(265 days)
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.
The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use.
The dual limb model regulates flow and is for use in hospitals and for home care use.
The exhalation valve are used with adults, pediatrics, and neonates.
The exhalation valves are for single patient use and can be used for a maximum of 30 days.
The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.
The Altech® Exhalation Valves (Single Limb and Dual Limb) underwent non-clinical performance testing to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 5356-1 (Conical fittings) | Meet performance criteria | Fittings were tested according to ISO 5356-1 and meet the performance criteria |
| ISO 5367 (Leakage) | < 70 ml/min | Leakage of <70 ml/min |
| ISO 5367 (Resistance to Flow) | Adult < 0.06 cmH2O/l/m, Pediatrics < 0.12 cmH2O/l/m, Neonate < 0.74 cmH2O/l/m | Adult < 0.06 cmH2O/l/m, Pediatrics < 0.12 cmH2O/l/m, Neonate < 0.74 cmH2O/l/m |
| Performance after 30 days continuous use | Leakage and resistance to flow meet acceptance criteria per standard | Testing of leakage, resistance to flow met the acceptance criteria per each standard |
| Performance under various ventilator modes | Compatibility of the device with a ventilator | Testing over different ventilator modes was performed to confirm the compatibility of the device with a ventilator |
| ISO 10993-5 (Cytotoxicity) | Non-cytotoxic | Found non-cytotoxic |
| ISO 10993-10 (Sensitization/Irritation) | Non-sensitizer, Non-irritant | Non-sensitizer, Non-irritant |
| ISO 10993-11 (Pyrogenicity/Toxicity) | Non-pyrogenic, Non-toxic | Non-pyrogenic, Non-toxic |
| ISO 18562-2 (Particulate Material) | Met predefined acceptance criteria | Met the predefined acceptance criteria |
| ISO 18562-3 (Volatile Organic Chemicals) | Margin of Safety > 1 | Toxicological Risk Assessment resulted in Margin of Safety >1 |
| Leakage in main body | Not explicitly stated as acceptance criteria, but compared to predicate (predicate had <0.5 ml/min) | 6 ml/min for Subject Device, 2 ml/min for Predicate Device |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical performance data and comparative testing to a predicate device, rather than a clinical study with a "test set" of patient data. Therefore, information about patient sample size and data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the context of this submission. The "test set" refers to the physical devices undergoing various laboratory tests. The devices were tested pre- and post-aging, after 30 days of use, and after storage conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The "ground truth" for the non-clinical performance tests is established by published ISO standards and engineering specifications, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. The non-clinical performance tests rely on objective measurements and established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission focuses on non-clinical performance and substantial equivalence to a predicate device, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an exhalation valve, a physical medical device, not a software algorithm or AI. The tests performed are on the physical device's function.
7. Type of Ground Truth Used:
The "ground truth" for these performance tests is based on:
- International Standards (ISO): Specifically, ISO 5356-1, ISO 5367, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 18562-2, and ISO 18562-3.
- Engineering Specifications: Predefined acceptance criteria for various parameters like resistance to flow and material composition.
- Toxicological Risk Assessment: For volatile organic chemicals.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
December 23, 2021
Meditera Tibbi Malzeme San Ve TIC AS % Paul Dryden Consultant Meditera Tibbi Malzeme San Ve TIC AS c/o ProMedic LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704
Re: K210992
Trade/Device Name: Exhalation Valve (Single Limb, Dual Limb) Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: Class II Product Code: CBP Dated: November 22, 2021 Received: November 24, 2021
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.
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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 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 (QS) 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.
Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210992
Device Name
Altech® Exhalation Valve (Single Limb and Dual Limb)
Indications for Use (Describe)
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.
The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use.
The dual limb model regulates flow and is for use in hospitals and for home care use.
The exhalation valve are used with adults, pediatrics, and neonates.
The exhalation valves are for single patient use and can be used for a maximum of 30 days
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summarv Page 1 of 6
| Date Prepared: | 22-Dec-21 |
|---|---|
| Sponsor: | Meditera Tıbbi Malzeme San. ve Tic. A.Ş.İbni Melek OSB Mah. TOSBİ Yol 4 SokNo: 29 Tire Organize Sanayi BölgesiTire / İzmir / Turkey |
| Cenk Kılıç Kalkan, Quality ManagerT: +90 232 513 51 10 | |
| Submission Correspondent: | Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704 |
| Proprietary or Trade Name: | Altech® Exhalation Valves (Single Limb and Dual Limb) |
| Regulation Number: | 21 CFR 868.5870 |
| Regulation Name: | Non-rebreathing Valve |
| Product code: | CBP |
| Predicate Device: | Exhalation valve - K132143 |
| Manufacturer: | Intersurgical |
| Regulation Number: | 21 CFR 868.5870 |
| Regulation Name: | Non-rebreathing Valve |
| Product code: | CBP |
Device Description:
The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.
