(267 days)
Not Found
No
The description details a purely mechanical valve system that regulates CSF flow based on pressure differentials using physical components like a diaphragm, seat, and pin. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "implantable system used in the treatment of patients with hydrocephalus," which directly indicates its therapeutic purpose.
No
The device is described as an implantable system used in the treatment of hydrocephalus by shunting CSF, and its description focuses on its mechanism for regulating fluid flow and pressure, not on diagnosing conditions.
No
The device description clearly details a physical, implantable system with mechanical components (valve, diaphragm, seat, pin). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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". This describes a therapeutic device used within the body for treatment.
- Device Description: The description details a mechanical valve system that regulates fluid flow within the body. This is consistent with an implantable therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the Precision Flow OSV II is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles, peritoneal cavity, heart's right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis Orbis Sigmad Valve, Cordis Omnishunt® System, Cordis Polypropylene Connectors, Cordis Ventricular Antechamber, Cordis Straight or Finned Ventricular Catheters (with radiopaque dots)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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).
3
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 (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.
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
5
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) |