HYRDROMAX HMEF

K130664 · A-M Systems · CAH · Jun 21, 2013 · Anesthesiology

Device Facts

• Record ID: K130664
• Device Name: HYRDROMAX HMEF
• Applicant: A-M Systems
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

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 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.

Device Story

HydroMax™ HMEF is a patient-side breathing circuit filter and heat/moisture exchanger (HME). It features a standard 15mm/22mm conical connection and a female luer lock port for end-tidal CO2 gas sampling. The device utilizes electrostatic filter media to capture particulates and porous hygroscopic foam to retain/release patient moisture. Used in hospital, sub-acute, and home settings, it is operated by clinicians or caregivers. The device is placed in-line within the breathing circuit. By filtering gases and maintaining humidity, it protects the patient and equipment from cross-contamination and prevents airway drying. It is disposable and intended for single-patient use for up to 24 hours.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 9360-1 and ASTM F316-80. Key metrics: BFE >99.99969%, VFE >99.9946%, pressure drop 0.7-3.5 cmH2O (at 30-90 lpm), internal dead space 56 ml, and housing burst strength >10 psi. Biocompatibility assessed per ISO 10993-1.

Technological Characteristics

Electrostatic filter media; hygroscopic porous foam HME media. Standard 15mm/22mm conical fittings (ISO 5356-1) and luer lock port (ISO 594-2). Materials compliant with ISO 10993-1. Mechanical performance tested per ISO 9360-1 and ASTM F316-80.

Indications for Use

Indicated for patients with tidal volumes > 250 ml requiring filtration of inspired/expired gases and moisture retention in ventilator, anesthesia, or open flow circuits. Single patient use, < 24 hours duration. No contraindications.

Regulatory Classification

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.

Predicate Devices

• GE (Engstrom) HMEF 1000 (K964204)

Submission Summary (Full Text)

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## 510(k) Summary Page 1 of 5 18-Jun-13

# JUN 2 1 2013

| A-M Systems, Inc.<br>131 Business Park Loop<br>Sequim, WA 98382 | Tel - 360-683-8300<br>Fax - 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,<br>CAH - 21 CFR 868.5260<br>Class 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

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# 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

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510(k) Summary

.

Table 1 - Comparison to the Predicate

| Features | Predicate<br>GE (Engstrom) HMEF 1000<br>K964204 | Proposed<br>HydroMAX™ 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 sampling<br>Per 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%<br>VFE->99.99% | BFE->99.99969%<br>VFE->99.9946% |
| Moisture Output (mg/L) | Vt 250 - N/A<br>Vt 500 - 33<br>Vt 750 - 32<br>Vt 1000 - 30 | Vt 250 - 36.5<br>Vt 500 - 35.13<br>Vt 750 - 33.2<br>Vt 1000 - 32.53. |
| Moisture Loss (mg/L) | Vt 250 - N/A<br>Vt 500 - 4.5<br>Vt 750 - 5.5<br>Vt 1000 - 7.5 | Vt 250 - 7.63<br>Vt 500 - 8.97<br>Vt 750 - 10.9<br>Vt 1000 - 11.57 |
| Features | Predicate<br>GE (Engstrom) HMEF 1000<br>K964204 | Proposed<br>HydroMAXTM HME/F |
| Pressure Drop | 1.0 cmH2O @ 30 lpm<br>2.3 cmH2O @ 60 lpm<br>N/A | 0.7 cmH2O @ 30 lpm<br>2.0 cmH2O @ 60 lpm<br>3.5 cmH2O @ 90 lpm |
| Filter integrity<br>per 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 |

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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

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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 lpm<br>2.0 cmH2O @ 60 lpm<br>3.5 cmH2O @ 90 lpm |
| Filter Integrity (Bubble Point) Test | 244.43 microns |
| Dead Space (Internal Compressible<br>Volume 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 Drop<br>2.0 cm H2O @ 60 lpm |
| Storage - High and Low Temperature<br>and Humidity | Pressure Drop<br>2.0 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.

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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 [phone] or [phone] 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. Lee<br>ON: c=US, o=U.S. Government, ou=HHS,<br>ou=FDA-People, cn=James J. Lee,<br>0.9.2342.19200300.100.1.1=2000954859<br>Date: 2013.06.19 13:58:46 -04'00' | Acting<br>for<br>Dr. A<br>Harry |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K130664 |
|----------------|---------|
|----------------|---------|

ng BC Anya y

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