made along the scalp relative to palpable skull anatomic landmarks.

The Caroline Guide mechanically orients a catheter along a trajectory line between the posterior burr hole entrance point and the frontal target point. Surgeons using the predicate device and standard catheter placement techniques mentally visualize the intended catheter trajectory, orient the sylette by hand without mechanical assistance, and then manually advance the catheter towards the target.

Discription of non-clinical tests:

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Pre-clinical testing was carried out to confirm the validity of the geometric principles embodied in the Delia Localizer for shunt surgery patients. This involved the antomical analysis of head CT scans of patients with hydrocephalus. Additionally, the Delia Localizer was tested on cranial phantoms of differing head sizes to ensure that device accurately reduced the geometric principles to practice.

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.

Discussion of clinical tests:

The Caroline Guide was tested in a clinical trial at the Universities of Iowa and Washington. The trial were reported in the peer reviewed scientific literature (Appendix B) in 1995 and the device has been in routine clinical use at these two institutions since that time.

More recently, a clinical trial of the Delia Localizer in combination with Caroline Guide system was approved by the University of Iowa Institutional Review Board and clinical data is now available on clinical performance of the combined system.

Conclusions drawn from the nonclinical and clinical tests:

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

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1997

Matthew A. Howard III, MD President and CEO Surgical Solutions, Inc. 2550 Bluffwood Circle Iowa City, Iowa 52245

Re: K973277

Trade Name: The Caroline Guide and Delia Localizer Regulatory Class: II Product Code: HAW Dated: August 28, 1997 Received: September 2, 1997

Dear Dr. Howard:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (QS) 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Matthew A. Howard III, MD

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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) 594-4648. Additionally, for questions on the promotion and advertising of your devices, 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,

ia M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973277 510(k) Number (if known):_

Device Name:__Caroline Guide/Delia Localizer

Indications For Use:

Statement of indications for use:

l) Adults

Have enlarged ventricles
Have normal scalp, skull, external ear and orbital anatomy
Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus
Have no general contraindications to surgery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973277

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).