The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

Device Description

The HP Valve System is a hydrocephalus shunt designed to allow the surgeon to change the valve operating pressure without surgical intervention. Intraventricular pressure is maintained at a constant level by the device's rubyball-in-cone valve seat design. The center of a flat spring is attached to a fixed fulcrum, with one end resting on the ruby ball and the other end resting on an eighteen position spiral staircase shaped cam that rotates on a titanium pivot. When the cam rotates the tension on the spring changes as the distal end of the spring moves up or down the cam. The operating pressure of the valve is thereby adjusted. During programming, the programmer transmits a coded magnetic signal to the device, causing the cam to rotate. The device has 18 pressure settings, ranging from 30mm to 200mm H20, in 10mm increments.

AI/ML Overview

The provided text describes the HP Valve System, a hydrocephalus shunt, and its journey through FDA 510(k) approval in 1998. It references various tests and a clinical trial to demonstrate substantial equivalence to a predicate device. However, the document does not present explicit "acceptance criteria" for device performance in a numerical or categorical format, nor does it detail a study that directly "proves the device meets the acceptance criteria" with specific performance metrics. Instead, it describes a substantial equivalence claim based on various forms of testing and a clinical trial.

Therefore, the following information is extracted and inferred from the provided text as much as possible, with explicit notes on what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated in the document, this table will summarize the types of testing performed and the general conclusions regarding device performance, as described in the "Device Testing Summary" and the FDA's clearance letter.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials are safe for biological contact.	Directly Met: "Biocompatibility tests were performed per the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993 Biological Testing of Medical and Dental Materials and Devices. Testing results demonstrated that the device materials are biocompatible."
Performance (Mechanical/Functional): Device functions as intended through various operational and stress tests.	Directly Met: "Performance testing was conducted per and complies with the applicable sections of ASTM F647-94 - Standard Practice for Evaluating and Specifying Impantable Shunt Assemblies for Neurosurgical Applications. Performance testing included the following areas: Reprogramming, Fatigue, Corrosion, MRI, Wet Pressure and Programmer Evaluation. Testing results demonstrated the suitability of the device for its intended use." (Specific quantitative performance metrics or thresholds for each test, which would represent acceptance criteria, are not provided).
Clinical Equivalence (Safety & Effectiveness): Device performs as well as and is as safe and effective as currently marketed predicate devices.	Directly Met: "A controlled, randomized, clinical trial was conducted to support a claim of substantial equivalence. 377 patients were enrolled and followed for two years. Results indicated that the HP Valve System performs as well as and is as safe and effective as currently marketed hydrocephalus shunt systems." (Specific clinical endpoints, metrics, or statistical non-inferiority margins, which would represent acceptance criteria, are not provided).

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

Test Set Sample Size: For the clinical trial, 377 patients were enrolled. The document does not specify if this entire group represents a "test set" solely for evaluation or if it was the entire study population.
Data Provenance: The document does not explicitly state the country of origin. Given the submitter's location (Raynham, MA) and the FDA clearance process, it is highly probable the data is largely from the United States or comparable regulatory environments. The clinical trial was a prospective study ("followed for two years").

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

The document does not provide details on the number or qualifications of experts specifically used to establish ground truth for the clinical trial data. Clinical trials typically involve physicians and other medical professionals responsible for patient diagnosis, treatment, and outcome assessment, which implicitly serve as the "ground truth" for clinical effectiveness and safety measurements.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical trial's outcomes or safety data. In clinical trials, outcome data is typically collected through standardized protocols and reviewed by study investigators and potentially independent monitors, but a formal adjudication process beyond standard data review is not mentioned.

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 MRMC study was done. This device is a mechanical medical implant (hydrocephalus shunt), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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

No standalone algorithm performance study was done. As mentioned, this is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

Clinical Outcomes Data: For the clinical trial, the ground truth was established through patient clinical outcomes and safety profiles over two years, compared to currently marketed hydrocephalus shunt systems. This would include metrics related to shunt function, complications, revisions, and patient well-being, as assessed by treating physicians and follow-up examinations.
Engineering/Physical Standards: For the performance testing, the ground truth was established by adherence to ASTM F647-94 and internal engineering specifications, verifying mechanical and functional properties.
Biocompatibility Standards: For biocompatibility, the ground truth was established by compliance with ISO 10993 and Tripartite Biocompatibility Guidance, confirming material safety.

8. The Sample Size for the Training Set

Not applicable for this device. This is a mechanical medical device, not an AI/machine learning model, so there is no "training set." The design and manufacturing would be based on engineering principles and preclinical testing, not data training.

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

Not applicable for this device. As there is no "training set" for an algorithm, there is no ground truth established for it.

Summary

{0}------------------------------------------------

EXHIBIT I

510K Summary HP Valve System December 18, 1997

Submitter 1.

1 1998

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767 Diane Minear, Senior Regulatory Consultant, (508) 828-3532

Device Name 2.

Proprietary Name:	HP Valve System
Common Name:	Hydrocephalus Shunt
Classification Name:	Central Nervous System Fluid Shunt and Components
Regulatory Class:	Class II by 21 CFR §882.5550

3. Intended Use

The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

4. Device Description

{1}------------------------------------------------

Predicate Device Comparison 5.

The HP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the HAKIM Precision Valve System (K944222). Both devices utilize the same ball-in-cone valve mechanism to maintain intraventricular pressure. The valve design maintains intraventricular pressure at a constant selected level. Depending on the CSF flow rate and/or viscosity, the ball moves up or down within the cone under the control of the calibrated flat stainless steel spring. The cross section of the valve through which CSF flows automatically increases or decreases, therefore maintaining the selected pressure.

While the pressure regulating mechanism is identical in both devices, the variable pressure setting feature is only available with the HP Valve System, while the HAKIM Precision Valve System is available in five fixed pressure ranges.

Device Testing Summary હે.

Testing Performed	Comments
BiocompatibilityTesting	Biocompatibility tests were performed per the TripartiteBiocompatibility Guidance for Medical Devices and ISO 10993Biological Testing of Medical and Dental Materials andDevices. Testing results demonstrated that the devicematerials are biocompatible.
Performance Testing	Performance testing was conducted per and complies with theapplicable sections of ASTM F647-94 - Standard Practice forEvaluating and Specifying Impantable Shunt Assemblies forNeurosurgical Applications. Performance testing included thefollowing areas; Reprogramming, Fatigue, Corrosion, MRI, Wet Pressure and Programmer Evaluation. Testing resultsdemonstrated the suitability of the device for its intended use.
Clinical Evaluation	A controlled, randomized, clinical trial was conducted tosupport a claim of substantial equivalence. 377 patients wereenrolled and followed for two years. Results indicated that theHP Valve System performs as well as and is as safe andeffective as currently marketed hydrocephalus shunt systems.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1998

Ms. Diane Minear ·Senior Regulatory Consultant Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K974739 Trade Name: Hakim Programmable Valve System Regulatory Class: II Product Code: JXG Dated: June 24, 1998 Received: June 25, 1998

Dear Ms. Minear:

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.

{3}------------------------------------------------

Page 2 - Ms. Minear

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.

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

{4}------------------------------------------------

HAKIM PROGRAMMABLE VALVE SYSTEM Indications For Use

1<974739

The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ge 510(k) Numb

Prescription Use
(Per 21 CFR §801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).