(74 days)
General surgical fluid irrigation and infiltration.
The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
The principles of operation and technology incorporated in the 3600 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 a medical device (3600 Pressure Infusor) and the FDA's response. It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML medical devices.
Instead, this document describes a traditional medical device submission for substantial equivalence. The "study" here is essentially the comparison to predicate devices, and the "acceptance criteria" are implied by the FDA's finding of substantial equivalence.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) do not apply to this type of regulatory submission.
Here's how to interpret the document in the context of the prompt:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Device operates on similar principles to legally marketed predicate devices. | "The principles of operation and technology incorporated in the 3600 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." |
| Device has similar technological characteristics to predicate devices. | "The principles of operation and technology incorporated in the Valley West, Inc. 3600 are similar to other irrigation devices with the function to pressurizing bags of fluid..." |
| Device has the same intended use as predicate devices. | Indication for Use: "General surgical fluid irrigation and infiltration." (This is implicitly similar to predicate devices for the purpose of substantial equivalence). |
| Device does not raise new questions of safety or effectiveness compared to predicate devices. | The FDA's finding of "substantial equivalence" implies this was satisfied. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a comparison to predicate devices, not a performance study with a test set of data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of expert consensus on diagnostic or prognostic outcomes, is not part of a substantial equivalence submission for this type of device.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is not an AI/ML device, nor is it a study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable in the common sense for AI/ML. The "ground truth" for this submission is established through comparison to legally marketed predicate devices and their established safety and effectiveness.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) premarket notification for a traditional medical device (a pressure infusor). The "study" is the comparison to predicate devices, and the "acceptance criteria" are met by demonstrating substantial equivalence to those legally marketed devices based on shared principles of operation, technological characteristics, and intended use. The concepts of test/training sets, expert consensus for ground truth, and reader studies are not relevant to this type of regulatory submission.
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Image /page/0/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 and bolder than "Inc.". The text is black and appears to be printed on a white background.
MAR 2 4 1998
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:_139 8 00 89
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:
06 January 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)
Pressurized Irrigation/Infiltration Pump
Jet Lavage 21 CFR § 880.5475 (1997)
3600 Pressure Infusor
Common/Usual Name:
Proprietary Name:
Indication for Use:
General surgical fluid irrigation and infiltration.
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Valley West, Inc.
TRADE SECRET
510(k) SUMMARY (cont.)
Device Description:
The principles of operation and technology incorporated in the 3600 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.
Substantial Equivalence Claim:
The principles of operation and technology incorporated in the Valley West, Inc. 3600 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.
Product: MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc Manufacturer: Medex, Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980
Product: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995
Product: Automatic Surgical Irrigation Pump/Autocuff Manufacturer: Alton Dean Medical, Inc./Spartamed, Inc. 510(k) Number: K92286 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 -end of summary-
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1998
Mr. C. Kenneth French ·President Valley West, Incorporated Hwy. 6, North Meridian, Texas 76665
Re : K980089 3600 Pressure Infusor, Sigmacon 3600, Lapro Trade Name: Flow 3000 Regulatory Class: II Product Code: FRN Dated: January 6, 1998 Received: January 9, 1998
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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Requlations, Title 21, Parts 800 to 895. ਸੇ 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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Page 2 - Mr. French
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
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/dsma/dsmamain.html" .
Sincerely yours,
Timothy A. Ulatowski
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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Valley West, Inc.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 3600 Pressure Infusor for General Fluid Irrigation/Infiltration
Indications for Use:
The 3600 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)
Palacia Cuente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K980089
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use (Optional format 1-2-96)
§ 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).