(87 days)
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No
The description focuses on mechanical and fluid delivery components with no mention of AI/ML terms or functions.
No.
The device description and intended use indicate it is for delivering fluids and purging air, not for treating a disease or condition.
No
The device description clearly states its purpose is for isolating dental operatories from water supplies and introducing bottled solutions, not for diagnosis.
No
The device description clearly outlines physical components such as a dual reservoir system, rotary switch, pressure relief valve, and air filter, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the Pure Fluid Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to isolate a dental operatory from water supplies and introduce bottled solutions for dental procedures. It also provides filtered air for purging. This is a system for delivering fluids and air during a dental procedure, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical aspects of fluid delivery, pressure regulation, and air filtration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic, monitoring, or screening information
The Pure Fluid Delivery System is a device used in a dental setting to manage the delivery of fluids and air for procedural purposes. It does not perform any diagnostic testing on samples.
N/A
Intended Use / Indications for Use
The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.
Product codes
EIA
Device Description
The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.
The operation of the the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature.
The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental operatory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gray S. Nunnelly Chief Executive Officer Pure Company 2045 Preisker Lane Santa Maria, California 93454
JUL - 3 1997
Re : K971278 Pure Company Fluid Delivery System Trade Name: · Requlatory Class: I Product Code: EIA Dated: April 4, 1997 Received: April 7, 1997
Dear Mr. Nunnelly:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Nunnelly
through 542 of the Act for devices under the Electronic Product.Radiation Control provisions, or other Federal laws or requlations.
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 leqally 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) 594-4618. 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,
U. Claturst
A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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510(k) Number: K971278
Device Name: Pure Fluid Delivery System
Indications For Use: --
The Pure Fluid Delivery System is a dual reservoir system that isolates a dental operatory from municipal or rural water supplies. It can also be used to introduce bottled solutions that are commonly used in dental procedures through the dental unit. The Pure Fluid Delivery System also has a .01 Micron air filter that permits air purging of the dental unit with higher quality air.
The operation of the the Fluid Delivery System is facilitated by a rotary switch on the control face that permits switching between the contents of the two bottles being used. There is a built-in pressure relief valve that limits pressure in the bottles to 40psi as a safety feature.
The control face panel also has a quick disconnect that allows the solutions in the bottle selected to be used in an external dental device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K971278 |
| Prescription Use | |
| (Per 21 CFR 801.109) | ✓ |
| OR | |
| Over the Counter Use ____ |
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