Altera Filter and HME/Filter

K192713 · Meditera Tibbi Malzeme San VE Tic AS · CAH · Mar 16, 2020 · Anesthesiology

Device Facts

• Record ID: K192713
• Device Name: Altera Filter and HME/Filter
• Applicant: Meditera Tibbi Malzeme San VE Tic AS
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours. HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

Device Story

Altera Filter and HME/Filter are disposable, single-patient-use breathing circuit accessories. Configurations include a standalone filter or a combined heat and moisture exchanger (HME)/filter. The filter uses electrostatic charge in spun-fiber polypropylene media to capture microbes. The HME component uses treated paper or foam media to absorb exhaled heat and moisture, releasing it during inhalation to humidify dry gases. Devices feature standard 15mm/22mm conical connectors and a female luer lock port for end-tidal CO2 gas sampling. Used in clinical settings (hospitals, sub-acute, pre-hospital, home) by healthcare providers or patients to protect the patient/equipment from contaminants and maintain airway moisture. Output is filtered, humidified gas delivered to the patient's respiratory tract. Benefits include reduced risk of cross-contamination and prevention of airway desiccation during mechanical ventilation.

Clinical Evidence

Bench testing only. Performance testing included ISO 9360-1 (flow resistance <1.7 cmH2O @ 60 Lpm, moisture output 39 mg/L @ 1000 ml TV), ASTM F2101 (BFE >99.998%, VFE >99.96%), leakage testing (0.002 ml), and housing burst pressure (>76 kPa). Biocompatibility testing (ISO 10993/18562) confirmed non-cytotoxic, non-sensitizing, and non-irritant status. Accelerated aging (ASTM 1980-16) confirmed 3-year shelf life.

Technological Characteristics

Materials: Spun-fiber polypropylene (filter media), treated paper/foam (HME media). Principle: Electrostatic attraction for filtration; passive heat/moisture exchange. Dimensions: 15mm/22mm conical connectors per ISO 5356-1; luer port per ISO 80369-7. Dead space: 45 ml (filter), 55 ml (HME/Filter). Non-sterile, single-patient use, 24-hour duration. No software or electronic components.

Indications for Use

Indicated for patients with tidal volumes > 300 ml requiring assisted ventilation, anesthesia, or open flow systems for gas filtration and/or moisture maintenance. Use is limited to 24 hours in clinical settings including hospital, sub-acute, pre-hospital, and home environments.

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

• Zhejiang Haisheng Medical Device Co. Ltd. (K151498)

Submission Summary (Full Text)

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March 16, 2020

Meditera Tibbi Malzeme San. ve Tic. A.S. % Paul Dryden Consultant Meditera Tibbi Malzeme San. ve Tic. A.S. % ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K192713

Trade/Device Name: Altera Filter and HME/Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: February 25, 2020 Received: February 26, 2020

Dear Paul 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

#### K192713

Device Name

## Altera Filter and HME / Filter

Indications for Use (Describe)

Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home

For patient with Tidal Volumes > 300 ml.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510k Summary

#### Date Prepared:

16-March-2020

Meditera Tıbbi Malzeme San. ve Tic. A.Ş. Ibni Melek Mah Organize Sanayi Bolgesi Tire Izmir, TURKEY 35900 [phone]

| Official Contact: | Cenk Kılıç Kalkan<br>Quality Assurance Team Leader |
|----------------------------|--------------------------------------------------------------------------|
| Proprietary or Trade Name: | Altera Filter and HME/Filter |
| Common/Usual Name: | Filter, bacterial, breathing circuit |
| Classification Name: | 21CFR 868.5260<br>CAH - filter, bacterial, breathing circuit<br>Class II |
| Predicate Devices: | K151498 - Zhejiang Haisheng Medical Device Co. Ltd. |

#### Device Description:

The subject device is provided in two (2) configurations.

- Filter only ●
- . HME / Filter combination
- The common features are:
- Standard conical 15 mm / 22 mm fittings for connections
- Female luer lock port for gas sampling for end-tidal CO2 ●

### Principle of Operation:

There are two principles of operation with the subject devices:

- . Filtration is via the principle of electrostatic charges that attract and capture the microbes in the spunfiber polypropylene media.
- . Passive humidification is the use of a "treated" media (paper or foam) which absorbs the patient's exhaled heat and moisture and upon inhales the retained heat and humidity is released to the dry inhalation gases.

#### Indications for Use:

Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home or patient with Tidal

Volumes > 300 ml.

#### Technological Characteristic Comparison Table:

The following table presents a comparison of the subject device to the predicate.

