(101 days)
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
It is single patient use, disposable for patients with Tidal Volumes > 250 ml.
Duration of use < 24 hours.
The HydroMax™ HMEF is standard configuration housing with a CO2 sampling port.
The common features are:
- All have standard conical 15 mm / 22 mm fittings for connections ●
- Female luer lock port for gas sampling for end-tidal CO2 .
The principle of operation:
- The filter media is an electrostatic type of media and filters via electrostatic attraction .
- . The HME media a porous foam that has hygroscopic properties to retain and release moisture from the patient
The A-M Systems, Inc. HydroMax™ HMEF (Heat and Moisture Exchanger Filter) is a bacterial/viral filter intended for use with ventilators, anesthesia machines, and open flow systems to filter inspired and/or expired gases and retain moisture in the circuit. It is a single-patient use, disposable device for patients with tidal volumes greater than 250 ml and a duration of use of less than 24 hours. The device's performance was evaluated through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HydroMax™ HMEF are generally established by comparing its performance to a legally marketed predicate device, the GE (Engstrom) HMEF 1000 (K964204), and by meeting relevant international standards for medical devices (e.g., ISO 9360-1, ASTM F316-80). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate and meeting the performance characteristics of the relevant standards.
| Performance Characteristic | Predicate Device (GE (Engstrom) HMEF 1000) Performance | Acceptance Criteria (Implied) | Reported Device Performance (HydroMax™ HMEF) |
|---|---|---|---|
| Filtration Efficiency | |||
| Bacterial Filtration Efficiency (BFE) | >99.9999% | ≥ 99.9999% (based on predicate) | >99.99969% @ 30 lpm |
| Viral Filtration Efficiency (VFE) | >99.99% | ≥ 99.99% (based on predicate) | >99.9946% @ 30 lpm |
| Humidification Performance | |||
| Moisture Output (Vt 250 ml) | N/A | (Comparable to predicate/industry standard for HME) | 36.5 mg/L |
| Moisture Output (Vt 500 ml) | 33 mg/L | ≥ 33 mg/L (based on predicate) | 35.13 mg/L |
| Moisture Output (Vt 750 ml) | 32 mg/L | ≥ 32 mg/L (based on predicate) | 33.2 mg/L |
| Moisture Output (Vt 1000 ml) | 30 mg/L | ≥ 30 mg/L (based on predicate) | 32.53 mg/L |
| Moisture Loss (Vt 250 ml) | N/A | (Comparable to industry standard for HME) | 7.63 mg/L |
| Moisture Loss (Vt 500 ml) | 4.5 mg/L | (Comparable to predicate/industry standard for HME) | 8.97 mg/L |
| Moisture Loss (Vt 750 ml) | 5.5 mg/L | (Comparable to predicate/industry standard for HME) | 10.9 mg/L |
| Moisture Loss (Vt 1000 ml) | 7.5 mg/L | (Comparable to predicate/industry standard for HME) | 11.57 mg/L |
| Respiratory Mechanics | |||
| Pressure Drop @ 30 lpm | 1.0 cmH2O | ≤ 1.0 cmH2O (based on predicate) | 0.7 cmH2O |
| Pressure Drop @ 60 lpm | 2.3 cmH2O | ≤ 2.3 cmH2O (based on predicate) | 2.0 cmH2O |
| Pressure Drop @ 90 lpm | N/A | (Comparable to industry standard for HME) | 3.5 cmH2O |
| Dead Space (Internal Volume) | 77 ml | Not explicitly defined as 'criteria', but for comparison. | 56 ml |
| Structural Integrity & Safety | |||
| Filter Integrity (Bubble Point) | N/A | (Meet ASTM F316-80 requirements) | 244.43 microns |
| Housing Burst Strength | N/A | (Meet safety requirements/industry standard) | >10 psi < 20 psi |
| Leakage per ISO 9360-1 6.4 | N/A | 0 ml/min @ 70 cm H2O (per ISO standard) | 0 ml/min @ 70 cm H2O |
| Compliance per ISO 9360-1 6.5 | N/A | (Meet ISO standard requirements) | 1.1 ml/kPa |
| Other | |||
| Standard 22/15 mm connections | Yes | Yes (per ISO 5356-1) | Yes |
| Luer port for gas sampling (ISO 594-2) | Yes | Yes (per ISO 594-2) | Yes |
| Material Biocompatibility | Standard materials to ISO 10993-1 | Standard materials to ISO 10993-1 | Standard materials to ISO 10993-1 |
Note: "N/A" for the predicate indicates the information was not provided in this specific comparison table, not necessarily that the predicate does not meet these parameters. The "Acceptance Criteria (Implied)" are derived from the direct comparison to the predicate device and the referenced ISO/ASTM standards.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many filters were tested for BFE, VFE, pressure drop, etc.). It refers to "a number of bench tests."
The data provenance is from bench testing performed by Nelson Laboratories (for Bacterial/Viral filtration efficiency) and potentially other internal or external labs for other physical characteristics.
