(308 days)
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w). The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. The oral version of the device (Super Safety Silk) will be sold in both Murphy eye and Magill styles. The nasal version of the device (Nasal Safety Silk) will be offered in the Murphy eye style only.
This is a 510(k) premarket notification for a medical device (tracheal tube), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" are interpreted in the context of medical device performance testing for substantial equivalence, rather than a clinical study evaluating AI performance.
For this device, the "acceptance criteria" are the defined physical and mechanical properties the tracheal tube must exhibit, and the "study" is the performance testing conducted to demonstrate that the new device (Rusch Safety Silk Tracheal Tube Series) meets these criteria and is substantially equivalent to existing predicate devices.
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 | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cuff Bonding Leak Evaluation | No leak around the welding area | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Curvature Test | Must meet the product requirement of 140mm ± 20mm | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Collapse | The steel ball (OD = 75% of the stated ID) must pass through the lumen freely. | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Resting Diameter | The cuff resting diameter shall be within ± 15% of specification for each individual size | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Herniation | No abnormality or defect on the cuff (any part of the inflated cuff reaches beyond the nearest edge of the bevel will be considered as defect). No abnormality on the configuration of the cuff during deflating the cuff over a period of not less than 10s (any abnormality will be considered as defect). | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Side Arm Bonding Strength | Must be able to sustain a minimum of 15N | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Connector Bonding Strength | Tube-Connector bonding must meet the minimum specification to 50N | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Compression Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Unrestrained Burst Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Restrained Burst Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Sealing Pressure Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Biocompatibility | Materials have been tested per ISO 10993 | "All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified in the provided text.
- Data provenance: Not specified. This type of performance testing for medical devices is typically conducted in a laboratory setting by the manufacturer, not with human patient data in the sense of clinical trials for AI.
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 this type of medical device submission. "Ground truth" in the context of expert consensus or clinical outcomes is relevant for AI/ML device evaluations. For a tracheal tube, performance testing involves objective measurements against defined physical and mechanical specifications, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this involves objective physical testing, not subjective expert review requiring adjudication.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" is defined by the established engineering specifications, relevant ISO standards (like ISO 5361 for tracheal tubes), and internal product requirements. This is a functional truth derived from known physical properties and design objectives, not a clinical or expert "ground truth."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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JUN 0 6 2014
510(k) SUMMARY
Rusch Safety Silk Tracheal Tube Series
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 919-433-4996 Fax:
Contact Person
Lori Pfohl Regulatory Affairs Specialist
Date Prepared
6/3/2014
Device Name
Trade Name: Rusch Safety Silk Tracheal Tube Series
Common Name: Tracheal Tube
Classification Name: Tube, Tracheal (Class II per 21 CFR 868.5730, Product Code BTR)
Predicate Devices
Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786
Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy -K961837
Device Description
The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = < 0.1% DEHP w/w). The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector.
Teleflex Medical
Page 1 of 5
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The oral version of the device (Super Safety Silk) will be sold in both Murphy eye and Magill styles.
The nasal version of the device (Nasal Safety Silk) will be offered in the Murphy eye style only.
Indications for Use
-
Rusch tracheal tubes are indicated for oral or nasal intubation for airway . management.
Intended Population -
Adults
Intended Environment of Use -
Locations where ET intubation may be performed. .
Contraindications
None
Substantial Equivalence
The proposed device is substantially equivalent to the predicate devices:
| Teleflex MedicalSafety Silk SeriesOral / Nasalacheal | Teleflex MedicalOral / Nasal Tracheal Tubeatety Clear Plus) | Teleflex Medicalal / Nasal Tracheal | |
|---|---|---|---|
| Classification Name | Tube, Trachea(w/wo connector) | Same | Same |
| Product Code | 73 BTR | Same | Same |
| Regulation Number | 868.5730 | Same | Same |
| Indications for Use | Rusch trachealtubes are indicatedfor oral or nasalintubation forairwaymanagement. | Rusch Oral / Nasal TracheaTube, Cuffed,Magill/Murphy is a deviceinserted into a patient'strachea via the nose ormouth and used to maintainan open airway. | Oral or nasalintubation and airwaymanagement |
| Teleflex MedicalSafety Silk SeriesOral / NasalTracheal Tube(proposed) | Teleflex MedicalOral / Nasal Tracheal Tube(Safety Clear Plus)(K993786) | Teleflex MedicalOral / Nasal TrachealTube(K961837) | |
| Features | |||
| Environment of Use | Locations where ETintubation may beperformed | Not stated | Not stated |
| Patient Population | Adults | Not stated | Not stated |
| Contraindications | None | Same | Same |
| Single Use | Yes | Same | Same |
| Size Range | $5.0 mm - 10.0 mm$ | $2.0 mm - 4.0 mm$ | $4.5 mm - 11.0 mm$ |
| Cuffed | Yes | Same | Same |
| Radiopaque | Yes | Same | Same |
| Connection toventilation source | 15 mm connector | Same | Same |
| Method ofSterilization | Ethylene Oxide 10-6SAL | Same | Same |
| Biocompatibility | Materials have beentested per ISO10993 | Same | Same |
| No-DEHP | Yes | No | No |
| PackagingConfiguration | Ten (10) individualunits in a shelf box.Ten shelf boxes in ashipper | Same | Same |
| Sterile | Yes | Same | Same |
| Eye | Murphy and Magill | Same | Same |
| Tip | Beveled | Same | Same |
| Graduations | Multiple cmmarkings | Same | Same |
| Shaft | PVC | Same | Same |
| Cuff | PVC | Same | Same |
| Pilot Balloon | PVC | Same | Same |
| Inflation Valve | PVC | Same | Same |
| Inflation Tube | PVC | Same | Same |
| X-Ray Marker,Stripe | PVC with BariumSulfate | Same | Same |
| Connector | Polyamide | Polypropylene | Polypropylene |
Teleflex Medical
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Comparison to Predicate Device:
The proposed Safety Silk series tracheal tubes are substantially equivalent to the predicate devices with respect to indications for use, technology and construction. The proposed device is designed with different materials than the predicate. These proposed device materials are Non-DEHP.
