(281 days)
The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane) and The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. They are made primarily of polyvinylchloride with either a polyurethane (PU) or PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.
The provided text describes a 510(k) premarket notification for a medical device, the Salter Labs Trach-Vac Endotracheal Tube. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.
However, I can extract information related to the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence for a non-AI/ML medical device.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics and thresholds. Instead, it demonstrates performance by showing compliance with recognized standards and similarity to a predicate device. The "reported device performance" is essentially the device meeting these standards and exhibiting similar characteristics to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 for prolonged mucosal contact. | Passed ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation / Intracutaneous Reactivity and Skin Sensitization), and ISO 10993-18 (Chemical Characterization with Toxicological Risk Assessment). Material contacts classified as "Externally Communicating / Tissue and Surface Contact / Mucosal" with "Prolonged Duration of Use (> 24 hr, < 30 days)." |
| Physical and Mechanical Properties: Comply with relevant ISO standards. | Bench testing performed and passed for: - ISO 5361-1 (ET Tubes)- ISO 803369-7 (Luer fitting)- ISO 5356-1 (Conical Connectors = 15/22 mm) |
| Aging Performance: | Age testing performed (results not detailed, but implied as satisfactory for release). |
| Overall Equivalence to Predicate Device (K110269): Intended Use, Patient Population, Environment of Use, Technology and Principle of Operation. | - Intended Use: Similar for airway management, mechanical ventilation, anesthesia, and subglottic secretion removal.- Patient Population: Both for adult patients requiring airway management and potential subglottic suctioning.- Environment of Use: Both for clinical settings (hospital, ICU, ER, OR, field).- Technology and Principle Operation: Both are cuffed tubes with a suctioning lumen; utilize same mechanisms for cuff inflation and subglottic evacuation; sterile and single-use; same sizes (6.0-9.0 mm ID), Magill curve, 2 Murphy eyes, 15mm conical connector, and 6% Male Luer connector suction port. - Shelf life: 5 years. |
| Feature: Flexible Tip Design: Performance similar to reference device K100546. | The proposed device includes a flexible tip, similar to the Parker Flex Tip cleared under reference device K100546. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this document is not for an AI/ML device and does not involve test sets of patient data. The "test set" here refers to the physical devices undergoing bench and biocompatibility testing. The exact number of devices tested for each bench test is not specified in this summary but is typically part of the detailed test reports. The provenance of the data is from the manufacturer's own internal testing.
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 information is not applicable. This document does not describe a study involving expert-established ground truths for patient data. Ground truth in this context would be established by laboratory testing methods and compliance with engineering standards by qualified technical personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No adjudication method for expert review of data is mentioned, as it's not relevant for this type of device submission.
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 information is not applicable. An MRMC study is relevant for AI/ML devices involving human interpretation of outputs. This device is an endotracheal tube and does not involve "readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device has no algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of medical imaging or clinical data. "Ground truth" for this device is established by:
- Adherence to international standards (e.g., ISO for biocompatibility, ET tubes, Luer fittings, conical connectors).
- Physical and mechanical property measurements.
- Chemical characterization.
- Visual inspection and functional testing.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" or corresponding ground truth establishment process for this device.
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Salter Labs, Inc. % Paul Dryden Consultant Salter Labs 2365 Camino Vida Roble Carlsbad, California 92011
Re: K190878
Trade/Device Name: Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter Thin Cuff Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff Regulation Number: 21 CFR 868.5730
Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: December 10, 2019 Received: December 12, 2019
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 medical devices and radiation-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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190878
Device Name
Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM and Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuffTM
Indications for Use (Describe)
The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
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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510(k) Summary January 7, 2020
| Official Contact: | Salter Labs2365 Camino Vida RobleCarlsbad, CA 92011Mara Caler – Regulatory Affairs | |
|---|---|---|
| Submission Correspondent: | Tel: 760-795-7094Paul Dryden, ConsultantProMedic, LLCE - paul.dryden@promedic.ccT - 239-307-6061 | |
| Proprietary or Trade Name: | and | Salter Labs Trach- Vac Endotracheal Tube (SFTVPU) SubglotticSuction Tube with Salter Flex-Tip™ and Salter ThinCuff ™Salter Labs Trach- Vac Endotracheal Tube (SFTVVC) SubglotticSuction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ |
| Common/Usual Name: | Tracheal Tube (w and w/o connector) | |
| Classification Name: | BTR - tube, tracheal (w/wo connector)21CFR 868.5730, Class II | |
| Predicate Device: | K110269 - Well Lead Endotracheal Tube with Evacuation Lumen | |
| Reference Device: | K100546 - Parker ET Tube with Flex Tip |
Device Description:
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. It is made of primarily of polyvinylchloride with a polyurethane (PU) cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride).
