(158 days)
The 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.
The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set are comprised of a blocker catheter with a silicone balloon near the distal end. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. A nylon guide loop at the distal end of the blocker catheter is wrapped around the tip of the bronchoscope and tightened, in order for the bronchoscope to assist in the precise placement of the blocker catheter. An Arndt Multiport Airway Adapter, a proximal straight connector, a suction adapter, and a syringe are also provided with each set.
This document describes the premarket notification for the 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device proves it meets acceptance criteria through clinical performance metrics like sensitivity, specificity, etc.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics such as accuracy, sensitivity, specificity, and related study designs (e.g., sample sizes for test/training sets, expert consensus, MRMC studies), cannot be extracted directly from this document. This is a 510(k) submission, which primarily relies on technological characteristics and comparison to legally marketed predicate devices to establish substantial equivalence. Clinical performance studies with human readers or standalone algorithm performance are typically not required for this type of submission unless new questions of safety or effectiveness are raised.
The document does, however, detail various engineering and performance tests conducted to ensure reliable design and functionality of the device itself, rather than its clinical performance in diagnosing or assisting human experts.
Here's an attempt to address your points based on the available information, noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document provides a list of engineering and performance tests with their general acceptance criteria and outcomes. The performance is reported as meeting "established acceptance criteria." Quantitative results are not provided beyond "greater than or equal to" or "do not exhibit signs of leakage or burst."
| Test Type | Acceptance Criteria (General) | Reported Device Performance (General Outcome) |
|---|---|---|
| Tensile Tests (Catheter Shaft, Distal Sideport, Snare-to-Proximal Manifold Bond, Hub-to-Shaft Bond, Pilot Balloon Assembly-to-Manifold) (Zero-Time, Three-Year Accelerated Aged) | Peak load value greater than or equal to established acceptance criteria. | Demonstrated to be greater than or equal to the established acceptance criteria. |
| Analysis of Re-insertion Method of Snare (Zero-Time) | (Performed for characterization only, no specific acceptance criteria stated for performance) | This test was performed for characterization only. |
| Balloon Shear Loading Test (Zero-Time, Three-Year Accelerated Aged) | Test articles do not completely separate from the catheter shaft (both proximal and distal balloon bonds fail, i.e.) or, if the balloon ruptures, not fragment. | The acceptance criteria were met. |
| Pressurization Testing (Zero-Time, Three-Year Accelerated Aged) | Test articles do not exhibit signs of leakage or burst while pressurized. | The acceptance criteria were met. |
| Balloon Inflation Test (Zero-Time, Three-Year Accelerated Aged) | Inflation diameter of the test articles were demonstrated to be greater than the established acceptance criteria. | Demonstrated to be greater than the established acceptance criteria. |
| Balloon Burst Testing (Zero-Time, Three-Year Accelerated Aged) | Minimum failure volume of the test articles were demonstrated to be greater than the established acceptance criteria. | Demonstrated to be greater than the established acceptance criteria. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes device engineering and performance testing (e.g., tensile strength, balloon inflation) on the device itself, not a clinical study involving patients or human data for clinical performance evaluation. Therefore, "test set" in the context of clinical data or patient data is not applicable here. The "test articles" in the engineering tests refer to physical units of the device. The sample sizes for these engineering tests are not specified in the provided text. Data provenance (country of origin, retrospective/prospective) is also not applicable as it's not a clinical study using patient 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)
Not applicable. This is not a study requiring expert interpretation or ground truth establishment of clinical findings. The "ground truth" for the engineering tests would be established by validated test methods and physical property standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical findings.
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 a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (a physical blocker set), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the engineering tests described, the "ground truth" would be the established physical and material properties, and the performance expectations defined by the device's design requirements. These are validated through standard engineering and materials testing methodologies.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI study that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2016
Cook Incorporated Kotei Aoki Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K160542
Trade/Device Name: 5.0 Fr Arndt Endobronchial Blocker Set 9.0 Fr Arndt Endobronchial Blocker Set Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: July 1, 2016 Received: July 5, 2016
Dear Kotei Aoki:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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" (21 CFR 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K160542
Device Name
5.0 Fr Arndt Endobronchial Blocker Set 9.0 Fr Arndt Endobronchial Blocker Set
Indications for Use (Describe)
The 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.
