(45 days)
No changes are being made to the device, thus no Predicate Device is listed in this summary.
Not Found
No
The device description and intended use focus on a mechanical repair kit for pilot tubes, with no mention of AI or ML technologies.
No.
The device is described as a repair kit for endotracheal or tracheostomy pilot tubes, intended to maintain the integrity of an existing medical device, rather than directly treating a medical condition or disease itself.
No
Explanation: The device is a repair kit for endotracheal/tracheostomy tubes. Its purpose is to restore the integrity of a damaged pilot tube, allowing the cuff to be re-inflated, rather than diagnosing a condition.
No
The device description clearly outlines physical components: a swaged needle, micro-bore tubing, a catheter with Luer-Lock fitting, and a syringe. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The BE 409 Pilot Tube Repair Kit is a mechanical device used to repair a damaged pilot tube on an endotracheal or tracheostomy tube. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to restore the functionality of a medical device (the endotracheal/tracheostomy tube) by repairing a physical component.
The description clearly indicates a device used for a physical repair procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
Product codes
BSK
Device Description
The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
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.
No changes are being made to the device, thus no Predicate Device is listed in this summary.
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
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).
0
JAN 2 6 2012
Section 5 - 510(k) Summary Special 510 (k) Submission Page 1 of 2
Image /page/0/Picture/3 description: The image shows the logo for Instrumentation Industries, Inc. The logo includes a stylized graphic to the left of the company name. Below the company name is the tagline "We make Respiratory Care Work!"
。
. . .----
2990 Industrial Boulevard . Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
Date Prepared: 12/9/2011 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
SPECIAL 510(k) SUMMARY for the BE 409 Pilot Tube Repair Kit
| Trade Name | BE 409 Pilot Tube Repair Kit |
|---|---|
| Common | |
| Name | Pilot Tube Repair Kit |
| Classification | |
| Name | Inflatable Tracheal Tube Cuff, Accessory to |
| Regulation | 21 CFR 868.5750 |
| Purpose of | |
| 510(k) | |
| submission | The BE 409 Pilot Tube Repair Kit is used to repair an endotracheal or |
| tracheostomy pilot tube that no longer maintains cuff inflation pressure. To | |
| make the repair, the leaking pilot tube is cut and the needle of the BE 409 is | |
| inserted into the cut end of the pilot tube. A syringe is then attached to the | |
| inflation port of the BE 409 and the cuff is re-inflated. | |
| The BE 409 Pilot Tube Repair Kit, (K973755), has been sold into commerce | |
| since its approval in December, 1997, but it never included the syringe that is | |
| needed to complete the re-inflation of a repaired cuff. Instrumentation | |
| Industries, Inc. wishes to correct this oversight and requests permission to add | |
| one 10cc syringe (without needle) to each assembled BE 409 Pilot Tube | |
| Repair Kit. | |
| Additionally we request permission to change the User Instruction sheet for | |
| the BE 409 to update our company information as well as to make some minor | |
| changes within the User information. | |
| Predicate | |
| Device | No changes are being made to the device, thus no Predicate Device is listed in |
| this summary. |
1
Section 5 – 510(k) Summary
Special 510 (k) Submission Page 2 of 2 .
| Device Description | The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter. |
|---|---|
| Intended Use of the Device | When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube. |
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use. |
| Technological Characteristics | The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package. |
| Performance | Use of a BE 409 Pilot Tube Repair Kit assists a health professional in safely repairing an endotracheal or tracheostomy tube that no longer maintains cuff inflation pressure due to a leaky pilot line, thus reducing the need to re-intubate the patient. |
.. . ........
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a single snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Doris F. Walter Regulatory Affairs. Ouality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Park Bethel Park, Pennsylvania 15102
JAN 2 6 2012
Re: K113644
Trade/Device Name: BE 409 Pilot Tube Repair Kit Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: January 5, 2012 Received: January 6, 2012
Dear Ms. Walter:
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.
3
Page 2 - Ms. Walter
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance 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,
Q. for Anny D. Watson:
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Section 4 - Indications for Use Special 510(k) Submission Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name:
BE 409 Pilot Tube Repair Kit
Statement of Indications for Use:
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
Prescription Use ﮯ (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z. Schutk
(Division Sign-Off) ·Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: