(176 days)
For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use.
The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
The provided text describes a Premarket Notification 510(k) for the EMS PFT Filter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a study that establishes performance against predefined acceptance criteria for a novel device.
However, the document does list performance attributes for the EMS PFT Filter and compares them to those of a predicate device (PDS KoKo K934475), which can be interpreted as demonstrating that the EMS device meets performance levels comparable to a legally marketed device.
Here's an attempt to structure the information according to your request, with the understanding that this is a 510(k) submission, and the "study" is more of a comparison against a predicate, rather than a de novo clinical trial with specific acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are derived from the performance of the predicate device. The EMS PFT Filter is considered acceptable if its performance is comparable to or better than the predicate's.
| Attribute | Acceptance Criteria (Predicate Device K934475) | Reported Device Performance (EMS PFT Filter Model #5813) |
|---|---|---|
| Intended use | For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. | Same |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute | Same |
| Can be used with several different PFT machines | Yes | Yes |
| Design Features - Compact housing | Yes | Yes |
| Design Features - Various end-fittings | Yes | Yes |
| Dead Space (ml) | 60 ml | 75 ml |
| Resistance to flow at 720 lpm (per ATS standard for spirometry) | <1.5 cm H2O | 0.7 cm H2O |
| Resistance to flow at 60 lpm | <1.5 cm H2O | 0.5 cm H2O |
| Bacterial filtration | 99.99+% | 99.9999% |
| Viral filtration | 99.99+% | 99.999+% |
| Housing material | Polystyrene | Polystyrenc |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
Note on Differences: The dead space of the EMS PFT Filter (75 ml) is higher than that of the predicate (60 ml). However, the resistance to flow (0.7 cm H2O at 720 lpm and 0.5 cm H2O at 60 lpm) is better (lower) than the predicate's criteria of <1.5 cm H2O. The bacterial and viral filtration efficiencies are also better (higher) for the EMS filter. The document states, "There are no significant differences between the intended device and the predicates." This implies that the differences observed (like dead space, which is only slightly higher, and improved filtration/resistance) are not considered clinically significant enough to preclude substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" in the context of a clinical trial or algorithm validation. The performance data presented (e.g., dead space, resistance, filtration efficiency) are typically derived from laboratory testing of the device itself.
- Sample size: Not specified. It would usually involve testing a certain number of manufactured units to ensure consistency, but this is not detailed in the summary.
- Data provenance: The data would originate from bench testing performed by the manufacturer, Engineered Medical Systems, Inc. The country of origin is implied to be the USA (Indianapolis, IN). The data is prospective in the sense that it's generated for the device being submitted, but not from a prospective patient study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For a medical device like a PFT filter, "ground truth" for its physical performance (like filtration efficacy or resistance) is established through standardized engineering and microbiological testing methods, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this type of device performance is measured objectively through specified tests, not through expert adjudication of images or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging or AI algorithms where human readers interpret cases. This device is a passive filter; its performance is measured mechanistically, not through human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical filter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance metrics (e.g., bacterial/viral filtration, resistance, dead space) is established by standardized laboratory testing methods against established industry or regulatory standards (e.g., ATS spirometry standards mentioned for resistance). These are objective physical measurements.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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Premarket Notification 510(k)
Section 2 - Certifications and Summaries
MAR 1 4 2002
EMS PFT Filtcr
1013123
Engincered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page i of 2 March 7, 2002
| EMS | Tel (317) 246-5500 |
|---|---|
| 2055 Executive Dr. | Fax (317) 246-5501 |
| Indianapolis, IN 46241 | |
| Official Contact: | Bonnic Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Pulmonary Function Testing Filter |
| Common/Usual Name: | PFT filter |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Pulmonary Data Services - KoKo – K934475 |
Device Description:
The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
| Intended Use: | |
|---|---|
| Indicated Use -- | For use with pulmonary function testing. To filterair between the patient's exhaled air and the testingequipment. Single patient use. |
| Environment of Use -- | Hospital, Sub-acute Institutions |
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Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2
March 7, 2002
Comparison to Predicate Devices:
| EMS Proposed deviceFilter - Model # 5813 | Predicate PDS KoKoK934475 | |
|---|---|---|
| Attribute | ||
| Intended use | For use with pulmonary functiontesting. To filterair between the patient's exhaledair and the testingequipment | Same |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute | Same |
| Can be used with severaldifferent PFT machines | Yes | Yes |
| Design Features | ||
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 60 ml |
| Resistance to flow at 720 lpmper ATS standard forspirometry | 0.7 cm H2O | <1.5 cm H2O |
| Resistance to flow at 60 lpm | 0.5 cm H2O | <1.5 cm H2O |
| Bacterial filtration | 99.9999% | 99.99+% |
| Viral filtration | 99.999+% | 99.99+% |
| Weight | 40 gm | N/A |
| Materials | ||
| Housing polystyrenc | Yes | Yes |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
| Performance | ||
| None under Section 514 | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the predicates -- PDS -- Koko K934475.
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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 consists of a stylized eagle with its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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: K013123
Pulmonary Function Testing Filter Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II (two) Product Code: BZG Dated: December 14, 2001 Received: December 17, 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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Premarket Notification 510(k) Section 2 - Certifications and Summaries
adications for Use
EMS Pulmonary Function Filter
Page 1 of 1
(To be assigned) K013123
Device Name:
510(k) Number:
Intended Use:
For use with pulmonary function testing. To filter air between the patient's cxhaled air and the testing equipment.
Single patient use.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013123
Prescription Use - XX
(Per CFR 801.109)
or
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).