The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
| 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) Summary
5.0 Fr Arndt Endobronchial Blocker Set 9.0 Fr Arndt Endobronchial Blocker Set 21 CFR §868.5740 Date Prepared: August 1, 2016
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Kotei Aoki |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102630 |
| Contact Fax Number: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | 5.0 Fr Arndt Endobronchial Blocker Set |
| 9.0 Fr Arndt Endobronchial Blocker Set | |
| Common Name: | Endobronchial Blocker |
| Classification Name: | Tracheal/bronchial differential ventilation tube |
| Regulation | 21 CFR §868.5740 |
| Product Code | CBI |
Predicate Devices:
Device Description:
The 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set are comprised of a blocker catheter with a silicone balloon near the distal end. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. A nylon guide loop at the distal end of the blocker catheter is wrapped around the tip of the bronchoscope and tightened, in order for the bronchoscope to assist in the precise placement of the blocker catheter. An Arndt Multiport Airway Adapter, a proximal straight connector, a suction adapter, and a syringe are also provided with each set.
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Intended Use:
The 5.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require onelung ventilation. The 5.0 Fr Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older.
The 9.0 Fr Arndt Endobronchial Blocker Set is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require onelung ventilation. The 9.0 Fr Arndt Endobronchial Blocker is indicated for adult use only.
Comparison to Predicates:
The proposed 5.0 Fr Arndt Endobronchial Blocker Set is substantially equivalent to the predicate device the Arndt Pediatric Endobronchial Blocker (K002288) in that these devices have the same intended use, fundamental technological characteristics, method of operation, and materials of construction.
The proposed 9.0 Fr Arndt Endobronchial Blocker Set is substantially equivalent to the predicate device the Bronchial Blocker (K962167) in that these devices have the same intended use, fundamental technological characteristics, method of operation, and similar materials of construction.
The substantial equivalence of the modified devices to the predicate device is supported by testing. A substantial equivalence comparison of each proposed device is provided in Tables 1 and 2, respectively.
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| Predicate Device | Subject Device | ||
|---|---|---|---|
| Arndt Pediatric EndobronchialBlocker K002288 | 5.0 Fr Arndt EndobronchialBlocker Set | ||
| Regulation Number | 21 CFR §868.5740 | Identical | |
| Product Code | CBI | Identical | |
| Classification Name | Tracheal/bronchial differentialventilation tube | Identical | |
| Class | II | Identical | |
| Intended Use | Intended for use to differentiallyintubate a patient's bronchus inorder to isolate the left or rightlung for procedures which requireone-lung ventilation. | Identical* | |
| Material | Nylon | Identical | |
| Centimeter Marker | Yes | Identical | |
| Catheter | Inner Diameter (in) | 0.028 | Identical |
| Shaft | Outer Diameter (Fr) | 5.0 | Identical |
| Length (cm) | 50 | 50, 65 | |
| Tip Shape | Straight | Identical | |
| Number of Sideports | None | Identical | |
| Snare Material | Nylon | Identical | |
| Adapter Material | Polyamide | Identical | |
| Guide | Cap Material | Acetal | Identical |
| LoopSnare | Usable Loop length alongSemi-Major Axis (mm) | 5 | 10 |
| May Be Reinserted(reinforcement material) | No | Identical | |
| Material | Silicone | Identical | |
| Length (mm) | 8 | Identical | |
| Distal | Shape | Elliptical, Spherical | Spherical |
| Balloon | Inflation Media | Air | Identical |
| Inflation Volume (cc) | 2 | 0.5 – 2 | |
| Inflation Diameter (in) | 0.150 | Identical | |
| Manifold | Y-shape fitting Material | Polyamide | Identical |
| Assembly | Pilot Balloon AssemblyMaterial | Silicone | Identical |
| Used in Conjunction withEndotracheal Tube | Yes | Identical | |
| Used in Conjunction withBronchoscope | Yes | Identical | |
| Accessory Components | Arndt Multiport Airway Adapter,Proximal Straight Connector,Syringe | Arndt Multiport AirwayAdapter, Proximal StraightConnector, Syringe, SuctionAdapter | |
