(171 days)
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.
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 ●
The provided text describes a 510(k) premarket notification for a medical device called "Altera Filter and HME/Filter". It details the device's characteristics, indications for use, and a comparison with a predicate device, including performance data from nonclinical testing.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method (Attribute) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 9360-1 (Resistance to Flow) | Equivalent to a predicate | <1.7 cmH2O @ 60 lpm |
| ISO 9360-1 (Dead Space) | Equivalent to a predicate | 45 ml for filter only 55 ml for HME |
| ISO 9360-1 (Leakage) | No leak @ 1 psi for 2 min | 0.002 ml leak |
| ISO 9360-1 (Housing Burst Pressure) | No pass/fail criteria (reported value) | >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) | Moisture Output equivalent to predicate | 39 mg/L (Vt = 1000 ml @ 24 hours) |
| ISO 10993 and ISO 18562 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| ISO 10993 and ISO 18562 (Sensitization) | Non-sensitizer | Non-sensitizer |
| ISO 10993 and ISO 18562 (Irritation) | Non-irritant | Non-irritant |
| ISO 10993 and ISO 18562 (Chemical Characterization TRA) | Margin of Safety > 1 | Margin of Safety > 1 |
| ISO 10993 and ISO 18562 (Acute Systemic Toxicity) | Non-systemic | Non-systemic |
| ISO 10993 and ISO 18562 (Volatile Organic Compound) | Identified VOC | Identified VOC |
| ISO 10993 and ISO 18562 (Particulate Matter) | <12 micrograms/ m³PM | <12 micrograms/ m³ |
| ASTM 1980-16 (Accelerated Aging) | Device meets performance specification post-conditioning | Device met performance specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to nonclinical testing of a physical medical device. It does not mention clinical trials or studies involving human subjects in the typical sense of a "test set" for AI algorithms. The "tests" refer to laboratory-based performance and biocompatibility assessments of the device itself.
- Sample Size for Test Set: The sample sizes for each specific test (e.g., number of filters tested for flow resistance, BFE, etc.) are not explicitly stated in the provided text.
- Data Provenance: The document is a submission to the U.S. Food & Drug Administration (FDA) by Meditera Tibbi Malzeme San. ve Tic. A.S., located in Turkey. The tests are nonclinical, laboratory-based. The text does not specify where the testing laboratories are located, though it implies the data was generated to support a submission in the US. The data is nonclinical/laboratory test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. The "tests" performed are objective measurements of the device's physical and performance characteristics against established international standards (ISO, ASTM). Ground truth in this context is defined by the requirements of these standards and the measured physical properties, not by expert human interpretation like in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations (e.g., when multiple radiologists review images). For objective nonclinical device performance tests, the results are measured directly against defined criteria.
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 question is not applicable. The document describes a physical medical device (Altera Filter and HME/Filter) and its nonclinical performance testing. It does not involve any AI components, human readers, or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical breathing circuit filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this nonclinical device, the "ground truth" for the test results is based on:
- Established International Standards: ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards define the test methodologies and acceptable performance ranges.
- Predicate Device Equivalence: Many acceptance criteria are stated as "Equivalent to a predicate," indicating that the performance of the new device is compared against the known performance of a legally marketed, similar device (Zhejiang Haisheng Medical Device Co. Ltd - K151498).
- Direct Physical Measurements: The performance criteria (e.g., flow resistance, filtration efficiency, moisture output, burst pressure) are determined through direct, objective physical measurements in a laboratory setting.
8. The sample size for the training set
This question is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for a physical device.
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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
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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 (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
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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 +90 232 513 51 10
| Official Contact: | Cenk Kılıç KalkanQuality Assurance Team Leader |
|---|---|
| Proprietary or Trade Name: | Altera Filter and HME/Filter |
| Common/Usual Name: | Filter, bacterial, breathing circuit |
| Classification Name: | 21CFR 868.5260CAH - filter, bacterial, breathing circuitClass 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 HME21 CFR 868.5260 | CAH - Breathing Circuit bacterial filter and HME21 CFR 868.5260 | Same |
| Indications for Use | For use with ventilators, anesthesia machines andopen flow systems where filtration of inspired and/orexpired gases is desired and to add, maintain, retainmoisture for the exhaled breath of the patient. Use upto 24 hours. | Filter only - For use with ventilators, anesthesiamachines and open flow systems where filtrationof inspired and/or expired gases is desired. Useup to 24 hours.HME / Filter - For use with ventilators, anesthesiamachines and open flow systems where filtrationof inspired and/or expired gases is desired and tomaintain moisture levels in the patient'srespiratory tract during anesthesia, artificialrespiration and other types of assisted ventilation.Use up to 24 hours.Environment of use – clinical setting includinghospital, sub-acute, pre-hospital and homeFor patient with Tidal Volumes > 300 ml. | Similar |
| Principle of Operation | Filtration is via the principle of electrostatic chargesin the mediaPassive humidification is the use of a "treated" mediawhich absorbs the patient's exhaled heat and moistureand upon inhalesthe retained heat and humidity is released to the dryinhalation gases. | Filtration is via the principle of electrostaticcharges in the mediaPassive humidification is the use of a "treated"media which absorbs the patient's exhaled heatand moisture and upon inhalesthe retained heat and humidity is released to thedry 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 | PredicateZhejiang Haisheng Medical Device Co.Ltd | ProposedAltera Filter and HME / Filter | Comparison |
| Compatibility withenvironment and otherdevices | Intended for use with ventilators, anesthesia gasmachines | Intended for use with ventilators, anesthesia gasmachines | 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 mediaHME has HME mediaSampling port for expired gas sampling | Filter mediaHME has HME mediaSampling port for expired gas sampling | Similar |
| Characteristics | |||
| Biocompatibility | Not known | Externally communicating, Tissue, LimitedCytotoxicitySensitization IrritationLeachable and Extractables with TRAAcute Systemic ToxicityVolatile Organic Compound TestingParticulate Matter Testing | Similar |
| Performance testing | ISO 9360-1Flow resistance - <3 cmH2O @ 60 LpmHumidification – 32 mg/l @ TV 1000 ml | ISO 9360-1Flow resistance - <1.7 cmH2O @ 60 LpmHumidification – 39 mg/l @ TV 1000 mlLeakage - 0 ml/min | Similar |
| Dead space | < 65 ml | 45 ml - Filter55 ml – HME/Filter | Similar |
| Filtration efficiency | BFE - 99.999%VFE - 99.99% | BFE - 99.998%VFE - 99.96% | Similar |
| Connectors | Standard ISO 80369 small bore luer fittings Conical 15/22 mm | Standard ISO 80369 small bore luer fittingsConical 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 CompressibleVolume ml) | Equivalent to a predicate | 45 ml for filter only55 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 LuerISO 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 topredicate | Moisture OutputVt = 1000 ml @ 24 hours39 mg/L |
| ISO 10993 andISO 18562 | CytotoxicitySensitizationIrritation | Non-cytotoxicNon-sensitizerNon-irritant | Non-cytotoxicNon-sensitizerNon-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 performancespecification post-conditioning | Device met performancespecifications |
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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.
§ 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).