Principle of Operation:
Exhalation Valves have control line (L port) which passes the pressure from the ventilator to open or close the internal valve.
When starting to deliver an inspiratory breath, the ventilator pressurizes the exhalation valve, closing the exhalation path so that the positive pressure is delivered to the patient. At the end of inspiration, the pressure releases, the Exhalation valve gas pathway opens and the patient's exhaled gases then are vented to the room through the exhalation limb from device end of the valve for dual limb circuits or exhausted through the bottom opening of the valve for the single limb circuit.
Indications for Use:
The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached.
The single limb model directs flow and allows for pressure monitoring and may be used within hospitals
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510(k) Summarv Page 2 of 6
and for home care use.
The dual limb model regulates flow and is for use in hospitals and for home care use.
The exhalation valve are used with adults, pediatrics, and neonates.
The exhalation valves are for single patient use and can be used for a maximum of 30 days
Patient Population:
Adult, Pediatric and Neonates on mechanical ventilation.
Environments of use:
They may be used with ventilators that are indicated for home settings. In all cases the Exhalation valves are part of the ventilator circuit and would be consistent with the indications of the ventilator to which they are attached.
Difference Between Subject and Predicate
Table 2 below presents the differences between the subject device and the predicate which are:
- Indications for use include the addition of neonate population and adding a Dual limb model in ● addition to the single limb model
- . The technological characteristics are similar between the subject device and the predicate in that they both use a valve which opened or closed by pressure that is applied by the ventilator. The only difference is that the predicate does not offer a dual limb design which connects to a dual limb circuit thus directing expired gases to the ventilator whereas the single limb design for both devices exhausts the expired gases to the room as they connect to a single limb circuit.
- . Performance and Specifications are similar and the differences in expiratory resistance and leakage are within acceptable ranges
- Patient population of adding Neonates
- The use of the subject device is dependent upon the ventilator to which it is attached and its O indications for use.
Non-clinical Performance Data
Non-clinical performance testing is summarized in the below table.
| Test Methodology | Purpose | Results |
|---|---|---|
| ISO 5356-1 | Conical fittings for 15 / 22 mm | Fittings were tested according to ISO |
| Testing was performed pre- and post-aging | 5356-1 and meet the performance criteria | |
| and after 30 days use and after storage | ||
| conditions | ||
| ISO 5367 | Leakage | Leakage of <70 ml/min |
| Testing was performed pre- and post-aging | ||
| and after 30 days use and after storage | ||
| conditions | ||
| Resistance to Flow | Adult <0.06 cmH2O/l/m |
Table 1 - Summary of Non-clinical Testing
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510(k) Summary Page 3 of 6
| Storage condition andtesting post-aging | Testing was performed pre- and post-agingand after 30 days use | Pediatrics $< 0.12$ cmH2O/l/m | ||
|---|---|---|---|---|
| Evaluate performance after exposure tovarious storage conditions and post-aging | Neonate $< 0.74$ cmH2O/l/m | |||
| Performance after 30 days | Evaluate performance after 30 dayscontinuous use | Testing of leakage, resistance to flow metthe acceptance criteria per each standard | ||
| Performance undervarious ventilator modes | To evaluate performance when used invarious ventilator modes | Testing over different ventilator modeswas performed to confirm thecompatibility of the device with aventilator | ||
| ISO 10993-5 | Evaluate materials for cytotoxicity | Found non-cytotoxic | ||
| ISO 10993-10 | Evaluate materials for sensitization andirritation | Non-sensitizer | ||
| Non-irritant | ||||
| ISO 10993-11 | Evaluate materials for Material MediatedPyrogenicity and Acuta Systemic Toxicity | Non-pyrogenic | ||
| Non-toxic | ||||
| ISO 18562-2 | Particulate Material | Met the predefined acceptance criteria | ||
| ISO 18562-3 | Evaluate Volatile Organic Chemicals | Toxicological Risk Assessment resultedin Margin of Safety >1 |
The testing demonstrated the performance of the subject device to the above listed standards.
Comparative testing to the predicate as discussed in Table 2 below demonstrate the 2 devices to be substantially equivalent in performance, technological characteristics, principles of operation and indications for use.