The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff™ (6.0, 6.5, 7.0. 7.5, 8.0. 8.5, 9.0 mm ID) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. The tubing is made of primarily of polyvinylchloride (PVC) with a PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates
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510(k) Summary
January 7, 2020
a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization in the trachea after they pass through the vocal cords.
Indications for Use:
The Salter Labs Trach-Vac Endotracheal Tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.
Device Comparison
Table 1 compares the subject device to the predicate
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510(k) Summary January 7, 2020
Table 1 - Comparison of Proposed vs. Predicate Device
| Specifications | Predicate K110269Well Lead Endotracheal Tube with Evacuation Lumen | Subject deviceSalter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---|---|---|---|
| Device Use & General Characteristics | |||
| Regulation | 21 CFR 868.5730 | 21 CFR 868.5730 | Same |
| Class name | Tube, Tracheal (w/wo connector) | Tube, Tracheal (w/wo connector) | Same |
| Product code | 73 BTR | 73 BTR | Same |
| Intended Use | The Well Lead Endotracheal Tube with Evacuation Lumenis intended for Oral intubation and drainage of thesubglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal TubeSubglottic Suction Tube with Salter Flex-Tip™ andSalter ThinCuff™ is indicated for airway managementby oral intubation during mechanical ventilation andanesthesia including the capability to aid in theremoval of Subglottic secretions. | Similar withdetails related tothe tip design |
| Target PatientPopulation | The device is indicated for patients who require airwaymanagement via an endotracheal tube with subglotticsuctioning. | The device is indicated for adult patients who requireairway management via an endotracheal tube withsubglottic suctioning. | Both devices areintended for adults.however thepredicate wordingdid not include thespecifics |
| Indications for use | The device is intended for oral intubation and drainage ofthe subglottic space for airway management. | The Salter Labs Trach-Vac Endotracheal Tubes areindicated for nasal or oral intubation of the trachea foranesthesia and airway management, includingmechanical ventilation and suctioning of accumulatedsubglottic secretions in the trachea of adult patients. | Similar anatomicallocations andpopulation |
| Environment ofuse | Hospital, ICU | Professional use only: Intubation in the field(emergency medical services) or hospital environment,including ER, OR, and ICU. | The environmentsof use are similar.Use in the pre-hospitalenvironment isalso by trainedproviders |
| Principal ofOperation and | a. The device is packaged individually and supplied sterilewith a standard 15mm connector. | a. The device is packaged individually and suppliedsterile with a standard 15mm connector. | Same |
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510(k) Summary
January 7, 2020
| January) | 2020 | |
|---|---|---|
| -------------- | -- | ------ |
| Specifications | Predicate K110269Well Lead Endotracheal Tube with Evacuation Lumen | Subject deviceSalter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---|---|---|---|
| Device Use & General Characteristics | |||
| Mechanisms ofAction | b. The endotracheal tube has a curved construction withprimary lumen for patient ventilation. Two (2) narrowerlumens within the primary wall are used for cuffinflation and subglottic evacuation (vacuum). | b. The endotracheal tube has a curved constructionwith primary lumen for patient ventilation. Two (2)narrower lumens within the primary wall are usedfor cuff inflation and subglottic evacuation(vacuum). | Same |
| c. A low pressure, conformable cuff is inflated through theinflation line with pilot balloon using a standard 10ccsyringe (air only) through a one-way check valve. | c. A low pressure, conformable cuff is inflated throughthe inflation line with pilot balloon using a standard10cc syringe (air only) through a one-way checkvalve. | Same | |
| d. For evacuation of subglottic secretions, a separatesuction line connects to standard hospital vacuumreceptacles. Once properly intubated, subglotticsecretions are evacuated through the suction line justsuperior to the cuff. | d. For evacuation of subglottic secretions, a separatesuction line connects to standard hospital vacuumreceptacles. Once properly intubated, subglotticsecretions are evacuated through the suction line justsuperior to the cuff. | Same | |
| e. To facilitate proper positioning, the suction appendageand lumen line marker are radiopaque. | e. To facilitate proper positioning, the suctionappendage and lumen line marker are radiopaque. | Same | |
| Sterile orNon-Sterile | Sterile | Sterile | Same |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
| Use | Single patient/ single use only | Single patient / single use only | Same |
| Biocompatibility of Patient Contacting Materials | |||
