(158 days)
Not Found
No
The device description and performance studies focus on mechanical properties and physical components, with no mention of AI or ML.
Yes.
The device is intended to isolate a lung for procedures that require one-lung ventilation, indicating a direct therapeutic purpose for surgical or medical interventions.
No
The device is intended to isolate a lung for one-lung ventilation procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components such as a blocker catheter, silicone balloon, valves, adapters, and a syringe, indicating it is a hardware medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation." This is a surgical or procedural intervention performed directly on the patient's body.
- Device Description: The device is a physical catheter with a balloon, designed for insertion into the bronchus.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a medical device used for a therapeutic or procedural purpose within the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
CBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's bronchus, left or right lung
Indicated Patient Age Range
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 is indicated for adult use only.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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
2
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.
4
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.
5
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Arndt Pediatric Endobronchial | |||
| Blocker K002288 | 5.0 Fr Arndt Endobronchial | ||
| Blocker Set | |||
| Regulation Number | 21 CFR §868.5740 | Identical | |
| Product Code | CBI | Identical | |
| Classification Name | Tracheal/bronchial differential | ||
| ventilation tube | Identical | ||
| Class | II | Identical | |
| Intended Use | Intended for use to differentially | ||
| intubate a patient's bronchus in | |||
| order to isolate the left or right | |||
| lung for procedures which require | |||
| one-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 |
| Loop | |||
| Snare | Usable Loop length along | ||
| Semi-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 Assembly | ||
| Material | Silicone | Identical | |
| Used in Conjunction with | |||
| Endotracheal Tube | Yes | Identical | |
| Used in Conjunction with | |||
| Bronchoscope | Yes | Identical | |
| Accessory Components | Arndt Multiport Airway Adapter, | ||
| Proximal Straight Connector, | |||
| Syringe | Arndt Multiport Airway | ||
| Adapter, Proximal Straight | |||
| Connector, Syringe, Suction | |||
| Adapter | |||
| Packaging | Tyvek/polyethylene film pouch | Identical | |
| Sterilization | EtO | Identical | |
| Predicate Device | |||
| Bronchial Blocker | |||
| K962167 | Subject Device | ||
| 9.0 Fr Arndt Endobronchial | |||
| Blocker Set | |||
| Regulation Number | 21 CFR §868.5740 | Identical | |
| Product Code | CBI | Identical | |
| Classification Name | Tracheal/bronchial differential | ||
| ventilation tube | Identical | ||
| Class | II | Identical | |
| Intended Use | Intended for use to differentially | ||
| intubate a patient's bronchus in | |||
| order to isolate the left or right | |||
| lung for procedures which require | |||
| one-lung ventilation. | Identical | ||
| Catheter | |||
| Shaft | 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 | |
| Guide | |||
| Loop | |||
| Snare | Snare Material | Nylon | Identical |
| Adapter Material | Acetal | Polyamide | |
| Cap Material | Acetal | Identical | |
| Usable Loop length along | |||
| Semi-Major Axis (mm) | 15 | Identical | |
| May Be Reinserted | |||
| (reinforcement material) | No | Yes (Polyetheretherketone) | |
| Distal | |||
| Balloon | 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 | |
| Manifold | |||
| Assembly | Y-shape fitting Material | Acetal | Polyamide |
| Pilot Balloon Assembly | |||
| Material | Silicone | Identical | |
| Used in Conjunction with | |||
| Endotracheal Tube | Yes | Identical | |
| Used in Conjunction with | |||
| Bronchoscope | Yes | Identical | |
| Accessory Components | Arndt Multiport Airway Adapter, | ||
| Proximal Straight Connector, | |||
| Syringe | Arndt Multiport Airway | ||
| Adapter, Proximal Straight | |||
| Connector, Syringe, Suction | |||
| Adapter | |||
| 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.
6
7
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).