| Packaging | Tyvek/polyethylene film pouch | Identical | |
| Sterilization | EtO | Identical | |
| Predicate DeviceBronchial BlockerK962167 | Subject Device9.0 Fr Arndt EndobronchialBlocker Set | ||
| Regulation Number | 21 CFR §868.5740 | Identical | |
| Product Code | CBI | Identical | |
| Classification Name | Tracheal/bronchial differentialventilation tube | Identical | |
| Class | II | Identical | |
| Intended Use | Intended for use to differentiallyintubate a patient's bronchus inorder to isolate the left or rightlung for procedures which requireone-lung ventilation. | Identical | |
| CatheterShaft | Material | Polyethylene | Nylon |
| Centimeter Marker | Yes | Identical | |
| Inner Diameter (in) | 0.068 | Identical | |
| Outer Diameter (Fr) | 9.0 | Identical | |
| Length (cm) | 78 | 65, 78 | |
| Tip Shape | Straight | Identical | |
| Number of Sideports | None | 2 | |
| GuideLoopSnare | Snare Material | Nylon | Identical |
| Adapter Material | Acetal | Polyamide | |
| Cap Material | Acetal | Identical | |
| Usable Loop length alongSemi-Major Axis (mm) | 15 | Identical | |
| May Be Reinserted(reinforcement material) | No | Yes (Polyetheretherketone) | |
| DistalBalloon | Material | Silicone | Identical |
| Length (mm) | 23 | Identical | |
| Shape | Elliptical, Spherical | Spherical | |
| Inflation Media | Air | Identical | |
| Inflation Volume (cc) | 6 | 4 - 8 | |
| Inflation Diameter (in) | 0.350 - 0.450 | Identical | |
| ManifoldAssembly | Y-shape fitting Material | Acetal | Polyamide |
| Pilot Balloon AssemblyMaterial | Silicone | Identical | |
| Used in Conjunction withEndotracheal Tube | Yes | Identical | |
| Used in Conjunction withBronchoscope | Yes | Identical | |
| Accessory Components | Arndt Multiport Airway Adapter,Proximal Straight Connector,Syringe | Arndt Multiport AirwayAdapter, Proximal StraightConnector, Syringe, SuctionAdapter | |
| Packaging | Tyvek/polyethylene film pouch | Identical | |
| Sterilization | EtO | Identical |
Table 1 Substantial Equivalence Comparison – 5.0 Fr Arndt Endobronchial Blocker Set
- The 5.0 French Arndt Endobronchial Blocker is indicated for pediatric populations, in children 1 year and older. The predicate (K002288) was also indicated for pediatric use.
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Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements:
- Tensile Tests (the Catheter Shaft, the Distal Sideport, the Snare-to-Proximal . Manifold Bond, the Hub-to-Shaft Bond, and the Pilot Balloon Assembly-to-Manifold) (Zero-Time, Three-Year Accelerated Aged) - The peak load value of the test articles was demonstrated to be greater than or equal to the established acceptance criteria.
- Analysis of Re-insertion Method of Snare (Zero-Time) This test was performed . for characterization only.
- . Balloon Shear Loading Test (Zero-Time, Three-Year Accelerated Aged) – The test articles do not completely separate from the catheter shaft (both proximal and distal balloon bonds fail, i.e.) or, if the balloon ruptures, not fragment. The acceptance criteria were met.
- . Pressurization Testing (Zero-Time, Three-Year Accelerated Aged) - The test articles do not exhibit signs of leakage or burst while pressurized. The acceptance criteria were met.
- Balloon Inflation Test (Zero-Time. Three-Year Accelerated Aged) The inflation . diameter of the test articles were demonstrated to be greater than the established acceptance criteria.
- Balloon Burst Testing (Zero-Time, Three-Year Accelerated Aged) The . minimum failure volume of the test articles were demonstrated to be greater than the established acceptance criteria.
The results of these tests support a conclusion that the 5.0 Fr Arndt Endobronchial Blocker Set and the 9.0 Fr Arndt Endobronchial Blocker Set met the design input requirements based on the intended use and support the conclusion that these devices do not raise new questions of safety or effectiveness as compared to the predicate device. The subject devices are therefore substantially equivalent to the predicate devices, the Bronchial Blocker (Cook Incorporated, K962167) and the Arndt Pediatric Endobronchial Blocker (Cook Incorporated, K002288).
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).