(171 days)
Not Found
No
The device description and intended use are for a passive filter/HME device, and there is no mention of AI, ML, or any computational processing.
No
The device is described as a filter for inspired and expired gases and to maintain moisture levels in the respiratory tract. While it aids in patient breathing and comfort, its primary function is not to treat or cure a disease or medical condition, but rather to support the ventilation process and provide filtration.
No.
The device is a filter or HME/filter combination used to filter gases and maintain moisture during ventilation. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition. The "Female luer lock port for gas sampling for end-tidal CO2" is for gas sampling, not for diagnostic analysis by the device itself.
No
The device description clearly outlines physical components (fittings, luer lock port) and its function involves filtering and maintaining moisture in the respiratory tract, which are hardware-based functions. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a filter and/or HME (Heat and Moisture Exchanger) used with ventilators, anesthesia machines, and open flow systems to filter inspired/expired gases and maintain moisture in the respiratory tract.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is related to the air/gas pathway during ventilation.
The device is a medical device used in the respiratory support system, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / 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
For patient with Tidal Volumes > 300 ml.
Product codes
CAH
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting including hospital, sub-acute, pre-hospital and home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed as summarized in tables. Key results include:
- Resistance to Flow: 76 kPa
- Connectors: Meets the Standards
- Bacterial Filtration Efficiency (BFE) %: >99.998%
- Viral Filtration Efficiency (VFE) %: >99.96%
- HME Performance (Moisture Output): Vt = 1000 ml @ 24 hours 39 mg/L
- Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity): Non-cytotoxic, Non-sensitizer, Non-irritant, Non-systemic
- Chemical Characterization TRA: Margin of Safety > 1
- Volatile Organic Compound: Identified VOC
- Particulate Matter: 76 kPa
- Bacterial Filtration Efficiency (BFE) %: >99.998%
- Viral Filtration Efficiency (VFE) %: >99.96%
- Moisture Output: 39 mg/L
- Margin of Safety > 1
- Particulate Matter:
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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FORM FDA 3881 (7/17)
Page 1 of 1
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3
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 +90 232 513 51 10
| Official Contact: | Cenk Kılıç Kalkan
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
CAH - filter, bacterial, breathing circuit
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.
4
| 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 | ||
| 21 CFR 868.5260 | CAH - Breathing Circuit bacterial filter and HME | ||
| 21 CFR 868.5260 | Same | ||
| 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, maintain, retain | |||
| moisture for the exhaled breath of the patient. Use up | |||
| to 24 hours. | 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. | Similar | ||
| Principle of Operation | Filtration is via the principle of electrostatic charges | ||
| in the media | |||
| Passive humidification is the use of a "treated" media | |||
| which absorbs the patient's exhaled heat and moisture | |||
| and upon inhales | |||
| the retained heat and humidity is released to the dry | |||
| inhalation gases. | Filtration is via the principle of electrostatic | ||
| charges in the media | |||
| Passive humidification is the use of a "treated" | |||
| media which absorbs the patient's exhaled heat | |||
| and moisture and upon inhales | |||
| the retained heat and humidity is released to the | |||
| 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 | ||
| Zhejiang Haisheng Medical Device Co. | |||
| Ltd | Proposed | ||
| Altera Filter and HME / Filter | Comparison | ||
| Compatibility with | |||
| environment and other | |||
| devices | Intended for use with ventilators, anesthesia gas | ||
| machines | Intended for use with ventilators, anesthesia gas | ||
| machines | Same | ||
| Prescriptive | Yes | Yes | Similar |
| Packaged | Sterile | Non-sterile | Similar |
| Single patient use, | |||
| disposable | Yes, up to 24 hours | Yes, up to 24 hours | Similar |
| Basic components | Filter media | ||
| HME has HME media | |||
| Sampling port for expired gas sampling | Filter media | ||
| HME has HME media | |||
| Sampling port for expired gas sampling | Similar | ||
| Characteristics | |||
| Biocompatibility | Not known | Externally communicating, Tissue, Limited | |
| Cytotoxicity | |||
| Sensitization Irritation | |||
| Leachable and Extractables with TRA | |||
| Acute Systemic Toxicity | |||
| Volatile Organic Compound Testing | |||
| Particulate Matter Testing | Similar | ||
| Performance testing | ISO 9360-1 | ||
| Flow resistance - 76 kPa | |||
| ISO 80369-7 Luer | |||
| 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 | |
| predicate | Moisture Output | ||
| Vt = 1000 ml @ 24 hours | |||
| 39 mg/L | |||
| ISO 10993 and | |||
| ISO 18562 | Cytotoxicity | ||
| Sensitization | |||
| Irritation | Non-cytotoxic | ||
| Non-sensitizer | |||
| Non-irritant | Non-cytotoxic | ||
| Non-sensitizer | |||
| 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 |