| ISO 10993-1 | Externally Communicating / Tissue andSurface Contact / MucosalProlonged Duration of Use (> 24 hr, < 30 days) | Externally Communicating / Tissue andSurface Contact / MucosalProlonged Duration of Use (> 24 hr, < 30 days) | Same |
| Design | |||
| Sizes (ID) | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | Same |
| Curve | Magill | Magill | Same |
| Murphy eye | Yes - 2 eyes | Yes - 2 eyes | Same |
| Connector(size/type) | 15mm conical | 15mm conical | Same |
| Suction port for | 6% Male Luer connector | 6% Male Luer connector | Same |
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510(k) Summary January 7, 2020
| Specifications | Predicate K110269Well Lead Endotracheal Tube with Evacuation Lumen | Subject deviceSalter Labs Cuffed Trach-Vac Flex Tip ET Tube | Changes |
|---|---|---|---|
| Device Use & General Characteristics | |||
| removal ofsecretions thataccumulate abovethe cuff | |||
| Technological characteristics | |||
| Technologicalcharacteristics | The design is based upon the cuffed Tube with the additionof a third lumen within the tube. It terminates above thecuff via a 'notch' (evacuation port) which enables theentrance (via suction) of secretions which have pooledabove the cuff. Half way along the tube length the suctionlumen is joined to a suction tube which is external to themain tube. The suction tube is joined to the suction lumenin a similar manner to that of the joint between the inflatingtube and the inflating lumen. The distal end of the suctiontube terminates in a capped Luer connector which can beconnected to either the suction tubing or a syringe. | The design is based upon the cuffed Tube with theaddition of a third lumen within the tube. It terminatesabove the cuff via a 'notch' (evacuation port) whichenables the entrance (via suction) of secretions whichhave pooled above the cuff. Half way along the tubelength the suction lumen is joined to a suction tubewhich is external to the main tube. The suction tube isjoined to the suction lumen in a similar manner to thatof the joint between the inflating tube and the inflatinglumen. The distal end of the suction tube terminates in acapped Luer connector which can be connected toeither the suction tubing or a syringe. | Same |
| Shelf life | 5 years | 5 years | Same |
Differences
The differences between the Salter Labs Trach-Vac Endotracheal Tube with Salter Flex-Tig™ and Salter ThinCuff™ and the Well Lead Endotracheal Tube with Evacuation Lumen are below:
Table 2 - Differences between Proposed and Predicate
| Features | K110269 | Subject device |
|---|---|---|
| Tip design | Standard tip | The distal tip of the subject device includes a flexible tip, cleared in the reference device K100546,Parker Medical FLEX-TIP TRACHEAL TUBE. This reference device refers specifically to thedesign of the flexible tip at the distal end of the tube. |
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Substantial Equivalence Discussion
The proposed Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ is viewed as substantially equivalent to the predicate device because:
Indications -
- Both are indicated for airway management by tracheal or oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
Patient Population -
- Both are intended for adult patients requiring airway management and may require secretion . suctioning.
Environment of Use -
- For use in clinical settings by trained medical personnel ●
Technology and Principle Operation -
- Both are the same of a cuffed tube with a suctioning lumen. .
- The proposed device included the Flex-tip which is similar to the Parker Flex Tip cleared under . K100546.
Non-clinical Testing Summary -
We have performed tests appropriate for the proposed device. These tests include:
Biocompatibility of Materials -
The materials have been evaluated and tested in accordance with ISO 10993-1. Based upon ISO 10993-1 the subject device would be considered as having two types of patient contact.
- . Externally Communicating / Tissue and
- Surface Contact / Mucosal
- . Prolonged duration (> 24 hours and < 30 days)
The following testing was performed:
- . ISO 10993-5 (2009) - Cytotoxicity
- ISO 10993-10 (2013) Irritation / Intracutaneous Reactivity and Skin Sensitization ●
- ISO 10993-18 (2013) Chemical Characterization with Toxicological Risk Assessment ●
Bench testing -
- . Bench testing specific to
- ISO 5361-1 (2016) ET Tubes o
- o ISO 80369-7 (2016) Luer fitting
- o ISO 5356-1 (2016) = Conical Connectors = 15/22 mm
- Age testing ●
Clinical Testing Summary -
There was no clinical testing performed.
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Substantial Equivalence Conclusion
As established by description, data, and information contained within this 510(k), and as summarized in comparison table, the Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ is substantially equivalent to the predicate distributed commercially in the U.S. and worldwide. The Salter Labs Trach-Vac Endotracheal Tube Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff ™ has the same Intended Use, Indications for Use nor does it alter the fundamental scientific technology, operation principles, design, or manufacturing process.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).