(89 days)
Not Found
No
The device description explicitly states it uses compressed gas and a bladder to apply pressure, which is a purely mechanical process. There is no mention of AI, ML, or any related concepts.
No
The device is described as a 'Pressure Infusor' for 'fluid irrigation and infiltration', which are procedures for delivering fluids, not for treating diseases or conditions.
No
Explanation: The device is described as a "Pressure Infusor" used for "General surgical fluid irrigation and infiltration," which involves administering fluids, not diagnosing conditions. The description focuses on its mechanical operation for fluid delivery rather than diagnostic capabilities.
No
The device description explicitly states it uses a closed bladder (inflatable cuff) and applies direct pressure externally to a bag of fluid, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "General surgical fluid irrigation and infiltration." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a system for applying pressure to a fluid bag for infusion. This is a physical process for delivering fluids, not a method for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Mentioning any reagents, assays, or laboratory procedures
The device is clearly intended for use in a surgical setting to facilitate the delivery of fluids during procedures. This falls under the category of a medical device used for treatment or procedural support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
General surgical fluid irrigation and infiltration.
Product codes
FRN
Device Description
The principles of operation and technology incorporated in the 1000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
K800560, K953574, K922286, K924530, K973133, K980089
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
TRADE SECRET
510 (k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| Submitted by: | C. Kenneth French
President
Valley West, Inc.
Hwy 6, North
Meridian, Texas 76665
Telephone #: (254) 435-2306
Facsimile #: (254) 435-2226 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 19 November 1998 |
| Establishment Registration Number: | Valley West, Inc. is located at Hwy 6, North, Meridian, Texas 76665.
We are registered with the Food and Drug Administration as
Establishment Number 1645369. |
| Classification Name: | Pressure Infusor for an IV bag
21 CFR § 880.5420 (1997)
Laparoscope, Gynecologic and Accessories
21 CFR § 884.1720 (1996)
Jet Lavage
21 CFR § 880.5475 (1997) |
| Common/Usual Name: | Pressurized Irrigation/Infiltration Pump |
| Proprietary Name: | 1000 Pressure Infusor |
| Indication for Use: | General surgical fluid irrigation and infiltration. |
| Device Description: | The principles of operation and technology incorporated in the 1000
Pressure Infusor are equivalent to pressurized irrigation systems, which
use compressed nonflammable gases within a closed bladder (inflatable
cuff to apply direct pressure externally to a bag of fluid for infusion of
fluids). |
1
Valley West, Inc.
Substantial Equivalence Claim:
The principles of operation and technology incorporated in the Valley West, Inc. 1000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has found to be substantially equivalent to pre-amendment devices as outlined below.
MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc Product: Manufacturer: Medex. Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980
Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Product: Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995
Automatic Surgical Irrigation Pump/Autocuff Product: Manufacturer: Alton Dean Medical. Inc./Spartamed, Inc. 510(k) Number: K922286 Substantial Equivalence Date: Unknown
Product: Niagara Pump, 3.0 Liter High Volume Manufacturer: Cabot Medical Systems 510(k) Number: K924530 Substantial Equivalence Date: 05 February 1993
Product: Big Bag 3000 Manufacturer: Byron Medical 510(k) Number: K973133 Substantial Equivalence Date: 10 September 1997
Product: Lapro Flow 3000 Manufacturer: ASSC 510(k) Number: K980089 Substantial Equivalence Date:
-end of summary-
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1999
Mr. C. Kenneth French Valley West, Incorporated Highway 6, North Meridian, Texas 76665
K990447 Re : 1000 Pressure Infusion Sigmacon 1000 Trade Name: Regulatory Class: II Product Code: FRN 1998 Dated: November 19, February 12, 1999 Received:
Dear Mr. French:
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 The general controls provisions of the Act 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Please note: this response to your the Federal Register. 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 - Mr. French
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) 594-4692. 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,
Susan Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the text "Valley West, Inc." in a stylized font. The words are arranged horizontally, with "Valley" and "West" being larger than "Inc.". The font appears to be a serif font with a slight italic slant, giving it a formal and professional look.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 1000 Pressure Infusor for General Fluid Irrigation/Infiltration
Indications for Use:
The 1000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
L Over-the-Counter Use (Optional format 1-2-96)
Patricio Ciceretti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K990447