The data is retrospective in the sense that the device was manufactured, and then tested. There is no information on the geographical origin of the data beyond "Nelson Laboratories" and "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the study described is a non-clinical bench testing study of a medical device, not a human reader study or a diagnostic accuracy study involving human expert interpretation. The "ground truth" for these tests is established by standardized testing methodologies and instrument readings (e.g., filtration efficiency is determined by particle count, pressure drop by manometry).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or reader studies where human interpreters are involved in making decisions or interpretations that need to be reconciled.
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 section is not applicable as the study described is a non-clinical bench testing study for a physical medical device (a filter), not an AI-powered diagnostic tool. Therefore, there is no human reader component or AI assistance to evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical device (filter), not an algorithm or AI product. The "standalone performance" refers to the device's inherent physical characteristics as measured by the bench tests.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For this non-clinical bench testing study, the "ground truth" for the device's performance characteristics is established by:
- Standardized laboratory measurements: Using calibrated equipment and established protocols (e.g., ISO 9360-1, ASTM F316-80) to measure physical properties like filtration efficiency, pressure drop, moisture output, etc.
- Predicate device performance: The performance of the legally marketed predicate device serves as a benchmark for substantial equivalence.
8. The sample size for the training set
This section is not applicable as this is a non-clinical bench testing study of a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as #8.
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510(k) Summary Page 1 of 5 18-Jun-13
JUN 2 1 2013
| A-M Systems, Inc.131 Business Park LoopSequim, WA 98382 | Tel - 360-683-8300Fax - 360-683-3525 | |
|---|---|---|
| Official Contact: | David Green, Product Manager | |
| Proprietary or Trade Name: | HydroMax™ HMEF | |
| Common/Usual Name: | Bacterial / Viral Filter | |
| Classification Name: | Filter, Bacterial, Breathing Circuit,CAH - 21 CFR 868.5260Class 2 | |
| Predicate Devices: | GE (Engstrom) HMEF 1000 - K964204 |
Device Description
The HydroMax™ HMEF is standard configuration housing with a CO2 sampling port.
The common features are:
- All have standard conical 15 mm / 22 mm fittings for connections ●
- Female luer lock port for gas sampling for end-tidal CO2 .
The principle of operation:
- The filter media is an electrostatic type of media and filters via electrostatic attraction .
- . The HME media a porous foam that has hygroscopic properties to retain and release moisture from the patient
Indications for Use
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
It is single patient use, disposable for patients with Tidal Volumes > 250 ml.
Duration of use < 24 hours.
Environment of Use
Hospital, sub-acute care, and home settings
{1}------------------------------------------------
510(k) Summary Page 2 of 5 18-Jun-13
Predicate Device Comparison:
The proposed HydroMAX™ HMEF is similar in all respects to the predicate device, GE (Engstrom) HMEF 1000-K964204.
Comparative Table 5.1 discusses the major features of the proposed device and the legally marketed predicate device.
The HydroMAX™ HMEF is viewed as substantially equivalent to the predicate device based upon the following:
Indications -
- Intended to be placed in circuit for filtration and humidification of inspired and expired . gases - GE (Engstrom) HMEF 1000 - K964204.
Discussion - The indications for use are identical for the proposed and predicate device.
Technology -
- The filter and HME media are standard materials and the fundamental principle of ● operation are identical to the predicate.
Discussion - There are no differences in technology between the HydroMAX™ HMEF and the predicate GE (Engstrom) HMEF 1000 - K964204
Environment of Use -
- Home, Hospitals, Sub-acute institutions .
Discussion - The environment of use are identical between the HydroMAX™ HMEF and the predicate GE (Engstrom) HMEF 1000 - K964204
{2}------------------------------------------------
510(k) Summary
.
