(22 days)
The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
The principles of operation and technology incorporated in the Big Bag 3000 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 Byron Medical Big Bag 3000 Pressure Infusor, which is a device used for general surgical fluid irrigation and infiltration. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel or entirely new class of medical device.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Standalone algorithm performance.
- Type of ground truth used for performance validation.
- Sample size for the training set or how ground truth for the training set was established.
Explanation of document content:
The core of this 510(k) submission is to establish that the Big Bag 3000 Pressure Infusor is "substantially equivalent" to legally marketed predicate devices. This means that its fundamental technology, principles of operation, and indications for use are similar enough to existing devices that it does not raise new questions of safety or effectiveness.
The document explicitly states:
- "The principles of operation and technology incorporated in the Big Bag 3000 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." (Page 1)
- "The principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below." (Page 1)
It then lists several predicate devices (e.g., Medex. Inc. Pressure Infusor, Davol, Inc. Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer) with their 510(k) numbers and substantial equivalence dates. This is the primary "proof" provided – a comparison to devices already cleared by the FDA.
In summary, this document is a regulatory submission for substantial equivalence based on technological similarity to existing devices, not a detailed clinical or performance study with specific quantitative acceptance criteria.
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SEP 1 2 1997
Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in This 510(K) Summary of Saloty and Check Chool Chool and 21 CFR § 807.92
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
| Submitted by: | Steve BollingerV.P. Research and DevelopmentByron Medical, Inc.3280 East Hemisphere LoopTucson, AZ 85706 |
|---|---|
| Telephone #: (520) 573-0857Facsimile #: (520) 746-1757 | |
| Date Prepared: | 15 August, 1997 |
Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere
Loop, Tucson, AZ 85706. We are registered with the
Food and Drug Administration as Establishment
Number 2025576.
| Classification Name: | Pressure Infusor for an I.V. 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: | Big Bag 3000 Pressure Infusor |
| Indication for Use: | General surgical fluid irrigation and infiltration. |
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Byron Medical Confidential - TRADE SECRET
510(k) SUMMARY (cont.)
Device Description:
The principles of operation and technology incorporated in the Big Bag 3000 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 principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.
MX820-5 Pressure Infusor 500cc / MX 820-10 Product: Pressure Infusor 1000cc Manufacturer: Medex. Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980
Nezhat-Dorsey Hydro-Dissection Universal Bag Product: Saueezer Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995
Product: Automatic Surgical Irrigation Pump/Autocuff Alton Dean Medical, Inc./ Spartamed, Inc. Manufacturer: 510(k) Number: K922286 Substantial Equivalence Date: Unknown
Niagara Pump, 3.0 Liter High Volume Product: Cabot Medical Systems Manufacturer: 510(k) Number: K924530 Substantial Equivalence Date: 05 February 1993
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 & Human Services. The logo features a stylized representation of a human figure with three flowing lines forming the head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Mr. Steve Bollinger Vice President Research and Development Byron Medical, Incorporated 3280 East Hemisphere Loop Tucson, Arizona 85706
Re : K973133 Big Bag 3000 Pressure Infusor Trade Name: Regulatory Class: II Product Code: FRN Dated: Auqust 15, 1997 Received: August 21, 1997
Dear Mr. Bollinger:
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 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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 section 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. Bollinger
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 immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling requlation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
Clus
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number (if known): _K973133
Device Name: Big Bag 3000 Pressure Infusor for General Fluid Imgation/Infiltration
Indications for Use:
The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
(Please DO NOT WRITE BELOW THIS LINE - Continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
10
Patrici Cucomite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number
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).