(89 days)
General surgical fluid irrigation and infiltration.
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).
The provided text is a 510(k) summary for the "1000 Pressure Infusor" device. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device) that is not subject to premarket approval.
This document describes a medical device called a "Pressure Infusor" for general surgical fluid irrigation and infiltration, not an AI/ML powered device.
Therefore, most of the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this type of device and submission.
The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel technology like AI/ML.
Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly not present due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This document does not present a table of specific quantitative acceptance criteria or reported performance data in the way an AI/ML device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices, meaning its performance characteristics are assumed to be similar and acceptable if proven equivalent in function and safety.
The "performance" demonstration for this type of device would typically involve showing that it achieves the intended function (pressurizing fluid bags for irrigation/infiltration) safely and effectively, similar to the predicate devices. This usually involves:
- Materials Compatibility: Ensuring materials in contact with fluids are safe.
- Pressure Control: Demonstrating the device can achieve and maintain appropriate pressure ranges without exceeding safe limits.
- Leakage/Integrity: Proving the system is robust and leak-proof.
- Biocompatibility: If applicable, ensuring materials are biocompatible.
- Sterilization Validation: If the device or components are sterile.
However, none of these specific performance criteria or results are quantified or tabulated in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. There is no "test set" in the context of an AI/ML algorithm evaluation mentioned in this document. The submission is for a physical medical device (Pressure Infusor).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. Ground truth, in the context of expert consensus, is irrelevant for a mechanical device like a pressure infusor.
4. Adjudication Method for the Test Set
Not Applicable. There is no "test set" or diagnostic decision to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of physical device. Such studies are used for evaluating diagnostic performance, often in imaging, involving human readers and AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
Not Applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) as applied to AI/ML diagnostics is not relevant here. The "truth" for this device lies in its mechanical function, safety, and effectiveness.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Device and 510(k) Submission:
- Device Name: 1000 Pressure Infusor
- Indication for Use: General surgical fluid irrigation and infiltration.
- Device Description: Uses compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion.
- Substantial Equivalence Claim: The device's principles of operation and technology are similar to other irrigation devices (listed as predicates) previously found substantially equivalent by the FDA.
- Predicate Devices:
- MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc (Medex, Inc. - K800560)
- Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (Davol, Inc. - K953574)
- Automatic Surgical Irrigation Pump/Autocuff (Alton Dean Medical, Inc./Spartamed, Inc. - K922286)
- Niagara Pump, 3.0 Liter High Volume (Cabot Medical Systems - K924530)
- Big Bag 3000 (Byron Medical - K973133)
- Lapro Flow 3000 (ASSC - K980089)
- FDA Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
In essence, the "study" proving this device meets acceptance criteria is the demonstration that its design and function are sufficiently similar to multiple existing, approved predicate devices, implying it shares their established safety and effectiveness profile. This is a common pathway for physical medical devices where there isn't a complex diagnostic algorithm or novel biological interaction.
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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 FrenchPresidentValley West, Inc.Hwy 6, NorthMeridian, Texas 76665Telephone #: (254) 435-2306Facsimile #: (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 asEstablishment Number 1645369. |
| Classification Name: | Pressure Infusor for an IV bag21 CFR § 880.5420 (1997)Laparoscope, Gynecologic and Accessories21 CFR § 884.1720 (1996)Jet Lavage21 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 1000Pressure Infusor are equivalent to pressurized irrigation systems, whichuse compressed nonflammable gases within a closed bladder (inflatablecuff to apply direct pressure externally to a bag of fluid for infusion offluids). |
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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-
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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.
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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
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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
§ 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).