Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from CO2-absorbers.The Uni-Filter/S, angled Uni-Filter/S and Mini-Filter/S can also be used for gas sampling.

The device for use by qualified medical personnel only.

Device Description

The Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter incorporate an electrostatic filter media into a housing made of translucent plastic.

Dimensions and Matcrials

Diameter: Mini-Filter/S 45 mm. Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S S angled are 59 mm. Uni-Filter is 80 mm.
Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S angled length: 64 mm. Uni-Filter length: 73 mm.
Housing: PP Polypropylene
Filter: PP and acrylic fibers

Filtration efficiency:

Filtration efficiency viral
Mini-Filter/S 99,98%, Uni-Filter Junior, Uni-Filter/S/ angled Uni-Filter/S 99.999%, Uni-Filter 99.9%
Filtration efficiency against bacteria
Uni-Filter Junior >99.9999%, Uni-Filter/S/angled Uni-Filter/S 99.9999%, Uni-Filter 99.98%

The Mini-Filter/S, Uni-Filter/S, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.

They incorporate standard fittings for-
15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask
- 15 mm OD x 22 mm ID fitting to connect to the breathing circuit Y-piece
For the Mini-Filter/S, Uni-Filter/S and Uni-Filter/S angled : A gas sampling port
- -- female luer port with cap to allow sampling of expired CO2-gases

AI/ML Overview

The provided text describes a 510(k) premarket notification for several disposable bacterial/viral filters. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and studies proving the device meets those criteria.

Therefore, the requested information cannot be fully extracted based on the provided text alone, as it focuses on comparing the new devices to existing ones, not on establishing and meeting new, explicit performance acceptance criteria through independent studies.

However, I can extract the reported device performance characteristics that function as implicit "acceptance criteria" through comparison with predicate devices.

Here's a breakdown of what can be inferred and what cannot:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission, the "acceptance criteria" are the performance characteristics of the predicate device. The "reported device performance" is how the new devices compare to those predicates.

Performance Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (New Devices)
Mini-Filter/S Filtration Efficiency (Viral)	Datex-Ohmeda Mini-Filter/S (K030990) - Not explicitly stated but assumed to be met or exceeded.	99.98%
Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Filtration Efficiency (Viral)	Intersurgical Clear-Guard (K990949) - Not explicitly stated but assumed to be met or exceeded.	99.999%
Uni-Filter Filtration Efficiency (Viral)	Intersurgical Clear-Guard (K990949) - Not explicitly stated but the new device has "lower viral filtration efficiency" than the predicate. This suggests the predicate's viral filtration was higher.	99.9%
Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Filtration Efficiency (Bacteria)	Intersurgical Clear-Guard (K990949) - Not explicitly stated but new devices are "better or equal" to the predicate.	>99.9999%
Uni-Filter Filtration Efficiency (Bacteria)	Intersurgical Clear-Guard (K990949) - Not explicitly stated but new devices are "better or equal" to the predicate.	99.98%
Mini-Filter/S Breathing Resistance	Datex-Ohmeda Mini-Filter/S (K030990) - Updated labeling reflects a "more accurate measurement." New device still has "lower breathing resistances" than Datex-Ohmeda HMEF Mini (K023641).	Lower than Datex-Ohmeda HMEF Mini (K023641). Specific value not provided.
Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S, Uni-Filter Breathing Resistance	Intersurgical Clear-Guard (K990949) - New devices have "lower resistance" than the predicate.	Lower than Intersurgical Clear-Guard (K990949). Specific values not provided.
Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Weight	Intersurgical Clear-Guard (K990949) - New devices have "smaller weight."	Smaller than Intersurgical Clear-Guard (K990949). Specific values not provided.
Uni-Filter Weight	Intersurgical Clear-Guard (K990949) - Not explicitly stated, implied to be larger due to larger size.	Specific value not provided.
Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S Dead Space	Intersurgical Clear-Guard (K990949) - New devices have "smaller dead spaces."	Smaller than Intersurgical Clear-Guard (K990949). Specific values not provided.
Uni-Filter Dead Space	Intersurgical Clear-Guard (K990949) - New device is "a little bigger filter," implying a larger dead space.	A little bigger than Intersurgical Clear-Guard (K990949). Specific value not provided.
Materials	Medical grade plastic (common to predicate)	Medical grade plastic (PP Polypropylene, PP and acrylic fibers)
Biocompatibility	Biocompatible (non-cytotoxic and non-allergic), non-toxic (common to predicate)	Biocompatible (non-cytotoxic and non-allergic), non-toxic

Note: For 510(k) submissions, the "acceptance criteria" are often implicitly understood as being "at least as good as or better than" the predicate device in aspects related to safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Not provided. The submission is a regulatory filing focused on substantial equivalence, not a detailed scientific study report with specific test data. It only states performance characteristics as facts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This type of information is relevant for studies involving human interpretation or subjective judgment (e.g., medical imaging). For filter performance, objective laboratory tests are typically used.

4. Adjudication method for the test set:

Not applicable/Not provided. This is not relevant for the type of objective performance testing implied for these devices.

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. These are physical filters, not AI-powered diagnostic devices.

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

Not applicable. These are physical filters, not algorithms.

7. The type of ground truth used:

Objective laboratory measurements. While implicitly understood, the text doesn't provide details on the specific methods used (e.g., specific standards, test setups) for measuring filtration efficiency, breathing resistance, etc., but these would be based on established scientific and engineering principles. For example, "Filtration efficiency viral" would be determined by challenging the filter with a viral aerosol and measuring the reduction.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of physical filter performance testing.