Indications for Use -.
The indications for use are substantially equivalent for the proposed device when compared to the predicates. Each device is indicated for Oral or Nasal use in airway management.
Technology and construction -.
The design, fabrication, shape, size, etc. are substantially equivalent to the predicates. This design includes the disposable tracheal tube, cuff side arm assembly and 15mm connector.
. Environment of use -
While not specifically stated, the environments of use are equivalent to predicates
. Patient Population -
While not specifically stated, the patient population is equivalent to the predicate
Materials -.
All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing.
| Test | Reference toStandard (ifapplicable) | Principle of Test | Acceptance Criteria |
|---|---|---|---|
| Cuff BondingLeak Evaluation | N/A | To perform a visual check atthe welding point of the cuff | No leak around thewelding area |
| Tube CurvatureTest | 150 5361 | To measure the curvature ofthe tube | Must meet the productrequirement of 140mm± 20mm |
| Tube Collapse | ISO 5361 | The patency of the ET tubeairway lumen is tested bypassing a steel ball throughthe tracheal tube lumen withthe cuff inflated within atransparent tube | The steel ball (OD =75% of the stated ID)must pass through thelumen freelv. |
| Cuff RestingDiameter | ISO 5361 | The resting diameter of thecuff is measured when thecuff is inflated to a referencepressure which is intended toremove creases but minimizestretching of its walls | The cuff restingdiameter shall be within± 15% of specificationfor each individual size |
| Test | Reference to Principle of Test | Acceptance Criteria |
Performance Testing
Teleflex Medical
Page 4 of 5
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| Standard (if .applicable) | |||
|---|---|---|---|
| Cuff Herniation | ISO 5361 | The tendency of the cuff toherniate beyond the planeperpendicular to the long axisof the tube at the nearestedge of the bevel is tested byapplying an axial force withthe cuff inflated within atransparent tube. A cuff whichprotrudes excessively at itspatient end may partially orcompletely occlude the orificeat the patient end | No abnormality ordefect on the cuff (anypart of the inflated cuffreaches beyond thenearest edge of thebevel will be consideredas defect). Noabnormalitv on theconfiguration of the cuffduring deflating the cuffover a period of not lessthan 10s (anyabnormality will beconsidered as defect)." |
| Side ArmBonding Strength | N/A | To evaluate the retentionforce of the inflation lineconnection to the Trachealtube | Must be able to sustaina minimum of 15N |
| ConnectorBonding Strength | N/A | The security of theattachment of the connectorto the tracheal tube is testedby applying an axialseparation force to theconnector | Tube-Connectorbonding must meet theminimum specificationto 50N |
| TubeCompressionEvaluation | N/A | To measure the rigidity of thetube | Must be within therange of current data |
| Cuff UnrestrainedBurst Evaluation | N/A | To determine minimum cuffburst pressure underunrestrained conditions | Must be within therange of current data |
| Cuff RestrainedBurst Evaluation | N/A | To determine cuff burstvolume under restrainedconditions to simulateconditions in the trachea | Must be within therange of current data |
| Cuff SealingPressureEvaluation | N/A | To determine the minimumcuff pressure required to sealthe corrugated tube | Must be within therange of current data |
The Rusch Safety Silk Tracheal Tube Series has the same indications for use, technological characteristics and construction as its predicates. Performance test results demonstrate that the proposed device is substantially equivalent.
Teleflex Medical
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Teleflex Medical, Incorporated Ms. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K132415
Trade/Device Name: Rusch Safety Silk Tracheal Tube Series Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: May 05, 2014 Received: May 06, 2014
Dear Ms. Pfohl:
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. 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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Page 2 - Ms. Lori Pfohl
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit Sheth M.D. Clinical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132415
Device Name
Rusch Super Safety Silk Tracheal Tubes
Indications for Use (Describe)
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
Intended Population: Adults
Intended Environment of Use: Locations where ET intubation may be performed
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line – continue on a separate page if needed.
A FREE FOR FOR FOREDA USE ONLY AND ANNE AND ANNA ANDREA ASSA Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Todd D. Courtney -S 2014.06.05 15:19:37 -04
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§ 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).