(265 days)
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
- all other uses of sterile purified water the . practitioner, or clinician deems necessary.
- Not for parenteral administration. .
PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:
- particulates
- dissolved solids
- organics and inorganics
- microbial contaminants
- endotoxins
to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.
The device incorporates several complementary processes: - Prefiltration .
- Depth filtration .
- Deionization .
- Sterilizing membrane filtration ●
Here's a breakdown of the acceptance criteria and study information for the PrISMedical MainStream™ Water Purification Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative "acceptance criteria" for the device, but rather states that the device produces water that "meets the quality attributes of USP sterile purified water" and "meets the standards of USP Sterile Purified Water." The performance is reported as meeting these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produces water meeting quality attributes of USP sterile purified water | Device produces water that meets the quality attributes of USP sterile purified water. |
| Produces water meeting standards of USP Sterile Purified Water | Device produces water that meets the standards of USP Sterile Purified Water. |
The document also implies removal capabilities, which would be an aspect of performance leading to the USP standard:
- Removal of particulates
- Removal of dissolved solids
- Removal of organics and inorganics
- Removal of microbial contaminants
- Removal of endotoxins
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "the results of our testing," but does not provide details on the number of tests performed or the sample size of water used for testing.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. The testing was conducted by PrISMedical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" here is not established by human experts in the sense of medical image interpretation, but rather by objective chemical and microbial analysis against established compendial standards (USP Sterile Purified Water).
- Qualifications of Experts: Not applicable, as the ground truth is based on objective scientific standards rather than expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" is determined by objective laboratory analysis against the USP standards, not by human adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, this type of study was not done. An MRMC study is typically used for diagnostic devices involving human interpretation of medical images. This device is a water purification system, and its performance is assessed against objective water quality standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Yes, in a manner of speaking, the study focuses on the standalone performance of the device. The "algorithm" here is the physical purification process of the device itself. Its performance is measured directly by analyzing the characteristics of the output water against the USP standards, without human intervention or interpretation influencing the water quality assessment. The device operates independently to produce the purified water.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is compendial standards, specifically the standards for USP Sterile Purified Water. This is an objective, defined set of chemical, physical, and microbiological criteria that purified water must meet.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a physical medical device (water purification system), not an AI/machine learning algorithm that requires a "training set" of data. The device's design and manufacturing process are developed through engineering and scientific principles, not by training on a dataset in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device. The design of the device is based on established principles of water filtration and purification to achieve the desired output water quality.
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MAY 0 7 2002
K012716
Page 1 of 3
510(K) SUMMARY
As required by 512(1)(3)(A) of the Food, Drug and Cosmetic Act, PrISMedical Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." PrISMedical chooses to submit a summary of safety and effectiveness information.
| Applicant | PrISMedical Corporation1100 Trancas Street, Suite 250Napa, CA 94558Phone: (707) 258-8666FAX: (707) 258-0115Contact Person: Elaine Alambra |
|---|---|
| Tradename | MainStream™ Water Purification Device |
| Device Generic Name | Water Purification Device |
| Classification / Classification Name | To be determined |
| Predicate Device | Total Water Treatment Systems (TWTS) – K002045 |
| Product Description | PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:particulatesdissolved solidsorganics and inorganicsmicrobial contaminantsendotoxins |
PRISMEDICAL CORPORATION
510(K) SUMMARY - K012716
PAGE 1 of 3
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K01276
page 2 of 3
to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.
The device incorporates several complementary processes:
- Prefiltration .
- Depth filtration .
- Deionization .
- Sterilizing membrane filtration ●
To produce from EPA-grade drinking water, sterile purified water to be used within 24 hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used . in medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral � vaccine, or oral drug preparations; and
- all other uses of sterile purified water the . practitioner or clinician deems necessary.
- ◆ Not for parenteral administration.
Safety and functionality for this device were based solely on end product water characteristics. The materials, performance specifications and essential design characteristics of PrISMedical's MainStream™ water purification device are essentially identical to those of the Total Water Treatment Systems (TWTS) - K002045 predicate device. Both devices produce water
Intended use
Safety and Performance
PRISMEDICAL CORPORATION
510(K) SUMMARY - K012716
PAGE 2 of 3
{2}------------------------------------------------
K012716
Page 3 of 3
that meets the standards of USP Sterile Purified Water.
Conclusion
Based on the results of our testing and comparison of the requirements of the end product of the predicate device to compendial standards (Sterile Purified Water, USP), PrISMedical's MainStream™ Water Purification Device has been shown to be safe and effective for its intended use.
510(K) SUMMARY - K012716
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elaine Alambra Director, RA/QA PrISMedical Corporation 1100 Trancas Street NAPA CA 94558
MAY 0 7 2002
Re: K012716
Trade/Device Name: PrISMedical's MainStream™ Water Purification Device (WPD) Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis
Regulatory Class: II Product Code: 78 NHV Dated: March 7, 2002 Received: March 11, 2002
Dear Ms. Alambra:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K012716
Device Name:
Indications for Use:
MainStream™ Water Purification Device
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
- all other uses of sterile purified water the . practitioner, or clinician deems necessary.
- Not for parenteral administration. .
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Nancyc brogdon
K812916
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.