(178 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
The provided text describes a 510(k) premarket notification for the EMS HEPA Filter and HEPA Filter / HME, which are bacterial/viral filters and heat and moisture exchangers. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a full study report with detailed performance metrics against those criteria.
However, the "General Technical Characteristics" table [1] lists several performance attributes of the proposed devices, which can be interpreted as acceptance criteria based on established standards and the characteristics of predicate devices. The "Reported Device Performance" column reflects the device's measured or designed specifications.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in separate columns, nor does it present a formal study showing the device meets these criteria with numerical results from a specific test. Instead, it lists technical characteristics, which by their nature in a 510(k) summary, imply that the device performance meets or is equivalent to these values for substantial equivalence.
| Acceptance Criteria (Implied from "General Technical Characteristics") | Reported Device Performance (Implied from "EMS - Proposed Devices" column) |
|---|---|
| Indications for use - To filter inspired and / or expired gases. | Same (as predicate) |
| Intended for single patient, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 80 ml |
| Resistance to flow | < 3.4 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| Weight (gm) | 27 to 35 gm |
| Humidification output (mg H2O/l) | 27 mg H₂O /L at TV of 500 cc, where applicable |
| Housing material | Polystyrene |
| Filter media | Paper fiber |
| Performance Standards (Compliance) | |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| ISO 9360 - HME moisture output | Yes |
| DOE 3202-97 and ASTM D2986 - DOP | 99.97% (performance, implies compliance) |
2. Sample size used for the test set and the data provenance
The document states that "Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters." and "The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP." [0]. For BFE and VFE, it mentions "Nelson Lab." [1].
- Sample Size: The phrase "Each filter is individually tested" suggests that all manufactured filters undergo performance testing, but it doesn't specify the sample size of filters used for the validation testing that led to the reported performance figures in the table. It refers to ongoing quality control rather than a specific study sample size.
- Data Provenance: The testing for BFE and VFE was performed by "Nelson Lab." [1]. Other tests refer to specific standards (BS 3928, DOE 3202-97, ASTM D2986), implying these tests were conducted internally or by a contracted lab to meet those standards. The country of origin of the data is not explicitly stated, but the company is based in Indianapolis, IN, 46241, USA [0], and Nelson Labs is a US-based laboratory, suggesting US provenance. The data appears to be prospective in the sense of being generated specifically for the device's design verification and validation, as opposed to retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical device (filter/HME) and its performance metrics (e.g., filtration efficiency, resistance to flow, dead space) are determined by objective physical and biological testing methods against established standards, not by expert interpretation or consensus on images or clinical cases.
4. Adjudication method for the test set
Not applicable, as the tests are objective measurements against standards, not subjective interpretations requiring adjudication.
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. This device is a physical filter/HME, not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical filter/HME, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims are the established international and national standards for medical device filters and HMEs. These include:
- BS 3928 Sodium Flame for Air filters [0]
- DOE 3202-97 and ASTM D2986 – DOP for HEPA performance [0, 1]
- ISO 5356-1 Conical 15/22 [1]
- ISO 594-2 Luer Fittings [1]
- ISO 9360 - HME moisture output [1]
- Bacterial and Viral Filtration Efficiency testing methods (likely based on ASTM F2101 for BFE and ASTM F2100 for VFE, implicitly performed by Nelson Labs as this is their specialty expertise and standard industry practice for these claims). [1]
These standards define the test methods and acceptable performance ranges.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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| MAR 1 4 2002 | |
|---|---|
| -- | -------------- |
Engineered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 March 13, 2002
| Engineered Medical Systems2055 Executive Dr.Indianapolis, IN 46241 | Tel (317) 246-5500Fax (317) 246-5501 | |||
|---|---|---|---|---|
| Official Contact: | Bonnie Holly - Quality Manager | |||
| Proprietary or Trade Name: | EMS HEPA Filter and HEPA Filter / HME | |||
| Common/Usual Name: | Bacterial / Viral Filter and Heat and Moisture Exchanger | |||
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH | |||
| Predicate Devices: | Mallinckrodt Sterivent and Sterivent "S"- K941676Mallinckrodt - Hygroster - K941585Mallinckrodt Hygrobac "S" - K941381ARC Medical Filter - K011212Allegiance Two Way HEPA - K011132SIMS Filter - K002201 |
Device Description
The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.
| Intended Use | |
|---|---|
| Indicated Use -- | For use with ventilators, anesthesia machines, and open flowsystems where filtration of inspired and / or expired gases isdesired and to add maintain and retain moisture for the exhaledbreathe of the patient. For adults patients with Tidal Volumes> 150 ml. Intended for use up to 24 hours. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Emergency services |
| Non-Confidential Summary of Safety and Effectiveness |
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Page 2 of 2 March 13, 2002
General Technical Characteristics
| Attribute | EMS - Proposed devices |
|---|---|
| Indications for use - To filter inspired and / or expired gases. | Same |
| Intended for single patient, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 80 ml |
| Resistance to flow | < 3.4 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| Weight (gm) | 27 to 35 gm |
| Humidification output (mg H2O/l) | 27 mg H₂O /L at TV of 500 cc, where applicable |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Paper fiber |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| ISO 9360 - HME moisture output | Yes |
| DOE 3202-97 and ASTM D2986 - DOP | 99.97% |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
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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 depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Mr. Paul Dryden Engineered Medical Systems c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501
Re: K013089
EMS HEPA Filter and HME Combinations (model # 5804, 5805 and 5814) Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II (two) Product Code: 73 CAH Dated: December 13, 2001 Received: December 14, 2001
Dear Mr. Dryden:
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 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.
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Page 2 - Mr. Paul Dryden
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 2.3 | Indications for Use | ||
|---|---|---|---|
| Page 1 of 1 | |||
| 510(k) Number: | K013089 | (To be assigned) | |
| Device Name: | EMS HEPA and HEPA / HME | ||
| Intended Use: | For use with ventilators, anesthesia machines andopen flow systems where filtration of inspired and / orexpired gases is desired and to add maintain and retainmoisture for the exhaled breathe of the patient |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013084
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use ___
§ 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).