PRECISION FLOW OSV II

K971799 · Elekta Implants, SA · JXG · Feb 6, 1998 · Neurology

Device Facts

• Record ID: K971799
• Device Name: PRECISION FLOW OSV II
• Applicant: Elekta Implants, SA
• Product Code: JXG · Neurology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K971799 · Feb 6, 1998	PRECISION FLOW OSV II	Elekta Implants, SA	Published clinical literature (Sainte Rose et al., 1987); Post-market surveillance report (dated June 3, 1994); Clinical use data from predicate device (K913636)	The applicant utilized historical clinical performance data, including a published study and post-market surveillance of the predicate device, to validate the hydrodynamic specifications and clinical concept of the Precision Flow OSV II.	Hydrocephalus; CSF shunt; Post-market surveillance; Clinical literature

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Sainte Rose, Hooven MD, Hirsch JF: A new approach in the treatment of hydrocephalus; Clinical study/Literature; Follow-up/Duration: More than seven years; Study Period: 1987 (publication date)	Patients with hydrocephalus	Not applicable for this study	Hydrodynamic specifications and clinical performance of the OSV concept
Post-Market Surveillance report; Post-market surveillance; Study Period: Report dated June 3, 1994	Patients treated with Orbis Sigma Valve	Not applicable for this study	Clinical performance and safety

Indications for Use

The Precision Flow OSV II intended use is the same as the Orbis Sigma Valve: it is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Device Story

Precision Flow OSV II is an implantable variable resistance valve system for hydrocephalus treatment. It shunts cerebrospinal fluid (CSF) from ventricles to the peritoneal cavity or right atrium. The device operates via a flow-restricting diaphragm, a seat, and a notched pin housed in a polysulfone casing. It functions in three stages: Stage I (low differential pressure, 5-18 ml/hr flow); Stage II (flow regulation, 18-30 ml/hr flow); and Stage III (pressure relief mode for rapid flow during abrupt intracranial pressure elevation). The system maintains drainage rates near physiological CSF secretion (~20 ml/h). It is surgically implanted by a neurosurgeon. The device provides passive, pressure-responsive flow regulation to prevent intracranial hypertension and normalize intraventricular pressure, benefiting patients by managing hydrocephalus symptoms.

Clinical Evidence

No new clinical data provided. The device relies on clinical validation of the flow regulation concept established by the Orbis Sigma Valve, supported by over seven years of clinical use and previous premarket notifications (K913636).

Technological Characteristics

Variable resistance valve; polysulfone casing; synthetic ruby seat and notched pin; flow-restricting diaphragm. Operates via mechanical pressure response. Dimensions/form factor not specified. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients with hydrocephalus requiring CSF shunting from ventricles to peritoneal cavity or other drainage sites (e.g., heart's right atrium).

Regulatory Classification

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.

Predicate Devices

• Cordis Orbis Sigma Valve
• Cordis Omnishunt® System
• Cordis Polypropylene Connectors
• Cordis Ventricular Antechamber
• Cordis Straight or Finned Ventricular Catheters

Submission Summary (Full Text)

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FEB -6 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. Trade (proprietary) Name

Precision Flow™ OSV II

### 2. Common/Classification Name

Central Nervous System (CNS) Fluid Shunt System

### 3. Applicant's Name and Address

Elekta Implants S.A. Parc de Sophia Antipolis 2905 Route des Dolines F-06921 Sophia Antipolis, France

### 4. Classification

This device is classified as Class II (21 CFR 882.5550).

### 5. Predicate Devices

Cordis Orbis Sigmad Valve Cordis Omnishunt® System Cordis Polypropylene Connectors Cordis Ventricular Antechamber Cordis Straight or Finned Ventricular Catheters (with radiopaque dots)

### 6. Performance Standards

No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

### 7. Intended Use and Device Description

The Precision Flow OSV II intended use is the same as the Orbis Sigma Valve: it is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

# K971799

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The Orbis Sigma Valve and the Precision Flow OSV IT are both variable resistance valves that manuain a drainage rate close to the rate of CSF secretion (~ 20 ml/h) within the physiological range of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.

The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pln. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. The clearance between the seat aperture and the notched synthetic ruby nin varies depending on seat movements along the pin as pressure varies (see Section 4). Precision Flow OSV II and Orbis Sigma Valve are characterized by the same three stages of operation, that are defined below :

#### Stage / - Low Differential Pressure (DP)

This stage begins when the flow rate through the valve reaches 5ml/hr (DP will be between 30 and 80 mm H20). The valve remains in Stage I with CSF flow rates up to 18 ml/hr (DP will be hetween 40 and 120 mm H20).

### Stage II - Flow Regulation

When the DP increases, the valve operates as a variable resistance flow regulator. At DP ranges between 120 and 300 mm H,0, the valve restricts flow between 18 and 30 ml/hr.

### Stage III - Pressure Rellef Mode

Should the intraventricular pressure (IVP) elevate abruptly, the shunt operates in a rapid flow rate mode to facilitate NP normalization. The valve then reverts to Stage II or I, depending upon conditions.

The concept of the flow regulation linked to the OSV hydrodynamic specifications has been developed by Pr C. Sainte Rose M.D. ( Sainte Rose, Hooven MD, Hirsch JF: A new approach in the treatment of hydrocephalus. J Neurosurg. 86:213-226, 1987- attached to this section).

This concept has been validated by clinical studies and use over more than seven years (Refer to the OSV Premarket Notification K913636 and Post-Market Surveillance report dated June 3, 1994).

### 8. Biocompatibility

The biocompatibility of the materials used in the manufacture of the Precision Flow OSV II has been documented in the Premarket Notifications of the Orbis Sigma Valve, the Cordis Ventricular Antechamber and the Cordis Straight or Finned Ventricular Catheters. No new issues related to biocompatibility are raised.

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## 9. Summary of Substantial Equivalence':

The indications, contraindications, operating principle, and performance specifications of the Precision Flow OSV II are identical to those of the predicate Orbis Sigma Valve. The design, materials, manufacturing methods and specifications of the Precision Flow OSV II are equivalent to those of the predicate devices and do nul raise any new issues relating to safety and offectiveness for its intended use.

Any statement made in conjunction with this submission regarding substantial courvalence to any other product only relates to whether the product can be lawfully marketed without premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates w the fuct that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seq. (1977).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by a series of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Ms. Barbara Ramseyer RA Consultant Elekta Implants, SA 6011 Cellini Street Coral Gables, Florida 33146

Re: K971799

> Trade Name: Precision Flow OSV II Regulatory Class: II Product Code: JXG Dated: December 19, 1997 Received: December 23, 1997

Dear Ms. Ramseyer:

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 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 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

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Page 2 - Ms. Ramseyer

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

to coeepto

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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# Precision Flow OSV II

火971799 510(k) Number:

Device Name: Precision Flow ™OSV II

## Indications for Use:

The Precision Flow OSV II is an implantable system used in the treatment of patients The Frecision I Now OOT in is an implanticles to the poritoned cavity or other appropriate drainage site such as the heart's right atrium.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K971799 |

Prescription or Over the Counter Use
(Per CFR 801.109)
(Optional Format 1-2-96)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |