(265 days)
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No
The document describes a mechanical exhalation valve and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is an "Exhalation Valve" used with ventilators to regulate flow and pressure in breathing circuits for patients of all ages, which directly supports a therapeutic intervention (ventilation).
No.
The exhalation valves are components of ventilator circuits used to direct and regulate gas flow, not to diagnose medical conditions, and their performance studies focus on physical properties like leakage and resistance to flow, not diagnostic accuracy.
No
The device description and performance studies clearly indicate this is a physical exhalation valve with mechanical components and performance characteristics related to flow, pressure, and leakage, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the exhalation valves are used in ventilator circuits to manage airflow and pressure during ventilation. This is a life support function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the mechanical function of the valve in directing and regulating gas flow.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the valve (leakage, resistance to flow, biocompatibility) in the context of ventilation, not on diagnostic accuracy or clinical performance in identifying a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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 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
Product codes
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Adults, pediatrics, and neonates.
Intended User / Care Setting
Used within hospitals and for home care use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing is summarized in the below table.
| Test Methodology | Purpose | Results |
|---|---|---|
| ISO 5356-1 | Conical fittings for 15 / 22 mm. Testing was performed pre- and post-aging and after 30 days use and after storage conditions | Fittings were tested according to ISO 5356-1 and meet the performance criteria |
| ISO 5367 | Leakage. Testing was performed pre- and post-aging and after 30 days use and after storage conditions | Leakage of 1 |
The testing demonstrated the performance of the subject device to the above listed standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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 Sok | |
| No: 29 Tire Organize Sanayi Bölgesi | |
| Tire / İzmir / Turkey | |
| Cenk Kılıç Kalkan, Quality Manager | |
| T: +90 232 513 51 10 | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| 131 Bay Point Dr NE | |
| St. 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 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 Device
Altech® 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 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 exhalation valves are used to control
Inspiratory pressure and expel the expired air from
a patient being ventilated via a single limb
breathing system. The exhalation valve and single
limb breathing systems are used with
adults/pediatrics and prescribed by a Physician. A
pediatric population is defined as 10 kg to 40 kg in
weight. The product is not for use in neonates.
The device can be used within hospitals and for
home care use. It is a single patient use device and
can be used for a maximum of 30 days. | The subject has models for use in
both single and dual limb circuits.
Added neonates. Otherwise they are
similar. | |
| Patient pollution | Adult / Pediatric / Neonates | Adult / Pediatric | Similar except the subject can be
used with neonates if the ventilator to
which it is attached is so intended | |
| Environment of Use | Hospital and home consistent with the ventilator to which
they are attached | Hospital and home | Similar | |
| Fundamental
scientific technology | Place in-line with ventilator circuit, pressurized by
ventilator to open / close to direct flow | Place in-line with ventilator circuit, pressurized by
ventilator 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 Device
Altech® Exhalation Valves
(Single Limb and Dual Limb) Models | Predicate Device (K132143)
Intersurgical Exhalation valve | Comparison |
| Design Performance | | | | |
| Resistance to Flow
(cmH2O) | Dual
Inspiration
(placed on the expiration
side only) | Single
Inspiration
@ 30 Lpm – 0
@ 15 Lpm – 0
@ 2.5 Lpm – 0
Expiration
@ 30 Lpm – 1.95
@ 15 Lpm – 1.36
@ 2.5 Lpm – 0.80 | @ 30 Lpm – 0.9
@ 10 Lpm – 0.6 | Similar
Subject device included testing for
neonate. The predicate as a Single
limb there is no difference between
inspiratory and expiratory limbs.
The Dual limb configuration is
placed on the exhalation side of the
circuit. |
| Leakage in main
body ml/min | 6 | 2 |