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| Attribute | Predicate | Proposed | Comparison |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Zhejiang Haisheng Medical Device Co. | Altera Filter and HME / Filter | |
| | Ltd | | |
| 510k number | K151498 | K192713 | N/A |
| Classification | CAH - Breathing Circuit bacterial filter and HME<br>21 CFR 868.5260 | CAH - Breathing Circuit bacterial filter and HME<br>21 CFR 868.5260 | Same |
| Indications for Use | For use with ventilators, anesthesia machines and<br>open flow systems where filtration of inspired and/or<br>expired gases is desired and to add, maintain, retain<br>moisture for the exhaled breath of the patient. Use up<br>to 24 hours. | Filter only - For use with ventilators, anesthesia<br>machines and open flow systems where filtration<br>of inspired and/or expired gases is desired. Use<br>up to 24 hours.<br>HME / Filter - For use with ventilators, anesthesia<br>machines and open flow systems where filtration<br>of inspired and/or expired gases is desired and to<br>maintain moisture levels in the patient's<br>respiratory tract during anesthesia, artificial<br>respiration and other types of assisted ventilation.<br>Use up to 24 hours.<br>Environment of use – clinical setting including<br>hospital, sub-acute, pre-hospital and home<br>For patient with Tidal Volumes > 300 ml. | Similar |
| Principle of Operation | Filtration is via the principle of electrostatic charges<br>in the media<br>Passive humidification is the use of a "treated" media<br>which absorbs the patient's exhaled heat and moisture<br>and upon inhales<br>the retained heat and humidity is released to the dry<br>inhalation gases. | Filtration is via the principle of electrostatic<br>charges in the media<br>Passive humidification is the use of a "treated"<br>media which absorbs the patient's exhaled heat<br>and moisture and upon inhales<br>the retained heat and humidity is released to the<br>dry inhalation gases. | Same |
| Patient Population | Adults Tidal Volume >150 ml Pediatrics | Adults Tidal Volume >300 ml | Similar |
| Environments of use | Hospitals, sub-acute, pre-hospital and home | Hospitals, sub-acute, pre-hospital and home | Similar |
| Attribute | Predicate<br>Zhejiang Haisheng Medical Device Co.<br>Ltd | Proposed<br>Altera Filter and HME / Filter | Comparison |
| Compatibility with<br>environment and other<br>devices | Intended for use with ventilators, anesthesia gas<br>machines | Intended for use with ventilators, anesthesia gas<br>machines | Same |
| Prescriptive | Yes | Yes | Similar |
| Packaged | Sterile | Non-sterile | Similar |
| Single patient use,<br>disposable | Yes, up to 24 hours | Yes, up to 24 hours | Similar |
| Basic components | Filter media<br>HME has HME media<br>Sampling port for expired gas sampling | Filter media<br>HME has HME media<br>Sampling port for expired gas sampling | Similar |
| Characteristics | | | |
| Biocompatibility | Not known | Externally communicating, Tissue, Limited<br>Cytotoxicity<br>Sensitization Irritation<br>Leachable and Extractables with TRA<br>Acute Systemic Toxicity<br>Volatile Organic Compound Testing<br>Particulate Matter Testing | Similar |
| Performance testing | ISO 9360-1<br>Flow resistance - <3 cmH2O @ 60 Lpm<br>Humidification – 32 mg/l @ TV 1000 ml | ISO 9360-1<br>Flow resistance - <1.7 cmH2O @ 60 Lpm<br>Humidification – 39 mg/l @ TV 1000 ml<br>Leakage - 0 ml/min | Similar |
| Dead space | < 65 ml | 45 ml - Filter<br>55 ml – HME/Filter | Similar |
| Filtration efficiency | BFE - 99.999%<br>VFE - 99.99% | BFE - 99.998%<br>VFE - 99.96% | Similar |
| Connectors | Standard ISO 80369 small bore luer fittings Conical 15/22 mm | Standard ISO 80369 small bore luer fittings<br>Conical 15/22 mm | Similar |
| Shelf-life | 3 years | 3 years | Similar |
| Test Method | Purpose | Acceptance Criteria | Results |
| ISO 9360-1 | Resistance to Flow (cmH2O) | Equivalent to a predicate | <1.7 cmH2O @ 60 lpm |
| | Dead Space (Internal Compressible<br>Volume ml) | Equivalent to a predicate | 45 ml for filter only<br>55 ml for HME |
| | Leakage | No leak @ 1 psi for 2 min | 0.002 ml leak |
| | Housing Burst Pressure | No pass/fail criteria reported value | >76 kPa |
| ISO 80369-7 Luer<br>ISO 5356-1 Conical | Connectors | Passes Requirements | Meets the Standards |
| ASTM F2101 | Bacterial Filtration Efficiency (BFE) % | Equivalent to predicate | >99.998% |
| ASTM F2101 | Viral Filtration Efficiency (VFE) % | Equivalent to predicate | >99.96% |
| ISO 9360-1 | HME Performance | Moisture Output equivalent to<br>predicate | Moisture Output<br>Vt = 1000 ml @ 24 hours<br>39 mg/L |
| ISO 10993 and<br>ISO 18562 | Cytotoxicity<br>Sensitization<br>Irritation | Non-cytotoxic<br>Non-sensitizer<br>Non-irritant | Non-cytotoxic<br>Non-sensitizer<br>Non-irritant |
| | Chemical Characterization TRA | Margin of Safety > 1 | Margin of Safety > 1 |
| | Acute Systemic Toxicity | Non-systemic | Non-systemic |
| | Volatile Organic Compound | Identified VOC | Identified VOC |
| | Particulate Matter | <12 micrograms/ m³PM | <12 micrograms/ m³ |
| ASTM 1980-16 | Accelerated Aging | Device meets it performance<br>specification post-conditioning | Device met performance<br>specifications |

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K192713

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## Summary of Nonclinical Testing

The following table lists the non-clinical testing and the results.

## Conclusion:

The conclusions drawn from the nonclinical tests that the Altera Filter and HME / Fiter device is as safe, as effective, and performs as well as or better than the legally marketed device.