Table 1 - Comparison to the Predicate
| Features | PredicateGE (Engstrom) HMEF 1000K964204 | ProposedHydroMAX™ HMEF |
|---|---|---|
| Indications for use | For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. | For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is required. |
| Patient Use / Duration if use | Single patient use, disposable, < 24 hours | Single patient use, disposable, < 24 hours |
| Environment of Use | Hospital, Sub-acute Institutions, Home | Hospital, Sub-acute Institutions, Home |
| Patient Population | Tidal volume > 300 ml | Tidal volume > 250 ml |
| Contraindications | None | None |
| Standard 22 / 15 mm connections | Yes | Yes |
| Per ISO 5356-1 | Yes | Yes |
| Luer port for gas samplingPer ISO 594-2 | Yes | Yes |
| Various configurations | Straight, angled | Straight |
| Filtration method | Electrostatic | Electrostatic |
| Placement within the circuit | Patient-side | Patient-side |
| Weight (gm) | 24 gm | 21 gm |
| Internal volume/ Dead space per ISO 9360-1 | 77ml | 56 ml |
| Bacterial / Viral filtration efficiency (Nelson Labs) | BFE->99.9999%VFE->99.99% | BFE->99.99969%VFE->99.9946% |
| Moisture Output (mg/L) | Vt 250 - N/AVt 500 - 33Vt 750 - 32Vt 1000 - 30 | Vt 250 - 36.5Vt 500 - 35.13Vt 750 - 33.2Vt 1000 - 32.53. |
| Moisture Loss (mg/L) | Vt 250 - N/AVt 500 - 4.5Vt 750 - 5.5Vt 1000 - 7.5 | Vt 250 - 7.63Vt 500 - 8.97Vt 750 - 10.9Vt 1000 - 11.57 |
| Features | PredicateGE (Engstrom) HMEF 1000K964204 | ProposedHydroMAXTM HME/F |
| Pressure Drop | 1.0 cmH2O @ 30 lpm2.3 cmH2O @ 60 lpmN/A | 0.7 cmH2O @ 30 lpm2.0 cmH2O @ 60 lpm3.5 cmH2O @ 90 lpm |
| Filter integrityper ASTM F316-80 | N/A | 244.43 microns |
| Housing burst strength | N/A | >10 psi < 20 psi |
| Leakage per ISO 9360-1 6.4 | N/A | 0 ml/min @ 70 cm H2O |
| Compliance per ISO 9360-1 6.5 | N/A | 1.1 ml/kPa |
| Materials | Standard materials to ISO 10993-1 | Standard materials to ISO 10993-1 |
| Standards | ISO 9360-1 HME | ISO 9360-1 HME |
Page 3
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510(k) Summary Page 4 of 5 18-Jun-13
Non-clinical Testing Summary -
Performance -- Bench Testing
We performed a number of bench tests pre- and post-conditioning these included the results are summarized in Table 2 below.
- . Filtration efficiency
- Bacterial / Viral filtration efficiency per Nelson Laboratories o
- Pre - and Post - conditioning performance
- Includes Pressure Drop per ISO 9360-1 o
- Dead space per ISO 9360-1 ಂ
- Leakage test per ISO 9360-1
- . Filter integrity per ASTM F316-80
- Housing burst strength .
- . Environmental and Mechanical Testing
{4}------------------------------------------------
510(k) Summary Page 5 of 5 18-Jun-13
Table 2 - Summary of Non-clinical Testing
| Performance Characteristics | Results |
|---|---|
| Pressure Drop (cmH2O) | 0.7 cmH2O @ 30 lpm2.0 cmH2O @ 60 lpm3.5 cmH2O @ 90 lpm |
| Filter Integrity (Bubble Point) Test | 244.43 microns |
| Dead Space (Internal CompressibleVolume in ml) | 56 ml |
| Leakage per ISO 9360-1 6.4 | 0 ml/min @ 70 cm H2O |
| Compliance per ISO 9360-1 6.5 | 1 ml/kPa |
| Housing Burst Pressure (psig) | >10 psi < 20 psi |
| Mechanical Vibration and Shock | Pressure Drop2.0 cm H2O @ 60 lpm |
| Storage - High and Low Temperatureand Humidity | Pressure Drop2.0 cm H2O @ 60 lpm |
| Bacterial Filtration Efficiency (BFE) % | >99.99969% @ 30 lpm |
| Viral Filtration Efficiency (VFE) % | >99.9946% @ 30 lpm |
Material - Biocompatibility
- The materials are identical to predicates that have the identical intended use. .
- . This device would be considered -
.
- External communicating / Tissue / mucosal / limited duration (< 24 hr) o
- o However based on the potential of accumulative exposure the device would be consider permanent duration contact.
Discussion: We are utilizing identical materials and provide Material Certifications.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.
Page 5
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
A-M Systems, Inc. c/o Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K130664
Trade/Device Name: HydroMax™ HMEF Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing circuit bacterial filter Regulatory Class: II Product Code: CAH Dated: May 14, 2013 Received: May 15, 2013
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. Please note: CDRH docs not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA). it may be subject to 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.
{6}------------------------------------------------
Page 2 - Mr. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/6/Picture/6 description: The image shows a signature and contact information. The text "Sincerely yours," appears at the top of the image. Below the signature, the name "Tejashri Purohit-Sheth, M.D." is written, followed by "Clinical Deputy Director" and "DAGRID."
Kwame Ulmer, M.S. Acting Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page I of I
510(k) Number; K130664
Device Name: HydroMax™ HMEF
Indications for Use:
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
It is single patient use, disposable for patients with Tidal Volumes > 250 ml.
Duration of use < 24 hours.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Digitally signed by James J. LeeON: c=US, o=U.S. Government, ou=HHS,ou=FDA-People, cn=James J. Lee,0.9.2342.19200300.100.1.1=2000954859Date: 2013.06.19 13:58:46 -04'00' | ActingforDr. AHarry |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K130664 |
|---|---|
| ---------------- | --------- |
ng BC Anya y
PDF PAGE 39 of 133
Page 04.2
§ 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).