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

Not applicable. As above, no training set.

Summary

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

043120

MAR 1 - 2005

Premarket Notification 510(k) Summary As required by section 807.92 Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

November 8, 2004

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter

COMMON NAME:

Disposable Bacterial/Viral Filter

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

САН Breathing Circuit Bacterial Filter 868.5260

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Mini-Filter/S has the following similarities to the Datex-Ohmeda Mini-Filter/S predicate device (K030990). The Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Intersurgical Clear-Guard (K990949).

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

DEVICE DESCRIPTION as required by 807.92(a)(4)

The Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter incorporate an electrostatic filter media into a housing made of translucent plastic.

Dimensions and Matcrials

Diameter: Mini-Filter/S 45 mm. Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S S angled are 59 mm. Uni-Filter is 80 mm.
Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S and Uni-Filter/S angled length: 64 క్ mm. Uni-Filter length: 73 mm.
Housing: PP Polypropylene ഗ്ഗം
Filter: PP and acrylic fibers ട്ട

Filtration efficiency:

Filtration efficiency viral
Mini-Filter/S 99,98%, Uni-Filter Junior, Uni-Filter/S/ angled Uni-Filter/S 99.999%, Uni-Filter 99.9%
Filtration efficiency against bacteria
Uni-Filter Junior >99.9999%, Uni-Filter/S/angled Uni-Filter/S 99.9999%, Uni-Filter 99.98%

The Mini-Filter/S, Uni-Filter/S, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators.

They incorporate standard fittings for-
15 mm ID x 22 mm OD fitting to connect to the endotracheal tube or face mask S
- 15 mm OD x 22 mm ID fitting to connect to the breathing circuit Y-piece
S For the Mini-Filter/S, Uni-Filter/S and Uni-Filter/S angled : A gas sampling port
- -- female luer port with cap to allow sampling of expired CO2-gases

INTENDED USE as required by 807.92(a)(5)

Intended Use

Indications for use:

ട്ട്

Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from CO2-absorbers. The Uni-Filter/S, angled Uni-Filter/S and Mini-Filter/S can also be used for gas sampling.

The device for use by qualified medical personnel only.

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

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Mini-Filter/S has the following similarities to the Datex-Ohmeda Mini-Filter/S predicate device (K030990):

Mini-Filter/S is identical to predicate (K030990) in physical construction and all specifications except labeled resistance as described below.

The Mini-Filter/S has the following differences when compared to the Datex-Ohmeda Mini-Filter/S predicate device:

· The devices differ in labeled breathing resistance
· Labeling is updated to modify the contraindications

The main differences between the Mini-Filter/S and the predicate Datex-Ohmeda Mini-Filter/S (K030990) are due to fact that the updated labeling reflects a more accurate measurement of the breathing resistance values due to updated equipment calibration. There is no material or design change and the product itself is identical. Mini-Filter/S still has lower breathing resistances than Datex-Ohmeda HMEF Mini (K023641).

The main differences between the labeling is that it describes the use of the Mini-Filler/S with nebulizers and active humidification. In this issue Mini-Filter/S is similar to the legally marketed (predicate) Intersurgical Clear-Guard (K990949).

In summary, the Mini-Filter/S, described in this submission is substantially equivalent to the predicate Datex-Ohmeda Mini-Filter/S (K030990).

The Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Intersurgical Clear-Guard (K990949).

The Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter have the following similarities to the Intersurgical Clear-Guard (K990949) predicate devices:

· Have a similar indicated use
· Have the same fundamental scientific technology and use the same operating principle

The Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter have the following differences when compared to the Intersurgical Clear-Guard (K990949) predicate devices:

· The devices differ in Breathing resistance, weight, dead space and shelf life
· Labeling is updated to modify the contraindications
· Filtration efficiency against virus
· Filtration efficiency against bacteria

The main differences between the Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter and the predicate device Intersurgical Clear-Guard (K990949) are due to fact that Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter have better or equal filtration efficiency (except Uni-Filter has lower viral filtration efficiency), smaller weight , smaller dead spaces (except Uni-Filter which is a little bigger filter) and lower resistance than predicate Intersurgical Clear-Guard.

In summary, the Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter , described in this submission is substantially equivalent to the predicate Intersurgical Clear-Guard (K990949).

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

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

Filter's are normally used and installed by a trained nurse or doctor. Necessary precautions and warnings are stated on the instructions for use (Tab 9).

The Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter housing are made of medical grade plastic materials commonly known to be suitable for the application. The material used is biocompatible (non-cytotoxic and non-allergic), non-toxic

Disposable Filter's are meant for single patient use only. There is no applicable cleaning, disinfection or sterilization procedures that the operator could use

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S, Uni-Filter/S angled and Uni-Filter as compared to the predicate device.

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

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure with three arms or lines extending upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joe Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K043120

Ko+5120
Trade/Device Name: Mini-filter/S, Uni-Filter Junior, Uni-Filter/S Uni-Filter/S angled and Uni-Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: February 11, 2005 Received: February 14, 2005

Dear Mr. Kent:

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 referenced above and 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 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.

{5}------------------------------------------------

Page 2 - Mr. Kent

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 vour 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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Susan Rusner

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Mini-Filter/S, Uni-Filter Junior, Uni-Filter/S,Uni-Filter/S angled and Uni-Filter

Indications for Use:

The device for use by qualified medical personnel only.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page ___ of ___
K(0K) Number	K043120

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).