Substantial Equivalence Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Altech® Exhalation Valve (Single Limb and Dual Limb) demonstrate substantially equivalent to the predicate.
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510(k) Summary Page 4 of 6
Table 2 - Comparison - Subject vs. Predicate
| Subject DeviceAltech® Exhalation Valves | Predicate Device (K132143)Intersurgical Exhalation valve | Comparison | ||
|---|---|---|---|---|
| (Single Limb and Dual Limb) Models | ||||
| Classification | Product Code - CBP | Product Code - CBP | Similar | |
| CFR 868.5870 | CFR 868.5870 | |||
| Classification – Non-rebreathing Valve | Classification – Non-rebreathing Valve | |||
| Indications for Use | The exhalation valves are intended to be used in ventilatorcircuits consistent with the indicated use of the ventilatorto which they are attached.The single limb model directs flow and allows for pressuremonitoring and may be used within hospitals and for homecare use.The dual limb model regulates flow and is for use inhospitals and for home care use.The exhalation valve are used with adults, pediatrics, andneonates.The exhalation valves are for single patient use and can beused for a maximum of 30 days. | The exhalation valves are used to controlInspiratory pressure and expel the expired air froma patient being ventilated via a single limbbreathing system. The exhalation valve and singlelimb breathing systems are used withadults/pediatrics and prescribed by a Physician. Apediatric population is defined as 10 kg to 40 kg inweight. The product is not for use in neonates.The device can be used within hospitals and forhome care use. It is a single patient use device andcan be used for a maximum of 30 days. | The subject has models for use inboth single and dual limb circuits.Added neonates. Otherwise they aresimilar. | |
| Patient pollution | Adult / Pediatric / Neonates | Adult / Pediatric | Similar except the subject can beused with neonates if the ventilator towhich it is attached is so intended | |
| Environment of Use | Hospital and home consistent with the ventilator to whichthey are attached | Hospital and home | Similar | |
| Fundamentalscientific technology | Place in-line with ventilator circuit, pressurized byventilator to open / close to direct flow | Place in-line with ventilator circuit, pressurized byventilator to open / close to direct flow | Similar | |
| Disposable | Single patient, disposable up to 30 day use | Single patient, disposable up to 30 day use | Similar | |
| Non-sterile | Yes | Yes | Similar | |
| Subject DeviceAltech® Exhalation Valves(Single Limb and Dual Limb) Models | Predicate Device (K132143)Intersurgical Exhalation valve | Comparison | ||
| Design Performance | ||||
| Resistance to Flow(cmH2O) | DualInspiration(placed on the expirationside only) | SingleInspiration@ 30 Lpm – 0@ 15 Lpm – 0@ 2.5 Lpm – 0Expiration@ 30 Lpm – 1.95@ 15 Lpm – 1.36@ 2.5 Lpm – 0.80 | @ 30 Lpm – 0.9@ 10 Lpm – 0.6 | SimilarSubject device included testing forneonate. The predicate as a Singlelimb there is no difference betweeninspiratory and expiratory limbs.The Dual limb configuration isplaced on the exhalation side of thecircuit. |
| Leakage in mainbody ml/min | 6 | 2 | <0.5 | The difference in leakage iscompensated by the ventilator anddoes not raise new risk concerns |
| Pressure Ratio | 1:3 | 1:1.5 and 1:2 | Similar | |
| As Patient connectionISO 5356 | 22 mm / 22/15 mm | 22 mm / 22/15 mm | Similar | |
| Shelf-life | 3 years | 5 years | Similar | |
| Storage testing | -20°C to +50°C | -20°C to +50°C | Similar | |
| Inspiratory Trigger | 1 to 9 for pressure and volume control setting | < 30 ms | Similar | |
| Expiratory trigger | 1 to 9 Pressure | Not specified | Similar | |
| Subject Device | Predicate Device (K132143) | Comparison | ||
| Meditera Tibbi Exhalation Valve | Intersurgical Exhalation valve | |||
| Dual / Single Limb Models | ||||
| Biocompatibility | ISO 10993-5 - Cytotoxicity | ISO 10993 details not listed | SimilarAll applicable tests were performedfor the type of patient contact | |
| ISO 10993-10 - Sensitization and Irritation | ||||
| ISO 10993-11 - Material Mediated Pyrogenicity | ||||
| ISO 18562-2 - Particulate Material | ||||
| ISO 18562-3 – Volatile Organic Chemicals | ||||
| Toxicology Risk Assessment | ||||
| Biological Evaluation |
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510(k) Summary Page 5 of 6
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510(k) Summary Page 6 of 6
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).