(212 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. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.
The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
Here's an analysis of the provided text regarding the EMS Electra Filter and Filter/HME device, focusing on acceptance criteria and the study proving it meets those criteria:
The provided document is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to those of existing, legally marketed devices, rather than comprehensive clinical trials for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" as a separate, formal list against which the device was tested as one might see in a clinical trial. Instead, it presents general technical characteristics of the proposed device and demonstrates their equivalence to predicate devices. The "acceptance criteria" are implicitly defined by the performance of the predicate devices and existing standards for such devices.
| Attribute | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (EMS Electra) |
|---|---|---|
| Dead Space (ml) | - (Should be comparable to predicate devices) | 10 to 65 ml |
| Resistance to flow (Adult) | ≤3 cm H2O @ 60 lpm | ≤3 cm H2O @ 60 lpm |
| Resistance to flow (Pediatric) | ≤1.0 cm H2O @ 20 lpm | 1.0 cm H2O @ 20 lpm |
| Resistance to flow (Neonate) | ≤0.5 cm H2O @ 5 lpm | 0.5 cm H2O @ 5 lpm |
| Bacterial Filtration Efficiency (BFE) | 99.999+% (Based on Nelson Lab. results for predicate) | 99.999+% |
| Viral Filtration Efficiency (VFE) | 99.99+% (Based on Nelson Lab. results for predicate) | 99.99+% |
| Weight (gm) | - (Should be comparable to predicate devices) | 10 to 35 gm |
| Humidification Output (Adult, 1000cc TV) | 32 mg H2O/L | 32 mg H2O/L |
| Humidification Output (Pediatric, 250cc TV) | 32 mg H2O/L | 32 mg H2O/L |
| Humidification Output (Neonate, 50cc TV) | 30 mg H2O/L | 30 mg H2O/L |
| Tidal Volume Range (Neonate) | 20-70 cc | 20-70 cc |
| Tidal Volume Range (Pediatric) | 70-250 cc | 70-250 cc |
| Tidal Volume Range (Adult) | >150 cc | >150 cc |
| Standards Compliance | ISO 5356-1, ISO 594-2, ISO 9360 | Yes (Compliance asserted) |
2. Sample Size Used for the Test Set and Data Provenance:
The document details performance data derived from laboratory testing, specifically mentioning "Nelson Lab." for Bacterial and Viral filtration efficiency. This indicates the data is likely from professional testing laboratories rather than human clinical trials.
- Sample Size: Not explicitly stated for each test. For filtration efficiency, usually multiple samples of the filter media are tested. For resistance and humidification, often a set number of devices are tested according to a standard protocol.
- Data Provenance: The document states "Nelson Lab." for BFE and VFE, implying a specialized testing facility. The country of origin is not specified, but Nelson Labs is a well-known US-based testing laboratory. The data is prospective in the sense that the new device was fabricated and then tested to determine its performance characteristics. It is not retrospective in the sense of analyzing past patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluations are based on objective physical and biological performance tests, not subjective expert assessment of images or patient outcomes. The "ground truth" for these tests are the established scientific methodologies and standards by which filter performance, resistance, and humidification are measured.
4. Adjudication Method for the Test Set:
This is not applicable as the evaluation relies on direct measurement of physical properties and performance characteristics, not on subjective assessments that would require adjudication (e.g., medical image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable. The device is a filter/heat and moisture exchanger (HME), not an imaging or diagnostic AI system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this device.
6. Standalone (Algorithm Only) Performance:
This is not applicable. The device is a physical medical device (a filter), not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth used is objective laboratory measurement data and established performance standards. For example:
- For resistance, the ground truth is the measured pressure drop across the filter at specified flow rates.
- For filtration efficiency, the ground truth is the measured percentage of bacteria/viruses removed according to standardized laboratory testing protocols (e.g., using bacterial aerosols like Staphylococcus aureus).
- For humidification output, the ground truth is the gravimetric measurement of water vapor produced by the HME under specific temperature, humidity, and tidal volume conditions as per ISO 9360.
8. Sample Size for the Training Set:
This is not applicable. Since this device is a physical product and not an AI/machine learning model, there is no "training set." Its design and performance capabilities would be based on engineering principles, materials science, and testing iterations, not data training.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering specifications, industry standards (like ISO for connectors and HME moisture output), and the performance characteristics observed in predicate devices.
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APR 1 9 2002
EMS Electra
513122
Section 2 - Certifications and Summaries
Premarket Notification 510(k)
Engineered Medical Systems, Inc. 2055 Exceutive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 April 2, 2002
| Engineered Medical Systems | Tel (317) 246-5500 |
|---|---|
| 2055 Executive Dr. | Fax (317) 246-5501 |
| Indianapolis, IN 46241 | |
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Electra Filter and Filter / HME |
| Common/Usual Name: | Bacterial / Viral Filter and Heat and Moisture Exchanger |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH |
| Predicate Devices: | Mallinckrodt - Barrierbac "S" – K941536Mallinckrodt - Hygrobac "S", Hygroboy, Hygrobaby – K941381SIMS Filter – K002201 |
Device Description:
The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.
| 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. Model with tidal volumes ranging from20-70 cc for neonate, 70-250 cc for pediatric and >150 cc foradults. Use up to 24 hours. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Emergency services |
{1}------------------------------------------------
Premarket Notification 510(k)
EMS Electra
Section 2 - Certifications and Summaries
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 April 2, 2002
General Technical Characteristics
| Attribute | EMS - Proposed devices |
|---|---|
| Indications for use - To filter inspired and / orexpired 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) | 10 to 65 ml |
| Resistance to flow | ≤3 cm H2O @ 60 lpm - Adult1.0 cm H2O @ 20 lpm - Pediatric0.5 cm H2O @ 5 lpm Neonate |
| Bacterial filtration - BFE - Nelson Lab. | 99.999+% |
| Viral filtration - VFE - Nelson Lab. | 99.99+% |
| Weight (gm) | 10 to 35 gm |
| Humidification output (mg H2O/l) | 32 mg H2O/L at TV of 1000 cc - adult32 mg H2O/L at TV of 250 cc - pediatric30 mg H2O/L at TV of 50 cc - neonate |
| Tidal volume ranges | 20-70 cc - neonate70-250 cc - pediatric> 150 cc - adult |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Electrostatic polypropylene |
| 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 |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the I he uata within the submission conference and are substantially equivalent to the predicate devices.
.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol appears to be a stylized representation of a human figure or figures, possibly suggesting care or support. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" clearly visible.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2002
Mr. Paul Dryden Engineered Medical Systems c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501
Re: K013122
EMS Filter and Filter / HME (Model Numbers 5801, 5806, 5807, and 5810) Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: CAH Dated: March 14, 2002 Received: March 15, 2002
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.
{3}------------------------------------------------
Page 2 – Mr. Paul Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean f that FDA has made a determination that your device complies with other requirements of the Act that 1 Dr Hosal 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 Of R Part 877) its enstems (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) I mis letter with and my of substantial equivalence of your device of your device to a legally premaince noticated 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 O invi genefit 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,
Dale Tillman, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EMS Electra
ndications for Use ಿಂದ ಸಾಮಾನ್ಯ 2017-08-2 ::
Page 1 of 1
510(k) Number:
K013122 (To be assigned)
EMS Filter and Filter / HME
Device Name:
Intended Use:
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.
Various model range with tidal volumes of -20-70 ml for neonate, 70-250 ml for pediatric, and >150 ml for adult
Single patient use for a duration up to 24 hours.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K01322
Prescription Use _XX
(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).