The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treather systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

Device Description

The Gambro Posiclear filter consists of a encapsulated, micro porous pleated nylon membrane in a polypropylene housing designed to filter endotoxins, bacteria and particulates from water intended to be used for hemodialysis

AI/ML Overview

This 510(k) summary describes a medical device called the Gambro Posiclear Filter, a water purification subsystem for hemodialysis. The summary details the device's intended use and compares its technological characteristics to a predicate device. However, it does not provide specific acceptance criteria or a detailed study report that would allow for a comprehensive description as requested in the prompt.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document. The document states: "In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices." and "In vitro performance data / specifications are included in the labeling." This indicates that such data exists, but it is not included in the provided 510(k) summary. We can infer the general performance goals from the "Intended Use" section.

Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance
Ability to remove bacteria from water	"performs as well as the predicate devices"
Ability to remove endotoxin from water	"performs as well as the predicate devices"
Ability to remove particulate matter from water	"performs as well as the predicate devices"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The general statement "In vitro performance testing was performed" does not include details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as this device is a physical filter being tested for performance (e.g., filtration efficacy), not an AI or diagnostic device that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the same reason as point 3.

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:

This information is not applicable as this device is a physical filter, not an AI-assisted diagnostic or interpretation tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as this is a physical filter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this device, the "ground truth" would be established by direct measurement of the water quality (e.g., bacterial count, endotoxin levels, particulate matter) before and after filtration, using established laboratory testing methods. This is an objective, quantifiable ground truth determined by scientific assays, not expert consensus or pathology in a medical imaging context.

8. The sample size for the training set:

This information is not applicable as this is a physical device undergoing performance testing, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as point 8.

In summary of what is provided and what is not:

The provided 510(k) summary confirms that "In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices" and that the "Gambro Posiclear filters indicates that they are safe, effective, and perform as well as the predicate devices". However, the detailed data of this testing, including specific acceptance criteria, sample sizes, and the numerical results showing performance against those criteria, are stated to be "included in the labeling" but are not present in this summary. The comparison to the predicate device implies that the performance targets were at least equivalent to, if not better than, the established performance of the legally marketed predicate device.

Summary

{0}------------------------------------------------

N ् नि

510K(k) SUMMARY

SUBMITTER:	Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 (303) 231-5075
DATE PREPARED:	June 20th 2006
DEVICE NAME:	Gambro Posiclear Filter
CLASSIFICATION NAMES:	Water Purification Subsystem
PREDICATE DEVICE:	MINNTECH CORP. FIBERFLOW HOLLOW FIBER CAPSULE WATER FILTER

JAN - 4 2007#### Device Description:

Predicate Device:

MINNTECH CORP. FIBERFLOW HOLLOW FIBER CAPSULE WATER FILTER

Intended Use:

The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treatment systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

Technological Characteristics:

Comparing the proposed devices to the predicate devices, they are substantially equivalent to the predicate devices. Both the proposed and predicate devices use the a micro porous membrane to remove endotoxin, bacteria and particulates from water intended for hemodialysis.

000097

{1}------------------------------------------------

Summary of Non-Clinical Tests:

In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices.

Conclusions:

Testing performed on the Gambro Posiclear filters indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro performance data / specifications are included in the labeling.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Jeffrey R. Shideman, Ph.D. Director, Therapy Group Americas Gambro Corporate Research 7307 Glouchester Drive EDINA MN 55435

JAN 0 4 2007

Re: K061782

Trade/Device Name: Gambro Posiclear Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: June 10, 2006 Received: October 19, 2006 .

Dear Dr. Shideman:

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 (Premarket Approval}, it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006". The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo is surrounded by a dotted circle.

noting Public H.

{3}------------------------------------------------

Page 2 -

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,

This letter will allow you to begin marketing your device as described in your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KDløl782

Device Name: Gambro Posiclear

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehrich A. Strausser

(Posted November 13, 2003)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 2061782 510(k) Number .

000%02

Regulation Number and Section

§ 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.